Barr Pharmaceuticals, Inc. announced that its subsidiary, Barr Laboratories, Inc., has entered into an agreement with Cephalon, Inc. that will provide the company with a license to manufacture and market a generic version of Cephalon's ACTIQ (oral transmucosal fentanyl citrate) [C-II] cancer pain management treatment. The license will become effective on February 3, 2007, or earlier, depending on certain contingencies. The agreement also obligates Cephalon to supply Barr with a Cephalon-manufactured product for resale, if Barr cannot obtain US Food & Drug Administration (FDA) approval of an Abbreviated New Drug Application (ANDA) product prior to the license's effective date. Under certain circumstances, the agreement also would provide Barr with the right to manufacture and market a generic version of Cephalon's proposed sugar-free formulation of ACTIQ.

"This agreement will enable Barr to launch a fentanyl product at least 30 days prior to the expiration of any pediatric exclusivity period Cephalon might obtain on ACTIQ," said Bruce L. Downey, Barr's chairman and chief executive officer. "If Cephalon does not obtain pediatric exclusivity, the latest effective date of the license would be September 5, 2006. The license will be effective even earlier if CIMA/Cephalon obtains FDA approval of an OraVescent fentanyl product prior to these dates."

The agreement was entered into pursuant to a US Federal Trade Commission (FTC) consent agreement in connection with the proposed merger of CIMA and Cephalon, and is contingent upon final FTC approval and consummation of the merger.

ACTIQ is indicated for the treatment of breakthrough cancer pain in opioid tolerant patients and has current annual sales of approximately $319 million, based on IMS sales data for the twelve months ended June 2004.