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Alpharma licenses pain product from Idea

Alpharma has reached an agreement with German biopharmaceutical company Idea to license the exclusive US rights to ketoprofen in Transfersome gel, a prescription topical NSAID in Phase III development.

This license includes access to Idea's Transfersome technology platform that delivers drugs locally to targeted areas. In May 2007, Idea AG submitted a marketing authorization application in Europe for ketoprofen in Transfersome gel for the treatment of osteoarthritis. A prior regulatory submission with Swiss regulators was approved by SwissMedic in June 2007.

Two pivotal European trials, including a 12-week duration study in osteoarthritis, demonstrated that ketoprofen in Transfersome gel delivered a statistically significant improvement in pain, function and patient global response.

In addition, Idea will conduct two clinical studies to support an NDA submission to the FDA for this product candidate, which the company is targeting for late 2009. Alpharma anticipates a US product launch in early 2011 assuming the NDA is approved.

The terms of the license agreement between Alpharma's affiliate, Alpharma Ireland Limited, and Idea include a $60 million payment at closing. In addition to the initial payment, the company expects approximately $5 million ($0.10 earnings per share) in transaction related expenses during the third and fourth quarters of 2007.

The agreement also includes three clinical and regulatory progress milestone payments totaling $77 million that are expected to be made later this year or in 2008 based upon Idea's achievement of contractually specified conditions. An additional milestone payment of either $45 or $65 million, depending upon the results of one of the clinical trials for the product, is conditioned on US product approval.

Idea has agreed to pay the costs of specified studies being undertaken to obtain FDA approval, and Alpharma expects to incur minimal R&D expense prior to approval.