80_FR_69892 80 FR 69675 - Mylan N.V.; Analysis To Aid Public Comment

80 FR 69675 - Mylan N.V.; Analysis To Aid Public Comment

FEDERAL TRADE COMMISSION

Federal Register Volume 80, Issue 217 (November 10, 2015)

Page Range69675-69677
FR Document2015-28522

The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orders--embodied in the consent agreement--that would settle these allegations.

Federal Register, Volume 80 Issue 217 (Tuesday, November 10, 2015)
[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Pages 69675-69677]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28522]


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FEDERAL TRADE COMMISSION

[File No. 151 0129]


Mylan N.V.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement.

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SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair methods of competition. 
The attached Analysis to Aid Public Comment describes both the 
allegations in the draft complaint and the terms of the consent 
orders--embodied in the consent agreement--that would settle these 
allegations.

DATES: Comments must be received on or before December 3, 2015.

ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/mylanperrigoconsent online or on paper, 
by following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write ``Mylan N.V--Consent 
Agreement, File No. 151-0129'' on your comment and file your comment 
online at https://ftcpublic.commentworks.com/ftc/mylanperrigoconsent by 
following the instructions on the web-based form. If you prefer to file 
your comment on paper, write ``Mylan N.V.--Consent Agreement, File No. 
151-0129'' on your comment and on the envelope, and mail your comment 
to the following address: Federal Trade Commission, Office of the 
Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), 
Washington, DC 20580, or deliver your comment to the following address: 
Federal Trade Commission, Office of the Secretary, Constitution Center, 
400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 
20024.

FOR FURTHER INFORMATION CONTACT: Jasmine Rosner (202-326-3558), Bureau 
of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing consent orders to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis to Aid Public Comment describes the terms of the 
consent agreement, and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement package can be obtained 
from the FTC Home Page (for November 3, 2015), on the World Wide Web, 
at http://www.ftc.gov/os/actions.shtm.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before December 3, 
2015. Write ``Mylan N.V.--Consent Agreement, File No. 151-0129'' on 
your comment. Your comment--including your name and your state--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the 
Commission tries to remove individuals' home contact information from 
comments before placing them on the Commission Web site.
    Because your comment will be made public, you are solely 
responsible for making sure that your comment does not include any 
sensitive personal information, like anyone's Social Security number, 
date of birth, driver's license number or other state identification 
number or foreign country equivalent, passport number, financial 
account number, or credit or debit card number. You are also solely 
responsible for making sure that your comment does not include any 
sensitive health information, like medical records or other 
individually identifiable health information. In addition, do not 
include any ``[t]rade secret or any commercial or financial information 
which . . . is privileged or confidential,'' as discussed in Section 
6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 
4.10(a)(2). In particular, do not include competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    If you want the Commission to give your comment confidential 
treatment, you must file it in paper form, with a request for 
confidential treatment, and you have to follow the procedure explained 
in FTC Rule 4.9(c), 16 CFR 4.9(c).\1\ Your comment will be kept 
confidential only if the FTC General Counsel, in his or her sole 
discretion, grants your request in accordance with the law and the 
public interest.
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    \1\ In particular, the written request for confidential 
treatment that accompanies the comment must include the factual and 
legal basis for the request, and must identify the specific portions 
of the comment to be withheld from the public record. See FTC Rule 
4.9(c), 16 CFR 4.9(c).
---------------------------------------------------------------------------

    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online. To make sure that the Commission considers your 
online comment, you must file it at https://ftcpublic.commentworks.com/ftc/mylanperrigoconsent by following the instructions on the web-based 
form. If this Notice appears at http://www.regulations.gov/#!home, you 
also may file a comment through that Web site.
    If you file your comment on paper, write ``Mylan N.V.--Consent 
Agreement, File No. 151-0129'' on your comment and on the envelope, and 
mail your comment to the following address: Federal Trade Commission, 
Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 
(Annex D), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024. If possible, submit your paper comment to the 
Commission by courier or overnight service.
    Visit the Commission Web site at http://www.ftc.gov to read this 
Notice and the news release describing it. The FTC Act and other laws 
that the Commission administers permit the collection of public 
comments to

[[Page 69676]]

consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives on 
or before December 3, 2015. You can find more information, including 
routine uses permitted by the Privacy Act, in the Commission's privacy 
policy, at http://www.ftc.gov/ftc/privacy.htm.

