CELEX: 32015M7480
Language: en
Date: 2015-03-16 00:00:00
Title: Commission Decision of 16/03/2015 declaring a concentration to be compatible with the common market (Case No COMP/M.7480 - ACTAVIS / ALLERGAN) according to Council Regulation (EC) No 139/2004 (Only the English text is authentic)

|[pic]                             |EUROPEAN COMMISSION                                                                                      |

Brussels, 16.3.2015
C(2015) 1863 final

                                        [pic]

|To the Notifying Party:                                                |                                                                       |
|                                                                       |                                                                       |

Dear Sir/Madam,

Subject:    M.7480 – Actavis/ Allergan

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 17 February 2015, the European Commission received notification of a proposed  concentration  pursuant  to  Article  4  of  the  Merger
       Regulation by which which Actavis plc ("Actavis", Ireland) acquires within the meaning of Article 3(1)(b) of the Merger Regulation control
       of the whole of Allergan Inc. ("Allergan", US) by way of purchase of shares.[3]

       THE PARTIES AND THE OPERATION

    2) Actavis is an integrated global  specialty  pharmaceutical  company  engaged  in  the  development,  manufacturing,  marketing,  sale  and
       distribution of branded originator, generic, branded generic, biosimilar and over-the-counter pharmaceutical products. Actavis’s principal
       executive offices are located in Dublin, Ireland, and it is listed on the New York Stock Exchange.

    3) Allergan is a multi-specialty healthcare company with a portfolio of pharmaceuticals,  biologics,  medical  devices  and  over-the-counter
       consumer products, with a focus on several medical specialties, including ophthalmology, neurology, medical aesthetics  (including  breast
       aesthetics), medical dermatology and urology. Allergan’s corporate headquarters are located in Irvine, California and it is listed on  the
       New York Stock Exchange.

    4) The transaction consists in the acquisition of 100% of the share capital of Allergan by Actavis through cash and shares. A newly  created,
       indirect wholly controlled subsidiary of Actavis will merge with Allergan, which will then become a wholly owned subsidiary of Actavis.

    5) Therefore, the proposed transaction constitutes a concentration within the meaning of Article 3(1)(b) of the Merger Regulation.

       EU DIMENSION

    6) The undertakings concerned have a combined aggregate world-wide turnover of more than EUR 5 000 million[4] (Actavis: EUR  8  128  million,
       Allergan: EUR 4 666 million). Each of them has an EU-wide turnover in excess of EUR 250 million (Actavis: […] million, Allergan:  EUR  […]
       million), but they do not achieve more than two-thirds of their aggregate EU-wide turnover within one and the same Member State.

    7) The notified operation therefore has an EU dimension within the meaning of Article 1(2) of the Merger regulation.

       COMPETITIVE ASSESSMENT

1 Framework for assessment

    8) The Parties' activities overlap regarding ophthalmic pharmaceutical products (pharmaceuticals used in the treatment  of  diseases  of  the
       eye) and other eye care products (consumer vision products) that may be placed on the market as medical devices (CE-marked products) or as
       pharmaceuticals.

            ATC classification for pharmaceuticals

    9) When assessing the relevant market definition in past decisions  dealing  with  pharmaceutical  products,[5]  the  Commission  noted  that
       medicines may be subdivided into therapeutic classes by reference to the "Anatomical Therapeutic Classification"  (ATC),  devised  by  the
       European Pharmaceutical Marketing Research Association (EphMRA) and maintained by EphMRA and Intercontinental Medical Statistics (IMS).[6]

   10) The ATC system is a hierarchical and  coded  four-level  system  which  classifies  medicinal  products  according  to  their  indication,
       therapeutic use, composition and mode of action. In the first and broadest level (ATC1),  medicinal  products  are  divided  into  the  16
       anatomical main groups. The second level (ATC2) is either a pharmacological or therapeutic group. The third level  (ATC3)  further  groups
       medicinal products by their specific therapeutic indications, i.e. their intended use (e.g. S1K - Artificial tears and ocular lubricants).
       Finally, the ATC4 level is the most detailed one (not available for all ATC3) and  refers  for  instance  to  the  mode  of  action  (e.g.
       distinction of some ATC3 classes into topical and systemic depending on their way of action) or any other subdivision of the group.

