The agreement includes $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones, including a $3 million payment from Ovation to GTC at the closing, $2 million in payments anticipated for regulatory milestones in 2008, and up to an additional $4 million in milestone payments through a successful approval of ATryn in 2009 for the hereditary antithrombin deficiency, or Huntington’s disease (HD), indication.
ATryn is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties.
ATryn has already been granted both orphan drug designation and fast track status for HD by the FDA. GTC has requested priority review as part of the biologics license application (BLA), submitted for licensure of ATryn in preventing deep vein thrombosis in HD patients undergoing high risk surgical procedures and in childbirth.
Assuming GTC’s request for priority review is granted, a decision on market approval by the FDA could be reached in the first quarter of 2009.