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GTC Biotherapeutics Inc. has received a $1 million milestone payment from partner Ovation Pharmaceuticals Inc. for GTC’s ATryn anticoagulant drug.
GTC (Nasdaq: GTCB), based in Framingham, announced this week that the cash was awarded because ATryn had won approval from the U.S. Food and Drug Administration’s Blood Products Advisory Committee at its meeting in January 2009. Because the FDA approved the drug last month, GTC stands to win $3 million in additional milestone payments.
Ovation is GTC’s U.S.-based partner for the commercialization and development of ATryn. The drug is approved for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
Ovation is also expected to pay $1 million for GTC’s ATryn inventory in the second quarter when the product officially launches. To support that effort, Ovation is doubling its sales team dedicated to hematology and has created a medical sciences liaison team.
The two companies also plan to use ATryn as a supplement to restore heparin responsiveness in heparin-resistant patients. Heparin prevents the formation of blood clots, but its ability to prevent clotting depends on sufficient antithrombin in the bloodstream. GTC has already conducted studies on this usage, and one or more additional clinical trials may be needed obtain FDA approval. The anticipated Phase 3 clinical study will begin in 2009.
GTC develops therapeutic proteins produced through transgenic animal technology. It claims that ATryn is the first such drug approved in the world.
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