   11) In its past merger decisions in the pharmaceutical sector, the Commission has referred to the third level (ATC3) as the starting point for
       defining the relevant product market. However, in a number of cases, the Commission found that the ATC3 level classification did not yield
       the appropriate market definition within the meaning of the Commission Notice on the Definition of the Relevant Market. As a result, where
       appropriate and based on the factual evidence collected during the market investigation, the Commission has defined the  relevant  product
       market at the ATC4 level or at a level of molecule or a group  of  molecules  that  are  considered  interchangeable  so  as  to  exercise
       competitive pressure on one another.[7] The overlap in therapeutic uses does not necessarily imply any  particular  economic  substitution
       patterns between products.

            Consumer vision

   12) Consumer vision care products, such as ocular lubricants,  are  often  not  marketed  as  pharmaceutical  products.  In  its  past  merger
       decisions,[8] the Commission noted that for ocular lubricants the qualification as a pharmaceutical or a medical device  may  vary  across
       Member States.[9] The active ingredients in lens care preparations and ocular lubricants are generally common  chemical  compositions  and
       not under patent protection. Notwithstanding that consumer vision products are often not  pharmaceutical  products,  they  are  classified
       under the ATC2 (second level of the ATC classification) category S1. Each wider consumer vision product category is then grouped  under  a
       specific ATC3 class: for ease of reference, the relevant ATC3 level codes will therefore be used in the assessment below.

   13) Furthermore, consumer vision products can come in  various  galenic  forms  (e.g.  drops,  gels  or  ointments).  As  the  Commission  has
       acknowledged in its previous decisions,[10] medicines are differentiated not only by their active ingredient(s), but also, in  particular,
       as recognized by the European regulatory framework for medicines for human  use,  by  their  dosage,  pharmaceutical  form  and  route  of
       administration and this may limit their substitutability.[11]

            Geographic market definition

   14) The Commission considered in the past the national level as the relevant geographic level for analysing both pharmaceuticals and  consumer
       vision products.[12] The Notifying Party did not contest this, and the market  investigation  did  not  provide  any  indications  to  the
       contrary.

            Pipeline products

   15) In its previous decisions, the Commission assessed the competitive constraint likely to be exerted by products in research  &  development
       on existing product markets as well on possible future markets.[13] The Commission concluded that the  potential  for  these  products  to
       enter into competition with other products which are either on the market or at the development stage should be assessed by  reference  to
       their characteristics, intended therapeutic use, and expected therapeutic and economic substitutability.[14]

   16) In particular generic companies are usually developing a number of pipeline generic drugs which are intended to compete  with  originators
       which come off-patent.[15]

   17) As regards the geographic dimension of pipeline pharmaceuticals, in line with previous decisions,  the  Commission  considers  that  since
       pipeline products need to be assessed with reference to the R&D in a given area and if the extent that R&D for the  relevant  products  is
       global, the geographic scope of the market should be global or at least be EEA-wide.[16]

   18) Both Actavis and Allergan invest in the development of new products. Contrary to some previous cases, none of the pipeline  in  this  case
       concerns a situation whereby a Party would be the first generic entering the market after the loss of exclusivity of the other Party  (the
       specific case of bimatoprost is discussed further below).

   19) The Parties have identified in the Form CO product markets where the other Party has an existing market  share  and  the  other  party  is
       planning to enter:

         a. Actavis is planning to enter with a pipeline bimatoprost generic product, for which  Allergan  is  the  originator,  and  a  pipeline
            travoprost product, which falls in the same ATC3 category (see section 3.4);

         b. Allergan has three pipeline indications for Botox in therapeutic areas where Actavis has marketed treatments (see section 3.2);

         c. Allergan is developing a nasal spray, SER-120 (AGN 235258), based on desmopressin, while Actavis currently sells a desmopressin nasal
            spray. However, as Actavis' market share for desmopressin on all countries where it is active is generally less than  [0-5]%  and  in
            all cases under [5-10]%, this overlap will not be discussed further;

         d. Allergan has a product, Restasis, based on cyclosporine, approved in the US but in phase II  trials  in  the  EU.  Actavis  filed  an
            application to the US Food and Drug Administration for a generic version of  Restasis  in  November  2011,  but  later  withdrew  its
            application. However, as Restasis is not an approved product in the EU and Actavis does not have any  plans  to  develop  or  file  a
            generic version of Restasis in the EEA, this overlap will not be discussed further.

