CELEX: 32015M7645
Language: en
Date: 2015-07-29 00:00:00
Title: Commission Decision of 29/07/2015 declaring a concentration to be compatible with the common market (Case No COMP/M.7645 - MYLAN / PERRIGO) according to Council Regulation (EC) No 139/2004 (Only the English text is authentic)

|[pic]                             |EUROPEAN COMMISSION                                                                                      |

Brussels, 29.07.2015

C(2015) 5485 final

                                        [pic]

To the notifying party:

Dear Sir/Madam,

Subject:    Case M.7645 – Mylan/ Perrigo
Commission decision pursuant to Article 6(1)(b) of Council Regulation No 139/2004[1] and Article 57 of the Agreement  on  the  European  Economic
Area[2]

 1. On 23 June 2015, the European Commission received notification of a proposed concentration pursuant to Article 4 of the Merger Regulation by
    which the undertaking Mylan N.V. ("Mylan" or "the Notifying Party", the Netherlands) intends  to  acquire  within  the  meaning  of  Article
    3(1)(b) of the Merger Regulation control of the whole of the undertaking Perrigo Company plc ("Perrigo", Ireland) by way of  an  unsolicited
    public bid ("the Transaction")[3].

       THE PARTIES

 2. Mylan is a global pharmaceutical company which develops, licenses, manufactures,  markets  and  distributes  generic,  branded  generic  and
    specialty pharmaceuticals with a product portfolio of more than 1,400 marketed products (after completion of the acquisition of Abbott  EPD-
    DM, cleared by the Commission in 2015). Mylan is active in approximately  145  countries  and  territories  and  operates  approximately  40
    manufacturing facilities world-wide.

 3. Perrigo manufactures, markets and distributes proprietary pharmaceutical products as well as generics and over-the-counter ("OTC") products.
    In 2013, Perrigo was incorporated under the laws of Ireland following its  acquisition  of  Elan  Corporation  plc.  Perrigo  also  recently
    acquired Omega Pharma Invest N.V. ("Omega") (the transaction closed on 30 March 2015) and is in the  process  of  acquiring  GlaxoSmithKline
    (GSK)'s OTC business pursuant to the commitments accepted in the GSK/Novartis case[4].

       THE OPERATION

 4. On 24 April 2015, Mylan issued a legally binding commitment under the Irish takeover rules to commence an offer for the entire issued and to
    be issued share capital of Perrigo.

 5. If the bid is successful, Mylan will own the majority or the entirety of Perrigo's capital and voting rights and will acquire  sole  control
    over Perrigo.

 6. Consequently, the proposed Transaction constitutes a concentration within the meaning of Article 3(1)(b) of the Merger Regulation.

       EU DIMENSION

 7. The undertakings concerned have a combined aggregate world-wide turnover of more than EUR 5,000 million (Mylan: EUR 7,247 million;  Perrigo:
    above EUR 4,000 million)[5]. Each of them has an EU-wide turnover in excess of EUR 250 million (Mylan: EUR […] million; Perrigo:  above  EUR
    1,000 million), but they do not achieve more than two-thirds of their aggregate EU-wide turnover within one and the same Member State.

 8. The notified operation therefore has an EU dimension pursuant to Article 1(2) of the Merger Regulation.

       COMPETITIVE ASSESSMENT

1 Context

 9. The Parties' activities are by nature complementary. Indeed, the proposed Transaction involves an acquisition by  Mylan,  one  of  the  main
    European producers of prescribed generics, of Perrigo, a producer specialised in OTC drugs which recently extended its  portolio  in  Europe
    through its acquisition of Omega[6]. The rationale of the Transaction is for Mylan to diversify its pharmaceutical activities  on  a  global
    basis and especially expand its portfolio of OTC drugs. Indeed, post-Transaction, Mylan's portfolio of OTC products will grow from 2% to 29%
    of its total sales.

10. In the area of finished dose pharmaceuticals ("FDPs"), the combination of activities  of  Mylan  and  Perrigo  gives  rise  to  horizontally
    affected markets in different therapeutic areas (section 4.2). In addition, both parties develop  pipeline  products,  including  some  that
    overlap with the other Party's marketed FDPs (section 4.3). Finally, both parties are active in the production of APIs,  giving  rise  to  a
    limited number of vertically affected markets (section 4.4)[7].

2 Finished dose pharmaceuticals (FDPs)

1 General approach to the product market definition

1 Analysis based on ATC classification

11. In previous decisions concerning the pharmaceutical sector, the Commission has referred to the third level  of  the  Anatomical  Therapeutic
    Classification (ATC)[8] as the starting point for the purposes of defining the relevant product market.  However,  in  a  number  of  cases,
    especially concerning genericised products, the Commission found that the ATC3 level classification did not  yield  the  appropriate  market
    definition. As a result, in recent cases[9], the Commission has defined the relevant product market at a narrower level,  including  at  the
    ATC4 level or at the level of the "molecule" (i.e. active ingredient) or group of molecules  that  are  considered  interchangeable  from  a
    therapeutic perspective and between which there are proven economic substitution patterns so as to  exercise  competitive  pressure  on  one
    another.

12. In the present case, the Commission has taken, where possible, as a starting point the molecule level and assessed, on a case-by case basis,
    whether the market should be expanded by including other molecules within the class having the same indication.

13. Given the complementarity between Mylan's and Perrigo's activities, some of their products giving rise to affected markets do not overlap at
    the level of the specific molecule but only at the level of the  broader  ATC3  category.  This  is  due  to  the  fact  that  Mylan  offers
    pharmaceutical products based on specific active ingredients, whereas Perrigo focuses on  the  consumer  goods  segment  with  a  number  of
    products based for example on plant extracts which belong to the same ATC3 class due to the common indication they are  intended  to  treat,
    but are not directly substitutable due to different therapeutic characteristics and consumer profile.

14. Pharmaceutical products may be further subdivided into various segments on the basis of a variety of criteria,  and  in  particular  demand-
    related criteria.

2 Prescription drugs v. OTC drugs

15. In some past cases, the Commission defined separate markets for medicines which can be sold on prescription and those which can be sold over
    the counter[10]. This is because the therapeutic indications, regulation and legal frameworks, prices,  dosages,  marketing,  packaging  and
    labelling tend to differ between these drug categories, even when the active ingredient is identical.

16. OTC products may be advertised to the public at large. Prescribers do not need to intervene in the  purchase  of  these  products.  In  most
    cases, consumers choose OTC pharmaceuticals themselves (possibly upon a recommendation from a pharmacist) and purchases are not  reimbursed.
    By contract, prescription pharmaceuticals need to be prescribed by a physician, whose intervention is thus essential in the  choice  of  the
    product. Pricing for prescription products is influenced by the public health care system, which pays the purchase price (or  part  of)  via
    reimbursement. Marketing of prescription drugs, therefore, is targeted at prescribers, namely doctors and hospitals[11]. In  certain  cases,
    products which are available OTC may also be reimbursed if bought on prescription.