Analysis of Agreement Containing Consent Orders To Aid Public Comment

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Mylan N.V. (``Mylan'') that is designed to remedy the 
anticompetitive effects resulting from Mylan's acquisition of Perrigo 
Company plc (``Perrigo''). Under the terms of the proposed Consent 
Agreement, Mylan is required to divest to Alvogen, Inc. (``Alvogen'') 
all of its rights and assets to the following generic pharmaceutical 
products: (1) Acyclovir ointment; (2) bromocriptine mesylate tablets; 
(3) clindamycin phosphate/benzoyl peroxide gel; (4) hydromorphone 
hydrochloride extended release tablets; (5) liothyronine sodium 
tablets; (6) polyethylene glycol 3350 over-the-counter (``OTC'') oral 
solution packets; and (7) scopolamine extended release transdermal 
patches.
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments from interested persons. 
Comments received during this period will become part of the public 
record. After thirty days, the Commission will again evaluate the 
proposed Consent Agreement, along with the comments received, to make a 
final decision as to whether it should withdraw from the proposed 
Consent Agreement or make final the Decision and Order (``Order'').
    On September 14, 2015, Mylan launched a hostile tender offer to 
gain a controlling interest in Perrigo. The Commission alleges in its 
Complaint that the proposed acquisition, if consummated, would violate 
Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 
of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by 
lessening current and future competition in seven generic 
pharmaceutical markets in the United States. The proposed Consent 
Agreement will remedy the alleged violations by preserving the 
competition that otherwise would be eliminated by the proposed 
acquisition.

I. The Products and Structure of the Markets

    A generic pharmaceutical drug contains the same active ingredient 
as the brand name product, but typically at a much more affordable 
price. Pharmaceutical companies usually launch generic versions of 
drugs after a branded product loses its patent protection. When only 
one generic product is available, the price for the branded product 
typically acts as a ceiling above which the generic manufacturer cannot 
price its product. During this period, the branded product competes 
directly with the generic. Once multiple generic suppliers enter a 
market, the branded drug manufacturer usually ceases to provide any 
competitive constraint on the prices for generic versions of the drug. 
Rather, generic suppliers compete only against each other.
    Mylan's proposed acquisition of Perrigo will lessen competition in 
seven concentrated generic pharmaceutical product markets by reducing 
the number of current or future suppliers competing in each market. The 
proposed acquisition will reduce current competition in four generic 
pharmaceutical markets: (1) Bromocriptine mesylate tablets; (2) 
clindamycin phosphate/benzoyl peroxide gel; (3) liothyronine sodium 
tablets; and (4) polyethylene glycol 3350 OTC oral solution packets.
     Bromocriptine mesylate is a dopamine agonist used to treat 
Type 2 diabetes, pituitary tumors, Parkinson's disease, neuroleptic 
malignant syndrome, and hyperprolactinemia. The market for generic 2.5 
mg bromocriptine mesylate tablets is highly concentrated with only 
three current suppliers: Mylan, Perrigo, and Sandoz AG. Absent a 
remedy, the proposed transaction would consolidate the market from 
three to two suppliers.
     Clindamycin phosphate/benzoyl peroxide gel is a 
combination antibiotic and drying agent used to stop the bacterial 
infection that causes acne. Today, only Mylan supplies the market with 
generic clindamycin phosphate 1%/benzoyl peroxide 5% gel. Perrigo 
recently received FDA approval for generic clindamycin phosphate 1%/
benzoyl peroxide 5% gel and is poised to start supplying the market in 
the near future. As a result, the proposed transaction would reduce the 
number of generic clindamycin phosphate 1%/benzoyl peroxide 5% gel 
suppliers from two to one.
     Liothyronine sodium is a synthetic thyroid hormone used to 
treat hypothyroidism and to treat or prevent enlarged thyroid glands. 
Currently, only three suppliers provide generic liothyronine sodium 
tablets in the 0.005 mg, 0.025 mg, and 0.05 mg strengths: Mylan, 
Perrigo, and SigmaPharm Laboratories, LLC. The proposed transaction 
would further consolidate an already highly concentrated market, 
leaving two suppliers post-transaction.
     Polyethylene glycol 3350, a laxative, is an OTC oral 
solution packet used to treat occasional constipation. In the 17 gm/
packet OTC market, Mylan, Perrigo, and Gavis Pharmaceuticals, LLC, are 
the only active suppliers in the market. As a result, the proposed 
transaction would consolidate the number of active suppliers of generic 
polyethylene glycol 3350 OTC oral solution packets from three to two.
    Additionally, the proposed acquisition will reduce future 
competition in three generic pharmaceutical markets: (1) Acyclovir 
ointment; (2) hydromorphone hydrochloride extended release tablets; and 
(3) scopolamine extended release transdermal patches. In each of these 
markets, either Mylan or Perrigo is a likely new entrant in the near 
future. Without a remedy, the proposed acquisition would eliminate an 
independent entrant into each market, likely depriving customers of the 
significant cost savings that result when an additional generic 
supplier enters a concentrated market.
     Acyclovir ointment is a topical product used to slow the 
growth and spread of the herpes virus. Mylan and Amneal Pharmaceuticals 
LLC currently hold ANDAs and supply acyclovir 5% ointment. Allergan plc 
(``Allergan'') also sells an authorized generic version of acyclovir 5% 
ointment. Perrigo is one of a limited number of suppliers likely to 
enter this market in the near future.
     Hydromorphone hydrochloride is an analgesic used to treat 
moderate to severe pain in narcotic-tolerant patients. Perrigo and 
Allergan hold ANDAs for 8 mg, 12 mg, and 16 mg extended release 
tablets. In addition, Mallinckrodt plc markets an authorized generic 
version of hydromorphone hydrochloride extended release tablets. Mylan 
is one of a limited number of suppliers likely to enter this market in 
the near future.
     Scopolamine transdermal patches prevent nausea and 
vomiting associated with motion sickness and recovery from anesthesia 
and surgery. Novartis AG currently markets the branded version, 
Transderm Scop, which is available as a 1 mg/72 hour extended release 
transdermal patch. Perrigo holds the only approved ANDA for the generic 
version of Transderm Scop. Mylan is one of a limited number of other