2 Botox

   20) One of Allergan’s main products is BOTOX (onabotulinum toxin A), a product that Allergan acquired from a physician and  developed  into  a
       major product with multiple indications. BOTOX can be used for medical applications[17], as well as non-medical (aesthetics)  applications
       for which it is sold under the brand name Vistabel.[18]

   21) BOTOX (and Vistabel) are classified under the ATC class M3A – Peripherally Acting Muscle Relaxants. The  Parties'  activities  overlap  at
       ATC3 level due to Actavis marketing two M3A drugs[19] in several countries where BOTOX (and Vistabel) are also marketed. The Parties  also
       note that Actavis sells or is developing products that may overlap with two existing indications (chronic migraine and overactive bladder)
       and three pipeline indications (osteoarthritis pain, depression, and plaque psoriasis) for BOTOX. The great majority of  Actavis  products
       for these indications are in oral form[20] and are genericized.

   22) Allergan further submits that it does not have BOTOX  sales  segmented  by  indication,  as  BOTOX  is  not  sold  in  indication-specific
       packaging.[21] While the quantity and mode of administration changes according to the indication, all vial sizes are  distributed  with  a
       leaflet containing instructions for all indications in all languages. Since Allergan does  not  know  what  indication(s)  any  particular
       package of BOTOX has been used for, it cannot and does not apply different prices for different indications of BOTOX.

   23) Nonetheless, for the abovementioned therapeutic areas, the market investigation  confirmed  the  Parties'  view  that  BOTOX  and  Actavis
       products have distinct indications and uses, distinct mechanisms of action, and often distinct modes of administration  (most  of  Actavis
       products are in tablet form while BOTOX is administed as an injectable solution). In addition, in most cases, for a  given  indication,  a
       course of treatment with BOTOX has a significantly different price than a course of treatment with any of Actavis' products. While each of
       these elements taken separately is generally not sufficient to conclude on the absence of competitive concerns, in the  specific  case  at
       hand, their combination allow to conclude that BOTOX is unlikely to closely compete with  any  of  Actavis'  products  identified  by  the
       Parties, and that no serious doubts arise regarding these overlaps. As a result, these overlaps  will  not  be  assessed  further  in  the
       decision.

3 Analysis of affected markets

   24) The Parties' activities give rise to affected markets in the following areas:

         a. Miotics and anti-glaucoma preparations (ATC3 class S1E) in Hungary, Ireland, Latvia, Lithuania, Poland and the UK (section 3.4);

         b. Artificial tears and ocular lubricants (ATC3 class S1K) in Denmark and the UK (section 3.5).

   25) Moreover, a vertical relationship  occurs  between  the  activities  of  Actavis'  subsidiary  Medis  in  the  outlicensing  and  contract
       manufacturing of latanoprost, and Allergan's activities in the area of Miotics and anti-glaucoma preparations (for which latanoprost is an
       Active Pharmaceutical Ingredient), giving rise to affected markets in Italy and the UK (section 3.6).

4 Miotics and anti-glaucoma preparations (S1E)

1 Product market definition

   26) Glaucoma refers to a group of ocular disorders resulting in optic nerve damage or loss  to  the  field  of  vision,  typically  caused  by
       pressure build-up to the fluid of the eye. Anti-glaucoma products are aimed at reducing the intra-ocular pressure and  are  often  in  eye
       drop form. Other treatments include laser treatment and surgery.

1 Past Commission decisions

   27) The Commission previously considered that the ATC3 class S1E should be divided into (i) injectable miotics  (used  in  ocular  surgery  to
       induce the constriction of the pupil), (ii) anti-glaucoma (used mainly as an eyedrop to relieve  intraocular  pressure,  which  frequently
       accompanies glaucoma), based on the different indications.[22] It also considered that anti-glaucoma products can be  further  sub-divided
       based on:

         a. their mode of action (namely into prostaglandin analogues, beta-blockers, alpha-adrenergic agonists, carbonic  anhydrase  inhibitors,
            non-injectable miotics);

         b. the molecule that constitutes the active ingredient, depending on the specificities of each market.[23]

   28) The Commission has so far left the market definition for products in the S1E class open.

