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 .   
Brussels,  5.7.2021  
C(2021 ) 5107 final  
PUBLIC VERSION  
 
AstraZeneca plc  
1 Francis Crick Avenue  
Cambridge Biomedical Campus  
Cambridge CB2 0AA  
UK 
Subject : Case M. 10165 – ASTRAZENECA/ALEXION PHARMACEUTICALS  
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 31 May 2021, the Commission received notification of a proposed concentr ation 
pursuant to Article 4 of the Merger Regulation by which AstraZeneca plc (“AstraZeneca”, 
UK) acquires sole control of Alexion Pharmaceuticals Inc. (“Alexion”, US), (the 
“Transaction”).3 AstraZeneca is referred to as the “Notifying Party” and, together  with 
Alexion, the “Parties”.  
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the “Merger Regulation”). With effect from 1 December 2009,  the Treaty on the 
Functioning of the European Union (“TFEU”) has introd uced certain 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”).  
3  Publication in the Offi cial Journal of the European Union No C 215 , 07.06.2021, p. 10.  
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information omitted has been replaced by 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 1. THE PARTIES  AND THE OPERATION  
(2) AstraZeneca  is a UK -based global pharmaceutical company. It focuses on developing and 
marketing treatments for common diseases with large addressable patient populations, with 
three core therapy areas: (i) oncology; (ii) cardiovascular, renal, and metabolism; and (iii) 
respiratory and immunology.  
(3) Alexion  is a US -based biopharmaceutical company focusing on rare and ultra -rare diseases 
for which there is high unmet medical need. Alexion currently ma rkets only five drugs, 
including Soliris, a blockbuster drug for the treatment of several rare diseases ( […]). 
(4) On 12 December 2020, the Parties entered into a definitive merger agreement pursuant to 
which AstraZeneca agreed to acquire all of the shares of Alexion. Following completion of the 
Transaction, AstraZeneca will thus acquire sole control of Alexion. The refore, the  Transaction 
constitutes  a concentration within the meaning of Article 3(1)(b) of the Merger Regulation.  
2. UNION  DIMENSION  
(5) The undertakings  concerned have a combined aggregate worldwide turnover of more than 
EUR 5  000 million  (AstraZeneca : EUR 23 338 million ; Alexion : EUR 5 322 million ).4 Each 
of them has a  Union -wide turnover in excess of EUR 250 million  (AstraZeneca : EUR […] 
million ; Alexion : EUR […] million ), but they do not achieve more than two -thirds of their 
aggregate U nion-wide turnover within one and the same Member State. The notified 
operation therefore has a U nion dimension  pursuant to Article 1(2) of the Merger 
Regulation . 
3. GENERAL CONSIDERATION S 
3.1. Overview of the Parties’ overlapping activities  
(6) AstraZeneca and Alexion are both active in the development and commercialisation of 
pharmaceutical products . Their activities are highly complementary: AstraZeneca focuses on 
prescriptio n drugs for common diseases while Alexion is only active in the rare and ultra -rare 
disease space.5 Consequently, the Transaction only gives rise to a limited number of pipeline -
to-pipeline overlaps with respect to three indications, namely (i) lupus nephritis (“LN”) ; 
follicular lymphoma (“FL”); and (iii) peripheral T -cell lymphoma (“PTCL”) . 
(7) Moreover, A straZeneca manufactures inebilizumab  for its former subsidiary Viela Bio, Inc. 
(“Viela”), controlled by Horizon Therapeutics PLC (“Horizon”) since March 2021. This 
creates a vertical relationship with Alexion’s activities in the treatment of neuromyelitis 
optica spectrum disorder (“NMOSD”) and generalized myasthenia gravis (“gMG”), where 
Viela and  Alexion are competitors.  
3.2. General considerations on market definition  
(8) When defining relevant product markets in past decisions dealing with pharmaceutical 
products  in development (also called pipeline products),6 the Commission has  generally  
                                                 
4  Turnover calculated in accordance with Article 5 of the Merger Regulation.  
5  The European Commission defines a rare disease as one that affects less than 5/10  000 people – see 
https://ec.europa.eu/info/research -and-innovation/research -area/health -research -and-innovation/rare -diseases en .  
6  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 
 
 
 
