79486 Federal Register / Vol. 73, No. 249 / Monday, December 29, 2008 / Notices

The Commission therefore determines precautions. Comments that do not Analysis of Agreement Containing that the maximum allowable charge for contain any nonpublic information may Consent Order To Aid Public Comment the year 2009 will be $11.00. instead be filed in electronic form by The Federal Trade Commission By direction of the Commission. following the instructions on the web- (‘‘Commission’’) has accepted, subject to Donald S. Clark, based form at (http:// final approval, an Agreement secure.commentworks.com/ftc- Secretary. Containing Consent Orders (‘‘Consent TevaBarr). To ensure that the Agreement’’) from Teva Pharmaceutical [FR Doc. E8–30830 Filed 12–24–08: 8:45 am] Commission considers an electronic BILLING CODE 6750–01–S Industries Ltd. (‘‘Teva’’) and Barr comment, you must file it on that web- Pharmaceuticals Inc. (‘‘Barr’’) that is based form. designed to remedy the anticompetitive The FTC Act and other laws the FEDERAL TRADE COMMISSION effects of the acquisition of Barr by Commission administers permit the Teva. Under the terms of the proposed [File No. 081 0224] collection of public comments to Consent Agreement, the companies consider and use in this proceeding as Teva Pharmaceutical Industries Ltd. would be required to assign and divest appropriate. All timely and responsive to Watson Pharmaceuticals (‘‘Watson’’) and Barr Pharmaceuticals, Inc; public comments, whether filed in Analysis of Agreement Containing Teva’s rights and assets necessary to paper or electronic form, will be manufacture and market generic: (1) Consent Orders To Aid Public considered by the Commission, and will Comment chlorzoxazone tablets; (2) deferoxamine be available to the public on the FTC injection; (3) fluoxetine weekly website, to the extent practicable, at AGENCY: Federal Trade Commission. capsules; (4) carboplatin injection; and www.ftc.gov. As a matter of discretion, ACTION: Proposed Consent Agreement. (5) metronidazole tablets. The Consent the FTC makes every effort to remove Agreement also requires the companies SUMMARY: The consent agreement in this home contact information for to assign and divest to Watson all of matter settles alleged violations of individuals from the public comments it Barr’s rights and assets necessary to federal law prohibiting unfair or receives before placing those comments manufacture and market generic: (1) deceptive acts or practices or unfair on the FTC website. More information, metoclopramide hydrochloride (‘‘HCl’’) methods of competition. The attached including routine uses permitted by the tablets; (2) cyclosporine liquid; (3) Analysis to Aid Public Comment Privacy Act, may be found in the FTC’s cyclosporine capsules; (4) desmopressin describes both the allegations in the privacy policy, at (http://www.ftc.gov/ acetate tablets; (5) epoprostenol sodium draft complaint and the terms of the ftc/privacy.shtm). (freeze-dried powder) injection consent order—embodied in the consent FOR FURTHER INFORMATION CONTACT: (‘‘epop’’); (6) flutamide capsules; (7) agreement—that would settle these Stephanie C. Bovee, FTC Bureau of glipizide/metformin HCl tablets; (8) allegations. Competition, 600 Pennsylvania Avenue, mirtazapine orally disintegrating tablets NW, Washington, D.C. 20580, (202) 326- DATES: (‘‘ODT’’); (9) tamoxifen citrate tablets; Comments must be received on 2083. or before January 19, 2008 and (10) tetracycline HCl capsules. In SUPPLEMENTARY INFORMATION: Pursuant addition, the proposed Consent ADDRESSES: Interested parties are to section 6(f) of the Federal Trade Agreement requires the companies to invited to submit written comments. Commission Act, 38 Stat. 721, 15 U.S.C. divest Teva’s rights and assets necessary Comments should refer to ‘‘Teva-Barr, 46(f), and § 2.34 of the Commission to manufacture and market generic File No. 081 0224,’’ to facilitate the Rules of Practice, 16 CFR 2.34, notice is trazodone HCl tablets and thirteen oral organization of comments. A comment hereby given that the above-captioned contraceptive products to filed in paper form should include this consent agreement containing a consent Pharmaceuticals (‘‘Qualitest’’). reference both in the text and on the order to cease and desist, having been The proposed Consent Agreement has envelope, and should be mailed or filed with and accepted, subject to final been placed on the public record for delivered to the following address: approval, by the Commission, has been thirty days for receipt of comments by Federal Trade Commission/Office