Commission européenne, DG COMP MERGER REGISTRY, 1049 Bruxelles, BELGIQUE  
Europese Commissie, DG COMP MERGER REGISTRY, 1049 Brussel,   BELGIË  
 
Tel: +32 229 -91111. Fax: +32 229 -64301. E -mail: COMP -MERGER -REGISTRY@ec.europa.eu .  EUROPEAN COMMISSION  
Brussels, 29.7.2019  
C(2019 ) 5799 final  
PUBLIC VERSION  
 
To the notifying p arty 
Subject : M.9294 – BMS/Celgene  
Commission decision pursuant to Article 6(1)(b) of Council Regulation 
No 139/20041 and Article 57 of the Agreement on the European Economic 
Area2 
Dear Sir or Madam,  
(1) On 24 June 2019, the European Commission received a notification of a proposed 
concentration pursuant to Article 4 of the Merger Regulation by which Bristol -
Myers Squibb Company (“BMS”, United States) will acquire sole control of 
Celgene Corporation (“Celgene”, United States). In this Decision, BMS is referred 
to as the “Notifying Party”. Together, BMS and Celgene are referred to as the 
“Parties”.  
1. THE PARTIES AND THE O PERATION  
(2) BMS  is a g lobal pharmaceutical company headquartered in the United States. BMS 
is engaged in the development and commercialisation of innovative medicines in 
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the “Merger Regulation”). With effect from 1 .12.2009,  the Treaty on the 
Functioning of the European Union (“TFEU”) has introduced c ertain changes, such as the replacement of 
“Community” by “Union” and “common market” by “internal market”. The terminology of the TFEU 
will be used throughout this decision.   
2  OJ L 1, 3.1.1994, p. 3 (the “EEA Agreement”).  
In the published version of this decision, 
some information has been omitted 
pursuant to Article 17(2) of Council 
Regulation (EC) No 139/2004 concerning 
non-disclosure of business secrets and other  
confidential information. The omissions are 
shown thus […] . Where possible the 
information omitted has been replaced by 
ranges of figures or a general description.  
 
 
2 four main therapeutic areas: oncology , autoimmune diseases , cardiovascular 
diseases , and fibrotic diseases.  
(3) Celgene  is a global pharmaceutical company headquartered in the United States. 
Celgene is engaged primarily in the development and commercialisation of 
innovative therapies in oncology and autoimmune diseases.  
(4) On 2 January 2019, the Parties signed a Merg er Agreement pursuant to which BMS 
will acquire Celgene in a cash and stock transaction with an equity value of 
approximately USD 74  000 million (approximately EUR 62  700 million) (the 
“Transaction”). Upon closing of the Transaction, BMS will acquire sole control over 
Celgene.  
(5) The Transaction would therefore give rise to a concentration within the meaning of 
Article 3(1)(b) of the Merger Regulation.  
2. EU DIMENSION  
(6) The undertakings concerned have a combined aggregate worldwide turnover of more 
than EUR 5  000 million3 in 2018  (BMS: EUR 19  104 million; Celgene: EUR 12  939 
million). Each of them has an EU -wide turnover in excess of EUR 250 million  in 
2018  (BMS: […]; Celgene: […]), but they do not achieve more than two -thirds of 
their aggregate EU -wide turnover wi thin one and the same Member State.  
(7) The Transaction therefore has an EU dimension within the meaning of Article 1(2) 
of the Merger Regulation.  
3. FRAMEWORK FOR THE COMMISSION ’S COMPETITIVE ASSESSMENT  
3.1. General considerations on market definition  
3.1.1.  Relevant prod uct market  
(8) When defining relevant markets in past decisions dealing with finished dose 
pharmaceutical products,4 the Commission based its assessment on the following 
general approach.5  
                                                 
3  Turnover calculated in accor dance with Article 5 of the Merger Regulation and the Commission 
Consolidated Jurisdictional Notice (OJ C 95, 16.4.2008, p. 1).  
4  Finished dose pharmaceuticals (“FDPs”) refer to the finished dosage form of pharmaceutical products, 
which, in other words, a re ready to be used by customers. FDPs contain (i) an active pharmaceutical 
ingredient (or “API”, which correspond to the component present within the product that provides the 
pharmacological action in the body, e.g. acetyl salicylic  acid in an aspirin ta blet), or a combination of 
APIs and (ii) other excipients.  
5  See, for example, cases M.8974 – Procter & Gamble / Merck Consumer Health Business, decisi on of 
27.8.2018; M.7919 – Sanofi/Boehringer Ingelheim Consumer healthcare Business, decision of 4.8.2016; 
M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings, decision of 5.8.2013; 
M.5778 – Novartis/Alcon, decision of 9.8.2010; M.7276  – GlaxoSmithKline/ Novartis Vaccines Business 
 
 
 
3 (9) The Commission noted that medicines may be subdivided into therapeutic classes by 
reference to the Anatomical Therapeutic Classification (“ATC”), devised by the 
European  Pharmaceutical Marketing Research Association (“EphMRA”) and 
maintained by EphMRA and IQVIA, formerly known as Intercontinental Medical 
Statistics (“IMS”).  
(10) The ATC system is a hierarchical and coded four -level system, which classifies 
medicinal products  by class according to their indication, therapeutic use, 
composition, and mode of action  (“MoA”) . In the first and broadest level (ATC 1), 
medicinal products are divided into the 16 anatomical main groups. The second level 
(ATC 2) is either a pharmacological or therapeutic group. The third level (ATC 3) 
further groups medicinal products by th eir specific therapeutic indications. Finally, 
the ATC 4 level is generally the most detailed one (not available for all ATC 3) and 
refers for instance to the MoA  or any other subdivision of the relevant products.  
(11) The Commission has often referred to the third level (ATC 3) as the starting point 
for defining the relevant product market. However, in a number of cases, the 
Commission  found that the ATC 3 level classification did not yield the appropriate 
market definition within the meaning of the Commission  Notice on the Definition of 
the Relevant Market.6 In particular, the Commission has considered in previous 
decisions plausible product markets  at the ATC 4 level, at a level of a molecule or a 
group of molecules that are considered interchangeable so as t o exercise competitive 
pressure on one another.7 
(12) The Commission has also envisaged the possibility of defining the market by 
reference to the disease (and its degree of severity). For instance, in oncology, the 
Commission took into consideration the type o f cancer, its location and whether the 
cancer is in an initial or an advanced stage.8 Similarly, in autoimmune disease s, the 
Commission has typically identified relevant product markets by reference to 
indications.9  
(13) In its past decisional practice, the Co mmission has also considered relevant market 
segmentations  based on (i) the types of treatment ( e.g. chemotherapy, targeted 
therapies and immunotherapies in oncology;10 conventional and biologic treatments 
                                                                                                                                                      
(Excl. Influenza) / Novartis Consumer Health Business, decision of 28. 1.2015;  M.5865  – Teva / 
Ratiopharm, decision of 3.8.2010; and M.8889  – Teva / PGT OTC , decision of 29. 1.2010.  
6  OJ C 372, 9.12.1997, p . 5.  
7  See case M.9274 – GSK/Pfizer Consumer Healthcare Business , decision of 10. 7.2019, recital 15 and case 
M.7275 - Novartis/GSK Oncology , decision of 28. 1.2015, recitals 207 and 216.  
8  See case M.5476 - Pfizer/Wyeth , decision of 17. 7.2009, recitals 21 -26 (renal cell carcinoma).  
9  See case M.8955 - Takeda/Shire , decision of 20.11.2018, recital 49 (ulcerative colitis and Crohn’s 
disease).  
10  See case M.7275 - Novartis/GSK Oncology , decision of 28.11.2015, recital 31. The Commission found 
that, given the different ways in which they treat cancer, chemotherapies, targeted therapies, and 
immunotherapie s may not be substitutable and  they are most often used as complementary treatments. 
For instance, chemotherapies and targeted therapies attack cancerous cells directly, whereas 
immunotherapies work to enable the patient’s own immune system to attack the c ancer. Targeted 
therapies are designed to interact with a specific target associated with cancer, whereas chemotherapies 
are typically identified because they kill rapidly dividing cells. Targeted therapies and immunotherapies 
are also typically more expen sive than chemotherapies. Given their novelty, targeted therapies and 
immunotherapies are generally still under patent, while many chemotherapy drugs are off patent.  
 
 
4 in autoimmune diseases),11 (ii) the line of treatmen t,12 (iii) the  MoA ,13 and (iv) the 
mode of delivery ( “MoD”, e.g. oral, intravenous, intramuscular , and subcutaneous 
injections).14  
(14) As regards pipeline products, the Commission has in previous decisions considered 
market definitions based on the indication, the mode of action, and, where relevant, 
the line of treatment, but ultimately left open the exact delineation of the market.15 
The Commission added that when research and development (“R&D”) activities are 
assessed in terms of importance for future markets , the product market definition can 
be left open, reflecting the intrinsic uncertainty in analysing products that do not 
exist yet.16  
(15) The Commission will analyse in Section 4 below the relevance of these distinctions 
for the relevant product market definit ion in the present case.  
3.1.2.  Relevant geographic market  
(16) The Commission has consistently considered that the markets for FDP products are 
national in scope, in particular in view of the national regulatory and reimbursement 
schemes and the fact that competitio n between pharmaceutical firms still 
predominantly takes place at a national level.17 For pipeline products, the 
Commission has considered the geographic scope of the market to be at least EEA -
wide.18  
(17) The Commission will analyse in Section 4 below the relev ance of these precedents 
for the relevant geographic market definition in the present case.  
3.2. General approach to competitive assessment of horizontal effects of the 
Transaction  
(18) Article 2 of the Merger Regulation requires the Commission to examine whether 
notified concentrations are compatible with the internal market, by assessing 
whether they would significantly impede effective competition in the internal market 
or in a substantial part of it, in particular, as a result of the creation or strengthening 
of a dominant position or the removal of a significant competitive constraint.  
(19) In addition, Article 57(1) of the EEA Agreement requires the Commission to 
examine whether notified concentrations are compatible with the functioning of the 
                                                 
11  See case M.8955 - Takeda/Shire , decision of 20.11.2018, recitals 17 -25. 
12  See case M.7 275 - Novartis/GSK Oncology , decision of 28. 1.2015, recitals 33 and 143. Line of treatment 
refers to the setting for which a specific drug is indicated.  For example, a drug indicated for second -line of 
treatment should be used only after another therapy ( the first -line of treatment) has proven ineffective or if 
this other therapy cannot be prescribed altogether to a specific patient.  
13  See case M.8955 - Takeda/Shire , decision of 20.11.2018, recitals 31 -49. 
14  See case M.8401 - J&J/Actelion , decision of 9.06.2017, recital 60.  
15  See cases M.3354 - Sanofi -Synthelabo/Aventis , decision of 26. 4.2004, recital 57 ; and M.7275 - 
Novartis/GSK Oncology , decision of 28. 1.2015, recitals 85 -94. 
16  Case M.7275 - Novartis/GSK Oncology , decision of 28. 1.2015, recital 26.  
17  See cases M.8955 - Takeda/Shire , decision of 20.11.2018, recital 56 and M.8401 - J&J/Actelion , decision 
of 9.06.2017, recital 66.  
18  See most recently, case M.8955 - Takeda/Shire , decision of 20.11.2018, recital 56.  
 
 
5 EEA Agreement, by as sessing whether they would create or strengthen a dominant 
position as a result of which effective competition would be significantly impeded 
within the EEA territory or a substantial part of it.  
(20) In this framework, “competition” is understood to mean produ ct and price 
competition (actual or potential), as well as innovation competition, where the 
Commission assesses in particular potential horizontal non -coordinated effects.19 
The Commission considers that a concentration may not only affect competition in 
existing markets, but also competition in innovation and new product markets.20 This 
may be the case when a concentration concerns entities currently developing new 
products or technologies which either may one day replace existing ones or which 
are being de veloped for a new intended use and will therefore not replace existing 
products but create a completely new demand.21  
(21) In the pharmaceutical industry, the process of innovation is structured in such a way 
that it is typically possible at an early stage of c linical trials to identify competing 
research programmes (or “pipeline” programmes).22 Competing pipeline 
programmes can be defined as R&D efforts aimed at developing substitutable 
products and having similar timing. The timing of a research programme shoul d be 
assessed by reference to the stage of the on -going preclinical or clinical trials.23  
(22) In line with the past decisional practice in the pharmaceutical sector24 and the 
Commission’s decisions in Dow/Dupon t and Bayer/Monsanto ,25 the Commission has 
taken int o account a four -layer competitive assessment framework, which 
corresponds to the overlaps between the parties’ activities in terms of:  
(a) Actual (product and price) competition, assessing the overlaps between the 
parties' existing (marketed) products;26 
                                                 
19  See case M.8084 - Bayer/Monsanto , decision of 21. 3.2018, recital 48. The remainder of this Section 
focuses on horizontal, non -coordinated effects, as the Transaction does not give rise to non -horizontal 
overlaps or coordinated effects. Regarding the framework of assessment of horizontal n on-coordinated 
effects, see the Commission Guidelines on the assessment of horizontal mergers under the Merger 
Regulation (the “Horizontal Merger Guidelines”) OJ C 31, 5.2.2004, p. 5, paragraphs 24 -38.  
20  Horizontal Merger Guidelines, paragraph 8.  
21  Horizontal Merger Guidelines, paragraph 38.  
22  In the pharmaceutical industry, pipeline drugs go through several development stages, starting with 
preclinical trials in laboratories and on animals, and later moving on to clinical trials in humans (so called 
“Phase I”, “Phase II” and “Phase III” clinical trials which are detailed in fn. 27 below).  Clinical trials in 
humans are strictly regulated in order  to ensure the protection of trial subjects and the credibility of the 
results. In most jurisdictions, before a clinical trial can start, the sponsor must typically apply for and 
receive clinical trial authorisation from the competent authorities. The clin ical trial is also typically 
registered on public databases. All clinical trial protocols conducted in Europe are identified at European 
level with a unique number and registered in the European Clinical Trials Database (EudraCT database). 
ClinicalTrials.g ov is a web -based resource that provides easy access to information on publicly and 
privately supported clinical studies conducted worldwide. Unlike clinical trials, preclinical trials are not 
registered and their existence is not always publicly disclosed .   
23  See case M.7275 - Novartis/GSK Oncology , decision of 28. 1.2015, recital 90.  
24  See case M.7275 - Novartis/GSK Oncology , decision of 28. 1.2015, recitals 89 -90. 
25  See cases M.7932 - Dow/Dupont , decision of  27.3.2017, recitals 272 -302 and M.8084 - Bayer/Monsanto , 
decision of 21. 3.2018, recitals 48 -54. 
26  The Transaction does not give rise to horizontally affected markets involving existing (marketed) 
products in any EEA countries.  
 