3 envisaged market definitions based on the indication, the mode of action (“MoA”) and, 
where relevant, the line of treatment  (“LoT”) ,7 but ultimately left open the exact delineat ion 
of the market  definition .8 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 less clearly defined than for marketed products, reflecti ng the 
intrinsic uncertainty in analysing products that do not exist yet.9 In terms of geographic 
scope, the Commission has consistently considered that the markets for pipeline drugs are at 
least EEA -wide.10  
(9) The Commission will analyse in Sections 4 and 5  below the relevance of these precedents 
for the relevant product and geographic market definitions in the present case.  
3.3. General approach to competitive assessment  
(10) Article 2 of the Merger Regulation requires the Commission to examine whether notified 
conc entrations 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.  
(11) The Commission Guidelines on the assessment of horizontal mergers under t he Council 
Regulation on the control of concentrations between undertakings (the “Horizontal Merger 
Guidelines ”)11 specify that concentrations between actual or potential competitors may 
significantly impede effective competition as a result of the creation  or strengthening of a 
dominant position or the removal of a significant competitive constraint.12 The Horizontal 
Merger Guidelines also indicate that mergers involving a potential competitor may restrict 
effective competition by ways of horizontal anti -competitive effects, either coordinated or 
non-coordinated.13  
(12) In this framework, “competition” is understood to mean product and price competition 
(actual or potential) , but also innovation competition.14 In this respect, the Commission 
assesses i nnovation com petition in relation to (i) 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 
                                                                                                                                                      
“Phase III” clinical trials), which are s trictly regulated to ensure the protection of trial subjects and the reliability of 
the results. The phases of clinical development for pipeline products can be described as follows.  Phase I  starts with 
the initial administration of a new drug to humans, w ith 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 identify the appropriate dosage and exposure -response re lationship. 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 the intended indication and recipient population. Usually, Phase 
III trials will i nvolve 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 approval. Phase IV  begins after drug approval to 
monitor possible adverse reactions and/or new side effects over time.  
7  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 pro ven ineffective 
or if this other therapy cannot be prescribed to a specific patient.  
8  See case M.9294 – BMS/Celgene , para. 14.  
9  See cases M.9294 – BMS/Celgene , para. 16; and M.7275 - Novartis/GSK Oncology , para. 26.  
10  See most recently, case M.9461 – AbbVie/Allergan , para. 13.  
11  OJ C31, of 5 February 2004, p. 5.  
12  Horizontal Merger Guidelines, paras. 24 -25.   
13  Horizontal Merger Guidelines, paras. 22 and 58 -59. Section 4 (Horizontal analysis) focuses on horizontal non -
coordinated effects as the Tra nsaction does not give rise to horizontal coordinated effects.  
14  See case M.8084 - Bayer/Monsanto , para. 48.  
 
 
4 pipelines) ; and (ii) the capability to innovate in certain innovation spaces, assessing the risk 
of a significant loss of innovation competition resulting from a structural reduction of the 
overall level of innovation.15 
(13) The Commission Guidelines on the assessment of n on-horizontal mergers under the Council 
Regulation on the control of concentrations between undertakings (the “Non -Horizontal 
Merger Guidelines”)16 distinguish between two main ways in which vertical mergers may 
significantly impede effective competition, n amely input foreclosure and customer 
foreclosure.17  
(14) For a Transaction to raise input foreclosure competition concerns, the merged entity must 
have a significant amount of market power upstream.18 In assessing the likelihood of an 
anticompetitive input forec losure strategy, the Commission has to examine whether (i) the 
merged entity would have the ability to substantially foreclose access to inputs, (ii) whether 
it would have the incentive to do so, and (iii) whether a foreclosure strategy would have a 
signif icant detrimental effect on competition downstream.19  
(15) The Commission will analyse the horizontal overlaps and vertical links arising from the 
Transaction against this framework in Sections 4 and 5 below.  
4. HORIZONTAL ANALYSIS  
4.1. Lupus nephritis (“LN”)   
4.1.1.  Introdu ction  
(16) LN is a severe and rare renal complication of systemic lupus erythematosus  (“SLE”) , in which 
deposits of immune  complexes accumulate in the kidney and lead to renal injury.  LN is 
developed by around 30% of the  SLE patients . LN is characterised by a high unmet medical 
need, a large number of LN patients being refractory to treatments and progressing to end -
stage renal disease ( “ESRD”, i.e. a stage whe re the kidneys cease to function on a permanent 
basis) requiring dialysis and kidney transplant.  LN se verity can be classified based on the 
classification of the International Society of Nephrology (ISN) : Class I & II (mild disease) ; 
Class III & IV (severe and proliferative focal and diffuse disease) ; Class V (membranous 
disease, slower progression); Class  VI (ESRD – no treatment available) . 
(17) In the EEA, the current treatment algorithm for LN (Class III -V) consists of (i) a 
combination of steroids (glucocorticoids) with immunosuppressants ( e.g. mycophenolate 
                                                 
