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, 04.12.2020  
C(2020 ) 8771 final  
PUBLIC VERSION  
 
To the notifying party  
Subject : Case M. 9995  – PERMIRA HOLDINGS LIMITED / NEURAXPHARM 
MIDCO S.C.A.  
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 30.10.2020 , the European Commission received notification of a proposed 
concentration pursuant to Article 4 of the Merger Regulation  (“the Transaction”) , by 
which Permira Holdings Limited (“Permira”, Guernsey ) acquires within the meaning 
of Article 3(1)(b) of the Merger Regulation sole control of the whole of Neuraxpharm 
Midco S.C. A. (“Neuraxpharm”,  Luxembourg).3 Permira is designated hereinafter as 
the “Notifying Party” and together with Neuraxpharm 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 b e 
used throughout this decision.  
2  OJ L 1, 3.1.1994, p. 3 (the 'EEA Agreement').  
3  Publication in the Official Journal of the European Union No C 380, 11.11.2020, p.11 . 
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information omitted has been replaced by 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  
(2) Permira is a European private equity firm , which makes long -term investments in 
companies active in a wide variety of sectors.  
(3) Neuraxpharm  is a European specialty pharmaceutical company focused on the 
treatment of Central Nervous System ("CNS") disorders with their main activity being 
the production and  sale of Finished  Dose Pharmaceuticals ("FDPs") . Neuraxpharm  
also provides Contract Develo pment and Manufacturing Organization ("C DMO") 
services for FDPs and Active Pharmaceutical Ingredients (“APIs”) both to the 
Neuraxpharm  group companies and to third parties.  
2. EU DIMENSION  
(4) The Parties have a combined aggregate worldwide turnover of more than  EUR 5 000 
million (Perm ira EUR […] million, Neuraxpharm EUR […] million). Each of them 
has a Union -wide turnover in excess of EUR 250 million (Permira EUR […] million, 
Neuraxpharm EUR […] million), but they do not achieve more than two -thirds of 
their agg regate Union -wide turnover within one and the same Member State. The 
notified operation therefore has a Union dimension pursuant to Article 1(2) of the 
Merger Regulation.  
3. THE CONCENTRATION  
(5) Pursuant to a Sale and Purchase Agreement dated 20 September 2020,  between  
Neuraxpharm’s current owners and Permira,  Permira  will acquire all shares of 
Neuraxpharm  and each right attached to these , within the meaning of Article 3(1)(b) 
of the Merger Regulation . Therefore , Permira will have sole control over 
Neuraxpharm.  
4. MARKET DEFINITIONS  
4.1. Finished Dose Pharmaceuticals   
(6) FDPs are pharmaceutical products that have undergone all stages of production, including 
packaging in the final container and labelling. Production and sale of FDPs is one of the 
most common activit ies of pharmaceutical companies. Neuraxpharm produces and sells 
FDPs focused on the treatment of CNS disorders.  
 
3 (7) In its previous decisions,4 the Commission  used the Anatomical Therapeutic 
Classification (“ATC”) system as the basis for  the product market definition . The first 
level (ATC 1) is the most general and the fourth level (ATC 4) the most detailed. More 
specifically, the Commission referred to the ATC3 level, where pharmaceuticals are 
grouped in terms of  their therapeutic indications, i.e. their intended use , as the starting 
point for defining the relevant product market , since these groups of products generally 
have the same therapeutic indication and cannot be substituted by products belonging to 
other ATC 3 classes.  
(8) However, the Commission  also recognized  that it may be appropriate , if the circumstances 
of the case show that competitive constraints make it necessary, to carry out analyses at 
the more detailed ATC4 level , or possibly at the level of groups of molecules5 or 
individual molecules6. Relevant fa ctors to take into account include therapeutic  (e.g. 
prescription only, or administration allowed only under medical supervision)  or 
pharmacological criteria such as molecule class, formulation or mode of administration  
(e.g. topical versus systemic).7  
(9) The Notifying Party su ggests  to follow this approach in the present case.  It submits that its 
products fall into the C4A, N2B, N4A, N5A, N6A , N5B, N5C and N6D  classifications at 
ATC3 level and into the  C4A1, N2B0,  N4A0, N5A1, N5A9, N5B1, N6A9 , N5C0 and 
N6D 0 classifications at ATC4 level.  
(10) In any event, for the purposes of this Decision , it is not necessary to conclude on the exact 
product market definition for FDPs for the treatment of CNS disorders, as , regardless of 
the market definition considered,  the Transaction does not give rise to serious doubts as to 
its compatibility with the internal market or the functioning of the EEA agreement.  
(11) According to Commission precedents,8 the relevant geographic market for FDPs is 
national in scope , due to the reg ulatory barriers which result inter alia from the national 
reimbursement systems of the EU Member States .  
(12) The Notifying Party suggests to follow this approach in the present case. The Commission 
did not find any reason to depart from this approach in the present case.  
4.2. Contract Development and Manufacturing Organisation servi ces  
(13) CDMO is an arrangement under which a manufacturer provides upstream 
manufacturing services of FDPs and APIs under contract on behalf of third party 
pharmaceutical companies.9 
                                                 