[[Page 69677]]

suppliers likely to enter this market in the near future. As there is 
no generic version of Transderm Scop on the market today, it is likely 
that the price for scopolamine transdermal patches would significantly 
decrease with the onset of generic competition. Without a remedy, the 
proposed acquisition would eliminate the price reductions that would 
likely have accompanied Mylan's independent entry into this market.

II. Entry

    Entry into each of these generic pharmaceutical markets would not 
be timely, likely, or sufficient in magnitude, character, and scope to 
deter or counteract the anticompetitive effects of the proposed 
acquisition. The combination of drug development times and regulatory 
requirements, including approval by the United States Food and Drug 
Administration (``FDA''), is costly and lengthy.

III. Effects

    The proposed acquisition likely would cause significant 
anticompetitive harm to consumers by eliminating current or future 
competition between Mylan and Perrigo in these seven concentrated 
markets. In each of these markets, Mylan and Perrigo are two of a 
limited number of current or likely future suppliers in the United 
States. Market participants characterize each of the markets as a 
current or likely future commodity market, in which the number of 
generic suppliers has a direct impact on pricing. Customers and 
competitors have observed that the price of generic pharmaceutical 
products decreases with new entry even after several suppliers have 
entered the market. Removal of an independent generic pharmaceutical 
supplier from the relevant markets in which Mylan and Perrigo currently 
compete likely would result in significantly higher prices post-
acquisition. Similarly, the elimination of a future independent 
competitor would prevent the price decreases that are likely to result 
from the firm's entry. Thus, absent a remedy, the proposed acquisition 
will likely cause U.S. consumers to pay significantly higher prices for 
these generic drugs.

IV. The Consent Agreement

    The proposed Consent Agreement effectively remedies the proposed 
acquisition's anticompetitive effects in each relevant market. Under 
the Consent Agreement, Mylan is required to divest to Alvogen its 
rights to the seven relevant products. Alvogen is an international 
pharmaceutical company, with commercial operations in thirty-four 
countries. Its business focuses on developing, manufacturing, and 
distributing generic, branded, and OTC pharmaceutical products. Mylan 
must accomplish the divestitures to Alvogen and relinquish its rights 
to these products no later than thirty days after the proposed 
acquisition is consummated.
    The Commission's goal in evaluating possible purchasers of divested 
assets is to maintain the competitive environment that existed prior to 
the proposed acquisition. If the Commission determines that Alvogen is 
not an acceptable acquirer, or that the manner of the divestitures is 
not acceptable, the proposed Order requires Mylan to unwind the sale of 
rights to Alvogen and to divest the products to a Commission-approved 
acquirer within six months of the date the Order becomes final. The 
proposed Order further allows the Commission to appoint a trustee if 
Mylan fails to divest the products as required.
    The proposed Consent Agreement contains several provisions to help 
ensure that the divestitures are successful. The Order requires Mylan 
to take all action to maintain the economic viability, marketability, 
and competitiveness of the products to be divested until such time that 
they are transferred to a Commission-approved acquirer. Mylan must 
provide transitional services to Alvogen to assist it in establishing 
independent manufacturing capabilities. These transitional services 
include technical assistance to manufacture the divestiture products in 
substantially the same manner and quality employed or achieved by 
Mylan, and advice and training from knowledgeable Mylan employees. 
Mylan must also provide Alvogen with a supply of the divested products 
while Mylan transfers manufacturing technology to Alvogen or its 
designated manufacturer. The goal of the transitional services is to 
ensure that Alvogen will be able to operate independent of Mylan in the 
manufacture and sale of the divested products. Nothing in the Consent 
Agreement, however, precludes Alvogen from sourcing active 
pharmaceutical ingredients or other divestiture product inputs from 
Mylan on a negotiated basis.
    As Alvogen was unable to perform due diligence on the Perrigo 
products at issue, Mylan divested its own on-market, generic acyclovir 
ointment product rather than Perrigo's product in development. Because 
the competition that is preserved by the proposed Consent Agreement 
will only occur when the Perrigo product is launched, the proposed 
Order permits Mylan to retain the right to sell acyclovir ointment 
through a license from Alvogen until thirty days after Mylan receives 
approval for the Perrigo ANDA, but for no longer than three years. This 
provision is designed to permit Mylan to remain an active market 
participant pending the approval of Perrigo's acyclovir ointment ANDA 
but also ensures Mylan's continued incentive to develop and launch the 
Perrigo product.
    The purpose of this analysis is to facilitate public comment on the 
proposed Consent Agreement, and it is not intended to constitute an 
official interpretation of the proposed Order or to modify its terms in 
any way.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2015-28522 Filed 11-9-15; 8:45 am]
 BILLING CODE 6750-01-P