 
6 (b) Potential (product and price) competition, assessing the overlaps (i) between 
the parties’ existing (marketed) and pipeline products at advanced stages of 
development  and (ii) between the parties’ pipeline products at advanced stages 
of development. For pharma ceutical products, the Commission in principle 
considers programmes in Phase II and III clinical trials as being at an advanced 
stage of development;27 
(c) Innovation competition in relation to the parties’ ongoing pipeline products, 
assessing the risk of significant loss of innovation competition resulting from 
the discontinuation, delay or redirection of the overlapping pipelines 
(including early stage pipelines); and  
(d) Innovation competition in relation to the capability to innovate in certain 
innovation s paces, assessing the risk of a significant loss of innovation 
competition resulting from a structural reduction of the overall level of 
innovation.28 
(23) The Commission will analyse the overlaps between the activities of the Parties 
against this framework  in Se ction 4 below.  
                                                 
27  The phases of clinical development for pipeline products can be de scribed as follows.  Phase I  starts with 
the initial administration of a new drug into humans , with trials carried out on a small number of people 
(e.g. in oncology, the sample size is usually in the low tens). The focus of Phase I trials is to confirm that  
the drug is safe to use in humans and to identify the appropriate dosage and exposure -response 
relationship. They  typically involve one or a combination of the following aspects: estimation of initial 
safety and tolerability, characterisation of a drug's absorption, distribution, metabolism, and excretion, 
and early measurement of drug activity. Phase II  usually starts with the initiation of studies to explore 
therapeutic efficacy in patients. Studies in Phase II are typically conducted on a small group of  patients 
(generally around 20 to 50 up to some hundreds per cohort or treatment arm)  that are selected based on 
stricter criteria for indications . Phase III  trials aim  to demonstrate or confirm therapeutic benefit  in a 
larger group of patients (Phase III trials will typically have hundreds of patients and may have over a 
thousand, for example for autoimmune diseases) . Studies in Phase III are designed to confirm the 
preliminary evidence accumulated in Phase II that a drug is safe and effective for use in t he intended 
indication and recipient population. Usually, Phase III trials will involve a comparison of the 
investigational agent with a placebo or the standard of care therapy. These studies are also intended to 
provide an adequate basis for marketing app roval. Phase IV  begins after drug approval  to monitor 
possible adverse reactions and/or new side effects over time .  See Case M.8401 - J&J/Actelion , decision 
of 9.06.2017, footnote 6.  
28  In the present case, the Commission considers that the Transaction i s unlikely to raise competition 
concerns in this respect given the very large number of R&D organisations competing at global level 
(e.g. pharmaceutical and biotechnology companies, university research programmes) in the overlapping 
therapeutic spaces, whi ch are characterised by intensive R&D. For instance, in oncology, over 700 
companies are active in late stage R&D, including at least 14 large biopharmaceutical companies (see 
IQVIA - Global Oncology trends 2018 report, p. 42). In autoimmune diseases, a re port of the 
Pharmaceutical Research and Manufacturers of America (“PhRMA”) indicated that in 2016, there were 
311 medicines and vaccines in development by more than 150  companies for patients with autoimmune 
diseases (see http://phrma -docs.phrma.org/sites/default/files/pdf/medicines -in-development -report -
autoimmune -diseases.pdf  and http://phrma.org/si tes/default/files/pdf/medicines -in-development -drug-
list-autoimmune -diseases.pdf ).  
 
 
7 4. COMPETITIVE ASSESSMENT  
(24) BMS and Celgene are both active in the development and commerciali sation of 
pharmaceutical  products. The Parties’ activities give rise to limited horizontal 
overlaps in the EEA in relation to marketed and/or pipeline treatments in 
autoimmune diseases  (Section 4.1) , fibrotic diseases  (Section 4.2) , and oncology  
(Section 4.3).  
4.1. Autoimmune diseases 
4.1.1. Introduction 
(25) Autoimmune diseases result from a dysfunction of the immune system in which the 
body attacks its own organs, tissues, and cells. Autoimmune diseases can target 
almost any part of the body. Autoimmune diseases vary according to the part of th e 
body being targeted by the immune system, and include psoriasis (“PsO”), psoriatic 
arthritis (“PsA”), inflammatory bowel diseases (“IBD”) including ulcerative colitis 
(“UC”) and Crohn’s disease (“CD”), and systemic lupus erythematotus (“Lupus” or 
“SLE”).  Autoimmune diseases can range in severity, from mild to severe cases, with 
the gravity of the disease often increasing over time. They affect approximately 5 -
10% of the global population.29  
(26) In the autoimmune therapeutic space, the Parties activities overl ap with respect to 
the following indications: PsO (Section 4.1.2), PsA (Section 4.1.3), IBD (Section 
4.1.4) and Lupus (Section 4.1.5).  
4.1.2. Treatments for Psoriasis 
(27) Psoriasis (“PsO”) is a chronic  inflammatory disease, which causes an exaggerated 
reaction of the  natural  repair and defence mechanisms of the body. This exaggerated 
reaction causes red, scaly patches of skin to appear.  
(28) Patients can suffer from PsO of different gravity, ranging from mild to severe. PsO 
severity is typically  classified with reference30 to the body surface area (“BSA”)31 
percentage that is affected by the disease; the Psoriasis area and severity index 
(“PASI”);32 and the dermatology life quality index (“DLQI”).33  
                                                 
29  See notably the report summarising the presentations and discussions of a workshop on autoimmune 
diseases held at the European Parliament on 25.9.2017: 
http://www.europarl.europa.eu/cmsdata/133620/ENVI%202017-
09%20WS%20Autoimmune%20diseases%20%20PE%20614.174%20(Publication).pdf . 
30  See EMA, Committee for Medicinal Products for Human Use, Guidelines on Clinical Investigation of 
Medicinal Products for the Treatment of Psoriasis, 2004, p. 6, available at 
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-
products-indicated-treatment-psoriasis en.pdf .  
31  BSA is a percentage indicating the area affected by the disease compared to the whole body surface.  
32  PASI combines the assessment of the severity of lesions and the area affected into a single score in the 
range 0 (no disease) to 72 (maximal disease) .   
33  DLQI is based o n a ten -question questionnaire used to measure the impact of the skin disease on the 
quality of life of an affected person. The DLQI score ranges from 0 to 30.  
 
 
8 (29) In Europe, it is generally considered that a patient can be considered as suf fering 
from mild PsO when he/she has a BSA of 10% or less; a PASI score of 10 or less; 
and a DLQI of 10 or higher. A patient is considered as suffering from moderate -to-
severe PsO when he/she has a BSA exceeding 10%; a PASI score higher than 10; 
and a DLQI  lower than 10.34 
(30) Treatment for moderate -to-severe PsO is typically undertaken in steps through 
consecutive lines of treatment, matching the severity of the disease and the patient’s 
symptoms.35 This means that a patient has to first be prescribed with drugs  from the 
earlier line of treatment category and if these do not work, the patient can be moved 
to a drug from a subsequent line of treatment category.  
4.1.2.1.  Market definition  
(A) Relevant product market  
(A.i) Commission’s Precedents  
(31) The Commission has not assessed in de tail the relevant product market definition for 
PsO treatments  in the past.36  
(A.ii) The Parties’ view and Commission’s assessment  
Segmentation by reference to the severity of the disease  
(32) The Parties submitted that treatments for moderate -to-severe PsO and treatments for 
mild PsO belong to separate relevant product markets. In any event, the Parties 
argued that this question could be left open because the Transaction would not raise 
competi tion concerns even under the narrower of the two market segmentations, i.e. 
treatments for moderate -to-severe PsO.37  
(33) The market investigation suggested that there is a separate relevant product market 
for treatments for moderate -to-severe PsO. All the comp etitors and  the key opinion 
leaders (“KOLs”)38 who responded to the market investigation indicated that 
Celgene’s Otezla and its competing products target the treatment of  moderate -to-
                                                 
34  See notably EMA, Committee for Medicinal Products for Human Use, Guidelines on Clinical 
Investigation of Medicinal Products for the Treatment of Psoriasis, 2004,  p. 6. See also Definition of 
treatment goals for moderate to severe psoriasis: a European consensus, Arch Dermatol Res. 2011 Jan; 
303(1) 1 -10.  
35  The main guidelines in the EEA for the treatment of PsO are the European S3 Guidelines on the systemic 
treatment of PsO (the “S3 Guidelines”) from the European Dermatology Forum in cooperation with the 
European Academy of Dermatology and Venereology and the International Psoriasis Council . 
 36  In its decisional practice, the Commission considered topical anti -PsO products (skin creams available 
over the counter (“OTC”) or by prescription). See Case M.5530 - GlaxoSmithKline/Stiefel Laboratories, 
decision of  17.7.2009, recital 20. In that decision , the Commission has not considered any products 
comparable to the  products and pipeline projects of the Parties for the treatment of PsO.  
37  Form CO , paragraphs 245 -246. 
38  The KOLs contacted during the Commission's market investigation are leading exper ts in their field of 
expertise, and recognised figures in the European medical community.  
 
 
9 severe PsO39 and can usually be prescribe for this indication alone. KOLs also 
recalled that the available guidelines in the EEA specifically concern treatments for 
moderate -to-severe PsO.40 
Segmentation by line of treatment  
(34) The Parties submitted that in Europe, lines of treatment for PsO are not as well 
defined as in other diseases ( e.g. in oncology). The Parties added that references to 
different lines of treatment are rare in clinical guidelines for PsO.41 The Parties 
suggested that the issue could ultimately be left open because the Transaction would 
not raise competition concerns even if one looks at moderate -to-severe PsO 
treatments divided by lines of treatment.42  
(35) The majority of competitors  who responded to the market investigation  
acknowledged a three -fold categori sation of moderate -to-severe PsO treatments by 
line of treatment.43 According to these respondents, (i) first -line treatments for 
moderate -to-severe PsO include anti -inflammatory drugs, topical treatments, and 
phototherapies; (ii) second -line treatments include conventional systemic therapies 
(e.g. methoxetrate  or cyclosporine); and (iii) third -line treatments consist of 
biologics and small -molecule drugs.44 The vast majority of KOLs also agreed45 that 
the treatment algorithm for PsO is also organised  in lines of treatment , which 
include, after the use of topical treatments, (i) conventional systemic therapies and 
(ii) biologics and small -molecule drugs. Certain competitors and KOLs noted that 
the boundaries between the different lines of treatment are blurred,46 however, none 
of the respondents questioned the fact that biologics and small -molecule drugs are 
offered as the last line of treatment.  
(36) In any event, the exact relevant product market definition can be left open since the 
Transaction does not give rise to serious doubts as to its compatibility with the 
internal market and the functioning of the EEA Agreement even if a separate market 
were defined for the last line (third -line) treatments for moderate -to-severe PsO.  
                                                 
39  Replies to questions 10, 12, 13, 15 -18 – Questionnaire to competitors – Autoimmune diseases ; Non-
confidential minutes of a conference call with a KOL, 21 .5.2019 ; Non-confidential minutes of a 
conference call with a KOL, 16 .5.2019 ; Non-confidential minutes of a conference call with a KOL, 
2.5.2019, Non -confidential minutes of a conference call with a KOL, 30 .4.2019 ; Non-confidential 
minutes of a conference call with a KOL, 29 .4.2019 ; Non-confidential minutes of a conference call with 
competitor, 24 .5.2019.  
40  Non-confidential minutes of a conference call with a KOL, 16 .5.2019 ; Non-confidential minutes of a 
conferenc e call with a KOL, 2 .5.2019 ; Non-confidential minutes of a conference call with a KOL, 
30.4.2019.  
41  See A Nast et al, European S3 -Guideline on the systemic treatment of psoriasis vulgaris –Update 
Apremilast and Secukinumab –EDF in cooperation with EADV and IPC, J Eur Acad Dermatol Venereol. 
2017 Dec;  31(12):1951 -1963.  
42  Form CO, paragraph 256.  
43  See Replies to question 5 – Questionnaire to competitors – Autoimmune diseases.  
44  ‘Small molecule’ drugs are typically synthetised via chemical processes, and constitute the majority of 
drugs in use. Conversely, ‘large molecule’ drugs are typically produced through biologic processes like 
cell culture (these include many vaccines and monoclonal antibodies).  
45  See Non -confidential minut es of a conference call with a KOL, 30 .4.2019, Non -confidential minutes of a 
conference call with a KOL, 29 .4.2019, Non -confidential minutes of a conference call with a KOL, 
24.4.2019.  
46  See Replies to question 5 – Questionnaire to competitors – Autoimmu ne diseases and Non-confidential 
minutes of a conference call with a KOL, 29 .4.2019.  
 
 
10 Segmentation by mode of action  
(37) The Parties suggested that different treatments for moderate -to-severe PsO compete 
with each other, regardless of their MoA. The most important factors for a physician 
choosing a treatment against an autoimmune disease are efficacy and safety. The 
physician will consider a wide range of MoA  taking into account the specific needs 
of the patient.47 The Parties suggested that the issue could ultimately be left open 
because the Transaction would not raise competition concerns even if one looks at 
moderate -to-severe PsO treatments sub -segmented by  MoA.  
(38) The majority of competitors and KOLs who responded to the market investigation 
also suggested that treatments for moderate -to-severe PsO compete with each other, 
regardless of their MoA.48 As one KOL put it, “ what matters for doctors when 
choosing a P sO treatment is the drug’s efficacy as well as its safety. The drug’s 
mode of action is less important .”49 When asked to compare biologicals and small -
molecule drugs, the majority of competitors confirmed that “ all available third line 
treatments compete wi th one another […] regardless of mode of action ”.50 When 
asked to identify the closest competitor to a product or a pipeline project, the vast 
majority of competitors indicated products and pipeline projects with different 
MoA.51  
(39) In particular, in light of the Parties’ overlapping products, the Commission 
investigated whether there is a separate relevant product market for moderate -to-
severe PsO treatments with a specific MoA, namely tyrosine kinase 2 (“TYK2”) 
inhibition. TYK2 is an enzyme involved in the si gnalling of pro -inflammatory 
cytokines such as interleukins 12 and 23 and interferon I responses. A TYK2 
inhibitor specifically blocks TYK2 and therefore the creation of these pro -
inflammatory cytokines, which drive PsO and other autoimmune diseases. TYK2 
inhibitors seek to block specifically the TYK2 enzyme and not other kinases, which 
makes for a safer drug. TYK2 inhibitors are still under development today and none 
of them has been launched at this stage.  
(40) The market investigation suggested that TYK2 inh ibitors should not constitute a 
separate relevant product market. The majority of competitors and KOLs confirmed 
that TYK2 inhibitors will compete with other treatments for moderate -to-severe 
PsO, regardless of the MoA.52 For example, most competitors expec t that TYK2 
inhibitors (if/when launched) would have comparable efficacy and safety to 
biologics such as interleukin 12/23 (“IL -12/23”) inhibitors.53 Yet, a small minority 
                                                 
47  Form CO, paragraph 281.  
48  See Replies to questions 11 and 13 – Questionnaire to competitors – Autoimmune diseases.  
49  See Non -confidential minutes of a conference call with a KOL, 21 .5.2019. Several other KOLs stated 
that products of different MoA compete with each other as treatments for moderate -to-severe PsO. See 
Non-confidential minutes of a conference call with a KOL, 30 .4.2019, Non -confidential minutes of a 
conference call with a KOL, 29 .4.2019, Non -confidential minutes of a conference call with a KOL, 
24.4.2019.  
50  See Replies to question 13 – Questionnaire to competitors – Autoimmune diseases.  
51  See Replies to question 9 – Questionnaire to competitors – Autoimmune diseases.  
52  See Replies to question 22 – Questionnaire to competitors – Autoimmune diseases. See also Non-
confidential minutes of a conference call with a KOL, 24 .4.2019 ; Non-confidential minutes of a 
conference call with a KOL, 2 9.4.2019 ; and Non-confidential minutes of a conference call with a KOL, 
2.5.2019 .  
53  See Replies to questions 24 and 25 – Questionnaire to competitors – Autoimmune diseases.  
 
 
11 of competitors stated that TYK2 inhibitors have a unique profile of high efficacy and  
safety and are bound to disrupt the market of moderate -to-severe PsO treatments 
when they are marketed.54  
(41) In any event, the exact relevant product market definition can be left open since the 
Transaction does not give rise to serious doubts as to its comp atibility with the 
internal market and the functioning of the EEA Agreement even if a separate market 
were defined for TYK2 inhibitor treatments for moderate -to-severe PsO.  
(42) According to two competitors,  which constitutes a small minority of all the 
respon dents,  the possible market for TYK2 inhibitor treatments for PsO should be 
segmented even further. TYK2 inhibition can be achieved with two different 
mechanisms: an orthosteric mechanism (where the drug docks on the active site of 
the TYK2 enzyme) and an a llosteric mechanism (where the drug docks on the 
regulatory (non -active) sub -unit of the enzyme). According to the two competitors, 
allosteric TYK2 inhibitors are a distinct and unique class of treatments for 
autoimmune diseases because they are particular ly selective and this ensures a good 
safety profile and high efficacy. The market investigation did not support this claim . 
Indeed, the majority of KOLs stated that allosteric mechanisms are not unique and 
orthosteric TYK2 inhibitors could possibly achieve  comparable levels of efficacy 
and safety.55 One KOL  submitted that “ there is no evidence that an allosteric action 
mechanism leads to any benefits for the patient (in terms of efficacy or safety). Nor 
is an allosteric mechanism necessary to target a TYK2 ”,56 while another KOL 
added: “ increased selectivity  […] does not necessarily characteri [s]e every inhibitor 
with an allosteric mechanism ”.57 Similarly, a competitor who is currently developing 
a TYK2 inhibitor stated that “ overall, the use of an allosteric or  an orthosteric 
mechanism for TYK 2 inhibition does not make a difference for the patient (i.e. in 
terms of efficacy or safety). […] [A]n allosteric mechanism for TYK 2 inhibition is 
not necessarily more targeted than an orthosteric mechanism and may give r ise to 
similar side effects. ”58 For this reason, the Commission conclude s that, at this point 
in time and on the basis of the elements at its disposal,  no separate relevant product 
market can be defined for allosteric TYK2 inhibitor treatments for moderate -to-
severe PsO.  
Segmentation by mode of delivery  
(43) The Parties also suggested that different treatments for moderate -to-severe PsO 
compete with each other, regardless of their MoD. The most important factors for a 
physician choosing a treatment against an autoimmune disease are efficacy and 
safety. The physician will consider a wide range of MoDs taking into account the 
specific needs of the patient.59 The Parties suggested that the issue could ultimately 
be left open because the Transaction would not raise competition concerns even if 
one looks at moderate -to-severe PsO treatments sub -segmented by  MoD.  
                                                 
54  See Replies to questions 24 and 25 – Questionnaire to competitors – Autoimmune diseases.  
55  See Non -confidential minutes of conference call with KOL, 24 .4.2019, Non -confidential minutes of 
conference call with KOL, 24 .4.2019, Non -confidential minutes of conference call with KOL, 24 .4.2019, 
Non-confidential minutes of conference call with KOL, 16 .5.2019.  
56  Non-confidential minutes of conference call with KOL, 24 .4.2019 .  
57  Non-confidential minutes of conference call with KOL, 16 .5.2019.  
58  Non-confidential minutes of conference call with a competitor, 21 .5.2019.  
59  Form CO, paragraph 281.  
 
