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news.Ovation Pharmaceuticals has signed a definitive agreement to enter into an exclusive collaboration with GTC Biotherapeutics in Framingham, Massachusetts, to develop and market ATryn in the US.
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Ovation will obtain the exclusive license to the US rights to the product and will own certain assets, including the biologics license application, following approval.
The agreement calls for Ovation to make a series of potential payments to GTC for meeting regulatory, clinical and sales milestones, with the initial payment due upon closing, which is subject to Hart-Scott-Rodino review and other conditions.
ATryn is approved in Europe but not in the US for the treatment of a rare disorder called hereditary antithrombin deficiency, involving people who do not have sufficient antithrombin in their bloodstream.
Following approval of ATryn in the US, which is anticipated in early 2009, Ovation will be responsible for the launch, as well as sales and marketing of the product, while GTC will continue to be responsible for manufacturing.
Jeffrey Aronin, president and CEO of Ovation, said: “Collaborating with GTC on ATryn builds on Ovation’s expertise in developing, launching and marketing specialized products.”