                                                                               Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices                                                      69675

                                                    Bancorp MHC, Easthampton,                               the instructions on the web-based form.               not include any sensitive health
                                                    Massachusetts, is revised to read as                    If you prefer to file your comment on                 information, like medical records or
                                                    follows:                                                paper, write ‘‘Mylan N.V.—Consent                     other individually identifiable health
                                                       A. Federal Reserve Bank of Boston                    Agreement, File No. 151–0129’’ on your                information. In addition, do not include
                                                    (Prabal Chakrabarti, Senior Vice                        comment and on the envelope, and mail                 any ‘‘[t]rade secret or any commercial or
                                                    President) 600 Atlantic Avenue, Boston,                 your comment to the following address:                financial information which . . . is
                                                    Massachusetts 02210–2204:                               Federal Trade Commission, Office of the               privileged or confidential,’’ as discussed
                                                       1. ESB Bancorp MHC, Easthampton,                     Secretary, 600 Pennsylvania Avenue                    in Section 6(f) of the FTC Act, 15 U.S.C.
                                                    Massachusetts; (‘‘ESB MHC’’) to merge                   NW., Suite CC–5610 (Annex D),                         46(f), and FTC Rule 4.10(a)(2), 16 CFR
                                                    with Hometown Community Bancorp                         Washington, DC 20580, or deliver your                 4.10(a)(2). In particular, do not include
                                                    MHC, Oxford, Massachusetts                              comment to the following address:                     competitively sensitive information
                                                    (‘‘Hometown MHC’’), with ESB MHC as                     Federal Trade Commission, Office of the               such as costs, sales statistics,
                                                    the surviving entity to be known as                     Secretary, Constitution Center, 400 7th               inventories, formulas, patterns, devices,
                                                    ‘‘Hometown Financial Group, MHC’’;                      Street SW., 5th Floor, Suite 5610                     manufacturing processes, or customer
                                                    and ii) ESB Bancorp, Inc., Easthampton,                 (Annex D), Washington, DC 20024.                      names.
                                                    Massachusetts (‘‘ESB Bancorp’’), to                     FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                     If you want the Commission to give
                                                    merge with Hometown Community                           Jasmine Rosner (202–326–3558), Bureau                 your comment confidential treatment,
                                                    Bancorp, Inc., Oxford, Massachusetts                    of Competition, 600 Pennsylvania                      you must file it in paper form, with a
                                                    (‘‘Hometown Bancorp’’), with ESB                        Avenue NW., Washington, DC 20580.                     request for confidential treatment, and
                                                    Bancorp as the surviving entity to be                                                                         you have to follow the procedure
                                                                                                            SUPPLEMENTARY INFORMATION: Pursuant
                                                    known as ‘‘Hometown Financial Group,                                                                          explained in FTC Rule 4.9(c), 16 CFR
                                                                                                            to Section 6(f) of the Federal Trade                  4.9(c).1 Your comment will be kept
                                                    Inc. Upon consummation of the merger,
                                                                                                            Commission Act, 15 U.S.C. 46(f), and                  confidential only if the FTC General
                                                    Easthampton Savings Bank and
                                                                                                            FTC Rule 2.34, 16 CFR 2.34, notice is                 Counsel, in his or her sole discretion,
                                                    Hometown Bank will remain separate
                                                                                                            hereby given that the above-captioned                 grants your request in accordance with
                                                    wholly-owned subsidiaries of
                                                                                                            consent agreement containing consent                  the law and the public interest.
                                                    Hometown Financial Group, Inc.
                                                                                                            orders to cease and desist, having been                  Postal mail addressed to the
                                                       Comments on this application must
                                                                                                            filed with and accepted, subject to final             Commission is subject to delay due to
                                                    be received by November 27, 2015.
                                                                                                            approval, by the Commission, has been                 heightened security screening. As a
                                                      Board of Governors of the Federal Reserve             placed on the public record for a period
                                                    System, November 4, 2015.                                                                                     result, we encourage you to submit your
                                                                                                            of thirty (30) days. The following                    comments online. To make sure that the
                                                    Michael J. Lewandowski,                                 Analysis to Aid Public Comment                        Commission considers your online
                                                    Associate Secretary of the Board.                       describes the terms of the consent                    comment, you must file it at https://
                                                    [FR Doc. 2015–28467 Filed 11–9–15; 8:45 am]             agreement, and the allegations in the                 ftcpublic.commentworks.com/ftc/
                                                    BILLING CODE 6210–01–P                                  complaint. An electronic copy of the                  mylanperrigoconsent by following the
                                                                                                            full text of the consent agreement                    instructions on the web-based form. If
                                                                                                            package can be obtained from the FTC                  this Notice appears at http://
                                                    FEDERAL TRADE COMMISSION                                Home Page (for November 3, 2015), on                  www.regulations.gov/#!home, you also
                                                                                                            the World Wide Web, at http://                        may file a comment through that Web
                                                    [File No. 151 0129]
                                                                                                            www.ftc.gov/os/actions.shtm.                          site.
                                                    Mylan N.V.; Analysis To Aid Public                         You can file a comment online or on                   If you file your comment on paper,
                                                    Comment                                                 paper. For the Commission to consider                 write ‘‘Mylan N.V.—Consent
                                                                                                            your comment, we must receive it on or                Agreement, File No. 151–0129’’ on your
                                                    AGENCY:    Federal Trade Commission.                    before December 3, 2015. Write ‘‘Mylan                comment and on the envelope, and mail
                                                    ACTION:   Proposed Consent Agreement.                   N.V.—Consent Agreement, File No.                      your comment to the following address:
                                                                                                            151–0129’’ on your comment. Your                      Federal Trade Commission, Office of the
                                                    SUMMARY:    The consent agreement in this               comment—including your name and                       Secretary, 600 Pennsylvania Avenue
                                                    matter settles alleged violations of                    your state—will be placed on the public               NW., Suite CC–5610 (Annex D),
                                                    federal law prohibiting unfair methods                  record of this proceeding, including, to              Washington, DC 20580, or deliver your
                                                    of competition. The attached Analysis to                the extent practicable, on the public                 comment to the following address:
                                                    Aid Public Comment describes both the                   Commission Web site, at http://                       Federal Trade Commission, Office of the
                                                    allegations in the draft complaint and                  www.ftc.gov/os/publiccomments.shtm.                   Secretary, Constitution Center, 400 7th
                                                    the terms of the consent orders—                        As a matter of discretion, the                        Street SW., 5th Floor, Suite 5610
                                                    embodied in the consent agreement—                      Commission tries to remove individuals’               (Annex D), Washington, DC 20024. If
                                                    that would settle these allegations.                    home contact information from                         possible, submit your paper comment to
                                                    DATES: Comments must be received on                     comments before placing them on the                   the Commission by courier or overnight
                                                    or before December 3, 2015.                             Commission Web site.                                  service.
                                                    ADDRESSES: Interested parties may file a                   Because your comment will be made                     Visit the Commission Web site at
                                                    comment at https://                                     public, you are solely responsible for                http://www.ftc.gov to read this Notice
                                                    ftcpublic.commentworks.com/ftc/                         making sure that your comment does                    and the news release describing it. The
                                                    mylanperrigoconsent online or on                        not include any sensitive personal                    FTC Act and other laws that the
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    paper, by following the instructions in                 information, like anyone’s Social                     Commission administers permit the
                                                    the Request for Comment part of the                     Security number, date of birth, driver’s              collection of public comments to
                                                    SUPPLEMENTARY INFORMATION section                       license number or other state
                                                    below. Write ‘‘Mylan N.V—Consent                        identification number or foreign country                 1 In particular, the written request for confidential

