Durect licenses Eladur pain patch to Alpharma

Under the terms of the agreement between Alpharma’s affiliate, Alpharma Ireland Limited, and Durect, Alpharma will pay Durect an upfront license fee of $20 million, with possible additional payments of up to $93 million upon the achievement of predefined development and regulatory milestones spread over multiple clinical indications and geographical territories as well as possible additional payments of up to $150 million in sales based milestones.

If Eladur is commercialized, Durect would also receive a royalty on product sales. Alpharma will control and fund the development program. Closing of the transaction is anticipated to occur in the fourth quarter of 2008 and is contingent solely on completion of review under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

The FDA has previously granted to Durect orphan drug designation for bupivacaine for relief of persistent pain associated with post-herpetic neuralgia (PHN). If Eladur is the first bupivacaine product approved for PHN, under the 1983 Orphan Drug Act, Eladur would receive seven years of market exclusivity following the approval of the product by the FDA.

Eladur is an investigational transdermal drug patch intended to deliver bupivacaine for up to three days from a single application. Durect has previously announced positive results for Eladur from a 60 patient Phase IIa clinical trial of patients suffering from PHN.

Dean Mitchell, president and CEO of Alpharma, said: “We believe that this novel bupivacaine patch has the potential to expand the large and rapidly growing market for topical pain products with its patient friendly design and extended duration of therapeutic use, and we are pleased to be adding this to our pipeline of products in development.”