Titan Pharmaceuticals, Inc., a specialty pharmaceutical company, develops proprietary therapeutics for the treatment of serious medical disorders. The company’s product development programs focus primarily on pharmaceutical markets with significant unmet medical needs and commercial potential. The company is directly developing its product candidates and also utilizes corporate, academic and government partnerships as appropriate. The company’s principal asset is Probuphine, the primary slow release implant formulation of buprenorphine in development for the long term maintenance treatment of opioid dependence. Upon completion of the Phase 3 clinical studies of Probuphine, the company participated in a pre- new drug applications (NDA) meeting with the FDA, and subsequently prepared and submitted the NDA in 2012. Probuphine is the product specifically designed for the long-term treatment of opioid dependence and it utilizes ProNeura, its novel, proprietary, long-term drug delivery technology. The company’s ProNeura technology has the potential to be used in developing products for the treatment of other chronic conditions, such as Parkinson’s disease, where maintaining stable, around the clock blood levels of a dopamine agonist may benefit the patient and improve medical outcomes. Fanapt (iloperidone) is an atypical antipsychotic approved by the FDA for the treatment of schizophrenia being marketed by Novartis Pharma AG (Novartis) in the U.S. The U.S. patent expires in October 2016 (excluding a six-month pediatric extension). Vanda Pharmaceuticals, Inc. owns the development and commercialization rights to the oral and depot formulations of this product for the rest of the world. License Agreements The company has an agreement with Braeburn Pharmaceuticals Sprl (Braeburn) pursuant to which it granted Braeburn a right and license to commercialize Probuphine in the United States of America and its territories, including Puerto Rico, and Canada (the Territory). The company owns an exclusive worldwide license under U.S. and foreign patents and patent applications relating to the use of iloperidone for the treatment of psychiatric and psychotic disorders and analgesia from Sanofi-Aventis SA (Sanofi-Aventis). The company has an agreement with the University of Iowa Research Foundation. Under this agreement, it received a worldwide license to patent rights held by the University of Iowa Research Foundation covering the methods of treating biofilm formation, pseudomonas aeruginosa growth, human deficiency virus, and intracellular pathogens and pathogens causing chronic pulmonary infection using gallium maltolate. Patents and Proprietary Rights Four patent applications have been filed which incorporate the use of specific compounds with the continuous delivery technology, including three applications related to Probuphine for the potential treatment of opioid addiction and chronic pain. In June 2010, the United States Patent and Trademark Office (USPTO) issued a patent covering methods of using Probuphine for the treatment of opiate addiction. The company is the owner of this patent which claims a method for treating opiate addiction with a subdermally implanted device comprising buprenorphine and ethylene-vinyl acetate, a biocompatible copolymer that releases buprenorphine continuously for extended periods of time. This patent would expire in April 2024. Patents covering use of Probuphine for the treatment of opiate addiction have also issued in Australia, India, Japan, Mexico and New Zealand. Further prosecution of Probuphine applications is proceeding at the USPTO and corresponding agencies in Europe, Canada, India and Hong Kong. Patents covering certain dopamine agonist implants have already been issued or allowed in Europe, Japan, Australia, Canada, South Korea, Mexico, New Zealand, South Africa, and Hong Kong, while prosecution of the patent application continues in the U.S., Israel, India, Japan, and China. The company has filed additional patent applications for a heterogenous implant designed with properties that may provide benefits to the structural integrity of the implants and potentially enhance drug delivery. The company holds a license from Sanofi-Aventis under certain issued U.S. patents and certain issued foreign patents relating to iloperidone and its methods of use in the treatment of psychiatric disorders, psychotic disorders and analgesia. The term of the U.S. patent that covers certain aspects of its iloperidone product expires in October 2016, excluding a six month extension possible if an approval of pediatric indication is obtained. The company is the licensee from the University of Iowa Research Foundation (UIRF) of two issued U.S. patents (expiring in 2016) relating to methods of use of gallium compounds to inhibit the growth of P. aeruginosa, and the treatment of infections by pathogens causing chronic pulmonary infection. The company is also the licensee from UIRF of certain rights to patent applications covering the use of gallium complexes in preventing and also treating bacterial biofilm-based infections, for which patents have issued in Australia, Japan, Mexico, New Zealand, and South Africa, and prosecution in the U.S., Canada, Europe, China, Hong Kong, and India continues. History Titan Pharmaceuticals, Inc. was founded in 1992.
titan pharmaceuticals inc (TTNP:OTC US)
400 Oyster Point Boulevard
South San Francisco, CA 94080
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