 
12 (44) The market investigation was inconclusive on th e question of whether  the market for 
moderate -to-severe PsO treatments should be further sub -segmented based on  the 
MoD, e.g. whether there should be a separate relevant market for oral treatments of 
moderate -to-severe PsO . 
(45) On the one hand, all respondents recogni sed that efficacy and safety of the 
treatment60 (not MoD) are the key parameters driving prescription de cisions.61 The 
majority of competitors and KOLs added that oral products compete with injectable 
drugs (like biologics).62 Many KOLs also indicated that the vast majority of patients 
is open to an injectable product if it would ensure better results.63 Certai n KOLs 
added that in terms of adherence, oral and injectable treatments for PsO are not 
significantly different.64 An injectable treatment, e.g. once every 3 -4 weeks is 
comparable in terms of adherence and convenience with an oral drug that the patient 
need s to take twice per day.65  
(46) On the other hand, the majority of competitors confirmed that the MoD plays an 
important role to determine whether different types of moderate -to-severe PsO 
treatments compete with each other.66 Some respondents added that oral products 
have a unique convenience profile and dermatologists prescribe them for special 
categories of patients, e.g. frequent travellers or patients with needle phobia.67  
(47) In any event, the exact relevant product market de finition can be left open since the 
Transaction does not give rise to serious doubts as to its compatibility with the 
internal market and the functioning of the EEA Agreement even if a separate market 
were defined for oral third -line treatments for moderat e-to-severe PsO.  
                                                 
60  The exact efficacy ( i.e. therapeutic effectiveness) and safety ( i.e. existence or absence of adverse effects) 
profile of a drug depends on its MoA and the disease targeted. Drugs with different MoA may have, in 
some instances and to some extent, similar effic acy and safety profiles.  
61  See Replies to question 11 – Questionnaire to competitors – Autoimmune diseases.  
62  Non-confidential minutes of conference call with KOL, 30 .4.2019, Non -confidential minutes with 
competitor, 21 .5.2019, Replies to questions 9 an d 13 – Questionnaire to competitors – Autoimmune 
diseases.  
63  Non-confidential minutes of conference call with KOL, 30 .4.2019, Non -confidential minutes of 
conference call with KOL, 24 .4.2019, , Non -confidential minutes of conference call with KOL, 
24.4.2019, Non -confidential minutes of conference call with KOL, 16 .5.2019, Non -confidential minutes 
of conference call with KOL, 2 .5.2019.  
64  Non-confidential minutes of conference call with KOL, 16 .5.2019, Non -confidential minutes of 
conference call with KOL, 24.4.2019, Non -confidential minutes of conference call with KOL, 24 .4.2019 . 
65  Non-confidential minutes of conference call with KOL, 24 .4.2019, Non -confidential minutes of 
conference call with KOL, 24 .4.2019. As one competitor put it, “ compliance rates may  not differ too 
much. For injectables you need to visit the doctor’s office, which would improve compliance rates. Tablet 
use is convenient for the end user, in particular if dosing is once -daily. If tablet intake would be more 
that once a day, treatment c ompliance may be negatively impacted”  in Replies to question 14.1 – 
Questionnaire to competitors – Autoimmune diseases.  
66  See Replies to question 14 – Questionnaire to competitors – Autoimmune diseases.  
67 See Replies to question 14.1 – Questionnaire to co mpetitors – Autoimmune diseases, Non-confidential 
minutes of conference call with KOL, 3 .5.2019, Non -confidential minutes of conference call with KOL, 
30.4.2019.  
 
 
13 (B) Relevant geographic market  
(B.i) Commission’s Precedents and the Parties’ View  
(48) The Commission has consistently defined the geographic markets for marketed 
products against autoimmune diseases as being national in scope.68 With respect to 
pipeli ne products, the Commission has consistently held that the geographic market 
is either global or at least EEA -wide.69 
(49) The Parties submitted that they agree with the Commission’s approach to geographic 
market definition.70  
(B.ii) Commission’s assessment  
(50) Nothing in the market investigation suggested that the Commission should depart in 
the present case from its previous practice concerning the geographic market 
definition.  
(51) For the purpose of this Decision, the geographic market for marketed products for 
the treatment of moderate -to-severe PsO should be defined at national level.  
(52) The exact geographic scope of the market for pipeline treatments for moderate -to-
severe PsO can be left open, since the Transaction does not give rise to serious 
doubts as to its c ompatibility with the internal market and the functioning of the 
EEA Agreement even on the basis of the narrowest plausible geographic market 
definition, i.e. at EEA -wide level.  
4.1.2.2.  The Parties’ products  
(53) Parties’ marketed and pipeline drugs for the treatment o f moderate -to-sever e PsO are 
detailed in Table 1 below . 
                                                 
68  See cases M.7339 - AbbVie/Shire , decision of 16.10.2014, recitals 28 -30; M.5865 - Teva/Rat iopharm , 
3.8.2010, recital 83 ; M.3354 - Sanofi -Synthelabo/Aventis , 26.4.2004, recital 117.  
69  See cases M.8955 - Takeda/Shire , decision of 20.11.2018, recital 56 ; M.8401 – J&J/Actelion , decision of 
9.7.2017, recital 31 ; M.7275 – Novartis/GlaxoSmithKline oncology business , recitals 33 and 72 ; M.7872 – 
Novartis / GlaxoSmithKline , recital 29 ; and M.7559 – Pfizer / Hospira , recital 30.  
70  Form CO, paragraph 160.  

 
 
15 (57) Celgene owns an option to acquire the TYK2 inhibitor programme that is developed 
by Nimbus, a US biotech company.76 This programme is currently at preclinical trial 
stage and expected to start the Phase I clinical trials in […]. Nimb us’ programme is 
[…].77 
(58) The Transaction gives rise to overlaps between the marketed (existing) products of 
the Parties and their pipeline products at clinical trial stage in (i) a plausible market 
for third -line treatments for moderate -to-severe PsO and (ii ) a plausible market for 
oral third -line treatments for moderate -to-severe PsO. Taking into account the 
Nimbus preclinical asset that Celgene has an option to acquire, the Transaction gives 
rise to overlaps in the same markets and also in a plausible marke t for TYK2 
inhibitor treatments for moderate -to-severe PsO.78  
4.1.2.3.  Overlaps involving marketed products and pipeline programmes at clinical 
trial stage  
(A) Parties’ views  
(59) The Parties submit that the overlap between Celgene’s marketed drug (Otezla), on 
the one hand,  and BMS’ pipeline products (TYK2 inhibitor and RORγt agonist), on 
the other hand, would not give rise to competition concerns under any market 
delineation for the following reasons. First , Otezla has a limited position in EEA 
markets (with market shares well below 20% in all Member States where it is sold). 
Second , Otezla and each of BMS’ TYK2 inhibitor and RORγt agonist are 
differentiated products (with distinct MoA and efficacy/safety pr ofiles). Third , the 
competitive landscape in moderate -to-severe PsO treatments is crowded, with a large 
number of marketed products currently available on the market in the EEA and 
many pipeline projects under development. Fourth , with respect to BMS’ RORγ t 
agonist programme, the Parties argue that, assuming the clinical trials are successful, 
this Phase I pipeline product would not enter the market for a very long time, by 
which point Otezla will most likely have lost, or be close to losing, exclusivity. 
Finally , the Parties claim that, post -Transaction, the merged entity would have no 
ability and/or no incentive to discontinue (i) the development of BMS’ two pipeline 
projects or (ii) the supply of Otezla.79 
                                                 
76  [In 2017] , Nimbus entered into a warrant -to-acquire agreement with Celgene. Under the terms of this 
agreement, Celgene received an option to acquire Nimbus’ TYK2  inhibitor  programme […].  
77  Nimbus expects to start the Phase I trial […] by the beginning of […].  (see non-confidential minutes of a 
conference call with Nimb us, 13 .5.2019 ). 
78  In a plausible market including all treatments for moderate -to-severe PsO, the Transaction would also give 
rise to a horizontal overlap between the Parties’ activities in France, Italy, and Spain, where BMS markets 
Kenalog and Celgene of fers Otezla. However, this potential marketed -to-marketed overlap does not give 
rise to an affected market. The combined share of the Parties would not exceed 20% in any of these 
countries. Moreover, BMS’ Kenalog and Celgene’s Otezla are highly differentia ted products with (i) 
different ATC3 classifications (D5B (Systemic Anti Psoriasis Products) for Otezla and H2A (Systemic 
Corticosteroids, Plain) for Kenalog); (ii) different MoA (Otezla is a small molecule PDE -4 inhibitor, 
whereas Kenalog is a corticoster oid); and (iii) different uses (Kenalog is used for the short term relief of the 
symptoms of PsO, whereas Otezla is used to address the underlying cause of moderate -to-severe PsO).  
79  See Form CO, Autoimmune Diseases Chapter, paragraphs . 220 and ff.  
 
 
16 (B) Commission’s assessment  
(60) The evidence in the Commis sion’s file generally confirms the Parties’ claim. It  
allows the Commission to exclude serious doubts as to the compatibility of the 
Transaction with the internal market  and the functioning of the EEA Agreement  
resulting from the overlap of the Parties’ ac tivities in third -line moderate -to-severe 
PsO treatments or (more narrowly) in oral third -line moderate -to-severe PsO 
treatments .  
(61) First , the results of the market investigation show that none of the Parties’ drugs is 
or is expected to hold a particularly strong position in the moderate -to-severe PsO 
treatment space:  
- Otezla . Contrary to the US where it is considered a blockbuster,80 Celgene’s drug 
has a limited market position in the EEA. In  a potential market for third -line 
treatment for moderate -to-severe PsO, Otezla’s market share remains modest at 
national level (below 10% in 2018 in all EEA countries  where it was sold).81 
This is mainly due to the fact that , in the EEA, the S3 Guidelines  (and national 
clinical guidelines ) as well as the national reimbursement regimes, restrict the 
use of Otezla for cost -efficiency reasons.82 Otezla is typically prescribed as third -
line treatment ( i.e. after conventional systemic therapies have failed or in case of 
contraindicatio ns) and thus competes with other third -line treatments, including 
biologics  and biosimilars. These are all more efficacious than Otezla and 
physicians in the EEA tend to prefer them . The use of Otezla is even more 
limited in some EEA countries, where natio nal or regional guidelines 
recommend Celgene’s drug to be prescribed after  biologics have failed or in case 
of contraindications.83 During the market investigation, all competitors and 
KOLs consider Otezla’s efficacy to be lower (or much lower) than biologi cs’.84 
Several market participants and KOLs also highlighted potential tolerability 
problems associated to Otezla, in particular gastrointestinal issues, such as 
diarrhoea and nausea, and a risk of depression .85 The above considerations 
explain Otezla’s limi ted market position in the EEA;86 
- BMS TYK2 inhibitor pipeline project (BMS -986165) . Although BMS TYK2 
inhibitor is perceived as a promising drug by several market participants, m ost 
respondents to the market investigation indicated that its efficacy and safety  
                                                 
80  See minutes of the conference call with a KOL dated 29 .4.2019 .  
81  Source: IQVIA. See also Replies to question 10 – Questionnaire to competitors – Autoimmune diseases.  
82  In the US, a large share of health expenditure is covered by private insurances, whereas , in the EEA, 
health expenditure are mostly financed by national public health systems which are under public budget 
constraints. It follows that, in the EEA countries, the level of reimbursement of a therapeutic treatment is 
in general more closely relate d to the cost -effectiveness of the drug than in the US. See notably  Non-
confidential minutes of a conference call with a KOL dated 24.04.2019; Non-confidential minutes of a 
conference call with a KOL dated 29.04.2019; Non-confidential minutes of a conferen ce call with a 
KOL,  dated 16.5.2019; and Non-confidential minutes of a conference call with a KOL,  dated 3.05.2019 . 
83  See notably  Non-confidential minutes of a conference call with a KOL  dated 24.4.2019.  
84  Replies to questions 12 and 15 – Questionnaire to competitors – Autoimmune diseases.  
85  See notably Non-confidential minutes of a conference call with a KOL  dated 29 .4.2019 ; Non-confidential 
minutes of a conference call with a KOL  dated 30.4.2019 ; Non-confidential minutes of a conference call 
with a KO L dated 2.5.2019 . See also Replies to question 12 – Questionnaire to competitors – 
Autoimmune diseases.  
86  This is also confirmed by […] surveys […] (see Form CO, Annexes AI.20 and AI.22 […]). 
 
 
17 profile ( i.e. the two key elements in the choice of therapy87) will likely be 
comparable to or worse than biologics.88 As a KOL put it, “[t]oday in PsO, there 
are already many efficacious, cost -effective treatments with a proven safety 
profile and it will be difficult for TYK2 inhibitors to compete with them ”.89 BMS 
internal documents confirm this, citing public authorities in Europe and 
elsewhere who […];90 
- BMS RORγt agonist pipeline project (BMS -986251) : given its early  stage of 
development, the exact efficacy and safety profile of this pipeline drug and the 
line of treatment for which it will be approved are still unknown.91 Assuming it 
reaches the market and is approved as a third -line treatment, it is likely that more 
products will have entered the market and Otezla will likely have lost its 
exclusivity (scheduled to occur around 2028).  
(62) That being said, the results of the market investigation suggest that the MoD of the 
Parties’ drugs ( i.e. oral) could constitute a comp etitive advantage because some 
patients are reluctant to receive injections and because all the alternative  third -line 
treatments currently available on the market  (biologics) are injectable.92 However, 
this competitive advantage seems limited in practice s ince (i) in the EEA, the MoD 
does not drive prescription decisions93 (contrary to the US where the competitive 
dynamics are very different),94 especially when it comes to third -line treatments 
where efficacy and safety prevail; (ii) the number of patients re luctant to injections 
appears to be modest (around 5% of the patient population according to some 
KOLs)95; and (iii) many competitors are currently developing alternative oral drugs 
(see below Table 2). 
(63) Second , post -Transaction, the combined entity would co ntinue to face strong 
competitive constraints from a large number of actual and potential  competitors .  
                                                 
87  See notably Non-confidential minutes of a conference call wi th a KOL  dated 30.04.2019 and Non-
confidential minutes of a conference call with a KOL  dated 16.5.2019 . See also Replies to question 11 – 
Questionnaire to competitors – Autoimmune diseases.  
88  See notably Non-confidential minutes of a conference call with a KOL, dated 24.4.2019; Non-
confidential minutes of a conference call with a KOL, dated 29.4.2019; and Non-confidential minutes of 
a conference call with a KOL, dated 30.4.2019 . Replies to questions 24 and 25 – Questionnaire to 
competitors – Autoimmune dis eases.  
89  Non-confidential minutes of conference calls with a competitor, 29.4 .2019.  
90  Form CO, Annex AI.17, […].  
91  […]. 
92  Replies to questions 12, 14, 20, 27 and 28 – Questionnaire to competitors – Autoimmune diseases.  
93  See notably Non-confidential  minutes of a conference call with a KOL  dated 30.04.2019 and Non-
confidential minutes of a conference call with a KOL  dated 16.5.2019.  See also Replies to question 11 – 
Questionnaire to competitors – Autoimmune diseases.  
94  See notably Non-confidential m inutes of a conference call with a competitor, dated 4.6.2019; Non-
confidential minutes of a conference call with a KOL , dated 3.5.2019; and Non-confidential minutes of a 
conference call with a KOL , dated 29.4.2019 . 
95  See Non -confidential minutes of a con ference call with a KOL  dated 2.5.2019. See also Non-confidential 
minutes of a conference call with a KOL  dated 30.4.2019 . 