17. Furthermore, in some specific circumstances, OTC products and prescription drugs based on the same molecule may  compete  with  each  other,
    especially in cases where the status of the drugs is not clearly limited to  either  OTC  or  prescription[12].  It  may  occur  in  certain
    countries that some variations of a drug with the same brand name are classified as OTC, whilst others are classified as  prescription-only,
    depending on the package size, dosage or galenic form.

18. The case at hand concerns both prescription and OTC drugs, due to the  complementary  profile  of  the  two  companies  (Mylan  focusing  on
    prescription generic drugs and Perrigo specialising in the OTC and consumers good segment). Therefore, the Commission has, where  necessary,
    tested the appropriateness of the OTC/prescription distinction in its assessment on a case-by case basis.

3 Galenic form

19. As the Commission has found in its previous decisions[13], medicines are differentiated not only by their active ingredient(s), but also, in
    particular, as recognised by the European regulatory framework for medicines for human use, by their dosage, pharmaceutical form  and  route
    of administration which may limit their substitutability.

20. For the purposes of this decision, the Commission has looked at the "galenic form" of the FDPs with reference to the  first  letter  of  the
    typology of form codes (the so-called "New Form Code" or NFC) used by IMS/EphMRA. In general, the first letter differentiates between  forms
    for systemic and topical effect, site of application, and also between long-acting and ordinary forms.

21. The market investigation in this case provided indications that, for some of the products considered, different routes of administration and
    the pharmaceutical form of a medicine may be designed  to  serve  the  needs  of  different  patient  groups  and  would  therefore  not  be
    interchangeable. This was shown to be the case for the liquid form of certain drugs (such as syrups or oral  solutions),  which  are  mainly
    designed for a specific category of patients, such as patients with swallowing difficulties or paediatric patients.

22. In any event, as further detailed below in the Commission's product-specific assessments, the  question  of  whether  the  relevant  markets
    should be further subdivided according to the galenic form can be left open for the purpose of this decision.

2 Geographic market definition

23. The Commission has previously defined the geographic markets for  pharmaceutical  products  as  being  national  in  scope[14].  The  market
    investigation in this case did not provide any indications that such market definition should be revisited, in particular, in  view  of  the
    national regulatory and reimbursement schemes and the fact that competition  between  pharmaceutical  firms  predominantly  takes  place  at
    national level.

24. Therefore, for the purposes of this decision, the Commission's assessment of FDP markets is carried out on national basis.

3 Methodology used in the assessment of affected markets

25. In accordance with past Commission's practice in the pharmaceutical sector[15],  the  Commission  applied  a  system  of  filters  aimed  at
    determining the group of markets where concerns are most likely to arise and on which it focused its analysis.

26. Specifically, the markets were grouped in four groups:

                                                               • Group 1: where the Parties' combined market share exceeds 35% and the  increment
                                                                 exceeds 1%.

                                                               • Group 2: where the Parties' combined market share exceeds 35% but the  increment
                                                                 is below 1%.

                                                               • Group 3: where the Parties' combined market share is between 20%[16] and 35%.

                                                               • Group 1 "plus"[17]: there are  two  scenarios  of  non-Group  1  markets,  which
                                                                 deserve a closer attention: (1) the combined market share is below 35% but  only
                                                                 one other competitor remains on the market, and (2) the  combined  market  share
                                                                 exceeds 35% and the increment is below 1% but the party with the small increment
                                                                 is a recent entrant[18].

27. The notified concentration gives rise to a limited number of affected markets in the area of FDPs, both at the ATC3 level (same  therapeutic
    indication) and at the narrower molecule level. Some affected markets, the vast majority of which belonging to Group 3, arise only based  on
    the sub-segments Rx/OTC or galenic form.

28. More specifically, in the area of FDPs, taking  into  account  all  possible  alternative  market  definitions  (including  OTC/prescription
    segmentation, galenic form, etc.), the Transaction gives rise to eight Group 1 markets and nine Group 2 markets.

29. The Group 1 markets, which will be further analysed below, are the following:

                                                               • Two Group 1 affected markets  at  the  ATC3  level  in  class  A9A  (digestives,
                                                                 including enzymes acting on the digestive tract): one in  Belgium  occurring  at
                                                                 the ATC3 level and one in Hungary occurring at the ATC3 level, the  latter  only
                                                                 in the OTC segment. The overlaps occur for OTC products at the ATC3  level,  but
                                                                 not at the molecule level because whilst the Parties  sell  products  which  are
                                                                 classified under the same therapeutic indication, these products do not have the
                                                                 same active ingredient.

                                                               • Three Group 1 affected markets in France in class A2B1 (H2 antagonists)  (i)  at
                                                                 the ATC4 level , (ii) at the ATC4 level and galenic form A (H2 antagonists, oral
                                                                 solid ordinary form) and (iii) at the level of the  molecule  cimetidine  within
                                                                 such class.

                                                               • One Group 1 affected market in Portugal at the molecule level for ibuprofen sold
                                                                 OTC.

                                                               • Two Group 1 affected markets at the molecule level in the United Kingdom for the
                                                                 molecules procyclidine and lofepramine.

30. Besides, Group 2 and Group 3 affected markets were also analysed; the  Commission  assessed  the  competitive  situation  on  these  markets
    including the nature and the number of existing competitors. In this decision, these markets are not considered in detail  individually  and
    are covered by the general conclusions in relation to markets where the transaction  does  not  give  rise  to  serious  doubts  as  to  its
    compatibility with the internal market.

4 Product-specific assessment

31. The Commission analyses below in detail all the Group 1 markets resulting from the Transaction.  Group  1  markets  arise  in  the  area  of
    digestives in Hungary and Belgium (section 4.2.4.1), for cimetidine-based products in France (section 4.2.4.2), for ibuprofen-based products
    in Portugal (section 4.2.4.3) and for procyclidine and lofepramine-based products in the United Kingdom (section 4.2.4.4).

1 Digestives including enzymes (A9A) in Hungary and Belgium

32. The ATC3 class A9A covers digestives including enzymes, acting on the digestive tract.

33. In this case, one Group 1 affected market arises in Belgium at the ATC3 level and another Group 1 affected market arises in Hungary  at  the
    ATC3 level, but only in the OTC segment.

                                                                 The Parties' products

34. Mylan's A9A product (recently acquired from Abbott) is based on pancreatin and is sold under the trade name Creon in Belgium  and  Kreon  in
    Hungary. Pancreatin is a biological product containing three enzymes: lipase,  protease  and  amylase.  Creon/Kreon  is  indicated  for  the
    treatment of exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis or other conditions. It is protected by  process
    and formulation patents and is sold OTC in Belgium and in Hungary in the oral solid ordinary form.

