Targacept, Inc., a biopharmaceutical company, is engaged in the development of novel neuronal nicotinic receptors (NNR) Therapeutics to treat patients suffering from serious nervous system and gastrointestinal/genitourinary diseases and disorders. TC-5214 The company is conducting a Phase 2b clinical trial of TC-5214 as a treatment for overactive bladder. TC-5214 acts potently on a3ß4 and other NNRs. TC-1734 TC-1734 is a novel small molecule that modulates the activity of the a4ß2 NNR. The company is conducting a Phase 2b clinical trial of TC-1734 as a treatment for mild to moderate Alzheimer’s disease. Its ongoing Phase 2b clinical trial of TC-1734 is a potential registration study that is the subject of a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). TC-6499 TC-6499 is a novel small molecule that modulates the activity of the a3ß4 and other NNRs as an agonist. The a3ß4 NNR is located in the gastrointestinal tract and, based on observations from previous Phase 1 development of TC-6499 in contemplation of later-stage development as a treatment for pain. AZD1446 (TC-6683) AZD1446 is a novel small molecule that modulates the activity of the a4ß2 NNR and is subject to an ongoing collaboration agreement with AstraZeneca AB. The company discovered and advanced AZD1446 as part of a completed preclinical research collaboration that it and AstraZeneca AB conducted under its collaboration agreement. TC-5619 TC-5619 is a small molecule that modulates the activity of the a7 NNR. The company has completed Phase 2 clinical trials of TC-5619 in various indications. In 2013, the company completed a Phase 2b clinical trial of TC-5619 in negative symptoms and cognitive dysfunction in schizophrenia TC-6987 TC-6987 is a small molecule that modulates the activity of the a7 NNR. The company is evaluating potential future development options for TC-6987. Business Strategy Key elements of the company’s strategy include exploiting its pipeline of NNR therapeutics; evaluating opportunities to expand its pipeline deliberatively; and collaborating selectively. Patents and Proprietary Rights As of February 28, 2014, the company’s patent estate included 60 patents issued in the United States, 45 patent applications pending in the United States and approximately 600 counterpart patents and patent applications in countries other than the United States. Its issued patents and pending patent applications in the United States include composition of matter coverage on various different structural families of compounds. License Agreements Pursuant to a license agreement with University of South Florida Research Foundation (USFRF), the company holds an exclusive worldwide license under patents and patent applications owned by USFRF to develop and commercialize TC-5214, mecamylamine hydrochloride and other specified compounds. The licensed patent rights include issued patents covering the pharmaceutical composition of TC-5214. Competition The company’s competitors include Astellas Pharma; Pfizer/Almirall; Warner Chilcott/Bayer; Allergan; Ortho-McNeil Pharma; Merck & Co., Inc.; Eisai; Johnson & Johnson; Novartis; and Forest Laboratories. Regulatory Matters The company’s product candidates must be approved by the FDA through the new drug application process before they may be legally marketed in the United States. History Targacept, Inc., a Delaware corporation, was founded in 1997. The company was incorporated in 1997.
targacept inc (TRGT:NASDAQ GS)
100 North Main Street
Winston-Salem, NC 27101
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