FTC Challenges Barrs Proposed Acquisition of Pliva

Required Divestitures in Generic Drug and Organ Preservation Solution Markets Protect Consumers and Competition

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The Federal Trade Commission today announced its decision to challenge Barr Pharmaceutical, Inc.’s proposed acquisition of Pliva d.d for approximately $2.5 billion. The FTC’s complaint alleges that the acquisition as originally structured would have eliminated current or future competition between Barr and Pliva in certain markets for generic pharmaceuticals treating depression, high blood pressure and ruptured blood vessels, and in the market for organ preservation solutions, thereby increasing the likelihood that consumers would pay more for these vital products.

In settling the Commission’s charges, Barr is required to sell its generic antidepressant trazodone and its generic blood pressure medication triamterene/HCTZ. Barr also is required to divest either Pliva’s or Barr’s generic nimodipine for use in treating ruptured blood vessels in the brain. Finally, Barr is required to divest Pliva’s branded organ preservation solution Custodial.

“Preserving competition in the markets for pharmaceuticals and other health care products to the benefit of U.S. consumers is core to the FTC’s mission,” said Jeffrey Schmidt, Director of the FTC’s Bureau of Competition. “The Commission’s action today furthers that mission by requiring divestitures that will prevent U.S. consumers from paying higher prices for these life-saving products after the proposed transaction.”

The Relevant Products and Markets: The Commission has identified four product markets that likely would experience anticompetitive effects if the proposed acquisition was allowed to proceed unchallenged.

Trazodone hydrochloride is an antidepressent sold in several different formulations. There are five suppliers of generic trazodone in the U.S., but not all the suppliers are capable of supplying all formulations. Barr and Pliva are two of only three suppliers of the 150 mg formulation of generic trazodone.

Triamterene/HCTZ is a combination product used to treat high blood pressure. Currently, there are only five suppliers of generic triamterene/HCTZ tablets in the U.S. and several of those suppliers, other than Barr and Pliva, have a more limited competitive presence.

Nimodipine is used to treat symptoms resulting from a ruptured blood vessel in the brain. Although the patent for the branded version of this drug has expired, there are no generic equivalents currently on the market. However, Barr, in conjunction with Cardinal and, Pliva, in conjunction with Banner, plan to introduce the only two generic nimodipine products in the fall of this year.

Organ preservation solutions are used during the harvest of donor organs to flush and preserve them prior to transplant. Barr and Pliva are the only two significant competitors for these solutions. More information on the product markets, current competitors, and the proposed acquisition’s likely impact on competition and market shares can be found in the analysis to aid public comment on this matter on the FTC’s Web site.

The Commission’s Complaint: On June 27, 2006, Barr announced its intention to acquire all of the outstanding shares of Pliva, now valued at approximately $2.5 billion. According to the Commission’s complaint, the acquisition as proposed would violate Section 7 of the Clayton Act and Section 5 of the FTC Act, as amended, by eliminating competition in the markets for the manufacture and sale of: 1) generic trazodone hydrochloride tablets; 2) generic triamterene/HCTZ tablets; 3) generic nimodipine soft-gel capsules; and 4) organ preservation solutions.

In each of the three generic drug markets, the FTC has determined that Barr and Pliva are two of a small number of suppliers offering the product, or are the only two future competitors. The number of generic suppliers has a direct and substantial effect on generic pricing, as each additional generic supplier can have a competitive impact on the market. Because there are (or will be) multiple generic equivalents for the three pharmaceutical products at issue here, the branded versions do not (or will not) significantly constrain the generics’ pricing.

The market for organ preservation solutions also is highly concentrated, according to the complaint, and the acquisition as proposed would provide Barr with a near monopoly share absent the relief required by the consent order.