35. Unlike Creon/Kreon, Perrigo's A9A product, sold under the name Eau de Melisse Carmes in Belgium and Svedcsepp/Bittner in Hungary,  is  based
    on (non-enzyme) plant extracts. Eau de Melisse Carmes/Svedcsepp/Bittner is sold exclusively OTC in Belgium and in Hungary in the oral liquid
    form. It is used as a digestive and as an aid against stress, travel sickness and fatigue.

Product market definition

36. In the past cases dealing with molecules in the A9A class, the Commission examined the market at the ATC3 level[19].

37. The exact product market definition for A9A products can be left open in this case as the Transaction does not give rise to  serious  doubts
    as to its compatibility with the internal market under any plausible market definition, it being specified that Group 1 markets  arise  only
    at the ATC3 level and at the ATC3 level limited to OTC products.

                                                                 Competitive assessment

Belgium

38. In Belgium, the Parties' combined market share in the A9A class was [90-100]% in value  and  [90-100]%  in  volume  in  2014.  However,  the
    increment (Perrigo) is very small ([0-5]% in value and [0-5]% in volume, based on 2014 data). Moreover, there is no overlap at the  molecule
    level because Creon is based on a biological product (pancreatin), which is a combination of three enzymes, whereas Eau de Melisse Carmes is
    based on extracts of various plants (Angelica Archangelica/Coriandrum Sativum/Melissa Officinalis).

39. The Notifying Party submits that, despite being classified in the same ATC3 class, there is no competitive relationship  whatsoever  between
    the Parties' products. Creon is a pharmaceutical product which treats a particularly serious condition, exocrine  pancreatic  insufficiency,
    whereby the body does not have enough enzymes produced by the pancreas to process nutriments from food. On the other hand, Perrigo's product
    is a consumer product composed of a blend of herbs and plant extracts, typically purchased by patients belonging to families  in  which  the
    product has been traditionally used for the treatment of digestives disorders.

40. The market investigation indeed provided indications that due to these inherent different profiles, there  is  no  competitive  relationship
    between the two products. During the market investigation, respondents indicated that, due to the severity of the  condition  which  Mylan's
    product is intended to treat, they would not consider Perrigo's plant extract-based product as  an  effective  substitute  for  it[20].  The
    market investigation therefore supported the Notifying Party's view that Mylan and Perrigo's products are intended for  different  uses  and
    that any patient migration from one product to the other in response to a price increase can be excluded.

41. Taking into consideration all of the above, the Commission considers that Mylan's and Perrigo's products  in  the  ATC3  class  A9A  do  not
    compete with each other.

                                                                 Conclusion

42. In light of the above, the Commission concludes that the transaction does not give rise to serious doubts as to its compatibility  with  the
    internal market in relation to the ATC3 class A9A (digestives including enzyimes) in Belgium.

                                                                 Hungary

43. In Hungary, a Group 1 affected market arises only in the OTC segment of the A9A class, where the Parties' combined market share was [30-40]%
    in value and [20-30]% in volume with an increment (Perrigo) of [5-10]% in value and [10-20]% in volume in 2014. As  already  indicated  with
    respect to Belgium, there is no overlap at the molecule level because Kreon is based on pancreatin, which is a combination of three enzymes,
    whereas Svedcsepp/Bittner is based on plants extracts.

44. The Notifying Party submits that, despite being classified in the same ATC3 class, there is no competitive relationship  whatsoever  between
    the Parties' products. The underlying reasons are the same as explained for the Group 1 market in A9A class in  Belgium  (see  paragraph  39
    above). The market investigation confirmed that, similarly to Belgium, there is  no  competitive  interaction  between  both  products  (see
    paragraph 40 above) in Hungary.

45. Moreover, regarding Hungary specifically, Kreon faces direct competition from various pancreatin-based products in the OTC segment  sold  by
    other suppliers, such as Menarini and Farmage (which sells products from Richter Gideon in Hungary) with market shares of [20-30]% and  [20-
    30]% (value), respectively.

                                                                 Conclusion

46. In light of the above, the Commission concludes that the Transaction does not give rise to serious doubts as to its compatibility  with  the
    internal market in relation to the ATC3 class A9A (digestives including enzyimes) in Hungary.

2 Cimetidine (A2B) in France

47. Cimetidine belongs to the ATC3 class A2B which includes antiulcerants. The anti-peptic ulcer category encompasses a variety of drugs used to
    treat a range of common disorders considered to be related to acid secretion by the stomach. The ATC3 class  A2B  is  further  divided  into
    several ATC4 classes depending on the mode of action. Cimetidine belongs to the ATC4 class A2B1 which  contains  H2  antagonists.  Acid  (or
    proton) pump inhibitors discussed below, also called PPIs, belong to the ATC4 class A2B2.

                                                                 The Parties' products

48. In the ATC4 classes A2B1 and A2B2 in France, Mylan's primary products are acid pump inhibitors (A2B2) based  on  esomeprazole,  lansoprazole
    and omeprazole. Mylan also markets the following H2 antagonists (A2B1): cimetidine, famotidine, pantoprazole,  rabeprazole  and  ranitidine.
    Mylan's products are used for the treatment of a range of common disorders considered to be related to acid secretion by the  stomach,  such
    as dyspepsia, peptic and duodenal ulcer diseases as well as gastroesophageal reflux disease. As to cimetidine in particular, Mylan sells non-
    branded products which are marketed as prescription drugs in the oral solid ordinary form (from 10mg to 800mg) and in the parenteral form.

49. In the ATC4 classes A2B1 and A2B2 in France, Perrigo's product is a cimetidine-based product, sold under the brand Stomedine.  Stomedine  is
    also used for the treatment of a range of common disorders considered to be related to acid secretion by the stomach. Stomedine is  marketed
    as an OTC drug in France and is available in the ordinary oral solid form (200mg).

                                                                 Product market definition

50. In past decisions, the Commission has analysed this market both at the ATC3 (A2B – antiulcerants) and ATC4 level (A2B1 - H2 antagonists  and
    A2B2 - acid pump inhibitors).[21] In case 37.507 (AstraZeneca), the Commission defined a separate product  market  at  the  ATC4  level  for
    prescription proton pump inhibitors which did not include H2 blockers.[22]

51. More recently, in case M.7379 (Mylan/Abbott EPD-DM)[23], which concerned the H2 antagonist ranitidine, the  market  investigation  indicated
    that various molecules within the category of H2 antagonists are substitutable, including ranitidine. In addition, the results of the market
    investigation in that case indicated that within the family of antiulcerants, acid pump inhibitors (A2B2), such as omeprazole,  are  a  more
    recent and effective generation of products compared  to  H2  antagonists.  Hence,  acid  pump  inhibitors,  appeared  to  be  preferred  by
    doctors[24]. Given the one-way substitutability of H2 antagonists  by  acid  pump  inhibitors,  the  Commission  concluded  in  case  M.7379
    (Mylan/Abbott EPD-DM) that the relevant product market in relation to ranitidine-based products was wider than the  molecule,  but  narrower
    than the ATC3 class, likely comprising ATC4 classes A2B1 and A2B2.

