For the second time this year, Durect ($DRRX) faces a setback over its controlled-release anti-pain drug Posidur.
The Cupertino, CA-based company disclosed that its European development and marketing partner for the drug is backing out. Takeda Pharmaceutical ($TKPHF) is giving back European product rights to the drug, which it had owned since its September acquisition of Nycomed. Just a few weeks ago, Durect endured a 30% drop in its share price, after announcing disappointing Phase III data from a 305-patient trial showing Posidur failed to provide a statistically significant improvement in pain levels. (Patients with abdominal surgeries took part.)
Posidur blends bupivacaine with Durect's Saber controlled-release drug delivery technology, which uses a high-viscosity base to enable controlled release. The treatment is delivered directly into a surgical wound, where it proceeds with a controlled release of bupivacaine for up to three days, according to the company.
CEO James Brown put an optimistic spin on the company's latest news. In a statement, he said he was "disappointed" that Nycomed/Takeda ended its partnership, but Durect will seek a replacement partner for the European and other markets. And as Brown told us at the J.P. Morgan Healthcare Conference, the company will analyze data from its Phase III trial, evaluate positive, additional trial data regarding hernia and shoulder pain and submit everything to the FDA by midyear as part of a pre-NDA meeting to discuss how to proceed.
Durect inked a $212.5 million U.S. licensing deal with Hospira ($HSP) in 2010, which Brown added he expects will continue.
- here's the Durect release
Wheeling and dealing at J.P. Morgan 2012
Durect shares nosedive on Phase III upset
Durect's pain drug fails to clear key hurdle in PhIIb