Bayer Schering Pharma is handing back the worldwide commercialization rights to Epix's Vasovist, an MRA agent that has yet to win FDA approval. Their deal ends on March 1, 2009 and Bayer Schering will continue to supply Vasovist to the 19 countries where it is marketed. The FDA had rejected Vasovist, saying that it needed additional testing. Epix resubmitted its NDA earlier this year.
"We are pleased to regain complete worldwide commercial rights for Vasovist which has a PDUFA date of December 31, 2008," said Elkan Gamzu, Ph.D., interim chief executive officer of EPIX. "Pending FDA approval, Vasovist is positioned to become the first MRA contrast agent approved in the United States and it could be launched in 2009. Our goal remains to maximize the commercial value of Vasovist and we are committed to executing our monetization strategy which includes finding a marketing and commercialization partner for Vasovist."
- here's the release from Epix
- read the story from the Boston Globe