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, 31.5.2022  
C(2022 ) 3726 final  
PUBLIC VERSION  
 
CSL Limited  
45 Poplar Road  
Parkville, Victoria 3052  
Australia  
Subject : Case M. 10629  – CSL  / VIFOR PHARMA  
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 26 April 2022 , the European Commission received notification of a proposed 
concentration pursuant to Article 4 of the Merger Reg ulation by which CSL Limited 
(“CSL”, Australia), through its subsidiary CSL Behring AG  (“CSL Behring”) , will 
acquire  sole control of  Vifor Pharma Ltd. (“Vifor  Pharma ”, Switzerland)  (the 
“Transaction”) .3 CSL and Vifor Pharma are together referred to as 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 introduced 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 th e Official Journal of the European Union No C 180, 03.05.2022 , p. 14. 
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information omitted has been replaced by 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) CSL  is an Australia -based biotechnology company with a portfolio of life -saving 
medicines, including those that treat hemophilia and immune deficiencies (through 
CSL Behring), as well as vaccines to prevent influen za (through  its subsidiary  
Seqirus  UK Limited ). In addition, CSL Plasma, a division of CSL Behring, operates 
a plasma collection network.  
(3) Vifor Pharma  is a Swiss -based pharmaceutical company active worldwide in the 
development, manufacturing, and marketing of pharmaceutical products for the 
treatment of iron deficiency, nephrology (kidney care), and cardio -renal therapies.  
(4) The Transaction is effected b y way of a public tender offer to acquire all of Vifor 
Pharma’s publicly held shares, pursuant to a transaction agreement entered into by 
CSL and Vifor Pharma on 14 December 2021 (the “Transaction Agreement”). 
Pursuant to the terms of the Transaction Agree ment, CSL will acquire Vifor 
Pharma’s shares for USD 179.25 (approximately EUR 158) per share for a total cash 
purchase price of approximately USD 11.7 billion (approximately EUR 10.37 
billion).  
(5) Pursuant to the Transaction Agreement, CSL will acquire up to  100% and at least 
80% of the share capital of Vifor Pharma. Following the completion of the 
Transaction, CSL will thus acquire sole control of Vifor P harma, and  the Transaction 
constitutes a concentration within the meaning of Article 3(1)(b) of the Merge r 
Regulation.  
2. UNION  DIMENSION  
(6) The undertakings concerned have a combined aggregate world -wide turnover of 
more than EUR 5 000 million  (CSL: EUR 8 717 million; Vifor  Pharma : EUR 1 593  
million).4 Each of them has a  Union -wide turnover in excess of EUR 250 mi llion 
(CSL: […] million ; Vifor Pharma: […] 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) o f the Merger Regulation .  
3. GENERAL CONSIDERATION S  
3.1. General considerations on market definition  in relation to pipeline products  
(7) When defining relevant product markets in past decisions dealing with 
pharmaceutical products in development (also called pipeline products),5 the 
                                                 
4  Turnover calculated in accordance with Article 5 of the Merger Regulation . 
5  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 . Clinical 
trials in humans  (so called “Phase I”, “Phase II” and “Phase III” clinical trials) are strictly regulated to 
ensure the protection of trial subjec ts and the reliability of the results. The phases of clinical development 
for pipeline products can be described as follows.  A Phase I  clinical t rial starts with the initial 
administration of a new drug to humans, with trials carried out on a small number of people (e.g. in 
 
 
 
3 Commission has generally  envisaged market definitions based on the indication, the 
mode of action (“MoA”) , the mode of delivery (“MoD”)  and, where relevant, the 
line of treatment (“LoT”),6 but ultimately left open the exact delinea tion of the 
market definition.7 The Commission also found 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, 
reflecting the intrinsic uncertainty in analysing products that do not exist yet.8 In 
terms of geographic scope, the Commission has consistently considered that the 
markets for pipeline drugs are at least EEA -wide.9 
(8) The Commission will analyse in Sections 4.1.2  and 4.2.2  below the relevance of 
these precedents for the relevant product and geographic market definitions in the 
present case.  
3.2. General approach to competitive assessment  
(9) Article 2 of the Merger Regulation requires the Commission to examine whether 
notified concentrations are compatible w ith the internal market, by assessing whether 
they would significantly impede effective competition in the internal market or in a 
substantial part of it.  
(10) The Commission Guidelines on the assessment of horizontal mergers under the 
Council Regulation on the  control of concentrations between undertakings (the 
“Horizontal Merger Guidelines”)10 specify that concentrations between actual or 
potential competitors may significantly impede effective competition as a result of 
the creation or strengthening of a domin ant position or the removal of a signi ficant 
competitive constraint.11 The Horizontal Merger Guidelines also indicate that 
                                                                                                                                                      