52. Mylan supports a market definition comprising ATC4 classes A2B1 and A2B2.

53. The market investigation in the present case confirmed this wider than the molecule approach. Specialists in  the  gastro  therapeutic  area
    explained that the official recommendations from the French National Gastroenterology  Society  advise  to  prescribe  PPIs  instead  of  H2
    antagonists for patients with gastric problems in standard situations. This is due to the fact that PPIs  are  regarded  as  more  efficient
    drugs and easier to administer to patients than H2 antagonists.

54. Given the one-way substitutability of H2 antagonists (including cimetidine) by PPIs, the relevant product market in relation to  cimetidine-
    based products appears to be wider than the molecule. In any event the exact product market definition for cimetidine can be  left  open  in
    this case as the transaction does not give rise to serious doubts as to its compatibility with  the  internal  market  under  any  plausible
    market definition.

                                                                 Competitive assessment

55. In France, the proposed transaction gives rise to Group 1 affected markets at the ATC4 level (A2B1), at the ATC4 level (A2B1) limited to OTC
    products and at the level of the molecule cimetidine, which is the only molecule sold by Perrigo in this ATC4 class.

56. Based on 2014 data, the Parties' market shares were as follows:

Table 1 - Market shares for cimetidine, A2B1-A and A2B1 products (2014, value and volume)

|Level                   |Mylan (%)                              |Perrigo (%)                         |Combined (%)                     |

                                 |Val. |Vol. |Val. |Vol. |Val. |Vol. | |Molecule |[50-60] |[60-70] |[30-40] |[10-
                                 20] |[80-90] |[70-80] | |A2B1 – A |[30-40] |[30-40] |[0-5] |[0-5] |[30-40] |[40-
                                                                 50] | |A2B1 |[20-30] |[30-40] |[0-5] |[0-5] |[30-40]  |[40-50]  |  |The  highest
    combined market share in 2014 was at molecule level reaching [80-90]% in value, with [50-60]% for Mylan  and  [30-40]%  for  Perrigo.  On  a
    market limited to cimetidine-based products, the Parties' main competitor is Actavis with [10-20]% market share in 2014.

57. The Notifying Party submits that no competition concerns would arise even at the molecule level, since cimetidine is  a  mature  genericised
    market with a number of strong competitors, such as Actavis[25] and Teva.

58. The Notifying Party also indicated that, with the exception of Perrigo's OTC product, cimetidine products in France are reimbursed drugs and
    subject to a prescription requirement. Mylan's cimetidine product would therefore compete  much  more  closely  with  other  reimbursed  and
    prescribed cimetidine products that are available in comparable pack sizes (i.e. Teva and Actavis products), rather than with Perrigo's non-
    reimbursed OTC product that is only available in small pack size (due to regulation).

59. The market size for cimetidine in 2014 in France was EUR 1.7 million and has declined since 2012 by more than one third. This was  confirmed
    by physicians during the market investigation since H2 antagonists (including cimetidine) are gradually being replaced  by  newer  and  more
    efficient molecules within the PPIs category.

60. The market investigation in this case also indicated that Mylan's and Perrigo's products are not considered  by  market  paricipants  to  be
    close competitors in particular due to the OTC nature of Perrigo's products, as opposed to Mylan's products, which must be prescribed  by  a
    physician. One competitor indicated that "Mylan and Perrigo do not really compete on the cimetidine  market,  the  first  one  play  on  the
    generic side and Perrigo on the OTC business."[26]

61. This difference is reflected in the prices of the Parties' products. Indeed, the market investigation confirmed  that  there  are  important
    differences between the ex-factory price of Mylan's INN generic product and Perrigo's branded product for the same strength and dosage[27].

62. Finally, the market investigation did not reveal any concerns in relation to cimetidine-based products in France.

                                                                 Conclusion

63. In light of the above, the Commission concludes that the transaction does not give rise to serious doubts as to its compatibility  with  the
    internal market in relation to cimetidine-based products in France, irrespective of the precise product market definition.

3 Ibuprofen (M1A, M2A and N2B) in Portugal

64. Ibuprofen is a non-steroidal anti-inflammatory drug derivative of propionic acid used for relieving pain  and  fever  as  well  as  reducing
    inflammation. Ibuprofen is classified in several ATC classes, depending on the indication of the specific ibuprofen-based product. Ibuprofen
    can be sold both as prescribed and OTC drug.

65. In Portugal, a Group 1 affected market arises at the level of the molecule ibuprofen, irrespective of the ATC classification, only  for  the
    OTC segment.

                                                                 The Parties' products

66. In Portugal, Mylan's ibuprofen-based product is sold under the brand Brufen, recently acquired from Abbott. Brufen is classified  under  two
    different ATC classes, namely M1A1(anti-rheumatics, non-steroidal plain) where it is sold in oral solid form (from 200 mg to 600 mg) and  in
    oral liquid form, and N2B0 (general purpose non-narcotic analgesics and antipyretics) where it is sold in oral liquid form only.  Brufen  is
    marketed as both prescription and OTC drug in Portugal. Its indications (under both ATC4 classes) range from the treatment of pain,  to  the
    treatment of inflammation and fever.

67. Perrigo's ibuprofen based product sold in Portugal is called Ozonol. Ozonol is classified under two ATC classes, namely M2A0 (topical  anti-
    rheumatics and analgesics) where it is sold in a topical form and N2B0 where it is sold in the oral solid (200mg). Ozonol is sold as an  OTC
    product only in Portugal. Its indications range from the treatment of pain (e.g. muscle pain, trauma pain, toothaches, headaches,  menstrual
    pain, etc.) to symptoms associated with cold and flu.

                                                                 Product market definition

68. In previous decisions[28], the Commission analysed ibuprofen-based products within the respective ATC3 classes M1A and N2B. In one case, the
    Commission considered that the product market for ibuprofen could be defined at least at the ATC4 level, comprising all anti-rheumatic drugs
    belonging to the M1A1 class or wider[29].

69. The Notifying Party submits that the relevant product market for ibuprofen in Portugal shall be defined on the basis of each applicable  ATC
    code since the ibuprofen-based products marketed under each ATC class  aim  to  treat  different  indications.  Also,  the  Notifying  Party
    considers that, within a specific ATC class, ibuprofen is widely substitutable by products based on other molecules belonging  to  the  same
    class and therefore the market for ibuprofen should not be defined at the molecule level.