 
 
20 (68) Third , although some respondents consider that Otezla and BMS TYK2 inhibitor 
will closely compete  because they are both administered orally,108 the market 
investigation confirmed  that the Parties’ drugs are differentiated in terms of (i) MoA, 
as well as (ii) efficacy and safety profile109 which is the key factor in the choice of 
the treatment :110 
- Different MoA . The Parties’ drugs target different enzymes and pathways 
responsible for P sO. Otezla is a PDE -4 inhibitor, which inhibits the actions of 
PDE -4, an enzyme which turns cyclic adenosine monophosphate (“cAMP”) to 
adenosine monophosphate  (“AMP”). The inhibition of PDE -4 allows to reduce 
the production of pro-inflammation cytokines (such as TNF -α) and, thus, 
inflammation and other PsO symptoms. BMS -986165  is a TYK2 inhibitor, 
which specifically inhibits the TYK2, in order to target the IL -12 and IL -23 
pathways, which are genetically related to PsO.111 BMS -986251 is a RORγt 
agonist , the  way its works remains uncertain but antagonizing RORγt activity 
with synthetic small molecules seems to inhibit expression of IL -17A.  
- Different efficacy profile . Otezla significantly reduces the skin area affected by 
PsO in around one third of patients (P ASI 75 response rate112 of 29 -33%), while 
BMS TYK2 inhibitor is expected to be effective  in over two thirds of patients 
(PASI 75 response rate of 67 -75% b ased on the Phase II trial results ). This 
means the efficacy of the BMS TYK2 inhibitor is comparable to the efficacy of 
biologics, which achieve PASI 75 response rates of approximately 71 -91% (as 
shown in the Graph below). The PASI 90113 scores of patients treated with 
Otezla, BMS’ TYK2 inhibitor, and biologics corroborate this conclusion.114 This 
was also confi rmed by the vast majority of KOLs and competitors.115 
                                                 
108  See recital (69) below.  One competitor also flagged that Otezla is used by BMS as active comparator in 
the BMS TYK2 inhibitor Phase III clinical trials (see Replies to question 22 – Questionnaire to 
competitors – Autoimmune diseases).  This does not sugges t that BMS TYK2 inhibitors will compete 
more closely with Otezla than with other third -line treatments for moderate -to-severe PsO.  The choice of 
Otezla as a comparator is explained by the way clinical trials are designed and executed.  For its TYK2 
inhibi tor pipeline project, BMS could choose between running (i) a superiority trial, showing that the 
efficacy of its drug exceeds the efficacy of another therapy and (ii) a non -inferiority trial, showing that 
the efficacy of its drug is not lower than the effi cacy of another therapy.  Non -inferiority trials are much 
larger than superiority trials and they are more difficult to design and execute.  BMS thus chose to 
conduct a superiority trial, using Otezla […].  It was also easier to recruit patients for a tria l comparing two 
oral products than for a trial involving an injectable product ( e.g. a biologic), which would be BMS’ 
alternative.  In any event, […].   
109  As regards BMS RORγt agonist pipeline (BMS -986251), g iven its early stage of development (Phase I), 
the exact efficacy and safety profile of this pipeline is still unknown.  
110  See also recital (45) above.   
111  See also recital (39) above.   
112  A PASI 75 response rate is the percentage of patients that experienced a 75% reduction of their PASI 
score from the start to the end of the trial.  
113  A PASI 90 response ra te is the percentage of patients that experienced a 90% reduction of their PASI 
score from the start to the end of the trial.  
114  See Form CO, Annex 5.027, […].  
115  See Replies to question 24 – Questionnaire to competitors – Autoimmune diseases. In the non-
confidential minutes of a conference call dated  24.4.2019, a KOL stated: “[t]he clinical results of Otezla 
are closer to conventional systemic therapies (in terms of efficacy), whereas new small molecules, such 
as TYK2, are likely to be marketed as close substitutes to biologics .”  
 
 
21 […]  
Source : Form CO  
- Different safety profiles and monitoring requirements . While the exact safety 
profile of BMS TYK2 inhibitor will not be known until the completion of the 
ongoing Phase III trials, it will likely sit between Otezla (which has a very 
favourable safety profile) and biologics.116 As one KOL put it, “ Otezla has a 
very favourable safety profile and is generally well tolerated by patients with 
comorbidities. BMS -986165’s safety profile is not l ikely to be as favourable as 
Otezla’s since it has immunosuppressant effects (with an increased risk of 
exposing patients to infections) and will require upfront screening at least for 
tuberculosis and hepatitis B and C” .117 The fact that Otezla is likely to  be safer 
than BMS TYK2 inhibitor is corroborated by BMS’ internal documents, […].118 
(69) The above notwithstanding, some respondents consider that Otezla and BMS TYK2 
inhibitor will compete closely because they are both administered orally (as opposed 
to biolog ics that are injectable) .119 However, during the market investigation, 
respondents identified many other drugs as closely competing with the Parties. In 
fact, the majority of respondents consider that all third -line treatments for moderate -
to-severe PsO clos ely compete with each other.120 In addition, as already mentioned, 
the market investigation confirmed that the MoD is less important than efficacy and 
safety when a physician chooses treatment for moderate -to-severe PsO.121 
(70) Fourth , the Commission considers that, given the modest shares of Otezla in the 
EEA and the differentiated efficacy/safety profiles  of Celgene’s Otezla and BMS 
TYK2 , it is unlikely that the combined entity would have an  incentive to cease, 
repurpose or delay the development of BMS’ pipelines post -Transaction.  
(71) BMS TYK2 inhibitor is expected to be comparable to (injectable) biologics, 
including in particular the first generation of biologics ( i.e. TNF -α inhibitors), in 
terms of efficacy and safety. The successful introduction of BMS TYK2 inhibitor 
would likely lead to an overall increase in the number of PsO patients receiving 
treatment.122 BMS TYK2 inhibitor will also likely claim market share from all 
competing third -line treatments (including biologics and biosimilars).123 Moreover, 
BMS’ pipeline project is trialled for a much wider range of indications than merely 
PsO, for example in CD and Lupus, where there are no or limited overlaps between 
the activities of the Parties.  As a result, discontinuing or delaying the development of 
BMS TYK2 in an attempt to exclusively commercialise Otezla would result in the 
delay or loss of revenue streams in PsO and also in other indications. In addition, in 
BMS’ investor presentations, BM S TYK2 inhibitor is highlighted as one of the six 
new medicines to be launched by the merged entity in the next two years .124 This 
                                                 
116  See Replies to questions 16 -17 and 25 -26 – Questionnaire to competitors – Autoimmune diseases.  
117  Non-confidential minutes of a conference call with a KOL, 16 .5.2019.  
118  See Form CO, Annex AI.27,  […]. 
119  See Replies to quest ions 21 and 22 – Questionnaire to competitors – Autoimmune diseases.  
120  See Replies to questions 19, 21, 22 and 29 – Questionnaire to competitors – Autoimmune diseases.  
121  See notably Replies to question 11 – Questionnaire to competitors – Autoimmune disea ses. 
122  See Replies to question 23 – Questionnaire to competitors – Autoimmune diseases.  
123  See Replies to question 23 – Questionnaire to competitors – Autoimmune diseases.  
124  See, for example, https://bestofbiopharma.com/wp -content/uploads/2019/02/Bristol -Myers -Squibb -
Investor -Update.pdf .  
 
 
22 shows that BMS is publicly building up expectations amongst its investors that no 
delay in the development of BMS TYK2 inhibito r will take place.   
(72) With respect to BMS RORγt agonist, given the early stage of this pipeline (Phase  I) 
and the fact that Otezla will lose exclusivity in Europe around the time this asset 
would launch, if successful in trial, it is unlikely that the combin ed entity would 
have incentives to stop the development of BMS -986251 . Rather, it would make 
sense for the combined entity to continue the development of the project for life -
cycle management purposes.  
(73) Fifth , post-Transaction, it is unclear whether the Pa rties would have the ability 
and/or incentives to stop supplying or to repurpose Otezla in the EEA. Although one 
of the Parties’ internal documents125 suggests that, post -Transaction, […], this 
document seems to relate to the US market, where competitive dyn amics are 
different from the EEA.  
(74) In the EEA, for cost -efficiency reasons, the use and reimbursement of Otezla is 
restricted to patients who have first failed a conventional systemic therapy (or have 
contraindications). By contrast, in the US, there is no  such requirement, which 
allows Otezla to be used as an earlier stage treatment and for milder cases.126 […]. In 
fact, today Celgene is seeking to have Otezla approved for mild -to-moderate PsO 
[…] in the US.127 In any event, if the Parties decided to stop the supply of Otezla or 
to reposition it in the EEA (which remains unclear), the impact on the market would 
be limited given Otezla’s relatively modest market shares in the EEA (well below 
10% in all the EEA co untries where Otezla is sold)  and the existence of many actual 
and potential competitors (including oral drugs) .128 
(C) Conclusion  
(75) In view of the above, taking into account the results of the market investigation and 
all the evidence available  to it, the Commiss ion concludes that the Transaction does 
not raise serious doubts as to its compatibility with the internal market  and with the 
functioning of the EEA Agreement  resulting from the overlap of the Parties’ 
activities in third -line moderate -to-severe PsO treat ments or (more narrowly) in oral 
third -line moderate -to-severe PsO treatments .  
4.1.2.4.  Overlap involving a pipeline programme at preclinical trial stage  
(76) During the market investigation, two competitors identified an overlap between 
BMS TYK2 inhibitor pipeline , currently in Phase III trials , and the preclinical TYK2 
inhibitor programme developed by Nimbus, in which Celgene has a financial option. 
According to these competitors, the combination of these two assets under the 
control of the merged entity could negatively impact competition in th e market for 
moderate -to-severe PsO treatments. The Commission assesses these concerns in the 
remainder of this section.  
                                                 
125  Form CO, Annex 5.027, […].  
126  This explains why Celgene’s drug is considered a blockbuster in the US and not in the EEA.  See recital 
(61) above.  
127  Form CO, Section 6 – Autoimmune Diseases, p aragraph 248.  
128  See Table 3 above.  
 
 
23 (A) The Parties’  view  
(77) The Parties submit that the Transaction does not raise serious doubts as a result of 
the overlap between BMS TYK2 inh ibitor pipeline and Celgene’s option in Nimbus’ 
TYK2 inhibitor programme for two reasons. First , Nimbus’ TYK2 inhibitor project 
is at preclinical stage of development and has a very low probability of success so 
that it is wholly uncertain if it will ever reach the (EEA) market. Second , even if 
successful, Nimbus’ TYK2 inhibitor will be launched in the EEA no earlier than 
[…], that is to say  several years after the launch of BMS TYK2 inhibitor. This 
means that the two pipeline projects do not have “ similar timing ”129 and should not 
be considered as competing research programmes.  
(B) The Commission’s assessment  
(78) The Commission investigated the overlap between BMS TYK2 inhibitor pipeline 
(Phase III) and Celgene’s option in Nimbus’ TYK2 inhibitor pipeline (preclinical). 
The market investigation of the Commission showed that the Transaction would not 
give rise to ser ious concerns as to its compatibility with the internal market and the 
functioning of the EEA Agreement resulting from this overlap, irrespective of the 
relevant market delineation.  
(79) In a possible relevant market comprising all third -line treatments for mo derate -to-
severe PsO, the combined entity  would have one marketed product (Celgene’s 
Otezla) and three pipeline projects (BMS TYK2 inhibitor, Nimbus’ TYK2 inhibitor 
programme, assuming the relevant option is exercised, and BMS’ Rorγt antagonist in 
Phase I […]). In this market, the Transaction does not give rise to competition 
concerns for the reasons explained above regarding the overlap between BMS TYK2 
inhibitor and Otezla.130 The addition of Nimbus’ TYK2 inhibitor programme does 
not change that conclusion because the Parties’ drugs are not expected to exert 
strong competitive constraints in the market for moderate -to-severe PsO and they 
would continue to face a large number of actual and potential competitors, including 
biologics, biosimilars and small mole cule drugs .  
(80) In a possible relevant market comprising oral third -line treatments for moderate -to-
severe PsO, the combined entity would again have one marketed product (Otezla), 
the two TYK2 inhibitor programmes, and BMS -986251 (a ROR γt agonist in Phase I 
[…]). In this market, the Transaction does not give rise to competition concerns for 
the reasons explained above regarding the overlap between BMS TYK2 inhibitor, 
Otezla and BMS -986251.131 The addition of Nimbus’ TYK2 inhibitor programme 
does not change that conclusion because the Parties would continue to face a large 
number of potential competitors, with several oral drugs at a more advanced stage of 
development than Nimbus’  TYK2 inhibitor preclinical programme .  
(81) In a possible relevant market including only TYK2 inhibitors for the treatment of 
moderate -to-severe PsO, the combined entity would own BMS TYK2 inhibitor and 
the financial option to acquire Nimbus’ TYK2 inhibitor preclinical programme. In 
                                                 
129  See case M.7275 - Novartis/GSK Oncology , decision of 28. 1.2015, recital 90.  
130  See Section 4.1.2.3  above .  
131  See Section 4.1.2.3  above . 
 
 
24 this segment, the Transaction does not give rise to competiti on concerns for the 
reasons explained below.  
(82) First , post -Transaction, the combined entity will continue to face strong competitive 
constraints from several players developing TYK2 inhibitors for moderate -to-severe 
PsO. Post -Transaction, there will be at least five players developing TYK2 inhibitors 
as treatments for moderate -to-severe PsO. In addition to the combined entity, th ese 
include large pharmaceutical companies (such as Pfizer and AbbVie ) and also 
smaller pharmaceutical  companies (such as Nuevolut ion and Sareum). The pipeline 
projects of Pfizer and AbbVie are in clinical trial stage (Phase II and Phase I, 
respectively) which means that they are more advanced than the Nimbus preclinical 
asset. The pipeline projects of Nuevolution and Sareum have not  entered clinical 
development stage (similar to the Nimbus ’ preclinical asset). Therefore, post -
Transaction, several competing TYK2 inhibitor research programmes will remain on 
the market, in addition to the Parties’ programmes.  
(83) Second , each of the Parties ’ pipeline products appear to compete more closely with 
competitors’ pipeline products than the Parties' competing ones.  BMS TYK2 
inhibitor programme is at the most advanced clinical trial stage (Phase III). It is 
expected to receive approval in the EEA in  […] for the treatment of moderate -to-
severe PsO. By contrast, Nimbus’ TYK2 inhibitor is still at preclinical trial stage and 
it is expected to enter Phase I clinical trials in […]. In this sense, BMS TYK2 
inhibitor competes more closely with AbbVie’s and Pfizer’s pipelines (both at 
clinical trial stage) than it does with Nimbus’ programme. These projects have 
significantly higher chances of success, compared to Nimbus’ pipeline which is still 
at preclinical trial stage.132 In the market investigation, the va st majority of 
respondents did not  identify Nimbus as a close competitor of BMS TYK2 inhibitor 
programme. Rather, most of them referred to Pfizer’s TYK2 inhibitor pipeline 
project (as well as to other treatments with different MoA).133 Nimbus’ TYK2 
inhibitor programme competes more closely with other programmes which have not 
yet entered clinical trial stage, such as Sareum’s and Nuevolution’s projects.  
(84) During the market investigation, two competitors flagged that BMS and Nimbus are 
the only two companies developing allosteric TYK2 inhibitors.134 The two 
competitors , which constitute a small minority of the respondents,  argued that 
allosteric TYK2 inhibitors have a distinct and unique efficacy and safety profile and 
that, post-Transaction , all the relevant pipeline projects would be controlled by the 
combined entity. The market investigation did not support these concerns. The 
majority of KOLs and market participants indicated that allosteric mechanisms are 
not unique and orthosteric TYK 2  inhibitors could possibly achieve comparable 
levels of efficacy and safety .135 In any event, even assuming that allosteric TYK2 
inhibitors do have unique characteristics, the market investigation revealed that such 
                                                 
132 The market investigation confirmed that preclinical assets in  autoimmune diseases (like Nimbus’ 
programme) have a likelihood of success of less than 11%. Replies to question 31 – Questionnaire to 
competitors – Autoimmune diseases.  
133  See Replies to question 29 – Questionnaire to competitors – Autoimmune diseases.  
134  Replies to question 34.1 – Questionnaire to competitors – Autoimmune diseases.  
135  See recital (42) above.  
 