of the placed on the public record for a period interested persons. Comments received Secretary, Room 135-H, 600 of thirty (30) days. The following during this period will become part of Pennsylvania Avenue, N.W., Analysis to Aid Public Comment the public record. After thirty days, the Washington, D.C. 20580. Comments describes the terms of the consent Commission will again review the containing confidential material must be agreement, and the allegations in the proposed Consent Agreement and the filed in paper form, must be clearly complaint. An electronic copy of the comments received, and will decide labeled ‘‘Confidential,’’ and must full text of the consent agreement whether it should withdraw from the comply with Commission Rule 4.9(c). 1 package can be obtained from the FTC proposed Consent Agreement, modify it, 16 CFR 4.9(c) (2005). The FTC is Home Page (for December 19, 2008), on or make final the Decision and Order requesting that any comment filed in the World Wide Web, at (http:// (‘‘Order’’). paper form be sent by courier or www.ftc.gov/os/2008/12/index.htm). A Pursuant to an Agreement and Plan of overnight service, if possible, because paper copy can be obtained from the Merger dated July 18, 2008, Teva U.S. postal mail in the Washington area FTC Public Reference Room, Room 130- proposes to acquire all of the issued and and at the Commission is subject to H, 600 Pennsylvania Avenue, NW, outstanding shares of Barr for delay due to heightened security Washington, D.C. 20580, either in approximately $7.4 billion, plus the person or by calling (202) 326-2222. assumption of $1.5 billion of net debt, 1 The comment must be accompanied by an explicit request for confidential treatment, Public comments are invited, and may for approximately $8.9 billion. The including the factual and legal basis for the request, be filed with the Commission in either Commission’s Complaint alleges that and must identify the specific portions of the paper or electronic form. All comments the proposed acquisition, if comment to be withheld from the public record. should be filed as prescribed in the consummated, would violate Section 7 The request will be granted or denied by the ADDRESSES Commission’s General Counsel, consistent with section above, and must be of the Clayton Act, as amended, 15 applicable law and the public interest. See received on or before the date specified U.S.C. § 18, and Section 5 of the Federal Commission Rule 4.9(c), 16 CFR 4.9(c). in the DATES section. Trade Commission Act, as amended, 15

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U.S.C. § 45, by lessening competition in proposed acquisition reduces the generic metronidazole, resulting in a the U.S. markets for the manufacture number of competitors from three to combined market share of 89 percent. and sale of the following generic two. Tamoxifen citrate is a selective ∑ Trazodone is an antidepressant with pharmaceutical products: (1) estrogen receptor modulator that is used a sedative effect. In the generic tetracycline HCl capsules; (2) in the treatment of breast cancer. trazodone market, the proposed chlorzoxazone tablets; (3) desmopressin Cyclosporine is an immunosuppressant acquisition would result in a acetate tablets; (4) metoclopramide HCl drug used to prevent the rejection of combined market share of 75 percent. tablets; (5) carboplatin injection; (6) transplanted organs. Combined, Teva Apotex Group is the only other tamoxifen citrate tablets; (7) and Barr, currently account for 73 competitively significant supplier metronidazole tablets; (8) trazodone HCl percent of the generic tamoxifen citrate with 22 percent of the market. The tablets; (9) glipizide/metformin HCl market and 55 percent of the generic fourth supplier—Watson—has had tablets; (10) cyclosporine liquid; (11) cyclosporine liquid market. limited success in this market, having cyclosporine capsules; (12) flutamide Teva’s proposed acquisition of Barr captured only a 3 percent market capsules; (13) mirtazapine ODT; (14) share to date. would reduce the number of ∑ deferoxamine injection; (15) epop; (16) competitors from four to three in the Cyclosporine is an weekly fluoxetine capsules; and (17) following generic markets: (1) immunosuppressant drug used to thirteen generic oral contraceptive metoclopramide HCl tablets; (2) prevent the rejection of transplanted markets (collectively, the ‘‘Products’’). carboplatin injection; (3) metronidazole organs. In the generic cyclosprine The proposed Consent Agreement will tablets; (4) trazodone HCl tablets; (5) capsules market, Teva