70. Responses to the market investigation in this case did not support the Notifying Party's view that the market for  ibuprofen-based  products
    shall be defined according to specific ATC classes. Respondents generally explained that  although  ibuprofen-based  products  belonging  to
    different ATC classes may have different status (Rx or OTC), pack sizes, dosages and galenic forms[30], they tend to  compete  against  each
    other if they have the same reimbursement status, dosage and galenic form. In this context, one competitor explained that "even if ibuprofen
    products belong to different ATC classes, they might definitely compete in case of similar forms and  dosages"[31].  Indeed,  pharmaceutical
    companies typically cannot price discriminate between drugs based on the same molecule depending on the indication[32], which was  confirmed
    by one ibuprofen supplier stating that "no price and rebates differences are driven by different indications"[33].

71. Furthermore, ibuprofen-based products may have very similar indications across ATC classes.  The  Notifying  Party  submits  that  ibuprofen
    belonging to three different ATC codes (M2A0, M1A1 and N2B0) treats "mild to moderate pain",  including  "fever"  for  M1A1  and  N2B0.  One
    competitor indeed indicated that, although "M2A is positioned for local pain", "M1A and N2B compete directly with each other"[34].

72. As to the distinction between prescribed (Rx) and OTC ibuprofen, responses to the market  investigation  are  varied.  A  number  of  market
    participants indicated that the reimbursement policy and dosages for Rx and  OTC  ibuprofen-based  products  sold  in  Portugal  differ[35].
    Indeed, 200mg ibuprofen-based products are not reimbursed and can be sold OTC, whereas 600mg ibuprofen-based products are reimbursed (up  to
    37% for Mylan's Brufen product) and can only be sold under prescription[36]. However, it cannot  be  excluded  that  OTC  ibuprofen  and  Rx
    ibuprofen exert some sort of competitive pressure on each other. Some respondents indicated that when selling OTC  products,  pharmaceutical
    companies give strong rebates and discounts for promotion and placement purposes, which might lead to lower prices for  OTC  ibuprofen  than
    the co-payment level for Rx ibuprofen as a result of which competition can take place between OTC and Rx ibuprofen.

73. As to the distinction based on the galenic form, the market investigation gave indications that ibuprofen sold in the oral  solid  form  may
    not be fully substitutable with ibuprofen sold in the topical form. One competitor indicated that "we don't  consider  that  oral  ibuprofen
    products compete directly with topic[al] ibuprofen products"[37] and another that "topic[al] formulation […] don't  compete  with  the  oral
    ones"[38].

74. Finally, respondents to the market investigation did not exclude the existence of competitive constraints on ibuprofen-based  products  from
    other molecules within the same ATC class. One competitor highlighted in particular the existence of "constraints [on  ibuprofen]  of  other
    anti-inflammatory drugs"[39].

75. In any event the exact product market definition for ibuprofen in Portugal can be left open in this case as the Transaction  does  not  give
    rise to serious doubts as to its compatibility with the internal market under any plausible market definition.

                                                                 Competitive assessment

76. In Portugal, a Group 1 affected market arises at the molecule level irrespective of the ATC classification, but only in the OTC segment. The
    OTC ibuprofen segment represented EUR 3.4 million in 2014 in Portugal.

77. In 2014, Mylan's market share for OTC ibuprofen was [50-60]% in value and [70-80]% in volume and Perrigo's market share was [0-5]% in  value
    and [0-5]% in volume. The main competitors of Mylan in the OTC ibuprofen segment were Medinfar ([10-20]% in value), Bene Chemie ([5-10]%  in
    value) and Reckitt Benckiser ([5-10]% in value).

78. Mylan's and Perrigo's products do not appear to be close competitors in Portugal. Besides the fact that Perrigo's overall position is  small
    compared to Mylan's and its main competitors' positions, they compete only in the OTC 200 mg ibuprofen in oral solid  form.  Respondents  to
    the market investigation presented Perrigo's Ozonol product as being particularly well known in its topical form – where Mylan is not active
    – but not in the oral solid form[40].

79. Also, it must be noted that the OTC segment represents  a  relatively  small  proportion  of  the  total  sales  of  ibuprofen  in  Portugal
    (approximately EUR 3.4 million of a total of approximately EUR 19.2 million)[41].

80. None of the market participant raised possible competitive concerns as to ibuprofen-based products in Portugal, Rx or OTC, as  a  result  of
    the Transaction, but rather describe the market as being "high[ly] competitive"[42].

                                                                 Conclusion

81. Given the limited increment in market share (below 5%), the existence of strong competitors remaining  even  on  a  market  limited  to  OTC
    products belonging to all ATC codes and the absence of closeness of competition between Mylan and Perrigo, the  Transaction  does  not  give
    rise to serious doubts as to its compatibility with the internal market in relation to ibuprofen-based products in Portugal.

4 Group 1 markets in the United Kingdom

82. The Commission identified a number of affected markets in relation to FDPs sold by Mylan and Perrigo in  the  United  Kingdom.  Among  these
    overlaps, the Commission identified only two Group 1 affected markets at the molecule level, namely for procyclidine and lofepramine in  the
    United Kingdom.

1 Procyclidine (N4A) in the United Kingdom

83. Procyclidine belongs to the ATC3 class N4A which comprises anti-parkinson drugs that aim at  restoring  the  balance  between  dopamine  and
    acetylcholine in the brain. The ATC3 class N4A is not further subdivided into ATC4 classes.

                                                                 The Parties' products

84. In the United Kingdom, Mylan sells non-branded procyclidine-based products, which are named  after  the  active  ingredient  (Procyclidine).
    Mylan's procyclidine-based products are marketed as prescription drugs and are available in the oral solid ordinary form only.

85. Perrigo's procyclidine-based product is called Arpicolin (branded generic) and is also sold as a prescription drug. Arpicolin  is  available
    only in the oral liquid ordinary form.

Product market definition

86. In previous cases regarding the ATC3 class N4A, the Commission left open the question on whether the market shall be  defined  at  the  ATC3
    level[43].

87. The Notifying Party submits that the relevant product market is the ATC3 level N4A since the  treatment  of  Parkinson  is  complicated  and
    typically involves the use of multiple drugs. This would be further substantiated by the fact that most drugs in the  N4A  category  can  be
    used as a monotherapy or in combination with other drugs and are as such interchangeable. Moreover, the  Notifying  Party  claims  that  the
    market should be further subdivided on the basis of the galenic forms in which the different prducts are available. In their view, Perrigo's
    products target a different category of patients than Mylan's, since they are desgined for patients with  swallowing  difficulties  who  are
    unable to confortably take the medication they are prescribed.