15  See in the pharmaceutical sector case M.9294 – BMS/Celgene , para. 22. In the present case, the Transaction does not 
raise competition concerns in relation to (ii) since the Parties are not active in the same R&D spaces. Alexion’s R&D 
mainly focuses on rare diseases and, in particular, on the complement pathway ( i.e. a specific pathway of the immune 
system). Apart from a few isolated pipeline drug s, AstraZeneca is not present in those R&D spaces, which was 
confirmed by market investigation (see notably responses to question 52.1 of questionnaire Q1 to competitors: “ we 
are not aware of any presence of AstraZeneca in relation to the complement pathwa y” and “ Alexion currently has a 
strong position with respect to rare diseases in the inflammation field . (…) We are not aware of any activity of 
AstraZeneca in this area ”). Moreover, the rare diseases and complement pathway R&D spaces appear rather 
competi tive, with many players, including e.g. Roche, Takeda Shire, Sanofi and Apellis Pharmaceuticals (see 
responses to question 53.4 of questionnaire Q1 to competitors).  
16  OJ L24, 29.1.2004, p. 1.  
17  Section 5 (Vertical analysis) focuses on input foreclosure a s the Transaction does not give rise to customer 
foreclosure concerns.  
18  Non-horizontal Merger Guidelines, para. 35.  
19  Non-horizontal Merger Guidelines, para. 32. Each of these points will be analysed separately although the 
Commission recognises that th ey are intertwined.  
 
 
5 mofetil  (“MMF”) or cyclophosphamide (“CYC”)) as frontline treatments; and (ii) a 
combination of steroids with rituximab or calcineurin inhibitors for refractory LN.20 
4.1.2.  Market Definition  
(A) Product market definition  
(18) In the absence of Commission precedents for LN  treatm ents, the Notifying Party considers that 
all marketed and pipeline treatments for LN compete against each other and that the market 
should not be further segmented . In any event, the Notifying Party submits that th is question 
can be left open as no competition concerns arise under any plausible market definition s.21  
(19) The market investigation was not conclusive as to whether the treatments for LN should be 
sub-segmented notably because many of the LN drugs are still at the development stage and 
there i s an intrinsic level of uncertainty in assessing their future characteristics and market 
positioning. In particular, based on the results of the market investigation, it is not clear 
whether the following potential segmentation s are warranted : 
i. Segmentation based on the MoA : LN drugs with different MoAs target different 
pathway s and, thus , may translate into distinct efficacy and safety profile s, which are 
key factors for physicians when prescribing drugs.22 However , at this stage, given the 
limited available data, the exact efficacy and safety profile of the various LN pipeline 
drugs remains uncertain. Moreover,  all the competitors expect LN pipeline drugs based 
on different MoAs to compete with one another and generally consider that the MoA is 
not an important criterion for physicians;23  
ii. Segmentation based on the LoT: albeit some of the Parties’ internal documents 
distinguish LN drugs depending on their LoT and suggest limited competition between 
drugs belonging to different LoTs ,24 the results of the market investigation were not as 
clear. In particular , KOLs stress ed that the “place of LN pipeline drugs in the treatment 
algorithm is unclear ”25 and the feedback received from competitors regarding the 
competition between LN drugs belo nging to different LoTs was rather mixed.26 
(20) In any event , for the purpose s of this decision , the Commission concludes that the exact 
scope of the market for treatments of LN 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 under any plausible market definition s (i.e. segmentations by MoA 
and by LoT) .  
(B) Geographic Market Definition  
(21) As regards the geographic market  definition , the Commission has consistently considered 
the markets for pipeline drugs to be at least EEA -wide in scope.27 The Notifying Party does 
                                                 