and Barr have remedy the alleged violations by cyclosporine capsules; (6) flutamide roughly equal market shares and their replacing the lost competition that capsules; (7) glipizide/metformin HCl post-acquisition market share would would result from the acquisition in tablets; (8) deferoxamine injection; and be 41 percent. is each of the markets. (9) mirtazapine ODT. The structure of the market leader with 51 percent of each of these markets is as follows: the market. The fourth supplier— The Products and Structure of the Sandoz Inc. (‘‘Sandoz’’)— represents ∑ Metoclopramide HCl is a dopamine Markets approximately 8 percent of the receptor antagonist used to treat The proposed acquisition of Barr by market. nausea and vomiting as well as Teva would strengthen Teva’s ∑ Flutamide is an anti-androgen drug gastroesophageal reflux disease worldwide position in generic used to treat prostate cancer. Teva, pharmaceuticals and provide Teva with (‘‘GERD’’). In the generic Barr, Par Pharmaceutical Companies a stronger pipeline of generic products. metoclopramide HCl market, Teva (‘‘Par’’), and Sandoz are the four The transaction would reduce the and Barr are two of only four suppliers of generic flutamide. number of competing generic suppliers suppliers supplying all dosage forms Sandoz is the market leader with 34 in each of the relevant markets. The of metoclopramide HCl. Qualitest and percent of the market. Teva has 28 number of generic suppliers has a direct Mutual/URL Pharmaceuticals percent of the market, Par has 24 and substantial effect on generic pricing (‘‘Mutual’’) are the remaining two percent, and Barr has 14 percent. as each additional generic supplier can suppliers. A combined Teva and Barr Consequently, the proposed have a competitive impact on the would possess 82 percent of the acquisition would result in a market. Generic pharmaceutical overall generic metoclopramide HCl combined market share of 42 percent. customers are not likely to switch to the market based on current sales. ∑ Glipizide/Metformin, the generic equivalent branded product because ∑ Carboplatin, the generic version of version of BMS’s Metaglip®, is they are priced significantly higher than Bristol-Myers Squibb Company’s commonly prescribed as a first line the generic products. After more than (‘‘BMS’’) Paraplatin®, is a treatment for diabetes. one generic product is introduced, chemotherapy drug used to treat a Pharmaceuticals (‘‘Mylan’’), Sandoz, competition among the generic variety of cancers, mainly ovarian, Teva, and Barr are the four suppliers competitors drives pricing, and the lung, head and neck cancers. Teva of generic glipizide/metformin. branded product’s pricing largely and Barr are two of the leading Sandoz is the market leader with 37 becomes competitively irrelevant. suppliers of generic carboplatin percent. Barr and Teva have roughly In the markets for generic tetracycline injection with a combined market equal market shares of 25 and 26 HCl tablets, chlorzoxazone tablets, and share of 60 percent. APP percent, respectively. The fourth desmopressin acetate tablets, Teva and Pharmaceuticals and Bedford supplier—Mylan—has the smallest Barr are the only companies Laboratories (‘‘Bedford’’) are the two market share with 12 percent. Thus, manufacturing and selling products in remaining suppliers in the generic Teva’s proposed acquisition of Barr the United States. Tetracycline HCl is an carboplatin injection market with 11 would result in a post acquisition old, broad-spectrum antibiotic used now percent and 29 percent of the market, market share of 51 percent. primarily for the treatment of acne and respectively. ∑ Deferoxamine, the generic version of rosacea. Chlorzoxazone is a centrally ∑ Metronidazole is an anti-infective Novartis International AG’s Desferal®, acting muscle relaxant used to treat used in the treatment of a variety of is a chelating agent used to remove muscle spasms. Desmopressin acetate is bacterial infections. Barr is the market excess iron from the body. In the a synthetic replacement for an leader in the generic metronidazole generic deferoxamine market, a antidiuretic hormone that reduces urine market with 50 percent market share. combined Teva and Barr would production during sleep and is used to Teva is close behind with 39 percent possess 16 percent of the market. treat bed-wetting in children. Because of the market. Mutual and Amneal Inc. is the market leader with Teva and Barr are the only suppliers of Pharmaceuticals are the only other 73 percent market share. The these generic products in the United suppliers with 4 percent and 1 remaining supplier—Bedford—is a States, the proposed acquisition creates percent of the market, respectively. small competitor as reflected by its 11 a monopoly in each of these markets. Therefore, the proposed acquisition percent share of the market. Although In the generic tamoxifen citrate and combines two of the most the combined share of Teva and Barr cyclosporine liquid markets, the competitively significant suppliers of is only 16 percent, the proposed