88. The market investigation in this case revealed that the role of procylidine in the treatment of Parkinson is in itself not very  strong,  as
    there are other better alternatives in the market. Procyclidine does not seem to be the first line of treatment for Parkinson,  although  it
    is considered a good option for some specific symptoms such as memory problems[44].

89. As to the distinction between solid and liquid procyclidine-based products, specialists in the field indicated that in  the  United  Kingdom
    there has traditionally been a preference for the solid form, although the liquid form could be useful for  Parkinson  patients  (especially
    elderly) who have difficulties to swallow solid tablets.

90. In any event, the exact product market segmentation for procyclidine in the United Kingdom can be left open in this case as the  Transaction
    does not give rise to serious doubts as  to  its  compatibility  with  the  internal  market  under  any  plausible  market  definition  for
    procyclidine.

                                                                 Competitive assessment

91. In 2014, the Parties had a combined market share for procyclidine of [40-50]% in value. Mylan's market  share  in  value  was  [30-40]%  and
    Perrigo's market share was [10-20]%.

92. The Parties' main competitors in the United Kingdom are generic suppliers selling non-branded products, namely Aspen and Co-Pharma. Teva was
    also active in this market, but discontinued the supply of its proclydine-based products since  April  2014.  However,  Teva  still  owns  a
    dormant marketing authorisation.

93. The Notifying Party submits that, should the market be assessed at the level  of  the  molecule,  Mylan  and  Perrigo  would  not  be  close
    competitors, since both Parties are active with different galenic forms serving different groups of patients.

94. The market investigation provided indications that procyclidine-based products in the oral solid and oral liquid forms cannot be  considered
    close competitors as they target different categories of patients[45]. This appears to be particularly relevant for Parkinson  patients  who
    are at an advanced stage of the disease, due to the gradual worsening of their physical condition and  ability  to  swallow  solid  tablets.
    Specialists indicated that they would start the treatment with the solid form and would only consider switching the treatment to the  liquid
    form once the patient's condition gets to it. At that point in time, there is typically no way back to the solid form.

95. The liquid form is thus a niche market. This seems to be confirmed by the size of the liquid form market which represents approximately  12%
    of the total market for procyclidine-based products. The Parties' competitors are all active  in  the  solid  form  only.  However,  Perrigo
    positions itself as "specialist in liquid medicines" and only sells this product in the oral liquid form and devotes its marketing  strategy
    for procyclidine to highlighting the features and advantages of liquids for patients with swallowing difficulties.

96. This is further confirmed by the substantial differences in pricing between Mylan's and Perrigo's products. Indeed, the  average  ex-factory
    actual selling price of Perrigo's products is significantly higher than Mylan's equivalent product (for a comparable dosage and strength).

97. Finally, the internal documents submitted by the Notifying party on this specific molecule confirm that Mylan does not consider Perrigo as a
    competitor in the procyclidine market while other competitors, Aspen, Co-Pharma and Teva, are clearly mentioned in its documents.

Conclusion

98. In light of the above and the fact that Mylan and Perrigo are not close competitors and important players will remain  on  the  market,  the
    Transaction does not give rise to serious doubts as to its compatibility with the internal market in relation to procyclidine-based products
    in the United Kingdom.

2 Lofepramine (N6A) in the United Kingdom

99. Lofepramine belongs to the ATC3 class N6A which includes substances used in the treatment of depression and mood stabilisation. N6A  can  be
    subdivided into ATC4 classes N6A1 (herbal antidepressants), N6A3 (mood stabilizers), N64A (selective serotonin re-uptake inhibitor – SSRI  –
    antidepressants), N6A5 (serotonin-noradrenaline re-uptake inhibitor – SNRI – antidepressants) and N6A9 (other antidepressants). Lofepramine,
    which belongs to the ATC4 class N6A9 (other antidepressants), is a  tricyclic  antidepressant,  easing  depression  by  affecting  naturally
    occurring chemical messengers (neurotransmitters) used to communicate between brain cells.

                                                                 The Parties' products

100. In the United Kingdom, Mylan's lofepramine product is named after the active ingredient  upon  which  it  is  based  (Lofepramine).  Mylan's
    product is a prescribed drug and is sold in the oral sold ordinary form (70 mg).

101. Perrigo's product sold in the United Kingdom is Lomont. Lomont is a prescribed drug, sold only in the oral liquid ordinary form (70mg/5  ml,
    150 ml per packsize).

Product market definition

102. In previous cases regarding the ATC3 class N6A, the Commission left open the question on whether the market shall be defined  at  the  ATC3,
    ATC4 or molecule levels[46].

103. The Notifying Party submits that tricyclic anti-depressants, such as lofepramine, are an older  type  of  antidepressants  than  tetracyclic
    antidepressants and are no longer recommended as a first line of treatment for depression because they are more dangerous if an overdose  is
    taken and may cause more unpleasant side effects than other  newer  treatments  like  SSRI  and  SNRI.  Exceptions  to  the  replacement  of
    lofepramine based products by newer antidepressants may be people with severe depression that fails to respond to other treatments.

104. The Notifying Party considers that although various molecules within N6A9 class present differences in chemical structure,  Mylan's  product
    based on lofepramine competes with oral solid ordinary products based on  other  molecules  within  the  N6A9  class  which  all  share  the
    characteristics of being anti-depressants. In the Notifying Party's view, certain molecules from other ATC4 categories (SSRI and  SNRI)  may
    also be regarded as interchangeable with lofepramine-based antidepressants, even though SSRI and SNRI are generally more expensive.

105. Moreover, the Notifying Party claims that the market should be further subdivided on the basis of the galenic forms in which  the  different
    prducts are available. In their view, Perrigo's products target a different category of patients than Mylan's, since they are  designed  for
    patients with swallowing difficulties who are unable to confortably take the medication they are prescribed.

106. The market investigation confirmed that lofepramine-based products are progressively replaced by newer antidepressants drugs in  the  United
    Kingdom, like SSRI (first line of treatment) and SNRI (second line of treatment). However, physicians indicated that  lofepramine  is  still
    prescribed, in particular by general practitioners, for patients that may not tolerate  the  new  antidepressants  drugs,  such  as  elderly
    patients.

107. As to the distinction between solid and liquid lofepramine-based products, physicians in the United Kingdom indicated  that  they  are  more
    familiar with the solid lofepramine product and usually prescribe this drug in the solid form. Liquid form may be prescribed in  exceptional
    cases where patients cannot swallow.

108. In any event, the exact product market segmentation for lofepramine in the United Kingdom can be left open in this case as  the  Transaction
    does not give rise to serious doubts as to its compatibility with the internal market under any plausible market definition for lofepramine.

Competitive assessment

109. The market size for lofepramine in the United Kingdom is GBP 2 million in 2014, having decreased from approximately GBP 6 million in 2012.