20  Responses to question 4 of questionnaire Q1 to competitors and Non-confidential minutes of a call with a LN Key 
Opinion Leader (“KOL”) dated 21.04.2021 (1).  
21 Form CO, paras. 206 and ff.  
22 Responses to question 6 of questionnaire Q1 to competitors.  
23 Responses to questions 6 and 12 of questionnaire Q1 to competitors.  
24 See e.g. the Parties’ reply to RFI 1, Annex 17, p. 4: “ […]” (emphasis added).  
25  Non-confidential minutes of a call with a LN KOL dated 21.04.2021 (12:15 pm CET).  
26  Responses to question 5 of questionnaire Q1 to competitors. For instance, a competitor stated that although “ by 
definition of refractory LN, patients would need to fail the frontline treatment […] [i]n the case of relapse, either 
frontline treatment or nov el drug could be used ”. 
27  See Section 3.2 above.  


 
 
8 (31) Finally , none of the KOLs and competitors expressed concerns about the impact of the 
Transaction on the market for LN treatments in the EEA  and the potential discontinuation, 
re-orientation and delay of the Parties’ pipeline drugs.40 
4.1.5.  Conclusion  
(32) In view of the above considerations, 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 ma rket for the 
treatment s of LN  (and its plausible sub -segmentations) . 
4.2. Follicular Lymphoma (“FL”)  
4.2.1.  Introduction  
(33) FL is  a rare and indolent subtype of  Non-Hodg kin lymphoma  (blood cancer ), which leads to 
abnormal B -cells building up in the lymph nodes or other body parts. FL affects mainly 
older patients (the median age at diagnosis is above 60 years old) and progresses slowly  (the 
median time from diagnosis to death in FL is over 20 years ). Ultimately, 30 -40% of the FL 
cases transform into diffuse large B -cell lymphoma, a more aggressive type of lymphoma. 
There are different degrees of gravity ranging from stage I to IV: Stage I (the disease is 
located in a single region, e.g. a lymph node ); Stage II (the disease is located in two separate 
regions confined to one side of the diaphragm); Stage III (the disease involves both sides of 
the diaphragm)  and Stage IV (diffuse disease).  
(34) In the EEA, the current treatment algorithm for FL (stage III -IV) consists of (i) a 
combination of chemotherapy ( e.g. CHOP )41 with immunotherapy (typically CD20 
inhibitors, such as rituximab ) as first -line treatments for young/fit patients (no chemotherapy 
for old/unfit patients, e.g. rituximab  monotherapy); (ii) a co mbination of chemotherapy with 
immunotherapy as second -line treatments (either repetition of the first -line combined 
treatment or another combination); and (iii) PI3K inhibitors ( e.g. Idelalisib ) or novel agents 
(i.e. enrolment in clinical trials) for thir d-line treatments.42 
4.2.2.  Market definition  
(A) Product market definition  
(35) In the absence of Commission precedents  for FL  treatments , the Notifying Party submits that 
all marketed and pipeline treatments for FL belong to the same product market  and should 
not be further segmented.  In any event, according to the Notifying Party , this question can be 
left open as no competition concerns arise under any plausible market definition s.43 
(36) The market investigation was not conclusive as to whether the treatments for FL sho uld be 
sub-segmented , notably because many of the FL drugs are still at the development stage and 
there is an intrinsic level of uncertainty in assessing their future characteristics and market 
positioning. In particular, based on the results of the market  investigation, it is not clear 
whether the following potential segmentation s are warranted : 
                                                 
40  Responses to questions 17 and 18 of questionnaire Q1 to competitors. See also Non -confidential minutes of calls 
with LN KOLs, dated 21.04.2021 (12:15 pm CET and 3:30 pm CET).  
41  Chemotherapy combination of cyclophosphamide, hydrodaunorubicin, oncovin  and prednisone . 
42  Responses to question 20 of questionnaire Q1 to competitors and Non-confidential minutes of a call with FL KOL, 
dated 21 April 2021.  
43  Form CO, paras. 329 and ff.  