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transaction would combine two of OrthoNovum® 1-35, OthroNovum® 7/ substantial competition between Teva only four companies offering generic 7/7, Loestrin® FE (1mg/.02 mg & 1.5 and Barr and by increasing the deferoxamine injection in the United mg/.03 mg), Loestrin® FE (1mg/.2 mg), likelihood that customers will pay States. As discussed in Effects, below, Loestrin® FE 24, and Ovcon® 35. In higher prices. the number of suppliers is the driving each of these relevant markets, Teva is The competitive concerns can be factor for prices in generic markets. one of a limited number of firms capable characterized as both unilateral and ∑ Mirtazapine is an antidepressant used of developing a generic oral coordinated in nature. The homogenous to treat moderate to severe depression. contraceptive product that would nature of the products involved, the Only four companies currently supply compete in each of these markets, and minimal incentives to deviate, and the generic mirtazapine in the United is well-positioned to enter the markets relatively predictable prospects of States—Teva, Barr, Prasco in a timely manner. Both Teva and Barr gaining new business all indicate that Laboratories (‘‘Prasco’’), and are developing generic products the firms in the market will find it Aurobindo Pharma (‘‘Aurobindo’’). equivalent to Ortho Tri-Cyclen® Lo 28 profitable to coordinate their pricing. Prasco is the market leader with a 49 and are two of a limited number of firms The impact that a reduction in the percent market share. Barr has 26 with this product in development. number of firms would have on pricing percent of the market, and Teva has can also be explained in terms of 10 percent of the market. Aurobindo Entry unilateral effects, as the likelihood that is the smallest competitor with only 8 Entry into the markets for the the merging parties would be the first percent of the market. Hence, the manufacture and sale of the Products and second choices in a significant proposed acquisition would result in would not be timely, likely or sufficient number of bidding situations is a combined market share of 36 in its magnitude, character, and scope to enhanced where the number of firms percent. deter or counteract the anticompetitive participating in the market decreases In two product markets—epop and effects of the acquisition. Entry would substantially. fluoxetine weekly capsules—the not take place in a timely manner proposed acquisition would eliminate because the combination of The Consent Agreement important and significant future development times and Food and Drug The proposed Consent Agreement competition. Epop is used to treat severe Administration (‘‘FDA’’) drug approval effectively remedies the proposed primary pulmonary hypertension. Epop requirements takes at least two years. acquisition’s anticompetitive effects in is a new generic market and Teva is Entry would not be likely because many the relevant product market. Pursuant to currently the only generic epop of the relevant markets are relatively the Consent Agreement, Teva and Barr supplier. Barr has an epop product in small and in decline, so the limited are required to divest certain rights and development. Fluoxetine weekly sales opportunities available to a new assets related to the Products to a capsules are a widely-prescribed entrant would likely be insufficient to Commission-approved acquirer no later antidepressant. Both Teva and Barr have warrant the time and investment than ten days after the acquisition. generic products in development for the necessary to enter. Specifically, the proposed Consent fluoxetine weekly capsules market. Agreement requires that Teva divest the Effects There are few firms that are capable of, oral contraceptive products and and interested in, entering these The proposed acquisition would trazodone to Qualitest and that Teva/ markets. cause significant anticompetitive harm Barr divest the remainder of the Oral contraceptives are pills taken by to consumers in the U.S. markets for the Products to