Pharmaceutical Business review

Alkermes Enters Into License Agreement With Acceleron Pharma

Alkermes and Acceleron Pharma have enetred into a license agreement. Under the terms of the agreement, Alkermes will have worldwide rights to the Medifusion technology in return with an upfront payment and equity investment in Acceleron as well as future development, regulatory and sales milestones and royalties on product sales.

Acceleron will retain all rights to the technology for products derived from the TGF-beta superfamily. As part of the agreement, Acceleron is expected to develop two selected drug compounds using the Medifusion technology through preclinical studies. At this point Alkermes will assume responsibility for all clinical development and commercialisation of these two compounds and any other compounds Alkermes elects to develop resulting from the platform.

Alkermes has licensed a proprietary long-acting Fc fusion technology platform, called the Medifusion technology, which is designed to extend the circulating half-life of proteins and peptides.

ALKS 6931, the lead candidate from the Medifusion platform, is a fusion protein of a soluble TNF receptor with the Fc component of human immunoglobulin G1. In-vivo studies have shown a significantly extended half-life of ALKS 6931 beyond the half-life of etanercept. Alkermes expects to file an Investigational New Drug Application (IND) for ALKS 6931 in 2010.

Richard Pops, chief executive officer of Alkermes, said: “We are very pleased to have in-licensed this broadly applicable technology from Acceleron and look forward to applying this new technology to develop a long-acting TNF candidate.

“In addition to this lead product candidate, we believe there are several other important protein therapeutics for which we can use the Medifusion platform to develop long-acting products that may offer valuable new treatment options for patients.”

John Knopf, chief executive officer and founder of Acceleron, said: “We believe this technology platform for fusion protein optimisation could have a major impact on people required to take injections on a frequent basis, and that Alkermes is the ideal collaborator as the clear leader in the development of long-acting therapeutics.

“Acceleron has advanced three internally discovered fusion proteins into human clinical trials, each of which is based on our knowledge and expertise in fusion protein optimisation. We believe Alkermes will be a great partner to generate value from this promising Fc fusion protein platform.”