 
 
10 (40) AstraZeneca is developing capivasertib,  an AKT inhibitor , which is target ing patients that 
[…] and only recently started Phase II trials for FL (in May 2021 ). If the trials are 
successful, capivasertib  is expected to reach the EEA market at the earliest in […]. 
(41) Alexion is developing cerdulatinib , a dual SYK/JAK inhibitor  currently undergoing Phase 
I/IIa trials for Non -Hodgkin Lymphoma, includin g FL (and PTCL), […]. Cerdulatinib  was 
acquired by Alexion […] in July 2020  in the context of a broader transaction  (i.e. Alexion’s  
acquisition of Portola Pharmaceuticals)  […]. Since then, [Alexion’s plans for 
cerdulatinib ].52  
(42) Therefore, in the market for FL treatments (including in the potential segment for […]), the 
Transaction gives rise to a pipeline -to-pipeline overlap between AstraZeneca’s capivasertib  
and Alexion’s cerdulatinib . No overlap arise s if the market is segmented by MoA.  
4.2.4.  Competitive assessment  
(43) The Notifying Party  argue s that no competition concerns arise in FL under any plausible 
market delineations given notably (i) the early development stage and the uncertain 
development status of the Parties’ pipeline products, (ii) th eir different MoAs, (iii) 
[Alexion’s plans for cerdulatinib ], and (iv) the existence of many competing drugs .53  
(44) The market investigation  generally confirms the Notifying Party’s  claim s and, for the 
reason s set out  below, 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 between the Parties’ activities in FL .  
(45) First , the Parties’ FL pipeline drugs are not seen by KOLs as being particularly promising 
and the Parties are not perceived as major players in FL.54 In particular, a KOL stressed that 
“the first preliminary data for the Parties’ pipeline drugs is not very promising ”.55 The 
market participants also generally note that the exact profiles and prospects of these drugs 
remain uncertain due to their early stage  of development and the limited available data .56 
(46) Second , AstraZeneca’s and Alexion’s pipeline products have different MoAs  and, thus,  are 
developed, they are not expected to closely compete  (should they both reach the market) .57 
(47) Third , as illustrated in Table 4 below, and irrespective of the exact scope of the market,58 the 
Parties  face a large number of competing (marketed and pipeline) drugs . In this respect , 
market participants generally consider that the FL pipeline  is very competitive , including 
drugs that are more advanced and more promising than the Parties’ .59 For instance , a 
                                                 
52  Form CO, paras. 326 -328.  
53  Form CO, paras. 357 and ff.   
54  See notably Responses  to question 29 of questionnaire Q1 to competitors.  
55 Non-confidential minutes of a call with a FL KOL, dated 21.04.2021.  
56  Responses to question 29 of questionnaire Q1 to competitors. See also non-confidential minutes of a call with a FL 
KOL, dated 21.0 4.2021.  
57  Responses to question 31 of questionnaire Q1 to competitors.  
58  As explained in Section 4.2.2(A), the novel agents currently in the FL pipeline are expected to be mainly prescribed 
after the failure of frontline treatments (similarly to the Part ies’ drugs) . 
59  Responses to questions 26, 27 and 29 of questionnaire Q1 to competitors. See also Non-confidential minutes of a call 
with a FL KOL, dated 21.04.2021 identifying bispecific antibodies CD20 and CD3 (such as Regeneron’s pipeline 
drug) and CAR T cell therapies (currently under development by Novartis and BMS) as the most promising pipeline 
drugs based on the currently available data.  

 
 
