DURECT Says Pfizer Will Continue Development Program For REMOXY

(RTTNews) - DURECT Corporation(DRRX), Tuesday said that that Pfizer Inc. (PFE) has stated that it will continue the development program for REMOXY Extended-Release Capsules CII, having achieved manufacturing technical milestones. With the guidance received from the FDA earlier this year, Pfizer announced that they will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011.

These new clinical studies will include, in part, a pivotal bioequivalence study with the modified REMOXY formulation to bridge to the clinical data related to the original REMOXY formulation, and an abuse-potential study with the modified formulation. As announced earlier, the complete response submission is not expected to occur prior to mid-2015.

In addition, Pain Therapeutics, Inc. (PTIE), has got back all rights from Pfizer with respect to the three other ORADUR-based opioid drug candidates. Pain Therapeutics has stated that they have not yet made a decision to develop or out-license the three product candidates.

Separately, Pain Therapeutics in a statement said that the deal with their exclusive, worldwide partner for REMOXY, Pfizer remains unchanged. Pain said that they are eligible to receive from Pfizer a $15 million payment upon FDA approval of REMOXY. After commercial launch, Pain will get a royalty of 20 percent of net sales of REMOXY in the United States, as to the first cumulative $1 billion in net sales, which royalty is set at 15 percent, from Pfizer.