                                                    Agreement, File No. 151–0129’’ on your                  equivalent, passport number, financial                treatment that accompanies the comment must
                                                                                                                                                                  include the factual and legal basis for the request,
                                                    comment and file your comment online                    account number, or credit or debit card               and must identify the specific portions of the
                                                    at https://ftcpublic.commentworks.com/                  number. You are also solely responsible               comment to be withheld from the public record. See
                                                    ftc/mylanperrigoconsent by following                    for making sure that your comment does                FTC Rule 4.9(c), 16 CFR 4.9(c).



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                                                    69676                      Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices

                                                    consider and use in this proceeding as                  I. The Products and Structure of the                  enlarged thyroid glands. Currently, only
                                                    appropriate. The Commission will                        Markets                                               three suppliers provide generic
                                                    consider all timely and responsive                         A generic pharmaceutical drug                      liothyronine sodium tablets in the 0.005
                                                    public comments that it receives on or                  contains the same active ingredient as                mg, 0.025 mg, and 0.05 mg strengths:
                                                    before December 3, 2015. You can find                   the brand name product, but typically at              Mylan, Perrigo, and SigmaPharm
                                                    more information, including routine                     a much more affordable price.                         Laboratories, LLC. The proposed
                                                    uses permitted by the Privacy Act, in                   Pharmaceutical companies usually                      transaction would further consolidate
                                                    the Commission’s privacy policy, at                     launch generic versions of drugs after a              an already highly concentrated market,
                                                    http://www.ftc.gov/ftc/privacy.htm.                     branded product loses its patent                      leaving two suppliers post-transaction.
                                                                                                                                                                     • Polyethylene glycol 3350, a
                                                                                                            protection. When only one generic
                                                    Analysis of Agreement Containing                                                                              laxative, is an OTC oral solution packet
                                                                                                            product is available, the price for the
                                                    Consent Orders To Aid Public Comment                                                                          used to treat occasional constipation. In
                                                                                                            branded product typically acts as a                   the 17 gm/packet OTC market, Mylan,
                                                       The Federal Trade Commission                         ceiling above which the generic                       Perrigo, and Gavis Pharmaceuticals,
                                                    (‘‘Commission’’) has accepted, subject to               manufacturer cannot price its product.                LLC, are the only active suppliers in the
                                                    final approval, an Agreement                            During this period, the branded product               market. As a result, the proposed
                                                    Containing Consent Orders (‘‘Consent                    competes directly with the generic.                   transaction would consolidate the
                                                    Agreement’’) from Mylan N.V.                            Once multiple generic suppliers enter a               number of active suppliers of generic
                                                    (‘‘Mylan’’) that is designed to remedy                  market, the branded drug manufacturer                 polyethylene glycol 3350 OTC oral
                                                    the anticompetitive effects resulting                   usually ceases to provide any                         solution packets from three to two.
                                                    from Mylan’s acquisition of Perrigo                     competitive constraint on the prices for                 Additionally, the proposed
                                                    Company plc (‘‘Perrigo’’). Under the                    generic versions of the drug. Rather,                 acquisition will reduce future
                                                    terms of the proposed Consent                           generic suppliers compete only against                competition in three generic
                                                    Agreement, Mylan is required to divest                  each other.                                           pharmaceutical markets: (1) Acyclovir
                                                                                                               Mylan’s proposed acquisition of                    ointment; (2) hydromorphone
                                                    to Alvogen, Inc. (‘‘Alvogen’’) all of its
                                                                                                            Perrigo will lessen competition in seven              hydrochloride extended release tablets;
                                                    rights and assets to the following
                                                                                                            concentrated generic pharmaceutical                   and (3) scopolamine extended release
                                                    generic pharmaceutical products: (1)
                                                                                                            product markets by reducing the                       transdermal patches. In each of these
                                                    Acyclovir ointment; (2) bromocriptine
                                                                                                            number of current or future suppliers                 markets, either Mylan or Perrigo is a
                                                    mesylate tablets; (3) clindamycin
                                                                                                            competing in each market. The                         likely new entrant in the near future.
                                                    phosphate/benzoyl peroxide gel; (4)                     proposed acquisition will reduce