2 Notifying Party's views

   29) The Notifying Party submits that the appropriate market definition is the ATC3 class S1E, divided into (i)  injectable  miotics  and  (ii)
       anti-glaucoma products. The Notifying Party considers it inappropriate to sub-segment anti-glaucoma products  based  on  mode  of  action,
       since all anti-glaucoma products are aimed at reducing intraocular pressure and should therefore be considered as substitutable.

3 Commission's assessment

   30) The market investigation provided indications that the S1E market should be subdivided into anti-glaucoma products and injectable miotics.
       Indeed, the majority of prescribers having responded to the Commission's market investigation indicated  that  they  would  not  prescribe
       drops and injectable products interchangeably.[24] Several prescribers further mentioned  that  injectables  are  not  yet  available  for
       glaucoma and ocular hypertension.[25] As there is no overlap in relation to the injectable  miotics  market,  the  decision  will  further
       consider only the anti-glaucoma market.

   31) Regarding anti-glaucoma products, the market investigation indicated that the different molecule groups  (prostaglandin  analogues,  beta-
       blockers, alpha-adrenergic agonists, carbonic anhydrase inhibitors, non-injectable miotics) are  typically  used  sequentially,  switching
       from one category to the other depending on the observed effectiveness and tolerability.  Most  repondents  to  the  market  investigation
       indicated that prostaglandin analogues are usually prescribed first,[26] in line with the European Glaucoma Society Guidelines.[27]

   32) If the reduction of intraocular pressure observed is unsufficient, depending on the reduction reached, physicians usually prescribe either
       another monotherapy (a prostaglandin analogue or a betablocker) or a combination of a betablocker with a prostaglandin analogue.[28]

   33) Other categories (alpha-adrenergic agonists and carbonic anhydrase inhibitors) are used if  the  abovementioned  treatments  do  not  show
       sufficient result or in case of side-effect or counterindication. Non-injectable miotics and in particular pilocarpine, are usally used in
       very specific cases, such as closed angle glaucoma.[29]

   34) Within the ATC3 class S1E, the Parties' activities overlap at molecule-level regarding prostaglandin analogues, for which  four  molecules
       exist:

         a. latanoprost: the originator is Pfizer; latanoprost exists in generic version for several years;

         b. bimatoprost: the originator is Allergan with its Lumigan products. The patent for some formulations of Lumigan already expired in the
            EEA[30] (Lumigan 0.03 and 0.03 unit dose, not Lumigan 0.01), but they are protected by a supplementary protection certificate in some
            countries;

         c. travoprost: the originator is Alcon (a subsidiary of Novartis); travoprost exists in generic version for several years; and

         d. tafluprost: the originator is Santen; tafluprost is still under patent protection.

   35) Latanoprost is often the first choice of physicians within the group of prostaglandin analogues. This preference appears to be due to  its
       good price/effectiveness ratio as it was the first genericised prostaglandin analogue (and is still  the  only  genericised  prostaglandin
       analogue in most European countries), than to a significant therapeutic difference compared to  other  prostaglandin  analogues.  Although
       bimatoprost is sometimes considered as more efficient but with more side effects than other prostaglandin  analogues,  and  tafluprost  as
       less efficient but with less side-effects,[31] most respondents to the market investigation  consider  that  the  different  prostaglandin
       analogues do not significantly differ from a therapeutic and side effect point of view.[32] The absence of preservative also plays a  role
       in the prescription of prostaglandin analogues. Tafluprost is the most cited as delivered without preservative, but other  molecules  also
       exist in this form.[33]

   36) In light of the above, the Commission considers that the S1E market could  be  subsegmented  into  injectable  miotics  and  anti-glaucoma
       products. The latter could also be segmented by mode of action, and possibly further at molecule level depending on the category.  In  any
       event, the market definition can be left open for the purpose of this decision, as no serious doubts  arise  under  any  plausible  market
       definition.

