A total of $3 million of additional milestone payments from Ovation are pending as a result of the approval of ATryn by the FDA.
In addition to the payments for successful completion of the regulatory milestones, payment for $1 million of ATryn inventory is anticipated to support Ovation’s launch of the product in the second quarter. Ovation is doubling its sales team dedicated to hematology and has established a medical sciences liaison team to support the launch of ATryn.
Ovation and GTC are also collaborating on a joint development plan for ATryn as a supplement to restore heparin responsiveness in heparin resistant patients. GTC has previously conducted studies related to this indication and one or more additional clinical trials may be required to obtain FDA approval. The anticipated Phase III clinical study is projected to begin in 2009.
Geoffrey Cox, chairman and CEO of GTC Biotherapeutics, said: “We are pleased to build on the successful approval of ATryn to begin the commercialization and further development of the product in the US. Ovation is particularly well suited to bring the benefits of recombinant antithrombin to hereditary deficient patients who currently have limited options.”