                                                    hydromorphone hydrochloride                                                                                   Without a remedy, the proposed
                                                                                                            current competition in four generic                   acquisition would eliminate an
                                                    extended release tablets; (5)                           pharmaceutical markets: (1)
                                                    liothyronine sodium tablets; (6)                                                                              independent entrant into each market,
                                                                                                            Bromocriptine mesylate tablets; (2)                   likely depriving customers of the
                                                    polyethylene glycol 3350 over-the-                      clindamycin phosphate/benzoyl                         significant cost savings that result when
                                                    counter (‘‘OTC’’) oral solution packets;                peroxide gel; (3) liothyronine sodium                 an additional generic supplier enters a
                                                    and (7) scopolamine extended release                    tablets; and (4) polyethylene glycol 3350             concentrated market.
                                                    transdermal patches.                                    OTC oral solution packets.                               • Acyclovir ointment is a topical
                                                       The proposed Consent Agreement has                      • Bromocriptine mesylate is a                      product used to slow the growth and
                                                    been placed on the public record for                    dopamine agonist used to treat Type 2                 spread of the herpes virus. Mylan and
                                                    thirty days for receipt of comments from                diabetes, pituitary tumors, Parkinson’s               Amneal Pharmaceuticals LLC currently
                                                    interested persons. Comments received                   disease, neuroleptic malignant                        hold ANDAs and supply acyclovir 5%
                                                    during this period will become part of                  syndrome, and hyperprolactinemia. The                 ointment. Allergan plc (‘‘Allergan’’) also
                                                    the public record. After thirty days, the               market for generic 2.5 mg bromocriptine               sells an authorized generic version of
                                                    Commission will again evaluate the                      mesylate tablets is highly concentrated               acyclovir 5% ointment. Perrigo is one of
                                                    proposed Consent Agreement, along                       with only three current suppliers:                    a limited number of suppliers likely to
                                                    with the comments received, to make a                   Mylan, Perrigo, and Sandoz AG. Absent                 enter this market in the near future.
                                                    final decision as to whether it should                  a remedy, the proposed transaction                       • Hydromorphone hydrochloride is
                                                    withdraw from the proposed Consent                      would consolidate the market from                     an analgesic used to treat moderate to
                                                    Agreement or make final the Decision                    three to two suppliers.                               severe pain in narcotic-tolerant patients.
                                                    and Order (‘‘Order’’).                                     • Clindamycin phosphate/benzoyl                    Perrigo and Allergan hold ANDAs for 8
                                                                                                            peroxide gel is a combination antibiotic              mg, 12 mg, and 16 mg extended release
                                                       On September 14, 2015, Mylan                         and drying agent used to stop the                     tablets. In addition, Mallinckrodt plc
                                                    launched a hostile tender offer to gain                 bacterial infection that causes acne.                 markets an authorized generic version of
                                                    a controlling interest in Perrigo. The                  Today, only Mylan supplies the market                 hydromorphone hydrochloride
                                                    Commission alleges in its Complaint                     with generic clindamycin phosphate                    extended release tablets. Mylan is one of
                                                    that the proposed acquisition, if                       1%/benzoyl peroxide 5% gel. Perrigo                   a limited number of suppliers likely to
                                                    consummated, would violate Section 7                    recently received FDA approval for                    enter this market in the near future.
                                                    of the Clayton Act, as amended, 15                      generic clindamycin phosphate 1%/                        • Scopolamine transdermal patches
                                                    U.S.C. 18, and Section 5 of the Federal                 benzoyl peroxide 5% gel and is poised                 prevent nausea and vomiting associated
                                                    Trade Commission Act, as amended, 15                    to start supplying the market in the near             with motion sickness and recovery from
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                                                    U.S.C. 45, by lessening current and                     future. As a result, the proposed                     anesthesia and surgery. Novartis AG
                                                    future competition in seven generic                     transaction would reduce the number of                currently markets the branded version,
                                                    pharmaceutical markets in the United                    generic clindamycin phosphate 1%/                     Transderm Scop, which is available as
                                                    States. The proposed Consent                            benzoyl peroxide 5% gel suppliers from                a 1 mg/72 hour extended release
                                                    Agreement will remedy the alleged                       two to one.                                           transdermal patch. Perrigo holds the
                                                    violations by preserving the competition                   • Liothyronine sodium is a synthetic               only approved ANDA for the generic
                                                    that otherwise would be eliminated by                   thyroid hormone used to treat                         version of Transderm Scop. Mylan is
                                                    the proposed acquisition.                               hypothyroidism and to treat or prevent                one of a limited number of other