2 Competitive assessment

   37) Regarding anti-glaucoma products, the Parties are active in the following categories:

         a. prostaglandin analogues: latanoprost (Actavis), bimatoprost (Allergan, Actavis pipeline) and travoprost (Actavis pipeline);

         b. beta-blockers: timolol (Actavis and Allergan) and levobunolol (Allergan);

         c. combinations of prostaglandin analogues and beta-blockers: latanoprost/timolol (Actavis), bimatoprost/timolol (Allergan);

         d. alpha-2 adrenergic receptor agonists (also known as alpha agonists or adrenoceptors): brimonidine and  dipivefrine  (both  Allergan),
            and combination with a beta-blocker: brimonidine/timolol (Allergan);

         e. carbonic anhydrase inhibitors: dorzolamide and brinzolamide (both Actavis, the first one  is  marketed,  the  second  is  a  pipeline
            product), and combination with a beta-blocker: dorzolamide/timolol (Actavis);

         f. non-injectable miotics: pilocarpine (Actavis and Allergan's pipeline).

   38) The Parties' activities give rise to affected markets:

         a. at the level of anti-glaucoma products overall;

         b. in relation to the following molecule groups: prostaglandin analogues, and prostaglandin analogues in combination with beta-blockers;

         c. and at the following molecule levels: bimatoprost and pilocarpine.

                                            Table 1 - ATC3 class S1E, overview of the affected markets

|S1E (MIOTICS AND ANTI-GLAUCOMA PRODUCTS), 2011-2013                                                                                    |
|Market            |Country     |Value Share 2011-2013 (%)                                                                   |Sales     |
|(segment)         |            |                                                                                            |value 2013|
|Overall anti-glaucoma market                                                                                                           |
|Overall                                                                                                                                |
|Prostaglandin Analogues Only                                                                                                              |
|Market       |Country    |Value Share 2011-2013 (%)                                                                          |Sales value  |
|(segment)    |           |                                                                                                   |             |
|Overall S1K market                                                                                                                        |
|Overall                                                                                                                     |             |
|Multi-dose                                                                                                                  |DK           |

Drops |DK |[40-50] |[40-50] |[40-50] |[10-20] |[10-20] |[10-20] |[50-60] |[50-60] |[50-60] |998 | | |UK |[0-5] |[0-5]  |[0-5]  |[50-60]  |[40-50]
|[40-50] |[50-60] |[40-50] |[40-50] |32 821 | |Source: Form CO

1 Denmark

   39) The Transaction leads to a combined market share of [30-40]% with an increment of [5-10]% at S1K level. Should the market be segmented  in
       multi- and unit-dose, the Transaction would lead to a combined market share of [40-50]%, with an increment of  [0-5]%  in  the  multi-dose
       segement. Should a segmentation by galenic form be considered, the combined market share would reach [50-60]%, with an increment  of  [10-
       20]% in the drops segment.

   40) The strong presence of Actavis is due to its acquisition of Danish ophthalmological company Optha A/S in 2005. On the overall  S1K  market
       (even if the market is segmented between multi- and unit-dose)[45], the combined market share of  the  Parties  remains  moderate  with  a
       number of active competitors, such as Novartis ([40-50]%), Santen Seiyaku ([10-20]%) and Valeant ([0-5]%). One prescriber also pointed  to
       a recent market entry by competitor Thea.[46]

   41) As regards the potential market for drops, the total sales value was less than EUR 1 million in 2013. Market shares and total sales  value
       have been relatively stable in the course of the the last three years. In addition, strong rivals such as Novartis  ([30-40]%  share)  and
       Valeant Pharma ([5-10]% share) are also active in this segment. The market investigation confirmed that the products of these  competitors
       can be reimbursed in Denmark – as those of the Parties.[47]

   42) In light of the above and of all available evidence, the Commission concludes that the  Transaction  does  not  raise  serious  doubts  as
       regards artificial tears and ocular lubricants in Denmark.

2 The UK

   43) At the S1K level the transaction leads to a combined market share of [40-50]% with an increment of [0-5]%. If the market were segmented in
       multi- and unit-dose, the transaction would lead to a combined market share of [60-70]%, with an increment  of  [0-5]%  in  the  unit-dose
       segment[48]. Similarly, if a segmentation by galenic form were performed, the combined market share would be [40-50]%, with  an  increment
       of [0-5]% in the drops segement.

   44) In all the potential product markets, Actavis only contributes an insignificant increment. Moreover, there are other strong players active
       on the market such as Novartis ([10-20]% share), Valeant ([5-10]% share )and Scope Ophtalmics ([10-20]% share), and  more  than  20  other
       competitors.

   45) In light of the above and of all available evidence, the Commission concludes that the  Transaction  does  not  raise  serious  doubts  as
       regards artificial tears and ocular lubricants in the UK.