4  COMP/M.1846  – GlaxoWellcome / SmithKline Beecham , 8 May 2000 ; COMP/M.1878  – Pfizer  / Warner -
Lambert , 22 May 2000 ; COMP/M.3751 –Novartis / Hexal , 27 May 2005 ; COMP/M.4402 – UBC / 
Schwarz Pharma , 21 Nov 2006 ; COMP/M. 5253 – Sanofi -Aventis / Zentiva , 4 Feb 2009 ; COMP/M.5295  
– Teva / Barr Pharmaceuticals , 19 Dec 2008 ; COMP/M.5555  – Novartis  / EBEWE , 22 Sep 2009 ; 
COMP/M.5778  – Novartis / Alcon , 9 Aug 2010 ; COMP/M.6258  – Teva / Cephalon , 13 Oct 2011 ; 
COMP/M.6969  – Valeant Pharmaceuticals International / Bausch&Lomb Holdings , 5 Aug 2013 ; 
COMP/M.7480  – Actavis / Allergan , 16 Mar 2015 ; COMP/M.755 9 – Pfizer / Hospira , 4 Aug 2015.  
5  COMP/M.5865 – Teva / Ratiopharm , 3 Aug 2010, paras. 12 -14. 
6  COMP/M. 7559 – Pfizer / Hospira , 4 Aug 2015, paras. 84, 90 and 98 . 
7 COMP/M.3354 – Sanofi -Synthelabo / Aventis , 26 Apr 2004, paras. 15 and 16; COMP/M.4314 – Johnson 
& Johnson / Pfizer Consumer Healthcare , 11 Dec 2006, para. 12; COMP/M.7480  – Actavis / Allergan , 16 
Mar 2015, para. 11. 
8  COMP/M.7480 Allergan/ Actavis , 16 Mar 2015, para.14; COMP/M.6969 – Valeant Pharmaceuticals 
International / Bausch & Lomb Holdings,  5 Aug 2013, paras. 48 -50. 
 
4 (14) In the past, the Commission distinguished the C DMO market for FDPs  from the 
CDMO market for APIs. On the one hand, CDMO for APIs involve the evaluation, 
characterisation, development of production and scaling -up processes in relation to the 
manufacture of API s. On the other hand, CDMO services at the FDP level mainly 
pertain to the development of an appropriate dosage formulation and the large -scale 
manufacture of the final drug products. Second, from a supply -side perspective, 
CDMO services at the API and FDP  levels do not involve the same equipment and 
require specific know -how and expertise. The Commission has found in the past that 
multiple CDMO players do not have the capability to be active throughout the CDMO 
value chain and are exclusively active either  at the API level or at the FDP level.10 
(15) As regards the CDMO market for FDPs , further segmentations were considered in 
relation to  (i) the pharmaceutical form manufactured (e.g. solids, semi -solids, 
injectables), (ii) the conditions of manufacture (toxicity , sterile environment, etc.) , (iii) 
the type of API used for its production  and the delivery mechanism used (swallowing, 
intravenous, injection, etc .).11 The Notifying Party suggests to follow this approach in 
the present case.   
(16) In any event, for the purpos es of this Decision, it is not necessary to conclude on the 
exact product market definition for  CDMO services, as regardless of the market 
definition considered , the Transaction does not give rise to serious doubts as to its 
compatibility with the internal market and the functioning of the EEA Agreement.   
(17) The relevant geographic market for C DMO services according to Commission 
precedents was found to be worldwide or at least EEA -wide12, as CDMO services are 
generally procured anywhere in the EEA, regardless of the EEA country where the 
pharmaceutical products are subsequently marketed , given the economics of the 
services under consideration, as well as the lack of a ny trade or other barriers .  
(18) The Notifying Party suggests to follow this approach in the present case. The 
Commission did not find any reason to depart from this approach in the present case.  
5. COMPETITIVE ASSESSMENT  
5.1. Analytical Framework  
(19) Under Articles 2(2)  and 2(3) of the Merger Regulation, the Commission must assess 
whether a proposed concentration would significantly impede effective competition in 
the internal market or in a substantial part of it, in particular through the creation or 
strengthening of a  dominant position.  
(20) Frequently, a merger can entail horizontal effects. In this respect, in addition to the 
creation or strengthening of a dominant position, the Commission Guidelines on the 
                                                                                                                                                      