 
25 drugs are currently under development by c ompanies other than BMS and 
Nimbus.136  
(85) Third , the Commission takes into account the competitive pressure to be exerted on 
TYK2 inhibitors by alternative treatments for moderate -to-severe PsO (already 
marketed or under development). The market investigation showed that TYK2 
inhibitors will be one of the many drugs in the unconcentrated space of moderate -to-
severe PsO treatments. TYK2 inhibitors will face competition from marketed 
biologics (including TNF -α inhibitors , IL-17 inhibitors, IL -23 inhibitors, and I L-
12/23 inhibitors), their biosimilars, and also a large number of pipeline drugs, 
including several oral pipelines in Phase II and Phase III.137 A competitor developing 
a TYK2 inhibitor took the view that its drug will “ not just compete with other small 
molecules (e.g. Otezla or BMS’s TYK2 inhibitor) but also with biologics in the very 
crowded space of moderate -to-severe PsO treatments ”.138  
(86) This is also confirmed by the majority of respondents to the market investigation 
who do not expect TYK2 inhibitors to b e more efficacious139 or significantly safer140 
than existing treatments. A KOL indicated that “ BMS’ TYK2 inhibitor seems to be 
one of the many pipeline projects that exist today for the treatment of PsO. ”141  
Another KOL added that “[m] any products currently on the market for PsO have an 
efficacy and safety profile that is superior to the efficacy and safety profile of the 
combined BMS/Celgene portfolio. The fact that Celgene purchased an option to 
acquire the TYK2 inhibitor programme of a US company, Nimbus, doe s not change 
this conclusion. There are several companies that develop pipeline projects for 
PsO”.142   
(87) Fourth , it is unlikely that the Transaction will lead to a loss of innovation on the 
hypothetical market for TYK2 inhibitors PsO treatments. Indeed, Celgen e is not 
developing the Nimbus programme itself. It simply has a financial option to 
purchase the programme, with a set expiry date.143 Assuming that the combined 
entity decides not to exercise this option ( e.g. because it also owns the BMS TYK2 
inhibitor pr ogramme), the Nimbus project would not be necessarily discontinued. 
Nimbus would be free to continue the development of its TYK2 inhibitor 
programme on its own and/or look for an alternative partner.144 As Nimbus itself put 
it, “if Celgene does not exercise the option, Nimbus will be free to continue the 
development of the TYK2 inhibitor programme on its own and/or look for an 
                                                 
136  See notably non-confidential minutes of conference calls with competitors , 21.5.2019 . 
137  Replies to questions 8.2 and 22 – Questionnaire to competitors – Autoimmune diseases and non-
confidential minutes of conference calls with a competitor, 29.4.2019.  
138  See non -confidential minutes of a co nference call with a competitor, 21 .5.2019. Another competitor 
having a TYK2 inhibitor programme in clinical trial indicated that “ the relevant market for moderate -to-
severe PsO treatments includes topical and biologic treatments ”; see non -confidential min utes of a 
conference call with a competitor, 24 .5.2019.  
139  See replies to question 24 – Questionnaire to competitors – Autoimmune diseases.   
140  See r eplies to question 25 – Questionnaire to competitors – Autoimmune diseases  
141  See n on-confidential minutes of a conference call with a KOL, 29 .4.2019.  
142  See n on-confidential minutes of a conference call with a KOL, 29 .4.2019.  
143  [Confidential contractual terms ]. See Form CO, Annex AI.3, […] See the Parties ’ reply to RFI 8, 
15.7.2019.  
144  See non -confidential minutes of a conference call with competitor, 21.5.2019, who stated: “Post -
Transaction, if Celgene were to not exercise its option to purchase Nimbus’ project, Nimbus would seek 
to conclude a new partnership agreement, which can be exp ected to be easy.”  
 
 
26 alternative partner .”145  Nimbus added: “ [i]f the merged entity does not exercise the 
option, other pharmaceutical companies are likely t o be interested in acquiring 
Nimbus’ TYK2 programme. In this respect, Nimbus explained that, before reaching 
an agreement with Celgene, it had engaged in discussions with several 
pharmaceutical companies (excluding BMS, precisely because it already had its  own 
TYK2 inhibitor pipeline) and that several of them had expressed interest in its TYK2 
inhibitor programme.”146 
(88) It is also unlikely that the combined entity would have an incentive to exercise the 
option, purchase the Nimbus pipeline asset, and then disco ntinue it. This would 
involve  automatically a significant investment, because the exercise of the option 
requires an upfront payment of […]147 by the combined entity to Nimbus for an asset 
whose development and launch on the market remain highly uncertain (5 % for small 
molecule drugs).148  
(89) During the market investigation, two competitors , which constitute a small minority 
of the respondents,  also raised the concern that by holding an option over the 
Nimbus TYK2 inhibitor programme, the combined entity could delay the 
programme’s development to limit the competitive constraints on the BMS TYK2 
inhibitor drug. However, any such delay ( e.g. through requests of excessive amounts 
for information by the combined entity) is unlikely to have a significant impact on 
the overall timeline of the Nimbus project, which is today more than […] away from 
the market, and its launch is still uncertain.149 In any event , as explained above,150  
before […] (when Nimbus’ TYK2 inhibitor is expected to be launch ed), other TYK2 
inhibitor products more likely to have entered the EEA market and exert competitive 
constraints on BMS TYK2 inhibitor.  
(C) Conclusion  
(90) For all these reas ons, the Commission concludes that the Transaction would not give 
rise to serious concerns as to its compatibility with the internal market and the 
functioning of the EEA Agreement resulting from this overlap, irrespective of the 
relevant market delineatio n. 
4.1.3.  Treatments for Psoriatic Arthritis (“PsA”)  
(91) PsA is a chronic, systemic, autoimmune joint disease associated with PsO. It occurs 
when cells from the immune system move into a patient’s skin and joints, and 
produce proteins that cause swelling and pain.  
                                                 
145  See non -confidential minutes of a conference call with Nimbus, 13.5.2019.  
146  See non -confidential minutes of a conference call with Nimbus, 13.5.2019.  
147  [Confidential contractual terms]  See the Parties’  reply to RFI  8. 
148  See http://www.appliedclinicaltrialsonline.com/large -vs-small -molecule -success -rates .  The likelihood of 
success appears slightly higher (11%) for preclinical assets  in autoimmune diseases , (i.e. including both 
biologics and small molecule drugs) See Replies to question 31 – Questionnaire to competitors – 
Autoimmune diseases.  
149  The market investigation largely confirmed that preclinical assets in autoimmune diseases (like Nimbus’ 
programme) have a likelihood of success of less than 11%. Replies to question 31 – Questionnaire to 
competitors – Autoimmune diseases.  
150  See recitals (82)-(84) above.  

 
 
28 (96) Celgene markets Otezla in the EEA as a third -line treatment for PsA. Otezla is a 
PDE -4 inhibitor with the active ingredient apremilast. It received a marketing 
authorisation  from the EMA for PsA in 2015 and since then has been launched in 
Austria, Belgium, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, 
Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Slovakia, Slovenia, 
Spain, Sweden, the UK, and Liechtenstein.153  
(97) BMS markets Kenalog for the treatment of PsA in Spain. Launched in the 1960s, 
Kenalog is a synthetic glucocorticoid corticosteroid with the active ingredient 
triamcinolone acetonide. Kenalog is used for short -term relief of the symptoms of PsO 
as opposed t o the long -term treatment of the underlying disease. Kenalog has lost 
market exclusivity and there is a large number of generic alternatives for Kenalog.  
(98) BMS markets Orencia for the treatment of PsA in Germany. Launched in 2017, 
Orencia is a T cell costimulatory agent with the active ingredient abatacept.  
(99) BMS is developing an oral small molecule drug for PsA, namely BMS -986165, 
which is a TYK2 inhibitor.154 The project will shortly commence  Phase II trials  for 
this indication. It is expected to enter t he EEA market s in 2026 as a third -line 
treatment.  
(100)  […]. The way it works remains uncertain but antagonizing RORγt activity with 
synthetic small molecules seems to inhibit expression of IL -17A.  
(101)  The Transaction gives rise to overlaps between the marketed (ex isting) products of 
the Parties and their pipeline products at clinical trial stage in (i) in a plausible 
market including all treatments for moderate -to-severe PsA,155 (ii) a plausible market 
for third -line treatments for moderate -to-severe PsA and (ii) a p lausible market for 
oral third -line treatments for moderate -to-severe Ps A. 
4.1.3.3.  Competitive assessment  
(102)  The Transaction gives rise to marketed -to-pipeline overlaps between (i) Celgene’s 
Otezla (marketed), on the one hand, and (ii) BMS TYK2 inhibitor (Phase II pi peline) 
and RORγt agonist (Phase I pipeline), on the other hand.  
(103)  The Parties argue that no competition concerns arise in the market for PsA 
treatments or any of its plausible sub -segmentations as ( i) Otezla has a limited 
market share in EEA markets; (ii) O tezla and each of the BMS pipeline projects are 
differentiated products (with different MoA , projected levels of efficacy, and 
                                                 
153  Otezla is reimbursed in Czechia for PsO only. Otezla is not reimbursed for either PsO or PsA in Hungary, 
Malta, Norway and Portugal, bu t Celgene […]. 
154  See recital (39) above.  
155  Should  the market be defined as encompassing all treatments for PsA, marketed -to-marketed product 
overlaps potentially arise (i) between Celgene’s Otezla and BMS’ Kenalog in Spain and (ii) between 
Celgene’s Otezla and BMS’ Orencia in Germany. However, these pote ntial overlaps do not give rise to 
any affected market, the Parties’ combined shares in PsA in Germany and Spain being lower than 20% 
under any plausible market definition. Moreover, Celgene’s and BMS’s marketed PsA treatments are 
differentiated products w ith (i) different ATC3 classification s (D5B (Systemic Anti PsO Products) for 
Otezla, M1C (Specific Anti -Rheumatic Agents) for Orencia and H2A (Systemic Corticosteroids, Plain) 
for Kenalog); (ii) different MoA ; and (iii) different uses and patient  groups.  
 
 
29 expected safety profiles); (iii) there is a number of competing products for the 
treatment of PsA (in the market and under development) . The Parties also claim that, 
post-Transaction, the merged entity would have no ability or incentive to discontinue 
(i) the development of BMS’ pipeline products or (ii) the supply of Otezla.  
(104)  The market investigation broadly confirmed the Parties’ arguments regarding PsA 
treatments and allow s the Commission to exclude serious doubts as to the 
compatibility of the Transaction with the internal market  and the functioning of the 
EEA Agreement .  
(105)  First , in the market  for third -line treatment for PsA  in the EEA, Otezla’s market 
share remains limited at national level. Otezla holds less than 20% in each of the 
EEA countries  where it is marketed.156 Otezla is one of the many drugs available on 
the market, including biologics and small molecules (JAK inhib itors) but it is less 
efficacious. O ne KOL confirmed that “ Otezla has a lower efficacy profile than 
biologics, including TNF inhibitors, and JAK inhibitors.  […] Otezla is widely used 
in the US but is much less popular in Europe (for costs -efficiency reason s)”157 and 
another explained: “[in PsA] Otezla does not have a strong profile compared to the 
most effective treatments, which are TNF inhibitors and IL -17 inhibitors ”.158 
(106)  Second , Celgene’s Otezla and BMS TYK2 inhibitor and RORγt agonist  are 
differentiated compounds with (i) different MoA (Otezla is a PDE -4 inhibitor and 
BMS pipeline drugs are a TYK2 inhibitor and a RORγt agonist); (ii) different 
expected efficacy profiles (BMS TYK 2 will likely have higher efficacy than 
Otezla);159 and (ii i) different safety profiles and monitoring requirements (Otezla’s 
safety profile is expected to be higher than BMS TYK2 inhibitor, which could 
potentially have immunosuppressant effects and require monitoring, similarly to 
other JAK inhibitors).160 For all these reasons, BMS TYK2 inhibitor is expected to 
compete more closely with biologics and other JAK inhibitors (such as Pfizer 
marketed drug Xeljanz (tofacitinib))161 than with Otezla. BMS RORγt agonist  will 
likely compete with other products that are under d evelopment for PsA and have a 
RORγt agonist MoA ( e.g. Arrien’s ARN -6039, Akros’ JTE -451, and AstraZeneca’s 
AZD -0284) .162  
(107)  Third , post-Transaction, the combined entity will continue facing competitive 
constraints from a large number of actual and  potential  competitors (including under 
the narrowest market definition giving rise to an overlap, i.e. oral third -line 
treatments for PsA) .  
                                                 
156  The market share of the combined entity would remain below 20% in Germany, combining the shares of 
Celgene’s Otezla and BMS’ Orencia. The market share of the combined entity would remain below 20% 
in Spain, combining the shares of Celgene’s Otezla and BM S’ Kenalog.  
157  See non -confidential minutes of a conference call with a KOL, 3 .5.2019 . 
158  See non -confidential minutes of a conference call with a KOL, 30 .4.2019 . 
159  At Phase I clinical trial stage, the exact efficacy and safety profile of BMS RORγt agoni st remains to be 
confirmed.  
160  The exact safety profile of BMS TYK2 inhibitor remains unknown at this stage . 
161  See non -confidential minutes of a conference call with a KOL, 24 .4.2019 . This Key Opinion Leader 
indicated that “ JAK inhibitors other than TYK2  have proven to work very well on patients with significant 
joint involvement and minimal skin disease. JAK inhibitors, therefore, are a promising option for the 
treatment of PsA. Pfizer’s Xeljanz (tofacitinib) recently launched in Europe and many other JA K 
inhibitors are at clinical trial stage for a PsA indication ”. 
162  Form CO, Section 6 – Autoimmune Diseases, Table AI.9.  

