Barr will divest generic drugs for the treatment of depression, high blood pressure and ruptured blood vessels, as well as a branded organ preservation solution, to gain Federal Trade Commission clearance for the acquisition of Pliva.

Without the divestitures, the merger of Barr and Pliva would eliminate competition for drugs in those categories, the FTC said, announcing a consent order Oct. 20.

"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 agency said.

Under the settlement, Barr is required to sell its generic antidepressant trazodone and its generic blood pressure medication triamterene/hydrochlorothiazide to Apotex. There are only five suppliers of generic trazodone in the U.S., FTC said, noting that Barr and Pliva are two of only three that carry the 150 mg formulation. In addition, there are five suppliers of triamterene/HCTZ, but aside from Barr and Pliva, the others have a "more limited competitive presence."

Apotex, based in Toronto, currently does not compete in the U.S. market for these two drugs, FTC noted.

Barr is also required to divest either Pliva's or its own generic nimodipine soft gel capsules for the treatment of ruptured blood vessels in the brain. Both Barr and Pliva plan to introduce the only two generic nimodipine products later this year, according to the agency. The settlement calls for the divestiture of either Pliva's nimodipine assets to High Point, N.C.-based Banner Pharmacaps within 10 days after the acquisition, or Barr's assets to Cardinal Health within 60 days.

In addition, Barr is required to divest Pliva's branded organ preservation solution Custodial because "Barr and Pliva are the only two significant competitors" for organ preservation solutions, FTC said. The company plans to sell the product to Morristown, N.J.-based New Custodial. If that deal falls through, the FTC order would require Barr to divest its own organ preservation solution, ViaSpan , to a commission-approved buyer.

The order is subject to public comment until Nov. 20.

Barr moved forward with its plan to acquire Pliva for approximately $2.5 bil. in September after rival Actavis announced it was bowing out of a bidding war for the Croatian generic drug maker (¹ Also see "Barr Finalizes Pliva Acquisition" - Pink Sheet, 20 October, 2006.).

Commenting on the FTC action, Barr said the vote clears the way for the acquisition to close on Oct. 25.

"We are pleased that the FTC has voted 5-0 to allow the deal to proceed with minimal product divestiture," Barr said. "We can now close this acquisition and begin the process of integrating the two companies into the world's third largest generic pharmaceutical company."

-Jessica Merrill (j.merrill@elsevier.com)

FTC Clears Barr’s Acquisition Of Pliva Based On Divestiture Of Generic Drugs

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