Endo Pharmaceuticals Inc and Durect Corporation have signed an agreement that would give Endo the exclusive license to develop and commercialize Durect's sufentanil-containing transdermal patch in the US and Canada.

The sufentanil patch, which is in early-stage clinical development employs Durect's proprietary Transdur drug-adhesive matrix formulation and is intended to provide relief of moderate-to-severe chronic pain for up to seven days. Effective immediately, Endo will assume all remaining development and regulatory filing responsibility, including the funding thereof.

Under the terms of the agreement, Endo will pay Durect an upfront fee of $10 million, with additional payments of approximately $35 million upon achievement of predetermined regulatory and commercial milestones. Endo will also pay undisclosed royalties to Durect on net sales of the sufentanil transdermal patch, the release stated.

Peter A. Lankau, president and chief operating officer of Endo says, "We feel that Durect's sufentanil patch could offer physicians and patients significant benefits over currently marketed products. The product's weeklong duration combined with its reduced size (about 20% of the size of the on-market transdermal fentanyl patches but with a therapeutically equivalent dose) may offer improved patient convenience and compliance." The transdermal sufentanil patch is expected to compete in the $4 billion strong-opioid market.

As a result of Endo's license of the development and commercialization rights of the transdermal sufentanil patch from Durect and Endo's license of the development and commercialization rights of the topical ketoprofen patch from ProEthic Pharmaceuticals, Inc., the company is revising its guidance for 2005 to reflect the increased research and development costs expected to be incurred during 2005 for these two product opportunities, the release added.