Tico () @1/3/2007 2:59:34 PM Blokkeer
Press Release Source: GTC Biotherapeutics
ATryn(R) Market Authorization Transferred To LEO Pharma A/S
Wednesday January 3, 8:46 am ET
FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that the market authorization of ATryn® for the prophylaxis of venous thromboembolism in surgery of patients with congenital antithrombin deficiency has been transferred to its distribution and development partner, LEO Pharma A/S, following approval by the European Commission. ATryn® is a recombinant form of human antithrombin. Antithrombin is normally found in human plasma and has both anticoagulant and anti-inflammatory properties. The approval of the transfer of the market authorization enables LEO to enter into negotiation of reimbursement rates as part of preparing for the commercial launch of ATryn® in Europe on a country-by-country basis. The initial launch is being planned for around the end of the second quarter 2007.
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In addition, LEO is conducting a phase II study of ATryn® in Europe for the treatment of disseminated intravascular coagulation, or DIC, associated with severe sepsis. LEO has initiated the regulatory approval procedures to enable the opening of clinical sites and recruitment of patients into the study. GTC is continuing to supply the product to LEO to conduct this study.
Meeting these objectives in the development of the ATryn® program supports GTC's previous guidance that pro-forma cash and marketable securities at the end of 2006 will be approximately $50 million. While actual cash and marketable securities at the end of 2006 will be approximately $43.9 million, the pro-forma amount includes the scheduled completion in early January of the third and final tranche of the previously announced $25 million total investment by LFB Biotechnologies, as well as scheduled payments for delivery of a portion of the phase II clinical supply to LEO in January that was begun in late 2006. GTC expects to use $26 to 29 million of cash in 2007 on a pro-forma basis. This forecast is net of cash received from operations, but excludes the items included in the 2006 year end pro-forma cash balance. The net cash use for 2007 includes forecasted sales of ATryn® in the approved indication as well as to LEO for the DIC study. This forecast also reflects lower debt service payments due to refinancing of the loan with GE Capital in the last week of December 2006. This debt refinancing extended the amortization period from three to ten years and provided an additional $2.8 million of proceeds to GTC.
The 2007 cash use forecast includes planned support for completion of GTC's phase III study of ATryn® in the hereditary deficiency indication for the United States, the filing of a Biologics License Application in the United States, development of the recombinant human factor VIIa production system with LFB Biotechnologies, and preclinical activities in GTC's recombinant human alpha-1 antitrypsin and CD137 monoclonal antibody programs. The phase II DIC study activities in 2007 will be conducted and funded by LEO.
Background on the ATryn® DIC Study
DIC often develops as a result of severe sepsis. This is a large unmet medical need with approximately 220,000 cases in Europe and 250,000 cases in the United States with 50% mortality. Analysis of previous clinical experience indicates that treatment with antithrombin, without the concomitant use of heparin, has the potential to reduce the rate of mortality.
LEO's phase II study is based on Scientific Advice received from the European Medicines Agency. Approximately 200 patients are planned to be included in this study which is intended to define the optimum dosage and design for use in a subsequent phase III study. Recruitment into the phase II study is expected to take approximately 12 months.
About GTC Biotherapeutics, Inc.
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