5 Contract manufacturing and out-licensing of latanoprost / Miotics and anti-glaucoma preparations (S1E)

   46) Actavis (through its subsidiary Medis) out-licenses generic pharmaceutical products to third parties. Where Medis out-licenses products to
       third parties, Actavis usually also manufactures these products for the third parties.[49] In 2013, Medis generated total worldwide  sales
       of approximately EUR [200-250] million from outlicensing and product manufacturing, of  which  approximately  EUR  [200-250]  million  was
       derived from sales to customers situated in the EEA.

   47) In previous decisions, the Commission considered out-licensing as a separate activity upstream of the markets for finished  pharmaceutical
       products. The Commission looked at the out-licensing of the relevant intellectual property rights for each individual API  as  potentially
       constituting a relevant market.[50] The Commission has also  considered  contract  manufacturing  according  to  the  pharmaceutical  form
       manufactured, and also, in some cases, to the conditions of manufacture (e.g., the types of APIs used, toxicity  levels,  whether  sterile
       environment is required).[51]

   48) Medis supplies latanoprost in the EEA, and Allergan is active in the downstream market of miotics and anti-glaucoma preparations (S1E). As
       discussed in section 3.4 above, the S1E market can be further sub-segmented by molecule  group  (latanoprost  belonging  to  prostaglandin
       analogues) and at molecule-level (latanoprost). Affected downstream markets only arise with respect to prostaglandin  analogues  in  Italy
       (where Allergan's share is at most [30-40]%) and the UK (where Allergan's share is [30-40]%). However, for these two markets,  latanoprost
       supplied by Medis represent an immaterial share of sales of the downstream market ([0-5]% in Italy and [0-5]% in the UK). Therefore, other
       competitors are able to compete on the downstream market, either via contracts with other out-licensors and contract manufacturers, or  by
       producing latanoprost internally.

   49) In light of the above and of all available evidence, the Commission concludes that the  Transaction  does  not  raise  serious  doubts  as
       regards the vertical relationship between the contract manufacturing and out-licensing of latanoprost and the sale of  miotics  and  anti-
       glaucoma products.

       CONCLUSION

   50) 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 66, 24.02.2015 p. 10.
[4]   Turnover calculated in accordance with Article 5 of the Merger Regulation.
[5]   See for example cases M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings of 5 August 2013; M.5778 – Novartis/Alcon of  9
August 2010, and M.5865 – Teva/Ratiopharm of 3 August 2010.