oncology, the sample size is usually in the low tens). The focus of a Phase I trial is to confirm that the 
drug is safe to use in humans and identify the appropriate dosage and exposure -response relationship.  A 
Phase II  clinical trial 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  clinical trials aim to demonstrate or confirm  the therapeutic benefit in a larger group of patients 
(Phase III clinical 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 clinical trial s 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 approval by the regulatory agencies. There are also Phase  IV clinica l tria ls, but they  begin only 
after drug approval to monitor possible adverse reactions and/or new side effects over time. 
6  LoT refers to the setting for which a specific drug is indicated. For example, a drug indicated for second -
line treatment should be used only after another therapy (the first -line treatment) has proven ineffective or 
if this other therapy cannot be prescribed  to a specific patient.  
7  See e.g. case M.10165 – Astrazeneca/Alexion Pharmaceuticals , para. 8  and case M.9294 – BMS/Celgene , 
para. 14.  
8  See e.g. cases M. 10165 – Astrazeneca/Alexion Pharmaceuticals , para. 8. M.9294 – BMS/Celgene , para. 
16, and M.7275 - Novartis/GSK Oncology , para. 26.  
9  See most recently, case M. 10165 – Astrazeneca/Alexion Pharmaceuticals , para. 8. 
10  OJ C31, of 5 February 2004, p. 5.  
11  Horizontal Merger Guidelines, paras. 24 -25. 
 
 
4 mergers involving a potential competitor may restrict effective competition by ways 
of horizontal anti -competitive effects, either coordinated or non -coordinated.12 
(11) In this framework, “competition” is und erstood to mean product and price 
competition (actual or potential), but also innovation competition.13 In this respect, 
the Commission assesses innovation competition in relation to (i) the parties’ 
ongoing pipeline products, assessing the risk of signific ant loss of innovation 
competition resulting from the discontinuation, delay or redirection of the 
overlapping pipelines (including early stage pipelines); and (ii) the capability to 
innovate in certain innovation spaces, assessing the risk of a significan t loss of 
innovation competition resulting from a structural reduction of the overall level of 
innovation.14 
(12) The Commission will analyse the horizontal overlaps arising from the Transaction 
against this framework in Sections  4.1 and 4.2 below.   
4. COMPETITIVE ASSESSMEN T 
(13) The Transaction gives rise to only a limited number of pipeline -to-pipeline overlaps 
with respect to two indications: (i) sickle cell disease (“SCD”) and (ii) hidradenitis 
suppurativa (“HS”).15 
                                                 
12  Horizontal Merger Guidelines, paras. 22 and 58 -59. Se ction 4 (Horizontal analysis) focuses on horizontal 
non-coordinated effects as the Transaction does not give rise to horizontal coordinated effects.  
13  See recently case M.10165 – Astrazeneca/Alexion Pharmaceuticals , para. 12 and case M.8084 - 
Bayer/Monsanto , para. 48.  
14  See also e.g. the pharmaceutical sector case M.9294 – BMS/Celgene , para. 22. In the present case, the 
Transaction does not give rise to serious doubts as to possible competition concerns in relation to (ii)  the 
capability to in novate in certain innovation spaces . The Parties are generally not active in the same R&D 
spaces  and to a large extent the parties’ activities are complementary . CSL’s R&D capabilities are focused 
on plasma fractionation, recombinant technology, gene and c ell therapy and vaccines, while Vifor 
Pharma ’s activities are focused  on iron deficiency, nephrology and rare diseases. In the  majority of  the 
limited broad therapeutic areas where the Parties’ R&D activities could be considered as potentially 
overlapping (immunology, haematology, cardiovascular and metabolic, and transplant s), competitors 
confirm that none of the Parties are considered to be strong R&D players in the development of 
pharmaceutical products. The only overlapping therapeutic area where  one of  the Parties, namely Vifor 
Pharma, could potentially  be considered a strong player at R&D level is  nephrology. However, CSL has 
no marketed products in the nephrology area and competitors confirm that CSL could not be considered a 
strong R&D player in neph rology (see responses to questions 37.1. of questionnaire Q1 to competitors) , 
and that nephrology is a competitive  therapeutic area with many large players active, including 
AstraZeneca, Roche, Fresenius, Baxter, and Terumo (see responses to questions 37.2. of questionnaire Q1 
to competitors ). In addition, i n all the overlapping therapeutic areas, including , responding competitors 
consider that a sufficient number of companies will remain active (see responses to questions 39 of 
questionnaire Q1 to compet itors).  
15  For the sake of completeness, it should also be noted that th e Transaction also gives rise to two potential 
overlaps between marketed/late stage pipeline products of Vifor Pharma and early stage products (Phase I) 
of CSL because those pipeline p roducts could potentially be developed for the same indications in the 
future, namely: (i) anti -neutrophil cytoplasmic auto -antibody (“ANCA”) -associated vasculitis (“AAV”) 
and (ii) IgA nephropathy (IgAN).  
 