The complaint states that entry into the manufacture and sale of the four relevant products would not be timely, likely, or sufficient to counteract the alleged anticompetitive impact of the acquisition as proposed. There are significant regulatory barriers to entry, including gaining FDA approval for each drug. Further, in the case of organ preservation products, doctors are likely to be reluctant to switch to a new manufacturer.

Finally, the FTC contends that the proposed acquisition likely would eliminate actual, direct, and substantial competition between Barr and Pliva in the relevant markets by increasing the likelihood that Barr would be able to exercise unilateral market power, by increasing the likelihood and degree of coordinated interaction between the few remaining competitors, and by increasing the likelihood that consumers would pay more for these products.

Terms of the Order: The FTC’s consent order is designed to remedy the competitive harm resulting from Barr’s proposed acquisition of Pliva by preserving competition in the relevant product markets. In the markets for generic trazodone hydrochloride tablets and generic triamterene/HCTZ tablets, the order requires Barr to divest all of the Barr assets for these products to Apotex within 10 days of the acquisition. The order contains specific terms to ensure the divestitures are successful, including the requirement that Barr provide Apotex with various transitional services to enable it to compete successfully in these markets right away. According to the Commission, Apotex is a reputable generic manufacturer and is well-positioned to manufacture and market the acquired products in a competitive manner. In addition, Apotex does not compete in the U.S. market for these two drugs.

Next, the order preserves the actual and potential competition in the market for generic nimodipine soft-gel capsules by requiring either that: 1) Barr divest Pliva’s nimodipine assets to Banner no later than 10 days after the acquisition; or 2) Barr divest its own nimodipine assets to Cardinal no later than 60 days after the acquisition. Both Banner and Cardinal are reputable soft-gel capsule manufacturers and are well-positioned to make and sell nimodipine because they already are manufacturing generic nimodipine soft-gel capsules through joint ventures with Pliva and Barr, respectively.

Third, the order addresses competition in the market for organ preservation solutions by requiring Barr to divest Pliva’s organ preservation solution, Custodial, to New Custodial LLC no later than 10 days after the acquisition. The analysis to aid public comment that is linked to this press release on the FTC’s Web site explains in detail why New Custodial LLC is a well-positioned acquirer for these assets. However, if Barr’s sale of Pliva’s assets to New Custodial LLC fails, the order would require Barr to divest its own organ preservation solution, ViaSpan, to a Commission-approved buyer.

The consent order also allows the FTC to appoint a divestiture trustee if any of the proposed divestitures are not completed within six months and to appoint an interim trustee to oversee certain components of the divestitures, if necessary. Barr also must sign an agreement with the interim monitor appointed by the FTC, whose job it will be to ensure the Commission is informed about the status of the proposed divestitures.

The Commission vote to approve the consent order was 5-0. The order will be subject to public comment for 30 days, until November 20, 2006, after which the Commission will decide whether to make it final. Comments should be sent to: FTC, Office of the Secretary, 600 Pennsylvania Ave., N.W., Washington, DC 20580.

NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.

Copies of the complaint, consent order, and an analysis to aid public comment are available from the FTC’s Web site at http://www.ftc.gov and also from the FTC’s Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC’s Bureau of Competition seeks to prevent business practices that restrain competition. The Bureau carries out its mission by investigating alleged law violations and, when appropriate, recommending that the Commission take formal enforcement action. To notify the Bureau concerning particular business practices, call or write the Office of Policy and Coordination, Room 394, Bureau of Competition, Federal Trade Commission, 600 Pennsylvania Ave, N.W., Washington, D.C. 20580, Electronic Mail: antitrust@ftc.gov; Telephone (202) 326-3300. For more information on the laws that the Bureau enforces, the Commission has published “Promoting Competition, Protecting Consumers: A Plain English Guide to Antitrust Laws,” which can be accessed at http://www.ftc.gov/bc/compguide/index.htm.

Contact Information

Media Contact:

Mitchell J. Katz,
Office of Public Affairs

Staff Contact:
Stephanie C. Bovee,
Bureau of Competition