[6]   See for example cases M.6969 – Valeant Pharmaceuticals International/Bausch & Lomb Holdings of 5 August 2013; M.5865 –  Teva/Ratiopharm  of
3 August 2010; and M.5295 – Teva/Barr of 19 December 2008.
[7]   See cases M.6969 – Valeant Pharmaceuticals International/Bausch &  Lomb  Holdings  of  5  August  2013;  M.6705  –  Procter  &  Gamble/Teva
Pharmaceuticals OTC II of 9 November 2012; M.6613 – Watson/Actavis of 5 October 2012; and M.5865 – Teva/Ratiopharm of 3 August 2010.
[8]   See cases M.6969 – Valeant Pharmaceuticals International / Bausch & Lomb Holdings, Commission decision  of  5  August  2013  and  M.5778  –
Novartis/Alcon, Commission decision of 9 August 2010.
[9]   Medical devices are subject to the EC Medical Device Directive 93/42/EEC.
[10]  See M.5778 – Novartis/Alcon of 9 August 2010; M.5865 – Teva/ Ratiopharm of 3 August 2010; and M.5253 –  Sanofi-Aventis/Zentiva  4  February
2009.
[11]  See Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on  the  Community  code  relating  to  medicinal
products for human use (OJ L311, 28.11.2001, p.67), as amended by various subsequent acts.
[12]  See M.6969 – Valeant Pharmaceuticals International / Bausch  &  Lomb  Holdings,  Commission  decision  of  5  August  2013;  and  M.5778  –
Novartis/Alcon, Commission decision of 9 August 2010.
[13]  See M.6969 –  Valeant  Pharmaceuticals  International  /  Bausch  &  Lomb  Holdings,  Commission  decision  of  5  August  2013;  M.6278  –
Takeda/Nycomed, Commission decision of 29 July 2011;  M.5778 – Novartis/Alcon, Commission decision of 9  August  2010;   M.1878  –  Pfizer/Warner
Lambert, Commission decision of 22 May 2000; M.1846 – Glaxo Wellcome/Smithkline Beecham, Commission decision of 8 May 2000;  and  M.737  –  Ciba-
Geigy/Sandoz, Commission decision of 04 February 1998.
[14]  See M.7275 – Novartis/GlaxoSmithKline Oncology Business, Commission  decision  of  28  January  2015;  M.5476  –  Pfizer/Wyeth,  Commission
decision of 17 July 2009; M.1846 – Glaxo Wellcome/Smithkline Beecham, Commission decision of 8 May 2000.
[15]  See M.7275 – Novartis/GlaxoSmithKline Oncology Business, Commission decision  of  28  January  2015;  M.6258  –  Teva/Cephalon,  Commission
decision of 13 October 2011; and M.6613 – Watson/Actavis, Commission decision of 5 October 2012.
[16]  See M.7275 – Novartis/GlaxoSmithKline Oncology Business, Commission decision of 28 January 2015; and M.737 – Ciba-Geigy/Sandoz,  Commission
decision of 17 July 1996.
[17]  BOTOX is indicated to treat eight medical conditions: (i) certain types of eye muscle problems (strabismus); (ii)  abnormal  spasm  of  the
eyelids (blepharospasm); (iii) abnormal head position and neck pain that happens with cervical  dystonia  (CD);  (iv)  severe  underarm  sweating
(severe primary axillary hyperhidrosis); (v) increased muscle  stiffness  in  elbow,  wrist,  and  finger  muscles  in  people  with  upper  limb
spasticity; (vi) the prevention of headaches in adults with chronic migraine; (vii) leakage of urine (incontinence)  in  adults  with  overactive
bladder due to neurologic disease who still have leakage; and (viii) overactive bladder symptoms such as a strong need to  urinate  with  leaking
or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults.
[18]  Vistabel is a different brand name for BOTOX, with a dosage formulation and indication specific to the temporary improvement  of  glabellar
lines and canthal lines.
[19]  Cisatracurium Actavis 2mg/ml and Atracurium Besylat.
[20]  Cisatracurium Actavis 2mg/ml and Atracurium  Besylat  are  administered  by  intravenous  injection,  the  oxybutynin-based  Kentera  is  a
transdermal patch, some of Actavis' non-steroidal anti-inflammatory drugs are under gel form, the coal tar solution Exorex is a skin lotion.
[21]  BOTOX is sold in three sizes (50, 100 and 200 Units per glass vial), which may be used for any indication.

[22]  See case M.5778 – Novartis/Alcon, Commission decision of 9 August 2010.
[23]  In particular, the Commission analysed competition at pilocarpine level (a miotic),  while  timolol  (a  beta-blocker)  was  considered  as
potentially substitutable with other beta-blockers.
[24]  Responses to questionnaire Q2 – S1E – Prescribers, question 5.
[25]  Responses to questionnaire Q2 – S1E – Prescribers, questions 4.
[26]  Responses to questionnaire Q2 – S1E – Prescribers, question 9.2.
[27]  Responses to questionnaire Q2 – S1E – Prescribers, questions 7 and 9.1.
[28]  Responses to questionnaire Q2 – S1E – Prescribers, questions 9.2, 9.3, 10.1; minutes of a conference call with a prescriber on  5  February
2015.
[29]  Responses to questionnaire Q2 – S1E – Prescribers, question 7; minutes of conference call with a prescriber on 5 February 2015.
[30]  A supplementary protection certificate is still valid in parts of the EEA until March 2017.
[31]  Responses to questionnaire Q2 – S1E – Prescribers, question 11; minutes of a conference call with a prescriber on 5 February 2015.
[32]  Responses to questionnaire Q2 – S1E – Prescribers, questions 11, 12 and 13.
[33]  Responses to questionnaire Q2 – S1E – Prescribers, question 11; minutes of a conference call with a prescriber on 5 February 2015.