 As regards AAV, Vifor Pharma markets  avacopan (T avneos®), an approved and marketed drug for AAV 
in the EEA. CSL develops the pipeline product  […], with AAV as […]. At this stage, i t remains uncertain 
whether  AAV will be one of the indications for […]. Even i f […] is developed and approved for AAV, the 
Parties’ products are likely to be differentiated ( [products are differentiated on a number of relevant 
 
 
 
5  
4.1. Sickle cell disease (“SCD”)  
4.1.1.  Introduction  
(14) SCD is a group of inherited red blood cell disorders. It is a genetic condition present 
at birth. Due to nucleotide mutation in the β -globin gene, red blood cells carry 
abnormal h aemoglobin, which makes them prone to rupture, causing the adhesion of 
sickle cells and inflammatory cells to the blood vessels. This ultimately leads to an 
obstruction of blood flow and organ damage. People with SCD start to have signs of 
the disease during the first year of life, usually around 5 months of age. Symptoms 
and complications of SCD are different for each pers on and can range from mild to 
severe. SCD is a disease that worsens over time.16 
(15) There are several types of SCD depending on the sickle cell genes a person inherits 
from his/her parents. In all types of SCD, at least one of the two abnormal genes 
causes a p erson’s body to make h aemoglobin S.  Hemoglobin S (Hgb S) is an 
abnormal type of hemoglobin that can be inherited. Hgb S causes red blood cells to 
become stiff and abnormally shaped. Instead of having a normal round, disk shape, 
these red blood cells become  sickle -shaped, or crescent -shaped. These cells don't 
live as long as normal red blood cells. Because of their shape, they get stuck inside 
small blood vessels. These problems cause symptoms of sickle cell disease. The 
most common types of SCD are : 
- sickle cell trait (“SCT”) , which  occurs in people who inherit one sickle cell gene 
(“S”) from one parent and one normal gene (“A”) from the other parent ;  
- sickle cell an aemia (“SCA”) , which  is when a person has two h aemoglobin S 
gene (hemoglobin SS)  and is the mo st common and often most severe type of 
SCD ; and   
- haemoglobin SC disease and h aemoglobin Sβ (sickle beta) thalassemia are two 
other common types of SCD.17  
(16) One of the most common and severe complications of SCD is  a vaso-occulsive crisis 
(“VOC”) . VOC occur s when sickled red blood cells block blood flow to the point 
that tissues are deprived of oxygen . This in turn sets in motion an inflammatory 
response as the body tries to rectify the problem. The result is substantial pain, which 
                                                                                                                                                      
factors] ). Moreover, there are many marketed (6) and pipeline products currently in development for 
AAV, including at a late stage of development.  
 
[…] could also be considered for IgAN indication, and Vifor Pharma is developing Sparsentan (Phase III 
clinical trial) for th at same indication. However, for the same reasons as for AAV, given that […] is not 
yet determined for IgAN and the pipeline appears c ompetitive (there are more than 20 assets in clinical 
and pre -clinical development, some advanced in Phase II/III clinical trial), it is unlikely that the 
Transaction will give rise to competition concerns in this respect. These overlaps are therefore not further 
discussed in this decision.  
16  Form CO, para . 123. 
17  In addition to these types of SCD, there are much less common types, such as h aemoglobin SD, 
haemoglobin SE, and haemoglobin SO.  
 
 
6 can affect any part of the  body, but most commonly occurs in the back, chest, or 
extremities.18 
(17) In the EEA, the current treatment algorithm for the prevention  of SCD complications 
generally refers to prophylactic medication  to prevent VOC and other acute 
complications . Hydroxyurea i s a frontline prophylactic medication for SCD. Daily 
Hydroxyurea reduces the frequency of painful crises and might reduce several 
complications of SCD and prevent VOC. In case of lack of 
responsiveness/adherence, physicians would usually prescribe either c hronic blood 
transfusions or a secondary prophylactic medication (e.g. Adakveo and Oxbryta) to 
be taken as an alternative or in combination with Hydroxyurea.19  
(18) There is no specific treatment algorithm for the treatment  of VOC.20 The current 
standard of care  treatment of VOC is limited to supportive care with intravenous 
fluids and symptomatic (pain -relief) management with analgesics.21   
(19) For patients severely affected with SCD, hematopoietic stem cell transplantation can 
provide curative therapy, but its utilization is limited due to the limited availability 
of suitable donors and the significant risks and expense of the procedure.22 In 
addition, there are several potential genetic therapies currently under development 
as, one-time, possibly curative treatm ents of SCD with the goal to fix the mutations 
that cause sickle cell through the use of cutting -edge gene editing technologies. 
There is no currently approved form of gene therapy for SCD in the EEA.23 
4.1.2.  Market Definition  
(A)  Product Market  
(20) In the absence of Co mmission precedents for SCD treatments, the Notifying Party 
considers that a segmentation  of the market could be envisaged according to the 
severity of the disease and the LoT, as follows: (i) durable curative treatments (i.e. 
stem -cell transplants and, in  the future, gene therapies); (ii) prophylaxis treatments 
(prevention of VOC and other SCD symptoms); and (iii) treatments of VOC and 
other SCD complications (acute (on -demand) treatment).24 However, the Notifying 
Party considers that a segmentation by subt ype of SCD or by MoA is not 
appropriate.25 The Notifying Party does not give its view as to whether the market 
should be segmented based on the MoD. In any event, the Notifying Party submits 
that this question can be left open as no competition concerns arise under any 
plausible market segmentation.26 
                                                 
