BioCentury
ARTICLE | Company News

Cephalon, Barr Laboratories Inc. deal

August 16, 2004 7:00 AM UTC

In connection with CEPH's acquisition of CIMA Labs Inc. (CIMA, Eden Prairie, Minn.), BRL received a license to manufacture and market a generic version of CEPH's Actiq oral transmucosal fentanyl for cancer pain. The license will begin in February 2007 or in September 2006 if CEPH does not obtain pediatric exclusivity for Actiq. The license could become effective earlier upon FDA approval of CIMA's OraVescent fentanyl, at which time BRL also may obtain a license to manufacture and market a generic version of a sugar-free formulation of Actiq. CEPH plans to submit an sNDA for the sugar-free version this year and expects approval in mid-2005. OraVescent fentanyl is in Phase III testing for the same indication, and CEPH hopes to receive FDA approval in late 2006. ...