Watson. mouth to prevent ovulation and manufacture and sale of each of the The acquirer of the divested assets pregnancy. They are the most common generic markets listed above. In generic must receive the prior approval of the method of reversible birth control, used pharmaceutical markets, pricing is Commission. The Commission’s goal in by 82 percent of women in the United heavily influenced by the number of evaluating a possible purchaser of States at some point during their competitors that participate in a given divested assets is to maintain the reproductive years. market. Here, the evidence shows that competitive environment that existed The thirteen oral contraceptive the prices of the generic pharmaceutical prior to the acquisition. A proposed markets include two markets where products at issue decrease with the acquirer of divested assets must not both Teva and Barr participate, ten entry of each additional competitor. itself present competitive problems. markets where Barr participates and Evidence gathered during the Qualitest and Watson are well- Teva has a product in development and investigation confirms that pricing for positioned to manufacture and market one market where both Teva and Barr the generic pharmaceutical products at their respective acquired Products and have products in development. The two issue in the transaction is driven by the to compete effectively in those markets. markets where both Barr and Teva number firms that compete in the Both Qualitest and Watson develop, currently participate—generic Ortho- markets. Customers consistently state manufacturer, sell, and distribute Cyclen® and generic Ortho Tri- that the price of a generic generic pharmaceuticals within the Cyclen®—are already highly pharmaceutical decreases with the entry United States. Moreover, the concentrated. A combined Teva and of the second, third and even fourth divestitures to both companies do not Barr would have 68 percent of the competitor. The evidence also indicates present competitive problems of their generic Ortho-Cyclen® market and 51 that the presence of four significant own because neither competes in those percent of the generic Ortho Tri- competitors allows customers to markets. With their resources, Cyclen® market. Watson is the only negotiate lower prices than is the case capabilities, strong reputation, and other supplier in each of these markets. where there are fewer firms. The experience marketing generic products, Barr also competes in ten oral proposed transaction would eliminate the two companies are expected to contraceptive markets where Teva is one of at most four competitors in each replicate the competition that would be developing a competing product. These of the relevant markets and would cause lost with the proposed acquisition. markets include generic products that significant anticompetitive harm to If the Commission determines that are equivalent to Ortho-Cept®, consumers in the U.S. markets by either Watson or Qualitest is not Mircette®, Triphasil®, Alesse®, eliminating actual, direct, and acceptable acquirer of the assets to be

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divested, or that the manner of the the divestitures and transfers are OMB number, and OS document divestitures is not acceptable, the accomplished. identifier, to parties must unwind the sale and divest The purpose of this analysis is to [email protected], or call the assets within six months of the date facilitate public comment on the the Reports Clearance Office on (202) the Order becomes final to another proposed Consent Agreement, and it is 690–6162. Written comments and Commission-approved acquirer. If the not intended to constitute an official recommendations for the proposed parties fail to divest within six months, interpretation of the proposed Order or information collections must be directed the Commission may appoint a trustee to modify its terms in any way. to the OS Paperwork Clearance Officer to divest the Products. By direction of the Commission. at the above e-mail address within 60 The proposed remedy contains Donald S. Clark, days. several provisions to ensure that the Secretary. Proposed Project: Ensuring That divestitures are successful. The Order [FR Doc. E8–30831 Filed 12–24–08: 8:45 am] Department of Health and Human requires Teva and Barr to provide BILLING CODE 6750–01–S Services Funds Do Not Support transitional services to enable the Coercive or Discriminatory Policies or Commission-approved acquirers to Practices in Violation of Federal Law— obtain all of the necessary approvals