12 4.3. Peripheral T -Cell Lymphoma (“PTCL”)  
4.3.1.  Introduction  
(51) PTCL is  another rare type of Non-Hodgkin  lymphoma  (blood cancer) , which leads to 
abnormal T -cells building up in the lymph nodes or other body parts. PTCL is an aggressive 
disease (t he median time from diagnosis to death in PTCL is around three years) , which 
mainly affects older patients (the median age of diagnosis is  60 years old).  It is also an 
heterogeneous disease, with m any subtypes , including notably Angio -Immunob lastic T -cell 
lymphoma (“AITL ”), anaplastic large cell lymphoma (“ALCL ”), PTCL - not otherwise 
specified (“PTCL - NOS ”). PTCL is characterised by a high  unmet medical need, with low 
overall response rates to the few existing therapies and high mortality rate s.  
(52) In the EEA, the current treatment algorithm for PTCL consists of (i) chemotherapies (such 
as CHOP or CHOEP67), or a combination of CHOP with the anti -CD30 brentuximab vedotin 
Adcetris (for ALCL only), as frontline treatments, followed by an autologous stem cell 
transplant for young/fit patients responding to the chemotherapy (consolidation treatment); 
(ii) no real standard of care for relapse a nd refractory (“r/r”)  PTCL, except for ALCL 
patients who can be treated with Adcetris (monotherapy).68 
4.3.2.  Market definition  
(A) Product market definition  
(53) In the absence of Commission precedents  for PTCL  treatments , the Notifying Party 
considers that all marketed and potential pipeline treatments for PTCL are part of the same 
product market  and should not be further segmented.  In any event, the Notifying Party 
submits that this question can be left open as no competition concerns arise under any 
plausible market definition s.69 
(54) The results of the market investigation are not conclusive as to whether the treatments for 
PTCL  should be sub -segmented , notably because many of the PTCL  drugs are still at the 
development stage and there is an intrinsic leve l of uncertainty in assessing their future 
characteristics and market positioning. In particular, based on the results of the market 
investigation, it is not clear whether the following potential segmentation s are warranted:  
i. Segmentation based on the MoA : similarly to the other overlapping indication s, the 
Commission found that PTCL treatment s with the same MoA are “ more likely to be seen 
as close alternatives ”,70 with similar efficacy and safety profiles. That being said, at this 
stage, given the limited available data, the exact profile of the various PTCL pipeline 
drugs remains highly speculative71 and the feedback received from the market regarding 
the relevance of a segmentation of the PTCL market by MoA was not conclusive.72 In 
any event, as illustrated  in Tables 5 and 6 below, it appears that “[PTCL] drugs having 
the exact same MoA is fairly rare ”;73 
                                                 
67  CHOP  chemotherap y combination (see fn. 41) with the addition of etoposide.  
68  Responses to question 36 of questionnaire Q1 to competitors and Non -confidential minut es of a call with a PTCL 
KOL, dated 19.04.2021.  
69  Form CO, paras. 499 and ff.  
70  Non-confidential minutes of a call with a PTCL KOL, dated 29.04.2021.  
71  Non-confidential minutes of a call with a PTCL KOL, dated 22.04.2021.  
72  Responses to question 45 of questionnaire Q1 to competitors.  
73  Non-confidential minutes of a call with a PTCL KOL, dated 05.05.2021.  

 
 
14 [confidential summary of why Dizal ’s product is attributed to AstraZeneca for 
purposes of EU merger control assessment] . DZD4205 is a selective JAK1 and JAK3 
inhibitor currently undergoing Phase I/II trial s. At this stage, none of AstraZeneca’s pipeline 
drugs targets a specific PTCL subtype. All AstraZeneca’s pipe line drugs for the treatment of 
PTCL target relapse and refractory patients.  
(59) Alexion is developing cerdulatinib , a dual SYK/JAK  inhibit or, targeting both the JAK and 
SYK pathways (as opposed to AstraZeneca’s DZD4205, which is a more selective JAK 
inhibitor , targeting only the JAK pathway). Cerdulatinib  is currently undergoing Phase I/IIa 
trials  and does not target a specific PTCL subtype. It also targets relapse and refractory 
patients. Moreover, a s explained in Section 4.2.2(A), [Alexion’s plans for cerdulatinib ].79  
(60) Therefore , in the market for PTCL  treatments (including if the market is segmented by LoT), 
the Transaction gives rise to pipeline -to-pipeline overlaps for the treatment of PTCL 
between (i) AstraZeneca’s AZD4573 and Alexion’s cerdulatinib ; and (ii) Astrazeneca’s 
DZD4205 and Alexion’s cedulatinib . No overlap s arise if the market is segmented by MoA 
and by subtypes of PTCL  (since none of the Parties’ pipeline products is developed for a 
specific PTCL subtype) .  
4.3.4.  Competitive assessment  
(61) The Notifying Party argues that no competition concerns arise in PTCL under any plausible 
market delineations given notably the fact that the Parties’ pipeline products (i) are still at an 
early stage of development,  (ii) have differentiated MoAs  and (iii)  face strong competition 
from a number of drugs . The Notifying Party also submits that (iv) [Alexion’s plans for 
cerdulatinib ] and (v) Dizal ( i.e. the Chinese company controlled by AstraZeneca 
developing a PTCL pipeline) is subject to an ongoing I nitial Public Offering ( i.e. a public 
offering in which shares of a company are sold to investors; “IPO”) .80  
(62) The market investigation generally confirms the Notifying Party’s claim s and, for the 
reasons set out below , 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 s between the Parties’ activities in PTCL treatments .  
(63) First , the Parties’ PTCL pipeline drugs are not seen by KOLs and market participants  as 
being particularly promising.81 For instance, a  KOL  noted that the “ interest in SYK 
inhibition within the context of T -Cell Lymphomas […] has recently declined ” and stated 
that he was “pessimistic about the likelihood of the Parties getting licenses for treatments in 
PTCL ”.82 Another KOL explained that the limited preliminary data available for 
cerdulatinib  in PTCL did not suggest a significant improvement compared to the current 
standard of care.83 The respondents also generally stressed that the Parties’ products  are 
early stage pipeline drugs, with highly uncertain prospects .84  
(64) Second , the Commission received rather mixed feedback from the market about the 
differentiation between the Parties’ pipeline s, in particular between AstraZeneca’s DZD4205 
and Alexion’s cerdulatinib . On the one hand, some KOLs explained that these two drugs have 
the p otential to closely compete with each other  because of their similar MoAs (JAK inhibitor 
                                                 