18  Form CO, para. 124 -125. 
19  Non-confidential minutes of a call with a SCD  KOL, dated 9 March 2022  (3:00PM CET), paras. 6 -8. 
20  Form  CO para. 130.  
21  Form CO, para. 129.  
22  Form  CO, para. 180 and non-confidential minutes of a call with a SCD  KOL, dated 9 March 2022  
(3:00PM CET), para . 13. 
23  Form CO, para. 168 and 169.  
24  Form  CO, para 163.  
25  Form  CO, para 173 and 174.  
26  Form CO, para 165.  
 
 
7 (21) The market investigation was not conclusive as to whether the treatments for SCD 
should be sub -segmented  by the  severity of the disease /LoT, MoA , SCD sub -type or 
(MoD ). However market participants also noted  that pipeline treatments are still at 
the development stage and there is an intrinsic level of uncertainty in assessing their 
future characteristics and market positioning:  
(a) Segmentation based on the severity of the disease/ LoT: the responding  key 
opinion leaders ( KOLs ) generally agree with the treatment algorithm as 
presented, namely that the  three main categories of therapies for SCD as set 
out above in paragraph  (20) can be distinguished based on the severity of the 
disease.27 The majority of responding competitors also agree with such 
treatment categories.28  
More specifically, the market investigation generally confirms that stem -cell 
transplants (and gene therapy in the future) do not constitute a direct 
substitute to the use of therapies for the prevention of VOCs, recognising that 
treatment for SCD is complex.29 Stem-cell transplants are generally not 
available to all patients, are de pendent on donors and are considered invasive 
treatments suitable for the most severe forms of SCD.30 As for gene 
therapies, such therapies are in the development stage and there is an intrinsic 
level of uncertainty in assessing their future characteristics  and market 
positioning.  
With regard to the treatment and prevention of SCD complications,  
responding market participants  note that some treatments, in particular 
pipeline drugs in development, may be developed for both the prevention of 
SCD complication s, namely VOC,  and the treatment of such complications .31 
For example, one competitor stated “[t] here are many mechanisms of 
treatments being studied in SCD. Certain classes of therapies maybe both 
relevant to prevention and treatment of VOCs while others a re not .”32 In 
addition, one KOL explained that “[…] in principle, all drugs that are used 
for the prevention of VOC are also able to avoid progression of a 
vasoocclusive event. Depending on the mechanism of action and on how fast 
a drug works, its effect ma y help acutely or not. E.g. I would expect that P -
selectin inhibitors also in acute complications through immediate inhibition 
of p-selectin while hydroxyurea unfolds its effects over a period of some 
weeks or even months. Thus, [hydroxyurea]  does not help acutely [but ot her 
drugs may]”.33 
(b) Segmentation based on MoA:  SCD drugs with different MoAs target 
different pathways, and, thus, may translate into distinct efficacy and safety 
                                                 
27  Responses to question 2  of e-mail questionnaire to KOLs – SCD.  
28  Responses to question 4  of questionnaire Q1 to competitors - SCD HS . 
29  Responses to question 2(b)  of e-mail questionnaire to KOLs – SCD and responses to question 4 of 
questionnaire Q5  to competitors - SCD HS . 
30  Responses to question 5.1  of questionnaire Q1 to competitors - SCD HS ; and n on-confidential minutes of 
a call with a SCD KOL, dated 5 April 2022, 11:00AM CET .  
31  Response to question 6  of questionnaire Q1 to competitors - SCD HS ; and responses to question 2(c) of e -
mail questionnaire to KOLs – SCD.  
32  Response to question 6.1  of questionnaire Q1 to competitors - SCD H S. 
33  Response to question 2(c)  of e-mail questionnaire to KOLs – SCD . 
 