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                                                                               Federal Register / Vol. 80, No. 217 / Tuesday, November 10, 2015 / Notices                                                 69677

                                                    suppliers likely to enter this market in                four countries. Its business focuses on               the proposed Order permits Mylan to
                                                    the near future. As there is no generic                 developing, manufacturing, and                        retain the right to sell acyclovir
                                                    version of Transderm Scop on the                        distributing generic, branded, and OTC                ointment through a license from
                                                    market today, it is likely that the price               pharmaceutical products. Mylan must                   Alvogen until thirty days after Mylan
                                                    for scopolamine transdermal patches                     accomplish the divestitures to Alvogen                receives approval for the Perrigo ANDA,
                                                    would significantly decrease with the                   and relinquish its rights to these                    but for no longer than three years. This
                                                    onset of generic competition. Without a                 products no later than thirty days after              provision is designed to permit Mylan
                                                    remedy, the proposed acquisition would                  the proposed acquisition is                           to remain an active market participant
                                                    eliminate the price reductions that                     consummated.                                          pending the approval of Perrigo’s
                                                    would likely have accompanied Mylan’s                      The Commission’s goal in evaluating                acyclovir ointment ANDA but also
                                                    independent entry into this market.                     possible purchasers of divested assets is             ensures Mylan’s continued incentive to
                                                                                                            to maintain the competitive                           develop and launch the Perrigo product.
                                                    II. Entry                                               environment that existed prior to the                   The purpose of this analysis is to
                                                       Entry into each of these generic                     proposed acquisition. If the Commission               facilitate public comment on the
                                                    pharmaceutical markets would not be                     determines that Alvogen is not an                     proposed Consent Agreement, and it is
                                                    timely, likely, or sufficient in                        acceptable acquirer, or that the manner               not intended to constitute an official
                                                    magnitude, character, and scope to deter                of the divestitures is not acceptable, the            interpretation of the proposed Order or
                                                    or counteract the anticompetitive effects               proposed Order requires Mylan to                      to modify its terms in any way.
                                                    of the proposed acquisition. The                        unwind the sale of rights to Alvogen
                                                    combination of drug development times                                                                           By direction of the Commission.
                                                                                                            and to divest the products to a
                                                    and regulatory requirements, including                  Commission-approved acquirer within                   Donald S. Clark,
                                                    approval by the United States Food and                  six months of the date the Order                      Secretary.
                                                    Drug Administration (‘‘FDA’’), is costly                becomes final. The proposed Order                     [FR Doc. 2015–28522 Filed 11–9–15; 8:45 am]
                                                    and lengthy.                                            further allows the Commission to                      BILLING CODE 6750–01–P