 
 
31 efficacy/safety profiles of the Parties’ products, it is unlikely that the combined 
entity would have incentive s to cease, repurpose or delay the development of BMS’  
pipelines post -Transaction.  
(112)  BMS TYK2 inhibitor is expected to compete more closely with JAK inhibitors and 
biologics, in terms of efficacy and safety, than with Otezla. Moreover, BMS TYK2 
inhibitor pipelines are seeking authorisation for a much wider ran ge of indications 
than merely PsA. As a result, discontinuing or delaying the development of BMS 
TYK2 inhibitor in an attempt to exclusively commercialise Otezla would result in 
the delay or loss of revenue streams from PsA and other indications.  
(113)  As regar ds Otezla, if the combined entity decided to stop the supply of the drug or to 
reposition it in the EEA, the impact on the market would be limited given Otezla’s 
relatively modest market shares in the EEA (less than 20% at national level).  
(114)  With respect to  BMS RORγt agonist , given the early stage of this pipeline (Phase  I) 
and the fact that Otezla will lose exclusivity in Europe around the time this asset 
would be launch ed, if successful in trial, it is unlikely that the combined entity 
would have incentive s to stop the development of BMS -986251 . 
(115)  Fifth , the market investigation did not reveal any substantiated competition concerns 
in relation to the Transaction in a possible market for third -line PsA treatments or 
any of its plausible sub -segmentations.  
(116)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact on competition in the 
possible market for  PsA treatments (and its plausible sub -segmentations).  
4.1.4.  Treatments for inflammatory bowel disease (“IBD”)  
(117)  IBD typically refers to two conditions: UC and CD, which are inflammatory diseases 
that affect the digestive system. The main difference between them is that CD can 
affect any part of the gastroenterology tract , whereas UC is limited to the colon. 
Similarly, CD affects the full thickness of the intestinal wall whereas the 
inflammation caused by UC remains within the superficial lining of the intestine. 
Both diseases are found to have similarly debilitating effects.165 
(118)  Clinical guidelines, in particular the treatment guidelines issued by the European 
Crohn’s and Colitis organisation (ECCO), recommend a phased treatment for UC 
and CD consisting of three line s of treatment. The first -line treatment include 
aminosalicylates (such as mesalazine or sul fasalazine), which are effective at 
inducing and maintaining remission. The second line -treatment include 
corticosteroids and immunosuppressants, which are used for  moderate -to-severe 
cases, although remission cannot be maintained with steroid. The third -line 
treatment include biologics such as TNF -α inhibitors, anti -integrins and ustekinumab 
and small molecules.  
                                                 
165  See case M.8955 - Takeda/Shire , decision of 20.11.2018, recital 11.  

 
 
33 (124)  Celgene  has one pipeline product that is undergoing Phase III trials for the treatment 
of UC and CD, namely RPC -1063 (“ Ozanimod ”), which is a small molecule agonist 
of sphingosine -1- phosphate receptor 1 (“ S1P1 ”) and sphingosine -1-phosphate 
receptor 5 (“ S1P5 ”). Ozanimod works by preventing lymphocytes (including T and 
B cells) from migrating from lymphoid tissues to the sites of inflammation.  If 
successful in Phase III trials, Ozanimod is expected to enter the EEA market in […] 
(UC) and […] (CD)  as a third -line treatment.  
(125)  BMS is developing an oral small molecule drug for both UC and CD, namely, BMS -
986165, which is a TYK2 inhibitor .171 The project s are undergoing  Phase II trials 
and are expected to enter the EEA market in 2026 as a third -line treatment.  
(126)  […]. The way it works remains uncertain but antagonizing RORγt activity with 
synthetic small molecules seems to inhibit expression of IL -17A. 
(127)  The Transaction gives rise to overlaps between the Parties’ pipeline products at 
clinical trial stage i n (i) plausible market s including all treatments for IBD and each 
of UC and CD (ii) plausible market s for third -line treatments for IBD and each of 
UC and CD, and ( iii) plausible market s for oral third -line treatments for IBD and 
each of UC and CD.  
4.1.4.3.  Competi tive assessment  
(128)  The Parties  argues that no competition concerns arise in relation to  UC and CD 
treatments  in the EEA, under any plausible market definition,  given that (i) the 
Parties’ pipeline products are at different clinical phases and consequently do not 
have a “ similar timing ” 172 as regards their potential market entry, (ii) there is a 
crowded pipeline for treatments of IBD and, (iii) the Parties’ produc ts have different 
MoA , different anticipated usage and very different expected safety and efficacy 
profiles, so that they are unlikely to be close competitors. In addition, BMS -986251 
is seeking an indication only for UC.  
(129)  The market investigation broadly c onfirmed the Parties’  arguments and allows the 
Commission to exclude serious doubts as to the compatibility of the Transaction 
with the internal market and the functioning of the EEA Agreement in relation to UC 
and CD treatments , under any plausible market  definition .  
(130)  First , the Parties’ compounds and research programmes are very differentiated. 
Celgene’s Ozanimod is an agonist of the S1P1 and S1P5 receptors, whereas BMS 
TYK2 is a selective inhibitor of tyrosine kinase 2 and BMS -986251 is a RORγt 
agonist. The significant differences in Celgene’s Ozanimod as opposed to BMS 
TYK2 inhibitor are presented in the Figure below, from which it can be seen that 
S1P1 inhibition targets UC and CD within a completely different stage of the 
inflammatory process than smal l molecules belong ing to the JAK inhibitor  family  
such as BMS TYK2 inhibitor . According to the Parties, the different MoA in 
Ozanimod and BMS TYK2 inhibitor suggest that the two products will likely have 
differentiated efficacy and safety profiles (if and when they reach the market).  
                                                 
171  See recital (39) above.  
172  See case M.7275  - Novartis/GSK Oncology , decision of 28. 1.2015, recital 90.  
 
 
34 Figure 1 
 
[…]  
Source : Form CO.  
(131)  The only similarity between the Parties’ pipeline products is their oral MoD, which 
does not seem to constitute a key element for physicians when they prescribe third -
line treatment s for UC and CD . According to a KOL, “ the percentage of patients 
that insis t on an oral drug is limited. The most important consideration for patients 
is the efficacy of the drug, especially by the time they reach the stage of third -line 
defence followed by safety ”.173  
(132)  Second , each of Parties’ pipeline products are expected to com pete more closely 
with pipeline products of the competitors of combined entity.  Other companies are 
indeed developing pipeline products that are expected to compete more closely with 
BMS  TYK2 and Celgene’s Ozanimod respectively.174 BMS TYK2 inhibitor is 
expe cted to complete more closely with other compound from the JAK inhibitor 
family ( e.g. Pfizer’s Xeljanz (marketed), Abbvie’s Upadacitinib (Phase III) and 
Gilead’s Filgotinib (Phase III)) . Based on the data publicly available “ there seems to 
be no difference  in efficacy or safety, when comparing TYK2 inhibitors and JAK 1 or 
pan-JAK inhibitors for UC and CD ”.175 On the other hand, Celgene’ Ozanimod is 
expected to closely compete with  etrasimod, which is a being developed  by Arena 
Pharmaceuticals in the US. Accor ding to one KOL , etrasimod , which is currently 
undergoing Phase III clinical trials, “ will likely be as efficacious as  ozanimod but it 
may have an advantage over ozanimod in terms of safety profile [as it]  is expected to 
affect the patients’ heart less tha n other S1P1 receptor modulators ”.176  
(133)  Third , post-Transaction, the combined entity will continue facing competitive 
constraints from a large number of actual and  potential  competitors (including under 
the narrowest market definition giving rise to an overla p, i.e. oral third -line 
treatments for each of UC and CD) .  
(134)  Set forth below is a list of the main competing treatments (marketed in the EEA and 
under development) in third -line UC treatments and third -line CD treatments . 
 
 
                                                 
173  See non -confidential minutes of a conference call with a KOL, 26 .4.2019.  
174  By the time, and if, BMS RORγt agonist reaches the market, many other drugs, including several oral 
drugs will be av ailable on the market.  
175  See non -confidential minutes of a conference call with a KOL, 26 .4.2019.  
176  See non -confidential minutes of a conference call with a KOL, 26 .4.2019.  

 
 
36 and Gilead/Galapagos’ filgotinib , which are both in Phase III for each o f UC and 
CD, and Arena’s Etrasimod, which is in Phase III for UC and has the same MoA as 
Celgene’s Ozanimod ).  
(137)  Finally , the market investigation did not reveal any substantiated competition 
concerns in relation to UC and CD treatments in the EEA . Given the  differentiated 
MoA of Celgene ’s and BMS ’ pipeline projects, the risk of discontinuation or delay 
for some of them is limited  
(138)  In light of the above considerations supported by evidence collected over the course 
of the market investigation, the Commission c oncludes that the Transaction does not 
give rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact on competition in relation 
to UC and CD treatments , under any plausible marke t definition . 
4.1.5.  Treatments for Lupus  
(139)  Lupus is a long -term systemic autoimmune disease which is difficult to diagnose 
because it is a very heterogeneous disease ( no two cases of Lupus are exactly alike ) 
and its symptoms often mimic those of many other disease s. Lupus can cause 
inflammation in a wide range of bodily systems, and can involve a wide  range of 
complications depending on which bodily systems are affected. Symptoms include 
tiredness, mild skin rash or joint pain (in milder cases) and serious inflamma tion and 
damage in the skin, lungs, heart, kidneys.  
(140)  Lupus  is a very heterogeneous disease and it is difficult to identify clear lines of 
treatment .179 Lupus treatments include (i) nonsteroidal anti -inflammatory drugs  
(such as aspirin and ibuprofen ); (ii) antimalarials (such as hydroxychloroquine ); (iii) 
corticosteroids (such as prednisolone ); and (iv) immunosuppressant  drugs (such as 
azathioprine and methotrexate ). The use of biologics is less common in Lupus than 
in other autoimmune diseases. There is only one biologic on the market approved for 
lupus, namely, GSK’s Benlysta (belimumab). Another biologic, Roche’s Rituxan 
(rituximab), is also now widely used for the treatment of Lupus on an off -label basis.  
4.1.5.1.  Market definition  
(141)  The Commission has not previously analysed the relevant product market for Lupus 
treatments. In J&J/Actelion , whilst the Commission did not define the relevant 
product market for Lupus treatments, it excluded competition concerns in the Lupus  
space based of the differentiated MoA, MoD and likely line of treatment of J&J and 
Actelion ’s products.180 The Parties suggested that the relevant product for treatments 
of Lupus can be left open, as no competition concerns arise under any plausible 
market delineation ( i.e. by line of treatment, by MoA a nd by MoD). For the purposes 
of this Decision , it can be left open  whether the market for Lupus treatments should 
be sub -segmented. This is because the Transaction does not give rise to serious 
doubts as to its compatibility with the internal market and th e functioning of the 
                                                 
179  The main guidelines in Europe for the treatment of lupus are the EULAR recommendations for the 
management of SLE (2008). More recent guidelines regarding the management of lupus in adults have 
been published by the British Society for Rheumatology in October 2017.  
180  Case M.8401 - J&J/ Actelion , decision of 9.6.2017, footnote 5.  


 
 
39 (153)  There are many competitors developing pipeline drugs for Lupus. One KOL recalled 
that “ Celgene, BMS, and many of their rivals have pipeline products for the treatment 
of lupus ”.184 As shown in Table 9, more than 10 competing pipeline products for the 
treatment of Lupus are expected to be launched in the EEA by 2023, that is before the 
most advanced pipeline product of the Parties reaches the EEA market.  Many of the 
competing pipeline projects are based on MoA similar  to the MoA of the Parties’ 
pipeline programmes. For example, Eli Lilly’s baricitin ib is a JAK inhibitor, involving 
a MoA similar to the BMS TYK2 inhibitor. Roche’s fenebrutinib  and Merck KGaA’s 
evobrutinib constitute BTK inhibitors, similar to BMS -986195.   
(154)  On the narrowest plausible market giving rise to an overlap between the Parties’ 
pipeline products , which is the market restricted to oral treatments for Lupus, the 
combined entity will also face strong competitive constraints. Post -Transaction, 
competing oral treatments will include  at least  three Phase II projects developed by 
large pharmaceutical companies, such as Eli Lilly, Merck KGaA, and Roche . If 
successful, Eli Lilly’s baricitinib is expected to enter the market approximately 3 
years earl ier than any of the pipeline projects of the Parties.  
(155)  Third , the market investigation did not reveal any substantiated competition 
concerns in relation to the Transaction in a possible market for Lupus treatments or 
any of its plausible sub -segmentations.  A KOL added that “ [t]he fact that there is 
still a need for an efficacious lupus treatment makes it unlikely that the combined 
entity would decide to discontinue one of the pipeline projects that the Parties are 
developing today”.185 
(156)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact on competition in the 
possible market for Lupus treatments (a nd its plausible sub -segmentations).  
4.2. Fibrotic diseases  
4.2.1.  Introduction  
(157)  Fibrotic diseases include a broad range of diseases ( e.g. idiopathic pulmonary 
fibrosis, non -alcoholic steatohepatitis, advanced liver fibrosis) that involve fibrosis 
in some part of the body. Fibrosis is the formation of excessive tissue scarring and 
can occur in different organs , such as the lungs, liver, skin, eyes, heart, and kidneys.   
(158)  Fibrosis  often occurs as a result of sustained injury, which could be caused by, for 
example, trauma, toxins, inflammation or infection. Normally, an organ or tissue that 
is affected by an injury undergoes a process of healing through deposition of new 
collagen fi bres, repair of blood vessels, and other activities which restore the 
integrity of the tissue involved. When these repair processes – specifically the laying 
down of new collagen fibres – become dysregulated, excessive scarring can form. 
Excessive scarring  in turn can have a very significant impact on the function of the 
impacted organ.  
                                                 
184  Non-confidential minutes of a conference call with a KOL, 25 .4.2019 . 
185  Non-confidential minutes of a conference call with a KOL, 25.4.2019 . 
 
 
40 (159)  In fibrotic diseases, the Parties activities overlap with respect to the following 
indications: Idiopathic Pulmonary Fibrosis (“IPF”) (Section 4.2.2) and Non -
alcoholic stea tohepatitis  (“NASH”)  (Section 4.2.3).  
4.2.2.  Treatments for idiopathic pulmonary fibrosis  
(160)  Idiopathic pulmonary fibrosis (“IPF”) is a relatively rare chronic progressive disease 
that affects the lungs. The cause is unknown, and the disease is particularly complex 
as it is not driven by a single gene or cell type.  
(161)  IPF is caused by lung tissue becoming thick and stiff and eventually forming scar 
tissue within the lungs. The scarring, or fibrosis, seems to result from a cycle of 
damage and healing that occurs in the l ungs. Over time, the healing process stops 
working correctly and scar tissue forms. What causes these changes in the first place 
is unknown.  Symptoms of IPF include: shortness of breath, a dry cough, fatigue, 
unexplained weight loss, aching muscles and joi nts, and widening or rounding of the 
tips of the fingers or toes (clubbing). Disease progression can vary - some patients 
become ill very quickly and for others the disease progresses over months or years. 
The mean survival time from  diagnosis is 2 to 5 ye ars 
(162)  There is currently no cure for IPF. The main aim of the two marketed treatments 
currently available in the EEA (Roche’s pirfenidone and Boehringer Ingelheim’s 
nintedanib) is to relieve symptoms and to slow progression. As the condition becomes 
more adv anced, palliative care is offered. In addition, lung transplants may be an 
option for a small subgroup of patients with IPF who meet the necessary criteria.  
(163)  In 2015, the European Respiratory Society published, jointly with the American 
Thoracic Society, J apanese Respiratory Society and Latin American Thoracic 
Association, published guideline s on idiopathic pulmonary fibrosis treatment .186 
Only nintedanib and pirfenidone are conditionally recommended  by the guidelines . 
4.2.2.1.  Market  definition  
(164)  The Commission has not previously analysed the relevant product market for IPF 
treatments. The Parties suggested that the relevant product for treatments of IPF can 
be left open, as no competition concerns arise under any plausible market delineation 
(i.e. by line of treatment,  by MoA and by MoD). For the purposes of this Decision , it 
can be left open  whether the market for IPF treatment should be sub -segmented. 
This is because the Transaction does not give rise to serious doubts as to its 
compatibility with the internal market and the functioning of the EEA Agreement 
even under the narrowest market definition giving rise to an overlap between the 
Parties’ drugs ( i.e. oral treatments for IPF).  
(165)  As regards the geographic market definition,  the Commission has consistently 
considere d the market for pipeline products to be at least EEA -wide in scope.187 The 
Parties do not contest this. Nothing in the market investigation suggests  that the 
Commission should depart in the present case from its previous practice with respect 
to IPF treatme nts. 
                                                 
186  https://www.thoracic.org/statements/resources/interstitial -lung-disease/IPF -Full-length.pdf . 
187  See recital (16) above.  