 
8 profiles, which are the relevant  factors for physicians when pres cribing 
drugs.34 However , at this stage, given the limited available data, the exact 
efficacy and safety profiles of various SCD pipeline drugs remain highly 
speculative and it is thus difficult to predict which drugs are likely to 
compete with one another.35 As a consequence, the feedback received from 
market participants regarding the relevance of a segmentation of SCD  
treatments by MoA was not conclusive.36 
(c) Segmentation by SCD sub -type: responding KOLs generally agree that all 
marketed and pipeline drugs ar e indicated for several or all types of SCD.37 
The m arket feedback does not support a segmentation of the market by SCD 
sub-type38 and in particular noting that at the stage of clinical trials with 
limited data available, it would not be clear whether pipeli ne drugs would be 
more efficacious for a specific SCD sub -type.  
(d) Segmentation based on MoD:  as the Parties’ drugs are differentiated by 
MoD , the Commission investigated if the market could be segmented based 
on the  MoD  of SCD d rugs. The majority of responding competitors and 
KOLs indicated that pipeline drugs with a different MoD  (usually oral or IV) 
are direct substitutes and compete with one another.39 One competitor 
confirmed that “[i] t is expected that marketed and new therapies wil l directly 
compete regardless of the mode of delivery. IV and oral therapies are 
currently on the market and competing with one another ”.40  
(22) In any event, for the purposes of this decision, the Commission concludes that the 
exact scope of the market for SCD  treatments 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 definitions 
(i.e. segmentations by LoT, MoA , SCD su b-type or MoD ).  
(B)  Geographical Market  
(23) As regards the geographic market definition, the Commission has consistently 
considered the markets for pipeline drugs to be  global or  at least EEA -wide in 
scope.41 The Notifying Party does not contest the above. Nothin g in the marke t 
investigation suggests that the Commission should depart from its previous practice 
in the present decision with respect to SCD.  
                                                 
34  Responses to question 4(b) of e -mail questionnaire to KOLs - SCD.  
35  Non confidential minutes of a call with a SCD KOL, dated 9 March 2022 (3:00PM CET), para. 15.  
36  Responses to question 9 of questionnaire Q1 to competitors and Responses to question 4(a) of e -mail 
questionnaire to KOLs - SCD.  
37  Responses to question 2(b)  of e-mail questionnaire to KOLs – SCD.  
38  Responses to  questionnaire Q1 to competitors - SCD HS.  
39  Responses to question 9.2  of questionnaire Q1 to competitors - SCD HS.  Responses to question 4 (b) of e -
mail questionnaire to KOLs – SCD.  
40  Responses to question 9.2.1  of questionnaire Q1 to competitors - SCD HS.  
41  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.  

 
 
10 EEA Agreement resulting from the overlaps between the Parties’ pipeline treatments 
for SCD.  
(30) First , the Parties’ SCD pipeline drugs are not considered by the market participants 
as particularly close alternatives, for a number of reasons. Based on current 
development strategies of the Parties,48 whilst still at the early stages of 
development, the two pipeline drugs (Vamifeport and CSL889) are being developed 
for different phases of the SCD. This is also confirmed by market feedback, with one 
competitor expl aining: “[t] hese therapies are targeting different disease phases. 
Hemopexin would be used during acute VOCs to minimize VOC severity/duration or 
prevent acute VOC complications. Vamifeport would be used prophylactically to 
minimize the occurrence of VOCs.  The efficacy and safety endpoints these therapies 
will be expected to establish must be different for their respective disease phases .”49 
Another competitor, whilst noting limited public clinical data to date, noted that 
“[the two Parties’] products appear  distinct in terms of potential usage, as while 
vamifeport is being trialed for the prevention of SCD complications, CSL889 is 
being trialed for the treatment of SCD complications. They also have different 
mechanisms of action .”50 
(31) The Parties’ pipeline drugs are also differentiated in terms of MoA and MoD. CSL is 
developing an IV drug, namely CSL889 (Hemopexin) and Vifor Pharma is 
developing an oral inhibitor of ferroportin (Vamifeport). Hemopexin is a heme 
scavenger which is deplet ed in SCD due to intravascular hemolysis. […].51 By 
contrast, Vamifeport has a different mode of action, it is a ferroportin inhibitor that 
binds ferroportin, and blocks it to prevent excessive iron release into the blood . If 
developed, Vifor Pharma’s drug would most likely be used to […], while CSL’s 
drug would be used […]. In addition, t he majority of responding competitors did not 
expect  the SCD drugs currently being developed by CSL and Vifor Pharma to have 
similar efficacy and safety profiles.52  
(32) Second , irrespective of whether the market is segmented further, there are numerous 
existing  marketed drugs  or pipeline alternatives  (including  in Phase II or Phase III  
clinical trials ), as illustrated in Table 2 below.  The market investigation feedback 
confirmed that the SCD pipeline is increasingly competitive and includes drugs that 
would be expected to compete closer with each Party’s pipeline drugs  than the 
Parties’ pipeline drugs between them .53 This is further supp orted by internal 
documents of the Parties.54 
                                                 
48  Internal documents, e.g. […].  
49  Response to question 13.1 of questionnaire Q1 to competitors - SCD HS.  
50  Response to question 13.1 of questionnaire Q1 to competitors - SCD HS.  
51  Form CO, para. 173.  
52  Responses to question 13 of questionnaire Q1 to competitors - SCD HS . 
53  Response to question 12 of questionnaire Q1 to competitors - SCD HS.  
54  Internal docum ents, for example, […].  