                                                    III. Effects                                            appoint a trustee if Mylan fails to divest
                                                                                                            the products as required.
                                                       The proposed acquisition likely                         The proposed Consent Agreement
                                                    would cause significant anticompetitive                                                                       DEPARTMENT OF HEALTH AND
                                                                                                            contains several provisions to help
                                                    harm to consumers by eliminating                                                                              HUMAN SERVICES
                                                                                                            ensure that the divestitures are
                                                    current or future competition between                   successful. The Order requires Mylan to               Centers for Disease Control and
                                                    Mylan and Perrigo in these seven                        take all action to maintain the economic              Prevention
                                                    concentrated markets. In each of these                  viability, marketability, and
                                                    markets, Mylan and Perrigo are two of                   competitiveness of the products to be                 [60Day–16–0943; Docket No. CDC–2015–
                                                    a limited number of current or likely                   divested until such time that they are                0098]
                                                    future suppliers in the United States.                  transferred to a Commission-approved
                                                    Market participants characterize each of                acquirer. Mylan must provide                          Proposed Data Collections Submitted
                                                    the markets as a current or likely future               transitional services to Alvogen to assist            for Public Comment and
                                                    commodity market, in which the                          it in establishing independent                        Recommendations
                                                    number of generic suppliers has a direct                manufacturing capabilities. These                     AGENCY: Centers for Disease Control and
                                                    impact on pricing. Customers and                        transitional services include technical               Prevention (CDC), Department of Health
                                                    competitors have observed that the price                assistance to manufacture the                         and Human Services (HHS).
                                                    of generic pharmaceutical products                      divestiture products in substantially the
                                                    decreases with new entry even after                     same manner and quality employed or                   ACTION: Notice with comment period.
                                                    several suppliers have entered the                      achieved by Mylan, and advice and                     SUMMARY:   The Centers for Disease
                                                    market. Removal of an independent                       training from knowledgeable Mylan                     Control and Prevention (CDC), as part of
                                                    generic pharmaceutical supplier from                    employees. Mylan must also provide                    its continuing efforts to reduce public
                                                    the relevant markets in which Mylan                     Alvogen with a supply of the divested                 burden and maximize the utility of
                                                    and Perrigo currently compete likely                    products while Mylan transfers                        government information, invites the
                                                    would result in significantly higher                    manufacturing technology to Alvogen or                general public and other Federal
                                                    prices post-acquisition. Similarly, the                 its designated manufacturer. The goal of              agencies to take this opportunity to
                                                    elimination of a future independent                     the transitional services is to ensure that           comment on proposed and/or
                                                    competitor would prevent the price                      Alvogen will be able to operate
                                                                                                                                                                  continuing information collections, as
                                                    decreases that are likely to result from                independent of Mylan in the
                                                                                                                                                                  required by the Paperwork Reduction
                                                    the firm’s entry. Thus, absent a remedy,                manufacture and sale of the divested
                                                                                                                                                                  Act of 1995. This notice invites
                                                    the proposed acquisition will likely                    products. Nothing in the Consent
                                                                                                                                                                  comment on Data Collection for the
                                                    cause U.S. consumers to pay                             Agreement, however, precludes Alvogen
                                                                                                                                                                  Residential Care Community and Adult
                                                    significantly higher prices for these                   from sourcing active pharmaceutical
                                                                                                                                                                  Day Services Center Components of the
                                                    generic drugs.                                          ingredients or other divestiture product
                                                                                                                                                                  National Study of Long-Term Care
                                                                                                            inputs from Mylan on a negotiated
                                                    IV. The Consent Agreement                                                                                     Providers. The purpose is to collect data
                                                                                                            basis.
                                                       The proposed Consent Agreement                          As Alvogen was unable to perform                   for the residential care community and
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                                                    effectively remedies the proposed                       due diligence on the Perrigo products at              adult day services center components
                                                    acquisition’s anticompetitive effects in                issue, Mylan divested its own on-                     for the 2016 wave of the National Study
                                                    each relevant market. Under the                         market, generic acyclovir ointment                    of Long-Term Care Providers.
                                                    Consent Agreement, Mylan is required                    product rather than Perrigo’s product in              DATES: Written comments must be
                                                    to divest to Alvogen its rights to the                  development. Because the competition                  received on or before January 11, 2016.
                                                    seven relevant products. Alvogen is an                  that is preserved by the proposed                     ADDRESSES: You may submit comments,
                                                    international pharmaceutical company,                   Consent Agreement will only occur                     identified by Docket No. CDC–2015–
                                                    with commercial operations in thirty-                   when the Perrigo product is launched,                 0098 by any of the following methods:


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Document Created: 2018-03-01 11:25:53
Document Modified: 2018-03-01 11:25:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionProposed Consent Agreement.
DatesComments must be received on or before December 3, 2015.
ContactJasmine Rosner (202-326-3558), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
FR Citation80 FR 69675 

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