[34]  See cases M.6969 – Valeant Pharmaceuticals International / Bausch & Lomb Holdings, Commission decision  of  5  August  2013  and  M.5778  –
Novartis/Alcon, Commission decision of 9 August 2010.
[35]  According to the Notifying Party, unit-dose drops come in single use packages and thus generally do not contain preservatives,  while  most
multi-dose products contain preservatives to avoid microbial contamination. The Notifying Party therefore provide  market  shares  for  unit-dose
vs. multi-dose products, as a proxy for the presence vs. absence of preservatives.
[36]  Minutes of a conference call with a prescriber, 17 February 2015; minutes of a conference call with a presciber, 12 February 2015.
[37]  Minutes of a conference call with a prescriber, 4 February 2015.
[38]  Minutes of a conference call with a prescriber, 4 February 2015.
[39]  Minutes of a conference call with a prescriber, 12 February 2015.
[40]  Minutes of a conference call with a prescriber, 4 February 2015.
[41]  Minutes of a conference call with a competitor, 10 February 2015.
[42]  According to estimates by the Parties based on IMS data for Austria, Belgium, Croatia, Czech Republic, Denmark, Finland,  France,  Germany,
Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden and the UK, approximately  42%  of  all  purchased
ocular lubricants contain preservatives, whilst the rest do not.
[43]  There are currently two types of conservatives free products: those that comprise single-unit doses, and bottles with  a  filtering  system
preventing the entry of bacteria in the bottle (see minutes of a conference call with a prescriber, 4 February  2015;  minutes  of  a  conference
call with a competitor, 9 February 2015.  As data for sales of ocular lubricants with or without preservatives split by product are  not  readily
available, the Parties provided the figures for the unit-dose / multi-dose levels. Whilst these numbers assign the  sales  of  preservative  free
multi-dose products to the proxy for the products with preservative – multi-dose – they suffice  in  the  case  at  hand.  The  preservative-free
market segment would be slightly larger than the proxy suggests (11% in Denmark, 26% percent in the UK), whilst the market for ocular  lubricants
with preservatives would shrink accordingly. As demonstrated below, this eases rather than aggravates possible concerns in the affected markets
[44]  Minutes of a conference call with a prescriber, 12 February 2015, and minutes of a conference call with a prescriber, 4 February 2015.
[45]  As mentioned above, the distinction multi-dose / unit-dose mainly serves as a proxy for the  plausible  preservative  /  preservative  free
ocular lubricants market segments (multidose with preservatives 66.6% of the total S1K market, multidose without preservatives  11.4%,  unit-dose
22%). Given that Actavis sells a preservative-free multi-dose product in Denmark, namely Øjensalve Neutral Optha, an  eye  ointment  mainly  used
for the treatment of blepharitis symptoms, which can normally only be used overnight due to its heavy impact on a patient's vision, the  combined
market shares of the parties in the ocular lubricants segment with preservatives would be even lower than what these proxy data suggest.  Indeed,
Øjensalve Neutral Optha is by far the most sold, if not only preservative free multi-dose product available in Denmark.
[46]  Minutes of a conference call with a prescriber, 4 February 2015.
[47]  Minutes of a conference call with a prescriber, 17 February 2015.
[48]  As mentioned above, the distinction multi-dose / unit-dose mainly serves as a proxy for the  plausible  preservative  /  preservative  free
ocular lubricants market segments (multidose with preservatives 44.8% of the total S1K market, multidose  without  preservatives  26%,  unit-dose
29.2%). Given that neither Allergan nor Actavis sells any preservative-free multi-dose product in the UK,  the  combined  market  shares  of  the
parties in the preservative free ocular lubricants segement would be slightly lower than what these proxy data suggest (and  slightly  higher  in
the ocular lubricants with preservatives segment, where the Parties have a much lower market share however).
[49]  In most cases these products are manufactured by Actavis manufacturing sites, rther than by Medis itself.
[50]  See Teva/Ratiopharm, Case COMP/M.5865, Commission decision of August 3, 2010, para. 396  and  408;  and  Teva/Cephalon,  Case  COMP/M.6258,
Commission decision of October 13, 2011, para. 146 and 190; Actavis/Watson, Case COMP/ M.6613, Commission decision  of  October  5,  2012.  para.
133; Takeda/Nycomed, Case COMP/M.6278, Commission decision of July 29, 2011, para. 19.
[51]  Sanofi-Aventis/Zentiva, Case COMP/M.5253, Commission decision of February 4, 2009, para. 189.

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

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