GTC Biotherapeutics (GTCB) Enters into $257 Million Agreement With OVATION Pharmaceuticals, Inc. to Develop and Market ATryn(R) In The U.S.
FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) and OVATION Pharmaceuticals, Inc. ("OVATION") have entered into a collaboration agreement to develop and market ATryn® in the United States. ATryn® is GTC's recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The agreement includes $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones. The collaboration includes development and commercialization of ATryn® in the hereditary antithrombin deficiency, or HD, indication. 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 to be received in 2008. The collaboration also plans for further development in larger market acquired 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.
"We are very pleased to be working with OVATION to develop ATryn® in the U.S. market," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer. "OVATION's track record, award winning commercial capabilities, and their focus on hematology, make them an excellent collaboration partner as well as a strong match to maximize ATryn's potential as the market's only recombinant antithrombin."
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 with the acquired deficiencies, 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® has already been granted both Orphan Drug designation and Fast Track status for HD by the U.S. Food and Drug Administration. GTC has submitted the first part of a rolling Biologics License Application, or BLA, for the use of ATryn® in preventing deep vein thrombosis in HD patients undergoing high risk surgical procedures and in childbirth. Filing of the second and final part of this BLA submission is planned for the third quarter. Assuming GTC's request for priority review is granted, a decision on market approval by the FDA is anticipated in the first quarter of 2009.
ATryn® has been approved for use in the European Union for HD patients undergoing surgical procedures. LEO Pharma A/S is commercializing and developing ATryn® in Europe. LEO is already conducting a phase II dose ranging study of ATryn® as a potential treatment for DIC associated with severe sepsis. GTC will have access to LEO's European phase II study results for use in clinical and regulatory development in the U.S., which is estimated to be a $2 to 3 billion market. An international phase III program is anticipated, in which LEO Pharma and OVATION will share clinical development costs required for approval for this indication in the U.S. and Europe.
OVATION and GTC also expect to develop ATryn® as a supplement to restore heparin responsiveness in heparin resistant patients. Coronary artery bypass graft and related surgeries where a cardiopulmonary bypass machine, or CPB, is used requires that patients are anticoagulated prior to going on bypass, in order to avoid clot formation. Heparin is used to prevent the formation of blood clots in the CPB. Heparin's ability to prevent clotting depends on the presence of sufficient antithrombin in the bloodstream to achieve the desired anticoagulant effect. Over 20 percent of patients in CPB related surgeries exhibit heparin resistance. GTC has conducted studies related to this indication and one or more additional clinical trials may be required to obtain FDA approval.
The agreement between GTC and OVATION, which is expected to close within 30 days, is subject to certain closing conditions, including Hart-Scott-Rodino review.
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's focus is on CNS, hematology/oncology, and hospital-based therapies. 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. OVATION's web site is http://www.ovationpharma.com/.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn®, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa and IX, which are used for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC's intellectual property includes a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC's transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding prospects for developing and marketing ATryn® in the U.S., the anticipated timing of future developments in the HD, heparin resistance, and DIC associated with severe sepsis indications, and the timing for FDA review of ATryn®. Such forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from future results expressed or implied by such statements. Factors that may cause such differences include, but are not limited to, the risks and uncertainties discussed in GTC's most recent Annual Report on Form 10-K and its other periodic reports filed with the Securities and Exchange Commission, including the uncertainties associated with conducting clinical studies, and the risks and uncertainties associated with dependence upon the actions of collaboration partners and regulatory agencies. GTC cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and GTC undertakes no obligation to update or revise the statements, except as may be required by law.