Durect receives back European product rights to Posidur (PRNewswire) - Jan 30, 2012 - Durect reported that Takeda (through Nycomed) has given notice that it is returning its development and commercialization rights to Posidur in EU and their other licensed territories; Durect plans to work with partner Hospira to move the Posidur program forward in the U.S. and Canada and commence discussion with potential collaborators for other licensed territories; Durect currently is preparing integrated safety and efficacy reports for submission to FDA in conjunction with a pre-NDA meeting anticipated in mid-2012
Anticipated pre-NDA meeting • Collaboration agreement termination • Seeking partner • Pain
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CUPERTINO, Calif., Jan. 30, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that Takeda (through Nycomed) has given notice that it is returning its development and commercialization rights to POSIDUR™ (SABER™-Bupivacaine) in Europe and their other licensed territories. Takeda acquired its rights to POSIDUR through its acquisition of Nycomed in September, 2011. POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER™ technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. Takeda has committed to assist in an orderly and rapid transition of data generated by Nycomed back to DURECT.
"We are disappointed Nycomed will no longer be our partner, but would like to thank them for the collaboration over the past years," stated James Brown, President and CEO of DURECT. "Our plan is to work with our partner Hospira to move the POSIDUR program forward in the U.S. and Canada. We are currently preparing integrated safety and efficacy reports that tie together the entire body of work we've done with POSIDUR. This information will be submitted to the FDA in conjunction with a pre-NDA meeting that we anticipate will occur in mid-2012. We believe that Takeda's territories previously licensed to Nycomed represent an attractive commercial opportunity for POSIDUR and we will now commence discussions with potential collaborators around those rights."
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