Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment, 25353-25355 [2011-10783]

Download as PDF Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices FOR FURTHER INFORMATION CONTACT: Robert E. Feldman, Executive Secretary, FDIC, 550 17th Street, NW., Washington, DC 20429; telephone (202) 898–7043. SR Advisory Committee members will not receive any compensation for their services other than reimbursement for reasonable travel expenses incurred to attend SR Advisory Committee meetings. SUPPLEMENTARY INFORMATION: In accordance with the requirements of the Federal Advisory Committee Act (‘‘FACA’’), 5 U.S.C. App. 2, notice is hereby given that the Chairman of the FDIC intends to establish the FDIC SR Advisory Committee. After consultation with the General Services Administration as required by section 9(a)(2) of FACA and 41 CFR 102–3.65, the Chairman of the FDIC certifies that she has determined that the establishment of the SR Advisory Committee is in the public interest in connection with the performance of duties imposed on the FDIC by law. The SR Advisory Committee will provide advice and recommendations on a broad range of issues regarding the resolution of systemically important financial companies pursuant to the Dodd-Frank Act. The SR Advisory Committee also is intended to facilitate discussion on how the systemic resolution authority, and its implementation, may impact regulated entities and other stakeholders potentially affected by the process. The SR Advisory Committee will function solely as an advisory body, and in compliance with the provisions of FACA. To ensure relevant expertise on the SR Advisory Committee, members of the SR Advisory Committee should include financial market participants and professionals with relevant experience managing large, complex firms, investors, bankruptcy professionals, representatives from the audit, accounting, credit rating, and legal professions, as well as academic and other relevant experts. Dated at Washington, DC, this 28th day of April 2011. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary, Federal Deposit Insurance Corporation. [FR Doc. 2011–10794 Filed 5–3–11; 8:45 am] jlentini on DSKJ8SOYB1PROD with NOTICES BILLING CODE P FEDERAL MARITIME COMMISSION Notice of Agreement Filed The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. VerDate Mar<15>2010 17:45 May 03, 2011 Jkt 223001 Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the Federal Register. A copy of the agreement is available through the Commission’s Web site (www.fmc.gov) or by contacting the Office of Agreements at (202) 523–5793 or tradeanalysis@fmc.gov. Agreement No.: 010071–038. Title: Cruise Lines International Association Agreement. Parties: AMA Waterways; American Cruise Lines, Inc.; Azamara Cruises; Carnival Cruise Lines; Celebrity Cruises, Inc.; Costa Cruise Lines; Crystal Cruises; Cunard Line; Disney Cruise Line; Holland America Line; Hurtigruten, Inc.; Louis Cruises; Majestic America Line; MSC Cruises; NCL Corporation; Oceania Cruises; Orient Lines; Princess Cruises; Regent Seven Seas Cruises; Royal Caribbean International; Seabourn Cruise Line; SeaDream Yacht Club; Silversea Cruises, Ltd.; Uniworld River Cruises, Inc.; and Windstar Cruises. Filing Party: Christine Duffy, President; Cruise Lines International Association; 910 SE. 17th Street, Suite 400; Fort Lauderdale, FL 33316. Synopsis: The amendment adds Louis Cruises as a party to the agreement. By Order of the Federal Maritime Commission. Dated: April 29, 2011. Rachel E. Dickon, Assistant Secretary. [FR Doc. 2011–10899 Filed 5–3–11; 8:45 am] BILLING CODE 6730–01–P FEDERAL TRADE COMMISSION [File No. 111 0051] Hikma Pharmaceuticals PLC; Analysis of Agreement Containing Consent Orders To Aid Public Comment Federal Trade Commission. Proposed consent agreement. AGENCY: ACTION: 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 SUMMARY: PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 25353 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 https://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 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 https://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 https://www.ftc.gov/ to read the 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). E:\FR\FM\04MYN1.SGM 04MYN1 jlentini on DSKJ8SOYB1PROD with NOTICES 25354 Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices 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 https:// 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 https://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 § 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 https://www.ftc.gov/ os/actions.shtm. A paper copy can be obtained from the FTC Public Reference VerDate Mar<15>2010 17:45 May 03, 2011 Jkt 223001 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, antiinfective, 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 lowcost 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 E:\FR\FM\04MYN1.SGM 04MYN1 Federal Register / Vol. 76, No. 86 / Wesnesday, May 4, 2011 / Notices 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. jlentini on DSKJ8SOYB1PROD with NOTICES 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. XGen 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 XGen 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 VerDate Mar<15>2010 17:45 May 03, 2011 Jkt 223001 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. [FR Doc. 2011–10783 Filed 5–3–11; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Office of the Secretary Delegation of Authority Notice is hereby given that I have delegated to HHS’ Operating and Staff Division heads and the Chair(s) of the HHS Innovation Council, or their successors, the authorities vested in the Secretary under Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111–358) (which added Section 24 of the StevensonWydler Technology Innovation Act of 1980, 15 U.S.C. 3701 et seq), as amended, to administer and fund prize competitions aimed at stimulating innovation. This delegation excludes the authority under Section 24(k)(3) to develop guidelines for the appointment of judges, which I hereby delegate to the Chair(s), HHS Innovation Council. Additionally, I reserve the authorities under Section 24(m)(3)(B) to approve an increase in the amount of a prize after initial announcement has been made and to approve the award of more than $500,000 in cash prizes. These authorities may be redelegated. The authorities granted herein shall be exercised in accordance with the Department’s applicable policies, procedures, and guidelines. I hereby affirm and ratify any actions taken by you or your subordinates, which involve PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 the exercise of this authority prior to the effective date of this delegation. This delegation is effective upon date of signature. Authority: 44 U.S.C. 3101. Dated: April 22, 2011. Kathleen Sebelius, Secretary. [FR Doc. 2011–10847 Filed 5–3–11; 8:45 am] BILLING CODE 4150–04–P DEPARTMENT OF HEALTH AND HUMAN SERVICES HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations Office of the National Coordinator for Health Information Technology, HHS. ACTION: Notice. AGENCY: Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on October 8, 2010. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created four (4) workgroups or subcommittees to analyze the areas of clinical quality, clinical operations, implementation, and privacy and security. HIT Standards Committee’s Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or subcommittee to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) An assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify SUMMARY: By direction of the Commission. Donald S. Clark, Secretary. 25355 E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

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


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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 https://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 https://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 https://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 https://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 https://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 https://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
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