 
 
12 (33) Third , the Parties’ SCD pipeline drugs are generally not seen by market participants 
as being particularly promising.60 Whilst noting early stages of the clinical trials, 
competitors generally ranked a number of other drugs in development higher (on a 
scale 1 to 5, 1 as the lowest) in terms of how promising the potential treatment in 
development for SCD is expected to be.61 According to the KOLs that responded, 
there are dozens of promising compounds in Phase I and Phase II clinical trials for 
the management of SCD/prevention of VOC, such as Mitapivat developed by Agios 
and Etavopivat which is being developed by Forma Pharma ceuticals and just entered 
Phase III.62   
(34) Finally,  no respondents to the market investigation e xpress ed concerns about the 
impact of the Transaction on the market for SCD treatments in the EEA , and more 
specifically  the potential discontinuation, re -orientation or delay of the Parties’ 
pipeline drugs.63  
4.1.5.  Conclusion  
(35) 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 in ternal market 
and the functioning of the EEA Agreement as regards its impact on competition in 
the market for the treatment of SCD (and its plausible sub -segmentations).  
4.2. Hidradenitis suppurativa  (“HS”)  
4.2.1.  Introduction  
(36) Hidradenitis suppurativa (“HS”) , also kn own as acne inversa,  is a chronic disabling 
autoimmune inflammatory skin disease characterized by recurrent, painful nodules, 
boils, and abscesses. It is a long -term skin condition that causes painful bumps under 
the skin in the hair roots near some of the  sweat glands. Complications of HS can 
include: secondary infection, psychological effects and negative impact on quality -
of-life, pyogenic granuloma, lymphoedema  (female genital ), squamous cell 
carcinoma  (male anogenital ) and anemia of chronic disease.64 
(37) The symptoms of HS range from mild to severe . Disease severity and extent is 
measured by clinical and ultrasound assessment. The most commonly used tool to 
characterize the severity of HS, and the universally recommended tool across 
guidelines, is the Hurl ey staging system. The Hurley system describes three clinical 
stages :65 
- Stage I (mild): solitary or multiple isolated abscess formation without sinus tracts 
(draining tunnels) or scarring.  
                                                 
60  Response  to question 12  of questionnaire Q1 to competitors - SCD HS . 
61  Response to question 12  of questionnaire Q1 to competitors - SCD HS . 
62  Non-confidential minutes of a call with a SCD  KOL, dated 9 March 2022  (3:00PM CET), para. 10.  
63  Response to question 17  of questionnaire Q1 to competitors - SCD HS  and Responses to question 6 of e-
mail questionnaire to KOLs – SCD . 
64  Form CO, para. 191.  
65  Form CO, para. 210.  
 
 
13 - Stage II (moderate): recurrent abscesses, single or multiple spaced lesions, with 
sinus tract formation.  
- Stage III (severe): diffuse involvement of an area with multiple interconnected 
sinus tracts  and abscesses.  
(38) The treatment algorithm for  HS in the EEA  can generally be summarized as follows: 
(i) first -line treatments inc lude topical treatments such as topical clindamycin, (ii) 
second -line treatments include conventional systemic treatments with antibiotics 
(e.g. Rifampicin) and retinoids (e.g. Acitretin), and (iii) third -line treatments include 
systemic treatments with bi ologics (e.g. adalimumab and its biosimilar) and possibly 
in the future, novel agents currently in development.66 The third -line treatments  with 
biologics  are especially relevant for moderate -to-severe  HS patients  as “sooner or 
later antibiotics fail and patients with moderate -to-severe HS will start on 
biologicals”.67 
(39) In the EEA, the only approved drug for the treatment of moderate -to-severe HS is an 
anti-TNF-alpha monoclonal antibody, adalimumab (Humira). There are also 8 
Humira biosimilars marketed in th e EEA.68 Humira or its biosimilars are  usually  
prescribed as a first-line biologic, before other biologics  that are used off -label for 
HS (e.g. Infliximab)  and potentially novel agents.69 Market participants confirm that 
Humira and its biosimilars are, mainly for cost reasons, likely to continue being 
prescribed as first -line biologics before prescribing other biologics or the potential 
new drugs that are expected to reach the market.70 
(40) The K OLs and competitors confirmed that HS is a difficult disease to treat, and there 
is a high unmet need among HS patients.71 This is notably explained by the fact that 
the development of the disease and the effective treatments vary significantly across 
patie nts, and therefore each patient often needs to try multiple different treatments 
before finding the one most effective for them. Moreover, patients often lose 
response to biologics that previously worked for them, further increasing the need 
for multiple a lternative treatments.72  
                                                 
