[Federal Register Volume 76, Number 86 (Wednesday, May 4, 2011)]
[Notices]
[Pages 25353-25355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10783]


=======================================================================
-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

[File No. 111 0051]


Hikma Pharmaceuticals PLC; Analysis of Agreement Containing 
Consent Orders To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement.

-----------------------------------------------------------------------

SUMMARY: The consent agreement in this matter settles alleged 
violations of Federal law prohibiting unfair or deceptive acts or 
practices or 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 order--embodied in the consent 
agreement--that would settle these allegations.

DATES: Comments must be received on or before May 27, 2011.

ADDRESSES: Interested parties are invited to submit written comments 
electronically or in paper form. Comments should refer to ``Hikma, File 
No. 111 0051'' to facilitate the organization of comments. Please note 
that your comment--including your name and your state--will be placed 
on the public record of this proceeding, including on the publicly 
accessible FTC Web site, at http://www.ftc.gov/os/publiccomments.shtm.
    Because comments will be made public, they should not include any 
sensitive personal information, such as an individual'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. Comments also 
should not include any sensitive health information, such as medical 
records or other individually identifiable health information. In 
addition, comments should not include any ``[t]rade secret or any 
commercial or financial information which is obtained from any person 
and which is privileged or confidential. * * *,'' as provided in 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 
4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which 
confidential treatment is requested must be filed in paper form, must 
be clearly labeled ``Confidential,'' and must comply with FTC Rule 
4.9(c), 16 CFR 4.9(c).\1\
---------------------------------------------------------------------------

    \1\ The comment must be accompanied by an explicit request for 
confidential treatment, including the factual and legal basis for 
the request, and must identify the specific portions of the comment 
to be withheld from the public record. The request will be granted 
or denied by the Commission's General Counsel, consistent with 
applicable law and the public interest. See FTC Rule 4.9(c), 16 CFR 
4.9(c).
---------------------------------------------------------------------------

    Because paper mail addressed to the FTC is subject to delay due to 
heightened security screening, please consider submitting your comments 
in electronic form. Comments filed in electronic form should be 
submitted by using the following Web link: https://ftcpublic.commentworks.com/ftc/hikmabaxter and following the 
instructions on the Web-based form. To ensure that the Commission 
considers an electronic comment, you must file it on the Web-based form 
at the Web link: https://ftcpublic.commentworks.com/ftc/hikmabaxter. If 
this Notice appears at http://www.regulations.gov/search/index.jsp, you 
may also file an electronic comment through that Web site. The 
Commission will consider all comments that regulations.gov forwards to 
it. You may also visit the FTC Web site at http://www.ftc.gov/ to read 
the

[[Page 25354]]

Notice and the news release describing it.
    A comment filed in paper form should include the ``Hikma, File No. 
111 0051'' reference both in the text and on the envelope, and should 
be mailed or delivered to the following address: Federal Trade 
Commission, Office of the Secretary, Room H-113 (Annex D), 600 
Pennsylvania Avenue, NW., Washington, DC 20580. The FTC is requesting 
that any comment filed in paper form be sent by courier or overnight 
service, if possible, because U.S. postal mail in the Washington area 
and at the Commission is subject to delay due to heightened security 
precautions.
    The Federal Trade Commission Act (``FTC Act'') and other laws the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding as appropriate. The Commission will 
consider all timely and responsive public comments that it receives, 
whether filed in paper or electronic form. Comments received will be 
available to the public on the FTC Web site, to the extent practicable, 
at http://www.ftc.gov/os/publiccomments.shtm. As a matter of 
discretion, the Commission makes every effort to remove home contact 
information for individuals from the public comments it receives before 
placing those comments on the FTC Web site. More information, including 
routine uses permitted by the Privacy Act, may be found in the FTC's 
privacy policy, at http://www.ftc.gov/ftc/privacy.shtm.

FOR FURTHER INFORMATION CONTACT: Kari A. Wallace (202-326-3085), FTC, 
Bureau of Competition, 600 Pennsylvania Avenue, NW., Washington, DC 
20580.

SUPPLEMENTARY INFORMATION: Pursuant to section 6(f) of the Federal 
Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and Sec.  2.34 the 
Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that 
the above-captioned consent agreement containing a consent order 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 April 27, 2011), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm. A paper copy can be obtained from the FTC Public 
Reference Room, Room 130-H, 600 Pennsylvania Avenue, NW., Washington, 
DC 20580, either in person or by calling (202) 326-2222.
    Public comments are invited, and may be filed with the Commission 
in either paper or electronic form. All comments should be filed as 
prescribed in the ADDRESSES section above, and must be received on or 
before the date specified in the DATES section.