79  Form CO, paras. 326 -328.  
80  Form CO, paras. 512 and ff.  
81  Responses to question 46 of questionnaire Q1 to competitors.  
82  Non-confidential minutes of a call with a PTCL KOL, dated 05.05.2021.  
83  Non-confidential minutes of a call with a PTCL KOL, dated 19.04.2021.  
84  Non-confidential minutes of calls with PTCL KOLs, dated 19.04.2021 and 22.04.2021.  
 
 
15 vs. SYK/JAK inhibitor), which “overlap to some extent as they both target the JAK 
pathway ”.85 On the other hand, other KOL s stressed that a pure JAK inhibitor is more 
selective than a combined SYK/JAK inhibitor, with potentially less side effects:  “although the 
mechanisms of action of DZD4205 (JAK inhibitor) and cerdulatinib (SYK/JAK inhibitor) 
overlap to some extent […], the two drugs do not target the exact same pathwa ys and 
DZD4205 is more selective than cerdulatinib […] at this stage, it is not obvious that these 
pipeline drugs will have similar efficacy and safety profiles ”.86 Consequently, some 
respondents consider the new entity “ may have incentives to pursue in par allel the 
development of the Parties’ respective PTCL pipeline drugs (notably because these drugs may 
in fine be used in different settings) ”.87 That said, respondents generally emphasize the fact 
that, given the limited available data, it is too early to a ssess the closeness of competition 
between these drugs without speculating.88 
(65) Third , as illustrated in Table 6, and irrespective of whether the market is segmented  by 
LoT,89 the Parties  face several  drugs specifically approved or developed for PTCL, 
including one marketed drug recently approved (Adcetris)90 and many competing pipelines 
currently in Phase II (i.e. a stage of development similar to or more advanced than the 
Parties’) . In this respect, the evidence in the file suggests that the PTCL pipel ine is 
increasing ly competitive ( e.g. a KOL stressed the “ rising number pipeline treatments 
targeting PTCL ”)91 and includ es drugs that are seen as being more promising  than the 
Parties ’, such as Affimed’s AFM13 (anti-CD30/CD16 A) and SecuraBio’s Copiktra  (anti-
PI3K).92  
                                                 