 
 
42 4.2.2.3.  Competitive  assessment  
(172)  The Parties argue that no competition concerns arise in the market for IPF treatments 
or any of its plausible sub -segmentations , in particular because: (i) the products have 
different MoA , (ii) there is a crowded pipeline of competing  IPF trials, and (iii) the 
products are in early stages of clinical development .189 
(173)  Based on the available information, the Commission  considers  that the proposed 
Transaction does not raise  serious doubts as to the compatibility of the Transaction 
with the i nternal market  and the functioning of the EEA Agreement .  
(174)  First , Celgene’s CC -90001 (JNK inhibition) and BMS’ pipeline products, namely its 
financial option in ND -L02-s0201  (HSP47 inhibition)  and BMS -986278 are very 
differentiated. The Parties’ compounds h ave different MoA that affect different 
inflammatory pathways. Given the very different MoA  of these molecules, it is very 
likely that these drugs (if they ever reach the market) will serve different patient 
groups  and will likely have different efficacy and safety profiles.  
(175)  According  to the Parties, and based on the public data available at this stage, 
competing pipeline products are therefore likely to compete  more closely with the  
Parties’ pipeline products : 
- […] appears to be the closest competing pipel ine product for BMS -986278 as 
it inhibits autotaxin, which is upstream of the LPA pathway that is targeted by 
BMS -986278 ; 
- […] appears to be the closest competing pipeline product for BMS’ ND -L02-
s020 since […], is a direct antifibrotic, and it is administe red […]; 
- CC-90001’s MoA is unique, as it is the only JNK inhibitor in development for 
IPF. The closes t competing pipeline product could be […] as they both lower 
the level of the same protein in the body.  
(176)  Second , post-Transaction, the combined entity will  continue facing competitive 
constraints from a large number of actual and  potential  competitors (including under 
the narrowest market definition giving rise to an overlap, i.e. oral treatments for IPF) .  
(177)  Set forth below is a list of the main competing treatments (marketed in the EEA and 
under development) in IPF treatments . 
                                                 
189  See Form CO, Fibrotic diseases Chapter, paras. 48 and ff.  

 
 
44 stage which begins with an abnormal build -up of fat in the liver, which can progress 
to inflammation, hepatocyte degradation, fibrosis, cirrhosis and ultimately liver 
failure or liver cancer.  
(183)  Where  there is steatosis ( i.e. abnormal retention of lipids in the liver) as well as 
inflammation  and ballooning of cells in the liver, the condition is classified as 
NASH. NASH may initially present without fibrosis, but as the condition progresses, 
fibrosis develops. NASH  is generall y caused by lifestyle choices (such as poor diet 
and lack of exercise); however, unlike other fatty liver diseases, it is not caused by 
alcohol abuse or as a side effect of medication.  
(184)  The most common symptoms are fatigue and mild pain in the upper right abdomen. 
As the disease progresses to more advanced stages, more symptoms may become 
apparent including: bleeding easily, bruising easily, itchy skin, jaundice and fluid 
accumulation in abdomen.  
(185)  There are currently no treatments specifically marketed for N ASH. Doctors may 
recommend lifestyle interventions (such as changing diet and losing weight) and 
treating comorbidities ( i.e. one or more additional conditions that occur 
concomitantly or concurrently with a primary condition). Other options also include 
bariatric surgery or pharmacotherapy, including treatments with vitamin E, an 
SGLT2 inhibitor (such as Invokana which is approved as a diabetes medicine in the 
EEA), or pemafibrate (currently not approved in the EEA).  
(186)  In 2016, the European Association for t he Study of the Liver (“EASL”), the 
European Association for the Study of Diabetes (“EASD”) and the European 
Association for the Study of Obesity (“EASO”) have published Clinical Practice 
Guidelines for the management of NAFLD (“NAFLD Guidelines”). The NAF LD 
Guidelines note that no drug is approved for NASH by regulatory agencies and that 
no specific therapy can be recommended. The NAFLD Guidelines note that insulin 
sensitisers, antioxidants (such as vitamin E) and cytoprotective and lipid lowering 
agents m ay be helpful. In patients that are unresponsive to lifestyle changes and 
pharmacotherapy, bariatric surgery may be an option. The NAFLD Guidelines 
recommend diet and lifestyle changes as an important treatment.  
4.2.3.1.  Market definition  
(187)  The Commission has not previously analysed the relevant product market for NASH 
treatments. The Parties suggested that the relevant product for treatments of NASH 
can be left open, as no competition concerns arise under any plausible market 
delineation ( i.e. no line of treatmen t have been identified for the treatment of NASH 
and the Parties’ pipeline products neither have the same MoA nor the same MoD). 
For the purposes of this Decision , it can be left open  whether the market for NASH 
treatment should be sub -segmented. This is b ecause the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement even under the narrowest market definition 
giving rise to an overlap between the Parties’ drugs ( i.e. treatments for NASH).  

 
 
46 (193)  BMS is also d eveloping a HSP47 inhibitor. The HSP47 protein is essential for the 
formation of mature collagen (chronic injuries cause fibrosis by inducing collagen 
production). When stimulated, hepatic stellate cells, which store vitamin A, 
transform into myofibroblast s, which produce collagen responsible for fibrosis. The 
HSP47 -targeting siRNA is encapsulated in a vitamin A coupled liposome which 
delivers the siRNA to hepatic stellate cells, leading to decreased collagen production 
and cell apoptosis (programmed cell d eath). BMS -986036 is currently undergoing 
Phase II clinical trials and is not expected to reach the EEA market before […]. 
(194)  The Transaction gives rise to overlaps between the Parties’ pipeline products at 
clinical trial stage in a plausible market for NASH treatments.  
4.2.3.3.  Competitive assessment  
(195)  The Parties argue that no competition concerns arise in the market for NASH 
treatments or any of its plausible sub -segmentations no competition concerns arise, 
in particular because: (i) the products have different MoA , (ii) there is a crowded 
pipeline of competing NASH trials, and (iii) the products are in early stages of 
clinical development.196 
(196)  Based on the available information, the Commission considers that the proposed 
Transaction does not raise serious doubts as to the compatibility of the Transaction 
with the internal market  and the functioning of the EEA Agreement in relation to 
NASH treatments .   
(197)  First , Celgene’s CC -90001 and BMS’ pipeline products, namely BMS -986036 and 
BMS -986263 are differentiated compounds wit h (i) different MoA (CC-90001 is a 
JNK inhibitor and BMS pipeline drugs are a HSP47 inhibitor and a Pegylated 
FGF21);  and (ii) different MoD (while Celgene drug will be taken orally, BMS’ 
products will be administered through subcutaneous injection (BMS’ P egylated 
FGF21) and  through intravenous injection (BMS’ HSP47).  Based upon published 
preclinical data and early clinical data, it is very likely that these drugs (if they ever 
reach the market) will serve different patient groups. In particular, they would  likely 
have different efficacy and safety  profiles.197 
(198)  Second , post-Transaction, the combined entity will continue facing competitive 
constraints from a large number of actual and  potential  competitors (including under 
the narrowest market definition giving  rise to an overlap, i.e. treatments for NASH) .  
                                                 
196  See Form CO, Fibrotic diseases Chapter, paragraphs  56 and ff.  
197  Whilst the target NASH population for CC -90001 are patients with NASH with advanced fibrosis, BMS -
986036 and BMS -986263 target different pathways, and may be suited to different populations (BMS’ 
may be appropriate patients [description of anticipated target pati ent population ] (Celgene’s CC-90001 
[…]) and BMS -986263  may be more appropriate for patients […] (Celgene’s CC -90001 excludes 
subjects with a history of hepatitis and fibrosis from causes other than NASH […])). 

 
 
48 determination of the extent to which a cancer has spread is called ‘staging’. While 
the ‘stages’ by which the spread of a cancer is measured differs from cancer to 
cancer, in general, more severe cases are delineated by higher numbers.  
(205)  The range of treatments for cancer include traditional types of therap ies (such as 
surgery, radiotherapy and chemotherapy) and newer forms of treatment (such as 
targeted therapies and immunotherapies ). 
(206)  These different types of treatment may be approved as monotherapies or 
combination therapies. A combination therapy is when two or more drugs (or 
therapies) are used in parallel for the same indication, which may help to improve 
the efficacy and safety of the treatment. Each product that is part of the combination 
treatment is typically marketed by the company controlling the p roduct. and 
procured by customers on a stand -alone basis.199 
(207)  The oncology treatments offered by BMS and Celgene include chemotherapies, 
targeted therapies and immunotherapies. 200 
(208)  Given the different ways in which they treat cancer, chemotherapies, targeted 
therapies, and immunotherapies are most often used as complementary treatments:  
- Chemotherap ies involve the use of cytotoxic drugs to kill cancer cells, targeting 
cells that grow and divide at rapid rates.  However, chemotherap ies can also 
attack healthy cells, particularly fast -growing healthy cells, such as red and white 
blood cells and cells  comprising the hair follicles;  
- Targeted therapies  are drugs or other substances that interfere with specific 
molecules involved in tumour g rowth and progression . Targeted therapies are 
designed to specifically ‘target’ and act upon specific mutations, amplifications, 
molecular  aberrations  or proteins that are expressed by the form of cancer being 
targeted. As a  result, targeted therapies each  have a highly specific MoA;  
- Immunotherapies  are products that utilise a patient’s own immune system to 
fight cancerous cells. Immunotherapies do not attack cancerous cells directly  but 
are designed to enhance the body’s natural mechanisms to fight cancer,  helping 
the immune system to increase its natural ability to eliminate cancer cells.  
(209)  In oncology, the Transaction gives rise to limited number of marketed -to-pipeline 
overlaps and pipeline -to-pipeline overlaps involv ing early stage pipeline s (Phase I or 
Phase I/II)201, with the same MoA or different MoA . More specifically, the Parties’ 
                                                 
199  Development of combination therapies in oncology is typically done through clinical collaboration 
agreements, whereby two parties collaborate to conduct the applicable studies. In most cases, each party 
will contribute supply of their proprietary product f or the study, the parties will share costs equally, and 
one party will be responsible for the operational conduct (and sponsorship) of the study. However, cost -
sharing and operational responsibilities are negotiated terms, and it is not uncommon for one pa rty to 
bear greater than 50% of the costs of a given study. These clinical collaboration agreements very rarely 
contain co -commercialisation provisions (including bundling).  
200  Neither BMS nor Celgene offer surgery and radiotherapy as part of their oncolo gy treatment solutions.  
201  Phase I/II trials are possible (and frequently used in oncology). A Phase I/II study is a single study that 
includes a typical Phase I trial and a Phase II signal -seeking trial in a single study protocol. The next step 
after a Ph ase I/II study will depend on the strength of the evidence. Usually the drug candidate will be 
studied next in a larger Phase II trial, but where the evidence is particularly strong, it may be possible to go 
 
 
 
49 activities overlaps with respect to BET inhibitors (a targeted therap y) (Section 4.3.2) 
and various immunotherapies  (Section 4.3.3) .202  
4.3.2.  BET Inhibitors  
(210)  BET inhibitors belong to targeted therapies. Bromodomain and extra -terminal 
(“BET”) proteins are involved in the expression of several genes controlling 
activities which are key for cancer development, such as cell proliferation and 
metastatic spreading. B ET inhibitors block the BET proteins, thus preventing the 
expression of the relevant genes and limiting cancer development.  
(211)  There are currently no marketed BET inhibitors and all BET inhibitors under 
development are at an early stage ( e.g. Phase I or Phas e I/II clinical trials). BET 
inhibitor development covers several possible oncology indications.   
4.3.2.1.  Market Definition  
(212)  The Parties submitted  that it is not necessary for the Commission to reach a 
conclusion on precise market definition in this case as no com petition concerns arise 
under any plausible market delineation ( i.e. by MoA or by indication).  
(213)  The Commission has discussed relevant product market definition for Phase I/II and 
Phase II pipeline projects in targeted oncology therapies in GSK/Novartis Onco logy. 
In this case, the Commission found that “ the potential for […] clinical research 
programs to deliver substitutable products should be assessed by reference to the 
products’ characteristics and intended therapeutic use, in particular by reference to 
their mechanism of action and to the cancer types for which they are being 
investigated ”.203  
(214)  In the present case, the market investigation suggested that the relevant product market 
should be sub -segmented on the basis of the MoA, i.e. as a market for BET inhibitor 
drugs.204 The market investigation also indicated that the market for BET inhibitor  
drugs should not be sub -segmented further, i.e. by indication.205 This is due to the fact 
                                                                                                                                                      
on to a Phase II/III trial. The latter usually i ncludes two stages: the first stage will be a typical Phase II trial 
and the s econd stage may allow for the trial to be expanded into a full Phase III if there is sufficient 
evidence.  
202  As regards chemotherapies, the Transaction only gives rise to a de minimis  overlap between the Parties’ 
activities in Czechia where BMS markets Taxol and Celgene offers Abraxane.  Czechia is the […] EEA 
countries where BMS’ Taxol is sold (less than […] of sales in 2018). Abraxane and Taxol fall within the 
same ATC3 categor y (L1C ‘plant based antineoplastics’) and are both based on the paclitaxel molecule. 
However, t his de minimis  marketed -to-marketed overlap does not give rise to an affected market, the 
Parties' combined market share being lower than 20% under any plausible  market definition in Czechia.  
203  Case  M.7275 Novartis/GSK Oncology, decision 18.12.2015 , recital 90. In this case, the Commission thus 
defined a relevant product market for pipeline programmes involving MEK and B -Raf inhibitors for 
specific indications.  
204  None of the competitors and the KOLs participating in the market investigation contested that the Parties’ 
pipeline projects compete in a separate market for BET inhibitor drugs. See Replies of competitors on 
pre-notification BET inhibitor questionnaire of 27 .5.2019. Each of the Parties submitted internal 
documents showing that BMS and Celgene were […]. See Form CO, Annexes ONC.04 and ONC.06 for 
BMS and Annexes ONC.05 and ONC.07 for Celgene.  
205  A sub -segmentation based on MoD would not make a difference to the competitive assessment as all the 
pipeline programmes of the Parties and their competitors are oral.  


 
 
52 (225)  As shown in Table 15 above, the BET inhibitor pipeline is crowded, including 
several pipeline projects that would compete with the pipelines  of the combined 
entity post -Transaction.  These projects are at approximately the same stage as the 
Parties’ BET inhibitor clinical trials.  
(226)  In a narrower market that includes only BET inhibitors for […],213 the combined 
entity will still face competitive co nstraints from several competitors . There is at 
least one company which continues to develop a BET inhibitor  drug specifically for 
[…]. Moreover , all the companies developing BET inhibitors for other indications 
take the view that it is easy to expand the indications associated with their pipeline 
programme, for example to cover […].214  
(227)  Moreover , the market investigation did not reveal any substantiated competition 
concerns in relation to the Transaction in a possible market for BET inhibitor  drugs 
or specif ically in BET inhibitor  drugs for […].215  
(228)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact on competition in the 
possible market for BET inhibitor drugs (and its plausible sub -segmentations).  
4.3.3.  Other Overlaps  
(229)  Other areas where the Parties have early stage pipelines with the same indication but 
a different MoA are:  
- Immunoth erapies for colorectal cancer;  
- Immunotherapies for head and neck squamous cell cancer ("HNSCC");  
- Immunotherapies non -small cell lung cancer ("NSCLC");  
                                                 
213  In a plausible market including all targeted therapies for […], post -Transaction, the co mbined entity 
would control CC -90010 and BMS -986158, which are both described in Table 14.  The combined entity 
would also have a Phase I pipeline project, CC -486, which has a different MoA, namely, it  is a DNA 
methylase inhibitor. The Transaction does not  give rise to serious doubts as to its compatibility with the 
internal market and the EEA Agreement in a possible market for targeted therapies for […] for the 
following reasons.  First , BMS -986158 and Celgene’s CC -486 do not have the same MoA. Second , 
BMS -986158 and Celgene’s CC -90010 do have the same MoA (BET  inhibitor ) but there are several 
pipeline BET  inhibitor  drugs which are indicated for or could be expanded to […] (see recital (226)  
above). Third , the combined entity will face competition from at least three marketed targeted therapies  
(i.e. Roche’s rituximab and the rituximab biosimilars marketed by Celltrion and Sandoz) and at least 
seven pipeline programmes (developed by Roche, Jonhson & Jonhnson, MSD, and Gilead), some of 
which are more advanced than the pip eline projects of the Parties. Fourth , the market investigation did 
not reveal any substantiated competition concerns in relation to the Transaction in a possible market for 
targeted therapies for […].    
214  See recital (214)  above and Replies of competitors on pre -notification BET  inhibitor  questionnaire of 
27.5.2019.  
215  See Replies of competitors on pre -notification BET  inhibitor  questionnaire of 27 .5.2019.  For example, 
one competitor stated “ quite a few companies are already in Ph I and therefore it is unlikely to impact the 
future market shares or price ”. Similarly, another competitor stated “ Given that there are over 10 
companies competing in the field of BET inhibitors in a wide range of indi cations, […] the acquisition of 
Celgene by BMS is likely not going to have a significant impact on the competitive landscape of BET 
inhibitors ”. 
 
