Encysive Pharmaceuticals Inc. (Encysive) is a biopharmaceutical company focused on the discovery, development and commercialization of synthetic small molecule compounds for the treatment of a range of cardiovascular, vascular and related inflammatory diseases. The Company has been engaged principally in research and drug discovery programs and clinical development of certain drug compounds. Encysive has developed one United States Food and Drug Administration (FDA)-approved drug, Argatroban, for the treatment of heparin-induced thrombocytopenia (HIT), which is marketed by GlaxoSmithKline plc (GSK). The Company's lead drug candidate, Thelin (sitaxsentan sodium) is an endothelin receptor antagonist that has completed pivotal Phase III clinical trials for the treatment of pulmonary arterial hypertension (PAH), and is under review by the FDA, the European Medicines Agency (EMEA) and regulatory authorities in Canada and Australia. In addition, Encysive has earlier stage clinical product candidates in development, including TBC3711, a next-generation endothelin receptor antagonist. TBC4746, the integrin very late antigen-4 (VLA-4) antagonist, has been licensed to and is being developed by Schering-Plough Corporation and Schering-Plough, Ltd. (collectively referred to as Schering-Plough). Bimosiamose has been licensed to and is being developed by Revotar Biopharmaceuticals AG (Revotar), which was formerly the Company's majority-owned German subsidiary. Argatroban Argatroban, licensed from Mitsubishi Pharma Corporation and developed in North America by Encysive, is a synthetic direct thrombin inhibitor approved by the FDA in 2000. It is indicated for prophylaxis or treatment of thrombosis for patients with HIT, a profound allergic reaction to anti-coagulation therapy with heparin, and for use in HIT patients undergoing precutaneous coronary intervention. Argatroban was approved in Canada, during the year ended December 31, 2002, for use as an anti-coagulant therapy in patients with HIT syndrome. Encysive has licenses to a formulation patent, which expires in 2014, and a process patent that expires in 2017. Argatroban is marketed and sold by GSK under a license agreement, whereby the Company receives royalties on sales. Thelin In October 2002, Encysive completed and announced results of the 178-patient STRIDE-1 Phase IIb/III pivotal study in PAH with Thelin. In June 2003, the Company received a special protocol assessment (SPA), which is a binding written agreement between a clinical trial sponsor and the FDA on the design of pivotal trials, confirming that, if successful, the STRIDE-2 trial results, together with the results from STRIDE-1 and planned supportive trials, would be sufficient for the submission to the FDA of the Thelin new drug application (NDA). Additionally, the number of patient exposures for safety purposes was agreed to in the SPA. The Company successfully completed a Phase III pivotal clinical trial, STRIDE-2, during January 2005 and reported top-line clinical results in February 2005. STRIDE-2 enrolled 247 patients with World Health Organization (WHO) Class II-IV PAH, of primary or secondary causes. STRIDE-2 had an 18-week duration and tested two doses of Thelin (100 milligram and 50 milligram), versus placebo, dosed once daily in a double-blind fashion. Based on the results of the clinical program, Encysive filed a NDA for Thelin with the FDA and the FDA informed the Company that the NDA was filed on July 23, 2005, under a standard review classification. The target action date under the FDA Prescription Drug User Fee Act for Thelin is March 24, 2006, the date by which the Company expects to receive a response from the FDA on the NDA for Thelin. Encysive also submitted a Marketing Authorization Application with the European Agency for the Evaluation of Medicinal Products (EMEA) in July 2005. Additionally, during the year ended December 31, 2004, the Company obtained orphan drug designation for Thelin from both the FDA and the European Commission. Orphan drug designation in the United States g

• Download SqueezeTrigger (TM) Report
• Download FrictionFactor Report
• Download Daily Short Volume Report
• Download Real-Time Short Volume Tool
• Download Failures to Deliver

• No BuyIns.Net Alerts Available for ENCY