9  Among others these can be  i) pre -formulation/formulation development services; (ii) drug substance 
development and API synthesis services ; (iii) drug product services; (iv) drug packaging services; and (v) 
analytical testing of drug substances and drug products.  
10  COMP/M.9315 – CHR. Hansen / Lonza / JV , 16 Jul 2019, para. 17.   
11 COMP/M.9315 – CHR. Hansen / Lonza / JV , 16 Jul 2019, para. 20; COMP/M.8541 – Thermo Fisher 
Scientific / Patheon , 23 Aug 2017, para. 47; COMP/M.8385 – Pillarstone / Famar , 27 Feb 2017, para. 25.  
12  Case M.5953 - Reckitt Benckiser/SSL , 26 Oct 2010, paras. 64 -66. 
 
5 assessment of horizontal mergers under the Merger Regulation13 (“the Horizontal 
Merger Guidelines”) distinguish between two main ways in which mergers between 
actual or potential competitors on the same relevant market may significantly impede 
effective competition,14 namely (a) by eliminating important competitive co nstraints 
on one or more firms, which consequently would have increased market power, 
without resorting to coordinated behaviour (non - coordinated effects); and (b) by 
changing the nature of competition in such a way that firms that previously were not 
coordinating their behaviour are now significantly more likely to coordinate and raise 
prices or otherwise harm effective competition. A merger may also make coordination 
easier, more stable or more effective for firms, which were coordinating prior to the 
merger (coordinated effects).  Concentrations which, by reason of the limited market 
share of the undertakings concerned are not liable to impede effective competition 
may be presumed to be compatible with the internal market. An indication to this 
effect exi sts, in particular, where the market share of the undertakings concerned does 
not exceed 25 % either in the internal market or in a substantial part of it.15 
(21) Furthermore, a merger can entail vertical effects. The Commission Guidelines on the 
assessment of non-horizontal mergers under the Merger Regulation16 (the “Non- 
Horizontal Merger Guidelines”) also distinguish between two main ways in which 
non-horizontal mergers may significantly impede effective competition: (a) when they 
give rise to input and/or cus tomer foreclosure (non -coordinated effects); and (b) when 
the merger changes the nature of competition in such a way that firms that previously 
were not coordinating their behaviour, are now more likely to coordinate to raise 
prices or otherwise harm effec tive competition (coordinated effects).17 The Non-
Horizontal Merger Guidelines distinguish two types of foreclosure: (a) where the 
merger is likely to raise the costs of downstream rivals by restricting their access to an 
important input (input foreclosure)  and (b) where the merger is likely to foreclose 
upstream rivals by restricting their access to a sufficient customer base (customer 
foreclosure)18. According to the Non -Horizontal Merger Guidelines, the Commission 
is unlikely to find concern in non -horizon tal mergers, where the market share post -
merger of the new entity in each of the markets concerned is below 30%.19 
5.2. Competitive Assessment  
(22) Neuraxpharm’s  main activity (amounting to [significant share]  of its 2019 turnover) is 
the production and sale of FDPs . Moreover, Neuraxpharm, via its subsidiary 
Laboratory Lesvi S.L.U. (“Lesvi” , Spain ), provides C DMO services for FDPs, and, 
via its subsidiary INKE S.A.U. (“INKE” , Spain ), provides CDMO services for  APIs 
both to Neuraxpharm group ’s companies and to third parties.  
                                                 
13 Commission Guidelines on the assessment of horizontal mergers under the Merger Regulation, OJ C 31, 5 
February 2004, p. 5 –18.  
14 ibid, para.22.  
15 ibid, para. 18.  
16 Commission Guidelines on the assessment of non -horizontal mergers under the Merger Regulation , OJ C 
265, 18  October 2008, p. 6 –25.  
17 ibid, paras 17 -19. 
18 ibid, para. 30.  
19 ibid, para. 25.  
 
