Alliance in Gene Therapy for Hemophilia B

A partnership to commercialize a gene therapy treatment for hemophilia B has been announced by Bayer Corp. (Leverkusen, Germany) and biotechnology company Avigen, Inc. (Alameda, CA, USA). The therapy, called Coagulin-B, was developed by Avigen.

Under the terms of the agreement, Bayer, in collaboration with Avigen, will conduct the planned phase II/III clinical trials for Coagulin-B. Avigen, in collaboration with Bayer, will file for regulatory approvals and will be the holder of worldwide licenses. Bayer will be granted exclusive worldwide marketing and distribution rights to Coagulin-B, with Avigen receiving royalties on net sales as well as a share of the revenue from future sales.

The product's label will bear the names of both companies, Avigen as manufacturer and Bayer as distributor. The partnership is valued at up to $60 million, which includes a $15 million upfront purchase of Avigen stock by Bayer as well as milestone payments, the costs of clinical trials, and manufacturing costs.

Coagulin-B is Avigen's adeno-associated virus (AAV) vector, which carries the gene for factor IX, the missing or deficient protein that causes hemophilia B. Coagulin-B is designed to deliver the factor IX gene into the patient's muscle cells where it will continuously produce factor IX. Numerous animals studies have shown the product to be extremely safe and capable of producing therapeutic levels of the missing factor IX.

"We are confident that Coagulin-B will be the first gene therapy application for the treatment of hemophilia,” said Jan Turek, senior vice president and general manager, Biological Products Business Unit Worldwide, Bayer. "This is the kind of significant discovery the hemophilia community has been anxiously awaiting.”



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