66  See Responses to question 21 of questionnaire Q1 to competitors and Responses to question 2 of e -mail 
questionnaire to KOLs - HS. See also Non -confidential m inutes of a call with HS KOL, dated 25.03.2021 
(10:00 AM CET) and Non -confidential minutes of a call with HS KOL, dated 16. 03.2021 (10:00 AM 
CET).  
67  Response to question 2  of e-mail questionnaire to KOLs – HS. 
68  Form CO, para. 247. Biologics  are medicines whose active substance is made by or derived from living 
organisms (e.g., immunological products and medicines derived from human blood and plasma). 
Biosimilars aim to mimic the original patented biopharmaceutical molecule with an identical therapeutic 
mechanism and clinical attributes and can be described as “generic” versions of originator 
biopharmaceuticals, but, unlike for small molecule generics, they are not exact copies of the originator 
drug.  
69  See e.g. Non -confidential minutes of a call with HS KOL, dated 25.03.2022 (11:00 AM CET).   
70  See responses to question 21.2 of questionnaire Q1 to competitors, and question 3 of email questionnaire 
to HS KOLs. See also Non -confidential minutes of a call with HS KOL, dated 25.03.2022 (11:00 AM  
CET).  
71  See Non -confidential minutes of calls with HS KOL, dated 16 March 2022 (10:00 AM CET) and 14 
March 2022 (12:30 PM CET), Non -confidential minutes of a call with HS competitor, dated 24 March 
2022 (15:30 PM CET), and Responses to question 29 of que stionnaire Q1 to competitors . 
72  See e.g. Non-confid ential minutes of a call with an HS KOL dated 16.03.2022  (10:00 AM  CET).   
 
 
14 4.2.2.  Market definition  
(A) Product market  definition  
(41) In the absence of Commission precedents for HS treatments, the Part ies are of the 
view that a segmentation of the market for treatment of HS could be envisaged 
according to the Hurley stage of classification.73 The Parties further argue  that in any 
event, the exact scope of the product market can be left open because the Transaction 
will not raise competition concerns under any market segmentation.74 
(42) Given that the starting point for all  the developers of HS drugs is generally either 
moderate -to-severe HS or mild HS , with the Parties’ drugs belonging to the former 
category, the starting point for defining the relevant product market  is treatments  for 
moderate -to-severe HS. 
(43) The market investigation was not conclusive as to whether the treatments for 
moderate -to-severe HS should be sub -segmented , notably because many of the 
moderate -to-severe HS drugs are still at the development stage and there is an 
intrinsic level of uncertainty in as sessing future characteristics and market 
positioning. In particular, the results of the market investigation were not conclusive 
as to  whether the following potential segmentations are warranted:  
(a) Segmentation based on the MoA:  moderate -to-severe HS drugs with different 
MoAs target different pathways, and, thus, may translate into distinct 
efficacy and safety profiles, which are key factors for physicians when 
prescribing drugs.75 That being said, at this stage, given the limited available 
data, the exact ef ficacy and safety profiles of various moderate -to-severe HS 
pipeline drugs remain highly speculative and it is thus difficult to predict 
which drugs are likely to compete with one another .76 As a consequence, the 
feedback received from market participants regarding the relevance of a 
segmentation of the moderate -to-severe HS treatments by MoA was not 
conclusive.77  
(b) Segmentation based on the MoD:  The results of the market investigation 
were inconclusive on the question of whether  the market for moderate -to-
severe HS treatments should be further segmented based on  MoD.  On the one 
hand, all respondents recognised that efficacy and safety of the treatment 
(and not MoD) are the key parameters driving prescription decisions.78 On 
the other hand, the majority of comp etitors  and KOLs  indicated that the MoD 
may play an important role in determin ing whether different types of 
moderate -to-severe HS treatment will compete more closely with each other, 
                                                 
73  Form CO, para. 233.  
74  Form CO, para. 233.  
75  See e.g. Non -confidential minutes of a call with an HS competitor, dated 24.03.2 022 (15:30 PM CET) and 
Non-confidential minutes of a call with a HS KOL, dated 25.03.2022 (11:00 AM CET).  
76  See e.g. Non-confidential minutes of a call with a HS KOL, dated 25.03.2022 (11:00 AM CET).  
77  Responses to question 22.1 of questionnaire Q1 to co mpetitors and Responses to question 3 of email 
questionnaire to HS KOLs.  
78  See Responses to question 22.2 of questionnaire Q1 to competitors and Responses to question 3 of email 
questionnaire to HS KOLs. For example, one KOL explained: “Mode of delivery is secondary to efficacy, 
meaning if a drug is better than that is the reason it will be first - second or third -line rather than solely 
based on whether it has injection or oral delivery.”   

