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Company Signs Definitive Agreement to Partner with GTC Biotherapeutics to Develop and Market Anti-Coagulation Product
DEERFIELD, IL, USA | June 23, 2008 | OVATION Pharmaceuticals, Inc. announced today that it has signed a definitive agreement to enter into an exclusive collaboration with GTC Biotherapeutics in Framingham, Massachusetts, to develop and market ATryn® (antithrombin alfa) in the United States. OVATION will obtain the exclusive license to the U.S. rights to the product and will own certain assets, including the Biologics License Application, or BLA, 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 U.S. for the treatment of a rare disorder called hereditary antithrombin deficiency, or HD, involving people who do not have sufficient antithrombin in their bloodstream. Antithrombin is a protein that helps keep blood from clotting and has anti-inflammatory properties. Following approval of ATryn in the U.S., 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. ATryn has been granted both Orphan Drug designation and Fast-Track status for the HD indication by the U.S. Food and Drug Administration (FDA).
"Collaborating with GTC on ATryn builds on OVATION's expertise in developing, launching and marketing specialized products," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. "ATryn is an important addition to our hematology portfolio and represents a strong strategic fit with our overall business model of focusing on disorders where there is significant unmet medical need. We look forward to working with GTC to bring the first recombinant antithrombin product to the U.S. marketplace where we can have a meaningful impact on the lives of patients who could benefit from this innovative technology."
ATryn has completed phase III clinical trials in the U.S. for patients with HD who are undergoing high-risk surgical procedures or childbirth. In the U.S. approximately one in 2,000 to one in 5,000 people are diagnosed with the disease each year and half of all people diagnosed suffer a thrombosis before 25 years of age.
GTC recently initiated the Biologics License Application (BLA) filing on a rolling basis. ATryn is also being developed as a potential treatment for acquired antithrombin deficiencies such as heparin resistance (HR) during coronary artery bypass graft and related surgeries and as a potential treatment for disseminated intravascular coagulation associated with severe sepsis (DIC-sepsis). DIC is the widespread formation of clots within blood vessels, which often leads to organ failure.
The most common adverse events listed in the approved European labeling that may occur during treatment with ATryn include dizziness, headache, bleeding, nausea, bleeding at injection site and increased bleeding during treatment.
About OVATION Pharmaceuticals
OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on
central nervous system, hematology/oncology, and hospital-based therapies. The four new launches the company expects over the next three years will be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at http://www.ovationpharma.com/.
SOURCE: OVATION Pharmaceuticals, Inc
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