110. In the market for lofepramine in the United Kingdom, combining both solid and liquid forms, Mylan's market share was [40-50]% in  value  and
    [50-60]% in volume and Perrigo's market share was [5-10]% in value in 2014. The Parties' main competitors are Teva  and  Actavis.  Both  are
    selling lofepramine-based non branded generic in the oral solid form.

111. The Notifying Party submits that Mylan and Perrigo are not close competitors as their products  have  diverging  galenic  forms  and  target
    different patient groups. Indeed, Perrigo's liquid lofepramine product would specifically target patients with swallowing difficulties.

112. The market investigation in this case indicated that Mylan and Perrigo are not close competitors. Physicians  indicated  that,  unless  very
    specific circumstances where patients are not able to swallow, they always  prescribe  solid  form  lofepramine[47].  The  liquid  form  was
    consistently presented by competitors and wholesalers as a niche market[48]. This is confirmed by the size of the market  where  solid  form
    lofepramine based products represent almost 95% of the overall market. Also, the Parties' competitors, Teva, Actavis, Grey and Creo, are all
    active in solid form only, whereas Perrigo positions itself as "specialist in liquid medicines"  and  devotes  its  marketing  strategy  for
    lofepramine to highlighting the features and advantages of liquids for patients with swallowing difficulties.

113. Finally, Actavis' shortage as of November 2014 on the lofepramine market had a direct impact on Mylan's ex-factory prices,  increasing  from
    GBP […] in November 2014 to GBP […] in May 2015, which is an indication of the closeness of competition between oral solid  dose  providers.
    There is no evidence of such impact on Perrigo's liquid product. In addition, prices for Perrigo's liquid products are  considerably  higher
    than prices of Mylan's solid products.

Conclusion

114. In light of the above and in particular in view of the fact that Mylan and Perrigo are not close  competitors  and  a  number  of  important
    players will remain on the market, the Transaction does not give rise to serious doubts as to its compatibility with the internal market  in
    relation to lofepramine-based products in the United Kingdom.

3 Pipeline products

115. In addition to the marketed products, generic companies are  developing  pipeline  generic  FDPs.  Pipeline  generics  may  be  the  generic
    equilavent of originator drugs which come off-patent or new dosages or geographic markets for existing generic products.

116. In assessing generic pipeline competition, the Commission focused on instances where one party is  planning  to  enter  a  market  within  a
    period of two years and the other party (or the Parties combined) has a market share of 35% or more on any plausible market definition where
    the pipeline products and marketed products overlap[49].

117. In this case, the Form CO identified affected markets in some EEA countries in relation to Mylan's  pipeline  products  in  […]  therapeutic
    areas, [confidential information on Mylan's pipeline products].

118. However, none of the FDP markets are affected at the molecule level, but always at the level of the  ATC3/ATC4  class  limited  to  the  OTC
    segment. For all these markets, irrespective of the relevant market definition, Mylan would enter a  market  wider  that  the  affected  FDP
    markets. [confidential information on Mylan's pipeline products]. In light of this and the presence  of  other  important  competitors,  the
    Commission concludes that sufficient competition is likely to remain post-Transaction on these markets.

119. The Commission also identified affected markets in relation to Mylan's pipeline products and [confidential information on  Mylan's  pipeline
    products]. However, strong competitors will remain post-Transaction in the countries where affected markets arise.

120. Finally, in relation to Perrigo's pipeline products, the Commission identified two pipeline products overlapping  with  Mylan's  FDPs  where
    its market share was above 35% in the FDP markets at the molecule level or at the galenic form level. However, strong competitors will  also
    remain post-Transaction on these markets.

121. In view of the above, the Commission concludes that the Transaction does not give rise to serious doubts as to its  compatibility  with  the
    internal market in relation to pipeline products.

4 Active pharmaceutical ingredients (API)

122. The API is the substance in an FDP that is pharmaceutically active, as opposed to the  excipient  (inert  substance  in  which  the  API  is
    suspended).

123. Both Mylan and Perrigo supply a number of APIs in the EEA and world-wide, however no horizontally affected markets arise.  As  both  Parties
    are also active at the downstream level (FDPs), some vertical relationships arise as a result of the proposed Transaction.

                                                                 Market definition

124. In previous decisions, the Commission considered that APIs form separate product markets upstream of the markets for  FDPs.  The  Commission
    has looked at each individual API as potentially constituting a relevant market by itself, whilst noting  that  it  was  not  excluded  that
    certain APIs may be substitutable with each other for all, or for a range of, applications[50].

125. Geographically, API markets were considered to be at least EEA-wide and possibly global in scope[51].

126. The exact scope of the relevant product and geographic market can be left open as the Transaction does not give rise to  serious  doubts  as
    to its compatibility with the internal market under any plausible market definition.

                                                                 Competitive assessment

127. The Commission analysed the markets for each individual API supplied by Mylan and/or Perrigo at EEA and global levels.

128. Downstream vertically affected markets are markets where either party has a market share of more than 30% in the upstream API market (world-
    wide and/or EEA) and the other party has a market share exceeding 5% in an ATC3, ATC4 or molecule class[52] related to  the  FDP  containing
    that particular API.

129. Upstream vertically affected markets are those where either party has a market share of  more  than  30%  in  a  downstream  ATC3,  ATC4  or
    molecule class[53] and the other party has a market share of more than 5% in the corresponding upstream API market (world-wide  and/or  EEA)
    [54].

130. The transaction gives rise to vertically affected markets where Perrigo is active upstream (API) and Mylan is  active  downstream  (FDP)  in
    several EEA countries. The relevant APIs are fenofibrate, flumazenil, midazolam, moxonidine, pentoxifylline and tramadol. Also, based on the
    information provided by Perrigo, the Commission identified vertical links between Mylan's activities upstream (API) and  Perrigo's  FDPs  in
    the United Kingdom relating to flucanozole, loratadine, dipyridamole, memantine, mirtazapine, acyclovir,  losartan  potassium,  allopurinol,
    gabapentin and rivastigmine. Vertical links between Mylan's activities upstream (API) and Perrigo's FDPs were also identified in  Malta  for
    acyclovir.

131. However, in the instances where the Party active downstream has a significant market share in some FDP markets, the quantities of APIs  sold
    in the relevant countries are small compared to the corresponding total world-wide API volumes, always below 15%. Since suppliers  of  these
    APIs are active globally, the Parties will not have the ability nor an incentive to engage in customer foreclosure.

132. Also, in the limited instances where the Party active upstream has a significant market share, the quantities of APIs needed  by  the  other
    Party downstream is again very limited compared to the overall demand, so that an input foreclosure strategy is highly unlikely.

133. Finally, the market investigation did not reveal any concerns in relation to APIs.

Conclusion

134. In light of the above, the Transaction does not give rise to serious doubts as to its compatibility with the internal market in relation  to
    APIs.