85  Non-confidential minutes of a call with a PTCL KOL dated 19.04.2021. See also Non -confidential minutes of a call 
with a PTCL KOL , dated 29.04.2021 stating that, in theory, “ two treatment with the same or similar modes of action 
are more likely to be seen as close alternatives” but that “ there is no definitive answer ” as to whether AstraZeneca’s 
DZD4205 and Alexion’s cerdulatinib  would closely compete (emphasis added).  
86  Non-confidential minutes of a call with a PTCL KOL dated 22.04.2021. See also Non -confidential minutes of a call 
with a PTCL KOL dated 19.04.2021: “ DZD4205 is a more selective JAK inhibitor than cerdulatinib , which could 
potentially translate into a better safety and tolerability profile ”. 
87  Non-confidential minutes of a call with a PTCL KOL dated 22.04.2021.  
88  Non-confidential minutes of call with PTCL KOLs dated 19.04.2021, 22.04.2021 and 29.04.2021. See also 
Responses to question 47 of questionnaire Q1 to competitors.  
89  As explained in Section 4.3.2(A) above, the evidence in the file suggests that all pipeline drugs currently being 
developed (including the Parties’) are targeting relapsed and refractory PTCL.  
90  In the EEA, to the exception of Adcetris, there is currently no drug specifically approved for relapse and refractory 
PTCL. In the US, three drugs, namely Folotyn (pralatextrate), Istodax (romidepsin) and Beleodaq (belinostat), have 
been approved by th e FDA and are currently available on the market for relapse and refractory PTCL. However, 
given their limited proven clinical benefits, these drugs were considered as falling short of the EMA’s requirement 
for a drug to be approved and, thus, are not avail able in Europe.  
91  Non-confidential minutes of a call with a PTCL KOL dated 19.04.2021.  
92  Non-confidential minutes of calls with PTCL KOLs dated 19.04.2021 and 22.04.2021.  

 
 
17 5.2. The Parties’ activities and products  
(72) AstraZeneca manufactures inebilizumab  for its former subsidiary Viela Bio, Inc. (“Viela”, 
controlled by Horizon since March 2021). This creates a vertical relationship with Alexion’s 
activities in the treatment of NMOSD and gMG, where Viela and  Alexion are competitors . 
(73) Viela  (a spin -off of AstraZeneca acquired by Horizon in 202 1) markets in the US97 Uplizna  
(inebilizumab ), a drug used for the treatment of NMOSD. Uplizna is also undergoing Phase 
III clinical trials for the treatment of gMG. Viela sources manufacturing services related to 
Uplizna from AstraZeneca. Uplizna directly competes with some of Alexion’s markete d 
drugs and pipeline projects. In particular , (i) Alexion’s product Soliris (eculizumab ) is 
marketed, among others, for the treatment of NMOSD and gMG in the EEA ; and (ii) 
Alexion’s pipeline product Ultomiris ( ravulizumab ) is in Phase III clinical trials for the 
treatment of NMOSD and gMG.98 
5.3. Competitive assessment  
(74) As previously indicated, the Transaction gives rise to a potential vertical relationship 
between the manufacture (upstream) and the sales (downstream) of drugs for the treatment 
of NMOSD and gMG.  
(75) […], competition concerns have been raised in relation to the above vertical link on the 
ground that the new entity would have the ability and the incentive to implement an input 
foreclosure strategy by discontinu ing or degrad ing the manufacture of Uplizna  so as to 
favour Alexion’s products for the treatment of NMOSD and gMG . Consequently, […], the 
supply agreement between AstraZe neca and Horizon concerning Uplizna has been 
amended99 to prevent the above risk.100  
(76) In this respect, the Commission notes that the amended supply agreement includes 
provision s (i) to avoid the risk of supply disruption […] and (ii) to facilitate the transfer of 
the technology and the manufacture of Uplizna […]. Moreover, Horizon expressly 
confirmed to the Commission that it is satisfied with the amendments and that as revised, the 
supply agreement provides sufficient safegua rds to secure the manufacture of Uplizna.101  
5.4. Conclusion  
(77) In view of the above considerations, the Commission concludes that  the vertical link arising 
in relation to NMOSD and gMG  does not give rise to serious doubts as to the compatibility 
of the Transaction  with the internal market and the functioning of the EEA Agreement.  
                                                 
97  Uplizna  is not yet commercialised in the EEA. Horizon anticipates an EMA approval for NMOSD by the end of 
2021. Horizon does not yet ha ve a timeline for the marketing of Uplizna  for gMG in the EEA.  
98  Ultomiris is expected to be launched in the EEA in [ …] for NMOSD and [ …] for gMG.  
99  […].  
100  […].  
101  Non-confidential minutes of a call with Horizon, dated 30.04.2021.  
 
 
18 6. CONCLUSION  
(78) For the above reasons, the Commission has decided not to oppose the notified operation and 
to declare 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  
Executive Vice -President