Durect Corp. Offers Update on REMOXY, POSIDUR Programs: Will Discontinue Deal

DURECT Corporation

reported today that Pfizer Inc.

announced today that it has notified Pain Therapeutics, Inc.

that Pfizer has decided to discontinue its agreement to develop and commercialize REMOXY® (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics. As a result, Pain Therapeutics has the rights to develop and commercialize REMOXY on its own or with an alternative licensee. Pain Therapeutics had the rights to develop and commercialize this product candidate under a license from DURECT. Pfizer further announced that it has concluded an internal review of the top-line results of five recently completed clinical studies required to address the Complete Response Letter received in June 2011 from the U.S. Food and Drug Administration (FDA), that Pfizer and Pain Therapeutics will work together for an orderly transition of REMOXY to Pain Therapeutics, and that Pfizer will continue ongoing activities under the agreement for the next six months until the scheduled termination date. "We are surprised by Pfizer's decision given the late stage of this program, and continue to believe that REMOXY could play an important role in serving the needs of chronic pain patients while potentially reducing the misuse and abuse of oxycodone," stated James Brown, President and CEO of DURECT. "With respect to POSIDUR, we had a face-to-face meeting with the FDA on September 23 to discuss what needs to be done to address the issues cited in the Complete Response Letter, and we are currently awaiting feedback from the FDA regarding our questions posed at the meeting."