Ovation Pharmaceuticals has signed on to assist with the development and marketing of GTC Biotherapeutics’ ATryn® in the U.S. The agreement includes $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones.
The collaboration is initially focused on development and commercialization of ATryn for hereditary antithrombin deficiency (HD). The milestone payments include a total of $9 million through approval of ATryn for HD in the U.S., including $3 million paid upon closing and an additional $2 million expected this year. The collaboration also plans for further development in antithrombin deficiencies such as the treatment of heparin resistance in patients undergoing surgery requiring cardiopulmonary bypass and the treatment of disseminated intravascular coagulation associated with severe sepsis.
GTC will be responsible for production of ATryn and will receive a transfer price on commercial product, a royalty on net sales, and a payment for product used in clinical trials. As the collaboration proceeds, Ovation will fund GTC’s anticipated costs of clinical development. Ovation will be responsible for sales and marketing of ATryn in the U.S., including all launch activities.
ATryn, a recombinant form of human antithrombin, has already been granted both Orphan Drug designation and Fast Track status for HD. It has also been approved for use in the EU for HD patients undergoing surgical procedures. LEO Pharma is responsible for commercializing and developing ATryn in Europe.