Analysis of Agreement Containing Consent Order to Aid Public Comment

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an Agreement Containing Consent Orders (``Consent 
Agreement'') from Hikma Pharmaceuticals PLC (``Hikma'') that is 
designed to remedy the anticompetitive effects of Hikma's acquisition 
of certain assets from Baxter Healthcare Corporation, Inc. 
(``Baxter''). Under the terms of the proposed Consent Agreement, Hikma 
would be required to divest to X-Gen Pharmaceuticals, Inc. (``X-Gen'') 
all of Hikma's rights and assets relating to its generic injectable 
phenytoin and generic injectable promethazine products.
    The proposed Consent Agreement has been placed on the public record 
for thirty days for receipt of comments by interested persons. Comments 
received during this period will become part of the public record. 
After thirty days, the Commission will again review the proposed 
Consent Agreement and the comments received, and will decide whether it 
should withdraw from the proposed Consent Agreement, modify it, or make 
final the Decision and Order (``Order'').
    Pursuant to an Asset Purchase Agreement dated October 29, 2010, 
Hikma proposes to acquire Baxter's generic injectable pharmaceutical 
business in a transaction valued at approximately $111.5 million 
(``Proposed Acquisition''). The assets to be sold include chronic pain, 
anti-infective, and anti-emetic products, along with Baxter' Cherry 
Hill, New Jersey manufacturing facility and Memphis, Tennessee 
warehouse and distribution center. The Commission's Complaint alleges 
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 
competition in the U.S. markets for generic injectable phenytoin and 
generic injectable promethazine. The proposed Consent Agreement will 
remedy the alleged violations by replacing the competition that would 
otherwise be eliminated by the acquisition.

The Products and Structure of the Markets

    The Proposed Acquisition would reduce the number of generic 
suppliers in each of the relevant markets. The number of generic 
injectable suppliers has a direct and substantial effect on pricing.
    Phenytoin is an anti-convulsant drug used to control seizures and 
prevent them during or after surgery. In 2009, sales of injectable 
phenytoin totaled $1.5 million. The branded version of injectable 
phenytoin is no longer sold in the United States. The market for 
generic injectable phenytoin is highly concentrated; currently only 
Hikma, Baxter, and Hospira, Inc. (``Hospira'') sell the product in the 
United States. The acquisition of Baxter's injectable business by Hikma 
would therefore reduce the number of suppliers of injectable phenytoin 
from three to two.
    Generic injectable promethazine is used to relieve or prevent some 
types of allergies or allergic reactions, to prevent and control motion 
sickness, nausea, vomiting, and dizziness, and to help people go to 
sleep and control their pain or anxiety before or after surgery. Sales 
of generic injectable promethazine totaled $17 million in 2009. The 
market for generic injectable promethazine is highly concentrated. Only 
three companies currently sell generic injectable promethazine in the 
United States: Hikma, Baxter, and Hospira. Hospira's competitive 
significance in this market is limited because it only offers a 
premium-priced pre-filled syringe, while Hikma and Baxter offer lower 
priced ampules and vials that appeal to a broader range of customers. A 
fourth company has approval to sell generic injectable promethazine in 
the United States and has historically offered the product, but it is 
not currently manufacturing the product and its re-entry date is 
currently unknown. Thus, the acquisition would result in a market with 
only one low-cost competitor.

Entry

    Entry into the markets for the manufacture and sale of generic 
injectable phenytoin and generic injectable promethazine would not be 
timely, likely, or sufficient in magnitude, character, and scope to 
deter or counteract the anticompetitive effects of the acquisition. 
Entry would not take place in a timely manner because the combination 
of generic drug development times and regulatory requirements, 
including Food and Drug

[[Page 25355]]

Administration approval, takes at least two years. In addition to the 
regulatory hurdles facing a potential entrant, manufacturing 
difficulties in producing generic injectable products, combined with 
the small size of the markets in question, makes additional entry 
unlikely to occur.

Effects

    The Proposed Acquisition would cause significant anticompetitive 
harm to consumers in the U.S. markets for the manufacture and sale of 
generic injectable phenytoin and generic injectable promethazine. In 
generic injectable pharmaceuticals markets, price generally decreases 
as the second, third, or fourth competitors enter. Thus, reducing the 
number of competitors to two and one in each market, respectively, 
would cause anticompetitive harm to consumers in these U.S. markets by 
increasing the likelihood that consumers would pay higher prices.

The Consent Agreement

    The proposed Consent Agreement effectively remedies the Proposed 
Acquisition's anticompetitive effects in the relevant markets by 
requiring Hikma to divest certain rights and assets related to generic 
injectable phenytoin and generic injectable promethazine to a 
Commission-approved acquirer no later than ten days after the 
acquisition. The acquirer of the divested assets must receive the prior 
approval of the Commission. The Commission's goal in evaluating a 
possible purchaser of divested assets is to maintain the competitive 
environment that existed prior to the acquisition.
    The proposed Consent Agreement remedies the competitive concerns 
the acquisition raises by requiring Hikma to divest its generic 
injectable phenytoin and generic injectable promethazine products to X-
Gen, which will purchase all rights currently held by Hikma. X-Gen is a 
New York-based generic injectable pharmaceutical company with 40 active 
products and an active product development pipeline. With its 
experience in generic injectable markets and strong ties to 
manufacturing partners, X-Gen is expected to replicate the competition 
that would otherwise be lost with the Proposed Acquisition.
    If the Commission determines that X-Gen is not an acceptable 
acquirer of the assets to be divested, or that the manner of the 
divestitures is not acceptable, the parties must unwind the sale to X-
Gen and divest the phenytoin and promethazine product lines, within six 
months of the date the Order becomes final, to a Commission-approved 
acquirer. The Commission may appoint a trustee to divest the products 
if Hikma 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 Hikma 
to take all action to maintain the economic viability, marketability, 
and competitiveness of the products until such time as they are 
transferred to a Commission-approved acquirer. In addition, the parties 
must supply X-Gen with phenytoin and promethazine pursuant to a supply 
agreement while Hikma transfers the manufacturing technology to X-Gen 
or a third-party manufacturer of X-Gen's choice.
    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. 2011-10783 Filed 5-3-11; 8:45 am]
BILLING CODE 6750-01-P