Cephalon must grant Barr a license to manufacture a generic version of its fentanyl product Actiq as a condition of the firm's acquisition of Cima Labs.

The Federal Trade Commission said Aug. 9 that its consent order allowing the merger requires Cephalon to grant Barr "a fully paid, irrevocable license to make and sell a generic equivalent to Actiq."

The two companies have accepted the consent agreement and expect the merger to close in the next few days.

The merger raised anticompetitive concerns with FTC because transmucosal Actiq is the only drug for breakthrough cancer pain marketed in the U.S. Cima is developing OraVescent fentanyl, a fast-dissolving, effervescent tablet formulation.

Barr's generic "will be launched as soon as the FDA approves [OraVescent fentanyl], and in any event, no later than February 2007," FTC said. Cima plans to file the OraVescent fentanyl NDA in late 2004 or early 2005 and enter the market in 2006 or 2007, FTC noted.

Under the order, Cephalon must transfer the know-how and intellectual property for both the sugar and sugar-free versions of Actiq to Barr immediately. If Barr is unable to manufacture an FDA-approved generic version of Actiq by the time the licenses take effect, Cephalon would have to supply Barr with the product.

In addition, Cephalon is prohibited from making regulatory filings that would delay FDA approval of Barr's product.

Cephalon announced its proposed $515 mil. acquisition of Cima in November 2003.

- Scott Steinke

Cephalon/Cima Merger Contingent On Granting Generic Actiq License To Barr

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