       CONCLUSION

135. 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 Agreement. This decision is adopted in application of Article 6(1)(b) of the Merger Regulation and  Article
    57 of the EEA Agreement.

For the Commission
(Signed)

Margrethe VESTAGER
Member of the Commission

-----------------------
[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 the Official Journal of the European Union No C 215, 01.07.2015, p. 23.

[4]   M.7276 GlaxoSmithKline / Novartis Vaccines Business (ecl. Influenza) / Novartis Consumer Health Business.

[5]   Turnover calculated in accordance with Article 5 of the Merger Regulation.

[6]   In parallel to this Transaction, Perrigo is in the process of acquiring GSK's OTC business pursuant to  the  commitments  accepted  in  the
GSK/Novartis case. The Commission's competitive assessment of the Transaction takes into account this ongoing acquisition.

[7]   The Parties are also both active in outlicensing, contract manufacturing and distribution activities  in  the  EEA.  However,  no  affected
market arises and, therefore, these activities will not be further discussed in this decision.

[8]    Classification  devised  by  the  European  Pharmaceutical  Marketing  Research  Association  (EphMRA)  and  maintained  by   EphMRA   and
Intercontinental Medical Statistics (IMS).

[9]   M.5865 Teva/Ratiopharm, M.6613 Watson/Actavis and M.7379 Mylan/Abbott.

[10]  E.g. M.5865 Teva/Ratiopharm, paragraphs 22-24, M.5253 Sanofi-Aventis/Zentiva, paragraphs 21-24 and M.3751 Novartis/Hexal, paragraph  3.  In
      many cases, this distinction was however left open (e.g. M.7480 Actavis/Allergan, paragraph 64 and M.6613 Watson/Actavis paragraphs 10  and
      13).

[11]  M.5953 Reckitt Benckiser/SSL, paragraph 14.

[12]  M.5778 Novartis/Alcon, paragraph 14.

[13]        M.5778 Novartis/Alcon, M.5865 Teva/Ratiopharm, and M.5253 Sanofi-Aventis/Zentiva.

[14]  M.7379 Mylan/Abbott, paragraph 27.

[15]  M.5778 Novartis/Alcon, paragraph 25.

[16]  Initially, this group included markets where the combined market share ranges between 15% and 35%. However, in line with the new Notice  on
Simplified procedure (Commission Notice on a simplified procedure for  treatment  of  certain  concentrations  under  Council  Regulation  (EC)No
139/2004) this range was adapted from 20% to 35% to include only affected markets.

[17]  M.5778 Novartis/Alcon, paragraph 25.

[18]  No Group 1 "plus" markets were identified in this case (Form CO, footnote 48).

[19]  M.3853 Solvay/Fournier, paragraph 19.

[20]  Questionnaire Q1 – Pharmacies, Question 15,  Questionnaire  Q2  –  Wholesalers  and  distributors,  Question  14  and  Questionnaire  Q3  –
Competitors – Question 28.

[21]  M.1846 Glaxo Wellcome/Smithkline Beecham and M.3354 Sanofi-Synthelabo/ Aventis.

[22]  A.37.507/F3 AstraZeneca.

[23]  M.7379 Mylan/Abbott EPD-DM, paragraph 194 and following.

[24]  In particular, in that case, it was submitted that in France doctors prescribe acid pump inhibitors instead of H2 antagonists in more  than
95% of cases. Also, switching patients who are already taking  H2  antagonists  to  acid  pump  inhibitors  was  not  perceived  as  problematic.
Therefore, in that case H2 antagonists were regarded as substitutable by acid pump inhibitors, which seem to  be  more  effective  (although  the
reverse substitution does not occur).

[25]  The originator brand Tagamet developed by GlaxoSmithKline is currently marketed by Actavis in France.

[26]  Questionnaire Q3 – Competitors, Question 27.

[27]  Questionnaire Q3 – Competitors, Question 21.

[28]  M.5953 Reckitt Benckinser/SSL, paragraphs 17 and following, M.6258 Teva/Cephalon, paragraphs  50  and  following,  M.5865  Teva/Ratiopharm,
paragraph 250 and following and M.5253 Sanofi-Aventis/Zentiva, paragraph 146 and following.

[29]  M.7379 Mylan/Abbott EPD-DM, paragraph.337.

[30]  Questionnaire Q1 – Pharmacies, Question 11 and Questionnaire Q3 – Competitors, Question 8.

[31]  Questionnaire Q3 – Competitors, Question 19.

[32]  Questionnaire Q3 – Competitors, Question 9.

[33]  Questionnaire Q3 – Competitors, Question 8.1.

[34]  Questionnaire Q3 – Competitors, Question 19.

[35]  Questionnaire Q3 – Competitors, Questions 8 and 11 and Questionnaire Q2 – wholesalers and distributors, Questions 16 and 19.

[36]  Questionnaire Q3 – Competitors, Question 11.

[37]  Questionnaire Q3 – Competitors, Question 18.

[38]  Questionnaire Q3 – Competitors, Question 19.

[39]  Questionnaire Q3 – Competitors, Question 14.

[40]  Questionnaire Q3 – Competitors, Questions 16 and 18.

[41]  When asked which companies are the main players for ibuprofen products in Portugal, respondents therefore identified  companies  active  in
the prescribed field: Mylan with its Brufen product, Ratiopharm (Teva) with its non-branded generic ibuprofeno ratiopharm  and  Zambon  with  its
branded product Spidifen (Questionnaire Q3 – Competitors, Question 15).

[42]  Questionnaire Q3 – Competitors, Question 14.

[43]  M. 6258 Teva/Cephalon, paragraphs 69 and following.

[44]  Conference call with a neurologist on 15 July 2015.

[45]  Conference calls with a neurologist and with a competitor on 15 July 2015.

[46]  M. 5865 Teva/Ratiopharm, paragraphs 302 and following and M.6613 Watson/Actavis, pargraphs 29 and following.

[47]  Conference calls with a psychiatrist and neurologist on 15 July 2015

[48]  Conference call with a wholesaler on 16 July 2015 and with a competitor on 15 July 2015.

[49]  M.6258 Teva/Cephamon, paragraph 129 and M.6613 Watson/Actavis, paragraph 111.

[50]  M.5865 Teva/Rationpharm, paragraphs 393 to 395.

[51]  M.5865, Teva/Ratiopharm, paragraph 396.

[52]  Taking into account, at each level, further distinctions between Rx/OTC sales as well as galenic form.

[53]  Taking into account, at each level, further distinctions between Rx/OTC sales as well as galenic form.

[54]  M.5865 Teva/Ratiopharm, paragraph 399.

-----------------------
 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.

                                                                  PUBLIC VERSION

                                                                 MERGER PROCEDURE