6 (23) None of Permira’s controlled portfolio companies are pharmaceutical companies 
producing and selling  FDPs. However, Permira currently controls four portfolio 
companies  that are active in providing C DMO services. For FDPs,  these a re the  
Cambrex Corporation (“ Cambrex ”, U.K.), Q uotient  Sciences  (“Quotient ”, U.S.A.) 
and Lyophilization Services of New England  (“LSNE”, U.S.A.). For APIs these are 
Cambrex and CABB Group GmbH (“CABB”, Germany) .  
5.2.1.   Horizontal Overlap s 
(24) According to the  Notifying Party , the activities of the Parties overlap horizontally in : 
(i) C DMO services for FDPs between Lesvi and Cambrex, LSNE and Quotient, and 
(ii) C DMO services  for APIs between INKE and Cambrex.  
(25) For both overlaps, the combined market shares of the Parties post -Transaction would 
not exceed [5-10]% under every possible market definition , i.e. either  in the overall 
CDMO market , or in the CDMO market  further segmented  in the production of  (i) 
FDPs  and any of the possible re levant further sub -segmentations  and (ii) APIs , under 
either an EEA or a global market definition .  
(26) In view of the combined market shares  which are well below the threshold of 
paragraph 18 of the Horizontal Merger Guidelines , the Commission concludes that 
the Transaction does not raise serious doubts as to its compatibility with the internal 
market or the functioning of the EEA agreement, as regards this horizontal overlap 
in the market for CDMO services.  
5.2.2.  Vertical Relationships  
(27) According to the Notifying P arty, the Proposed Transaction would result in vertical 
relationships for: 
(i) the provision of CDMO services for APIs by Cambrex (upstream) and C DMO 
services for FDPs by Lesvi (downstream) ; 
(ii) the provision of CDMO services for FDPs by Cambrex, LSNE and Quotient 
(upstream) and Neuraxpharm’s pipeline products (downstream);  
(iii) the supply of chemicals by CABB (upstream) and C DMO services for APIs by 
INKE (downstream) ; 
(iv) the provision of C DMO services for APIs  by the INKE (upstream) and C DMO 
services for FDPs by Cambrex, LSNE and Quotient (downstream); and  
(v) the provision of C DMO services for FDPs by Cambrex , LSNE and Qu otient 
(upstream) and Neuraxpharm’s manufacture and supply of FDPs (downstream).  
 
7 (28) According to the Notifying Party , the combine d market shares of the Parties do not 
exceed 30% under any plausible market definition  in the vertical relationships listed in 
paragraph  (27) (i)-(iv) above . In view of the low combined market shares,20 the 
Commission concludes that the vertical relationships listed under (i)-(iv) above cannot 
in any way result in input or customer f oreclosure post -Transaction.  
(29) A vertically affected market arises between  the provision of C DMO services for FDPs 
by Permira’s portfolio companies Cambrex , LSNE and Quotient  (upstre am) and FDPs 
manufactured and supplied by Neuraxpharm (downstream).  
(30) According to the Notifying Party’s best estimates, the market share s of Permira 
(including Cambrex ’, LSNE ’s and Quotient ’s activities) in the upstream market for 
CDMO services for FDPs are below [5-10]%  both globally and in the EEA . If the 
CDMO for FDPs ma rket were to be further sub-segmented  in line with the plausible 
market definitions described above , the Notifying Party confirm s that the market share 
of Permira’s portfolio companies would be well below 30%. The possible sub -
segmentations are listed in T able 1 below:   
  
                                                 
20 ibid. 




 
12 market  power  to harm rival upstream C DMO services providers. 23 This is because the 
needs for C DMO services for FDPs are not differentiated according to the specific 
pathology covered by a specific FDP. Therefore, CDMO services providers provide 
the same services  for all FDPs. Consequently, this limited potential demand for 
CDMO services by Neuraxph arm for its FDPs for CNS disorders would in any event 
not allow the merged entity to foreclose its rival C DMO services providers upstream 
from accessing customers in the downstream markets for FDPs by withholding or 
reducing Neuraxpharm’s purchases (which are limited to FDPs for CNS disorders).  
(37) Therefore, the merged entity cannot foreclose its upstream competitors in the 
provision of C DMO services by denying access to the downstream market for FDPs 
for CNS disorders . 
6. CONCLUSION   
(38) For the above reasons, the E uropean 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  
 
                                                 
23  See, to that effect, Cases M.7975 Mylan/Meda of 20 Jul. 2016, paragraph 598 and COMP/M.5253 - 
Sanofi -Aventis / Zentiva, of 4 Feb. 2009, paragraph 533 .