 
53 - Immunotherapies small cell lung cancer ("SCLC");  
- Immunotherapies for ovarian cancer;  
- Immunotherapies for pancreatic cancer;  and 
- Immunotherapies for multiple myeloma.216 
4.3.3.1.  Market definition  
(230)  The Commission has not previously considered the  product market s for 
immunotherapies treating colorectal cancer, HNSCC, NSCLC, SCLC, ovarian 
cancer, pancreatic cancer, and multiple myeloma.  
(231)  For the purpose of this Decision, it can be left open217 whether the market for (i) 
immunotherapies for colorectal cancer, (ii) immunotherapies for HNSCC, (iii) 
immunotherapies for NSCLC, (iv) immunotherapies for SCLC, (v) immunotherapies 
for ovarian cancer, (vi) pancreatic cancer, and (vii) immunotherapies for multiple 
myeloma  (i.e. by type and stage of the disease, by line of treatment, by MoA and by 
MoD) as the Transaction does not give rise to serious doubts as to its compatibility 
with the internal market and the functioning of the EEA Agreement under any 
plausible market definition.  
(232)  As regards the geographic market definition,  the Commission has consistently 
considered the markets for marketed pharmaceuticals to be national in scope an d the 
market for pipeline products to be at least EEA -wide in scope.218 The Parties do not 
contest this. Nothing in the market investigation suggests  that the Commission 
should depart in the present case from its previous practice with respect to the 
above -mention ed immunotherapies.  
4.3.3.2.  Competitive assessment  
(A) Immunotherapies for colorectal cancer  
(233)  The Parties’ immunotherapies for colorectal cancer, and their main competitors are 
detailed in Table 16 below . 
                                                 
216  In oncology, both Parties are also developing drugs, at an early stage of development, which are currently 
indicated for "solid tumours" (with different MoA). Earlier stage trials (including Phase I and II studies) 
often investigate broader categories of cancer types, such as "solid tumours", because they are signal -
seeking and are looking to see which types of  tumours the treatment will be most effective against. Once 
a cancer type (or several cancer types) has positive results, the next trials will then focus on those 
particular indications and will no longer be listed as being for “solid tumours”. Given the d ifferent MoA 
of the Parties' early stage pipelines for "solid tumours" and the uncertainty as to whether these pipelines 
will result in products being approved for the same indications, the Commission considers that the 
potential pipeline -to-pipeline overl aps arising in "solid tumours" do not give rise to competition concerns.  
217  As explained in recital (14) above, a s regards pipeline products, the Commission has in p revious 
decisions considered that when R&D activities are assessed in terms of importance for future markets, 
the product market definition can be left open, reflecting the intrinsic uncertainty in analysing products 
that do not exist yet.   
218  See recital (16) above.  

 
 
55 stop a patient’s immune system from attacking cancerous cells;221 (ii) BMS -813160 
targets the C -C chemokine receptor pathway that involves C -C chemokine receptor 
types 2 (CCR2) and 5 (CCR5); this pathway is involved with inflammatory 
processes, tumour cell migration and tumour cell proliferation. BMS -813160 binds  
to CCR2 and CCR5 and prevents their activation; and (iii) […] to encourage 
immune activation and stimulate immune cells to attack cancer.  Celgene's does not 
have any treatments with the same MoA . […]. Should the Parties’ pipelines reach 
the market (which is uncertain), there is, at this point in time and based on the 
available information , no indication that the efficacy and safety profiles of these 
drugs (which have different MoA) w ould be similar .222 
(238)  Second , the development of […] is at a very early stage,  the first in -human clinical 
study began in […] and the completion the Phase I trial is not expected before […]. 
Assuming the clinical trials are successful, which remains highly uncertain, […] is 
not expected to be launched on the market before […]. Moreover, at such an early 
stage, prospective indications remain uncertain and subject to change  especially with 
respect to immunotherapies .223 
(239)  Third , the combined entity will face competition from several pipeline programmes, 
including the pipeline projec ts of MSD, Merck KGaA, and Mologen, which are in 
Phase III trial, i.e. more advanced than the pipeline projects of the Parties.  
(240)  Finally , the market investigation did not reveal any substantiated competition 
concerns regarding immunotherapies for colorecta l cancer.  
(241)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact on competition in relation 
to immunotherapies for colorectal cancer . 
(B) Immunotherapies for head and neck squamous cell cancer (" HNSCC")  
(242)  The Parties’ immunotherapies for the treatment of HNSCC, and their main 
competitors are detailed in Table 17 below . 
                                                 
221  BMS has trials with Opdivo, which involves several different combinations with different compounds, 
including (i) three targeted  therapies ( i.e. Cobimetinib, Daratumumab, trametinib ), as well as (ii) Yervoy  
(CTLA -4 inhibitor) and (iii) Relatlimab  (LAG -3 inihibitor) , which inhibit different immune pathways 
that controls the response, activation and growth of T -cells that fight cance r. 
222  Given their early stage of development, the exact efficacy and safety profile of th e Parties’ pipeline s is 
still unknown . 
223  As explained in recital 27, Phase I trials focus on safety and dosage and are not signal -seeking studies 
looking at the indications in which the immunotherapy may show some activity. Moreover, early studies for 
immunotherapies are generally intended to test multiple hypoth eses to see which ones are proven true ( i.e. a 
number of different indications are trialled to see in which ones the pathway seems to be implicated and 
where the treatment shows some activity). For this reason, early stage trials for immunotherapies typica lly 
include a range of different cancer types, which do not serve as a definitive guide as to the indications that 
may or may not be pursued in later stage trials (see Parties’ reply to RFI 7).  

 
 
57 (which is uncertain), there is, at this point in time and based on the available 
information , no indication that the efficacy and safety profiles of BMS’ and 
Celgene ’s drugs (which have different MoA) would  be similar .229 
(247)  Second , the development of [Confidential Celgene pipeline product ] is at a very 
early stage. Assuming the clinical trials are successful, which remains highly 
uncertain, [Confidential Celgene pipeline product ] is not expected to be launched on 
the market before [Confidential Celgene pipeline product ]. Moreover, at such an 
early stage, prospective indications remain uncertain and subject to change  
especially with respect to immunotherapies .230 
(248)  Third , the combined entity will face competition from one marketed product ( i.e. 
Keytruda, a PD -1 inhibitor which directly compete with Opdivo) and several  
pipeline programmes, including the pipeline projects of MSD, AstraZeneca, Sanofi, 
Merck KGaA, and Roche, which are in Phase II or III trials, i.e. a stage of 
development which is more advanced than Celgene's […] and similar to or more 
advanced than BMS' pipelines .  
(249)  Finally , the market investigation did not reveal any substantiated competition 
concerns regarding immunotherapies  for HNSCC.  
(250)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact  on competition  in relation 
to immunotherapies for HNSCC.  
(C) Immunotherapies for non -small cell lung cancer (“NSCLC”)  
(251)  The Parties’ immunotherapies for the treatment of NSCLC, and their main 
competitors  are detailed in Table 18 below . 
                                                 
229  Given the early stage of development  of Celgene’s pipeline and most o f BMS’ pipelines , the ir exact 
efficacy and safety profile s are still unknown . 
230  See footnote 223. 

 
 
59 inhibitor) .234 Should the Parties’ pipelines reach the market (which is uncertain), 
there is, at this point in time and based on the available information , no indication 
that the efficacy and safety profiles of BMS’ and Celgene’s drugs (which have 
different MoA) would  be similar .235  
(256)  Second , the development of MSC -1 is at a very early stage. Assuming the clinical 
trials are successful, which remains highly uncertain, MSC -1 is expected to be 
launched on the market after […]. Moreover, at such an early stage, prospective 
indications remain uncertain  and subject to change especially with respect to 
immunotherapies.236 
(257)  Third , the combined entity will face competition from at least three marketed 
product ( namely Keytruda (MSD), Imfinzi (AstraZeneca) Tecentric (Roche), three 
PD-1/PD -L1 inhibitors which dir ectly compete with BMS' Opdivo) and several  
pipeline programmes, including  Phase III pipeline projects developed by Sanofi 
Genzyme/Regeneron, Novartis, and Merck KGaA/Pfizer, which are more advanced 
that Celgene's pipeline.  
(258)  Finally , the market investigatio n did not reveal any substantiated competition 
concerns regarding immunotherapies  for NSCLC.  
(259)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact  on competition in relation 
to immunotherapies for NSCLC.  
(D) Immunotherapies for small cell lung cancer ("SCLC")  
(260)  The Parties’ immunotherapies for the treatment of SCLC, and their main competitors 
are detailed in Table 19 below . 
                                                 
234  See footnote 221 above for a description of the MoA of Yervoy.  
235  Given the early stage of development  of Celgene’s pipeline and some of BMS’ pipelines , their exact 
efficacy and safety profile s are still unknown . 
236  See footnote 223. 


 
 
62 (273)  First , Celgene's and BMS' pipelines have very different MoA : MSC -1 inhibits  is LIF 
inhibitor,244 while Yervoy is a CTLA -4 inhibitor .245 Should the Parties’ pipelines 
reach the market (which is uncertain), there is, at this point in time an d based on the 
available information , no indication that the efficacy and safety profiles of these 
drugs (which have different MoA) would  be similar .246 
(274)  Second , the development of MSC -1 is at a very early stage. Assuming the clinical 
trials are successful, w hich remains highly uncertain, MSC -1 is expected to be 
launched on the market after […]. Moreover, at such an early stage, prospective 
indications remain uncertain and subject to change especially with respect to 
immunotherapies.247 
(275)  Albeit more advanced (Phase II), the development BMS’ pipeline for ovarian cancer 
is also highly uncertain. In this respect, BMS explained that […]. 
(276)  Third , the combined entity will face competition from several  pipeline programmes, 
including  at least three  programmes developed by AstraZeneca, MSD and Roche, 
which are at a more advanced stage of development than the Parties' (Phase III).  
(277)  Finally , the market investigation did not reveal any substantiated competition 
concerns regarding immunotherapies  for ovar ian cancer.  
(278)  For all these reasons, the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact  on competition in relation 
to immunotherapies for ovarian cancer.  
(F) Immunotherapies for pancreatic cancer  
(279)  The Parties’  immunotherapies for the treatment of pancreatic cancer, and their main 
competitors are detailed in Table 21 below . 
  
                                                 
244  See recital (255)  above for a description of the MoA of MSC -1. 
245  See footnote 221 above for a description of the MoA of Yervoy.  
246  Given the early stage of developmen t of the Parties’ pipeline drugs , their exact efficacy and safety 
profile s are still unknown . 
247  See footnote 223. 

 
 
64 available information , no indication that the efficacy and safety profiles of these 
drugs (which have different MoA) would  be similar .254 
(284)  Second , the development of MSC -1 is at a very early stage. Assuming the clinical 
trials are successful, which remains highly uncertain, MSC -1 is expected to be 
launched on the market after […]. Moreover, at such an early stage, prospective 
indications remain uncertain  and subject to change especially with respect to 
immunotherapies.255 
(285)  Third , the combined entity will face competition from several  pipeline programmes, 
including  pipelines which are at an advanced stage of development (such as 
Pegilodecakin developed by Eli  Lilly, which is currently in Phase III trials).  
(286)  Finally , the market investigation did not reveal any substantiated competition 
concerns regarding immunotherapies  for pancreatic cancer.  
(287)  For all these reasons , the Commission concludes that the Transaction d oes not give 
rise to serious doubts as to its compatibility with the internal market and the 
functioning of the EEA Agreement as regards its impact  on competition in relation 
to immunotherapies for pancreatic cancer.  
(G) Immunotherapies for multiple myeloma  
(288)  Multiple myeloma is a haematological malignancy that affects plasma cells. It is 
highly treatable, but rarely curable. Multiple myeloma is staged by estimating the 
myeloma tumour cell mass based on the amount of myeloma protein in the serum 
and urine.  
(289)  The Parties’  immunotherapies for the treatment of multiple myeloma, and their main 
competitors are detailed in Table 22 below . 
                                                 
254  Given their early stage of development, the exact efficacy and safety profile s of Celgene’s pipeline and 
most of BMS’ pipelines are still unknown . 
255  See footnote 223. 

 
 
66 compatibility of the Transaction with the internal market and the functioning of the 
EEA Agreement in relation to immunotherapies for multiple myeloma . 
(293)  First , the Parties' pipelines are differentiated products, with distinct MoA  and 
different lines of treatment .  
(294)  BMS' Opdivo is a PD -1 inhibitor.260 Celgene ’s pipelines have different MoA:  
 Imnovid, Revlimid and Thalidomide are immunomodulators (IMid), which  
modulate (or strengthen) the activity of the body’s immune system to enable 
it to attack cancerous cells; whilst their exact modality is unclear, 
immunomodulators demonstrate anti -proliferative effects and help to ‘down -
regulate’ certain cytokines to assist the immune system to fight cancer;  
 CC-92480 and CC -220 are cereblon modulato rs, which act in a similar way 
to immunomodulators and work by binding to the cereblon protein which 
modulates the activity of the immune system;  
 bb2121, bb21217, and JCARH125 are CAR -T therapies, a novel form of 
immunotherapy involv ing the use of genetic  programming to improve the 
ability of immune cells to fight cancer . This is done by (i) removing a 
patient’s own T cells from their body, then  (ii) in a laboratory, genetically 
modifying those T cells, so that they subsequently include a gene called 
chime ric antigen receptor (“CAR”) which is able to bind to certain proteins 
on the patient’s cancerous cells, and finally (iii) injecting the  genetically 
modified T cells back into the patient’s body to attack their ca ncer; and  
 CC-93269 binds to both (i) the BC MA, a protein found on the tumour cells 
and (ii) the CD3 antigen, which is found on cytotoxic T -lymphocytes (T -cells 
that kill cancer), which helps to bring the T -cell to the tumour.  
(295)  Should the Parties’ pipelines reach the market (which is uncertain), ther e is, at this 
point in time and based on the available information , no indication that the efficacy 
and safety profiles of BMS’ and Celgene’s drugs (which have different MoA) would  
be similar .261 
(296)  Moreover, BMS’ Opdivo combination pipeline is for patients with relapsed and 
refractory multiple myeloma and is being trialled for a very late line of treatment 
(i.e. patients with at least three prior lines of treatment), whereas Celgene’s marketed 
and pi peline products are mostly prescribed or trialled as earlier lines of treatment.  
The Commission also notes that the study population in BMS’ Phase I trials includes 
patients who are refractory to immunomodulators, that is to say the MoA of 
Celgene’s market ed products.  
(297)  Second , BMS’ immunotherapy pipeline for multiple myeloma is at a very early stage 
(Phase I/II). Assuming the clinical trials are successful, which remains  highly 
uncertain, it is not expected to be launched before many years . Moreover, at such  an 
                                                 
260  See recital (237)  above for a description of the MoA of Opdivo . 
261  Given their early stage of development, the exact efficacy and safety profile s of BMS’s pipeline and 
several of Celgene’s pipelines are  still unknown . 
 
 
67 early stage, prospective indications remain uncertain and subject to change 
especially with respect to immunotherapies.262 In this respect, the Parties explained 
that trials investigating the expression of PD -1/PD -L1 molecules on malignant 
plasma cells h ave yielded discordant results and that monotherapies based on PD -
/PD-L1 inhibition have shown very limited efficacy in multiple myeloma.   
(298)  Third , the combined entity will face competition from several  pipeline programmes, 
including  (i) pipelines which are at a more advanced stage of development  than 
BMS’ pipeline (such as Keytruda developed by Merk) and (ii) pipelines with the 
same MoA  as the Parties’ ( e.g. PD-1 inhibitors, CAR -T therapy, CD3/BCMA 
Bispecific T cell Engager).  
(299)  Finally , the market investigation did not reveal any substantiated competition 
concerns regarding immunotherapies  for multiple myeloma.  
(300)  For all these reasons , the Commission concludes that the Transaction does not give 
rise to serious doubts as to its compatibili ty with the internal market and the EEA 
Agreement as regards its impact  on competition in relation to immunotherapies for 
multiple myeloma.  
5. CONCLUSION  
(301)  For the above reasons, the European Commission has decided not to oppose the 
notified operation and to de clare it compatible with the internal market and with the 
EEA Agreement. This decision is adopted in application of Article 6(1)(b) of the 
Merger Regulation and Article 57 of the EEA Agreement.   
For the Commission  
 
 
(Signed)  
Margrethe VESTAGER  
Member of th e Commission  
 
                                                 
262  See footnote 223.