DEPARTMENT OF HEALTH AND OMB No. 0990–NEW—Office of the from the FDA. These transitional HUMAN SERVICES Secretary. services include technology transfer assistance to manufacture the Products [Document Identifier: OS–0990–New] Abstract: The proposed information in substantially the same manner and collection is contained in the Final Rule quality employed or achieved by Teva Agency Information Collection entitled, ‘‘Ensuring That Department of or Barr. Most of the oral contraceptive Request; 60-Day Public Comment Health and Human Services Funds Do products had been divested to Teva Request Not Support Coercive or Discriminatory Policies or Practices in Violation of pursuant to a Commission Order in the AGENCY: Office of the Secretary, HHS. matter of Watson Pharmaceuticals, Inc./ In compliance with the requirement Federal Law.’’ The purpose of this Andrx Corporation, Docket No. C-4172 of section 3506(c)(2)(A) of the collection is to ensure, by requiring (October 31, 2006). This proposed D&O Paperwork Reduction Act of 1995, the written certification of compliance does not relieve Watson of any of its Office of the Secretary (OS), Department similar to other, existing certifications obligations pursuant to the Commission of Health and Human Services, is currently made by funding recipients Order issued in the above referenced publishing the following summary of a and applicants, that recipients of Watson/Andrx matter. proposed information collection request Department funds are aware of and The Commission has appointed for public comment. Interested persons comply with the legal obligations William Rahe of Quantic Regulatory are invited to send comments regarding imposed on them by the Church Services, LLC (‘‘Quantic’’) to oversee the this burden estimate or any other aspect Amendments (42 U.S.C. 300a–7), Public asset transfer and to ensure Teva’s and of this collection of information, Health Service Act section 245 (42 Barr’s compliance with all of the including any of the following subjects: U.S.C. 238n) and the Weldon provisions of the proposed Consent (1) The necessity and utility of the Amendment (Consolidated Agreement. Mr. Rahe is a senior proposed information collection for the Appropriations Act, 2008, Pub. L. 110– consultant at Quantic and has several proper performance of the agency’s 161 Div. G section 508(d), 121 Stat. years of experience in the functions; (2) the accuracy of the 1844, 2209). We estimate the universe . He is a highly- estimated burden; (3) ways to enhance and number of entities that would be qualified expert on FDA regulatory the quality, utility, and clarity of the required to certify to be 571,947. The act matters and currently advises Quantic information to be collected; and (4) the of certification consists of reviewing the clients on achieving satisfactory use of automated collection techniques certification language, reviewing regulatory compliance and interfacing or other forms of information relevant entity policies and procedures, with the FDA. In order to ensure that technology to minimize the information and reviewing files before signing. the Commission remains informed collection burden. Although some entities may need to about the status of the proposed To obtain copies of the supporting sign a certification statement more than divestitures and the transfers of assets, statement and any related forms for the once, we assume that the entity will the proposed Consent Agreement proposed paperwork collections only carefully review the language, requires Teva and Barr to file reports referenced above, e-mail your request, procedures and their files before signing with the Commission periodically until including your address, phone number, the initial statement each year.

ESTIMATED ANNUALIZED BURDEN TABLE

Number of Average Type of respondent Number of responses per burden hours Total burden respondents respondent per response hours

Hospitals (less than 100 beds) ...... 2403 1 30/60 1202 Hospitals (less than 100 beds) ...... 1129 1 30/60 565 Hospitals (200–500 beds) ...... 1160 1 30/60 580 Hospitals (more than 500 beds) ...... 244 1 30/60 122 Nursing Homes (less than 50 beds) ...... 2388 1 30/60 1194 Nursing Homes (50–99 beds) ...... 5819 1 30/60 2910 Nursing Homes (99—199 beds) ...... 6877 1 30/60 3439 Nursing Homes (more than 200 beds) ...... 1037 1 30/60 519 Physicians Offices ...... 234200 1 30/60 117100 Offices of Other Health Care Practitioners ...... 115378 1 30/60 57689 Outpatient Care Centers ...... 26901 1 30/60 13451

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