 
 
16 in the EEA is not  expected  before year […]. CSL324 is administered by way of 
subcutaneous injection.  
(49) Therefore, in the market for treatments for moderate -to-severe HS, the Transaction 
gives rise to pipeline -to-pipeline overlaps between Vifor Pharma’s avacopan and 
CSL’s CSL324. No overlap arises if the  market is segmented based on MoAs or on 
MoDs.  
4.2.4.  Competitive Assessment  
(50) The Notifying Party argues that there is no risk of significant loss of innovation 
competition resulting from this pipeline -to-pipeline  overlap , for the following 
reasons: (i) t he Parties’ pipeline products are not close alternatives,  as they have 
distinct MoA s and  MoD s, and have different target population s, (ii) the Parties face  
multiple competitor products at various stages of development, (iii) avacopan is 
under development  by CCXI […],83 and (iv) the Parties’ products have different time 
to market.84 
(51) The market investigation generally confirms the Notifying Party’s claims, 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 overlaps between the Parties’ activities in 
moderate -to-severe HS treatments . 
(52) First,  the Parties’ HS pipeline drugs are not seen by market participants as 
particularly promising . On a scale from 1 (not promising: potentially poor 
efficacy/safety profile) to 5 (very promising: potentially very good efficacy/safety 
profile) market participants generally give the  Parties’ HS pipeline drugs  a rating of 
3.85 Respondents also stressed that the Parties’ products are early stage pipeline 
drugs, with highly uncertain prospects.86  
(53) Moreover, all competitors expect promising late -stage pipeline drugs for HS to be 
launched in the EEA within the next 3 years.87 One compe titor for example states 
that “There are various promising late -stage pipeline assets with promise, including 
anti-IL17s such as Novartis Cosentyx (secukinumab) and UCB’s Bimzelx 
(bimekizumab).”88 KOLs share the view  that late -stage pipeline drugs for HS ar e 
expected to be launched in the short/medium term , stating for example: “Probably 
IL17A and IL17A/F antibodies will be quickly launched in Europe followed by IL36 
                                                 
83  […]. See Form CO, para. 251.  
84  Form CO, paras. 235 -260. 
85  See Responses to question 25 of questionnaire Q1 to competitors.  
86  See e.g. Non -confidential minutes of a call with a HS KOL, dated 25 March 2022 (11:00 AM CET), and 
Responses to question 25 of questionnaire Q1 to competitors. A c ompetitor for example states: “Since 
most competitive drugs are still in clinical development, it is difficult to know how competitive the HS 
pipeline is and how promising pipeline drugs would be for the treatment of HS.”  
87  Responses to question 24 of questionnaire Q1 to competitors.  
88  Response to question 24 of questionnaire Q1 to competitors.  


 
 
19 development of two drugs for the treatment of HS.102 One market participant for 
instance  states : “pharmaceutical companies are likely to have an incentive to 
develop more than one drug for HS.”103 and a KOL: “[p]ost-Transaction the new 
entity would therefore highly likely retain the incentive to continue developing both 
CSL324 and Avacopan for HS.”104 
(59) Finally , no market participants  expressed concerns about the impact of the 
Transaction on the market for (moderate -to-severe) HS in the EEA and the potential 
discontinuation, re -orientation and delay of the Parties’ pipeline drugs.105 
4.2.5.  Conclusion  
(60) 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 marke t for treatments of moderate -to-severe HS (and its plausible 
segmentations).  
5. CONCLUSION  
(61) For the above reasons, the European Commission has decided not to oppose the 
notified operation and to declare it compatible with the internal market and with the 
EEA A greement. 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  
                                                 
102  See Responses to question 31 of questionnaire Q1 to competitors, Responses to question 6 of email 
questionnaire to KOLs – HS, and Non -confidential minutes of a call with HS KOLs, dated 16 March 2022 
(10:00 AM CET) and 25 March 2022 (11:00 AM CET).  
103  Non-confidential minutes of a call with an HS market participant, dated 24 March 2022 (15:30 PM CET).  
104  Non-confidential minutes of a call with HS KOLs, dated 16 March 2022 (10:00 AM CET).  
105  See Response s to question 32 of Q1 questionnaire to competitors and Responses to question 6 of email 
questionnaire to HS KOLs.