Titan Announces Filing of Iloperidone NDA.SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif. -- Titan Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange : TTP TTP (thymidine triphosphate): see thymine. ) today announced that a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) has been submitted to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for iloperidone, an investigational atypical antipsychotic for the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. . The application includes data from 35 clinical trials and more than 3,000 patients treated with iloperidone. In Phase III clinical testing, iloperidone has been demonstrated to be potentially safe and effective in the treatment of schizophrenia in both the acute and the chronic setting. In addition, iloperidone demonstrated a potentially favorable side effect profile, with low potential for weight gain and induction of diabetes, low extrapyramidal symptoms Extrapyramidal symptoms (EPS) A group of side effects associated with antipsychotic medications. EPS include parkinsonism, akathisia, dystonia, and tardive dyskinesia. Mentioned in: Schizophrenia including akathisia, and low incidence of sleepiness and effects on cognition. The NDA submission also contains pharmacogenetic data aimed to further improve the benefit/risk profile of iloperidone in the treatment of patients with schizophrenia. The NDA was submitted by Vanda Pharmaceuticals Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : VNDA). Upon commercialization of iloperidone, Titan will receive a royalty of between 8-10% on worldwide sales. "We are very pleased that the iloperidone NDA has been filed. This is an important milestone for Titan, and a major step towards potentially providing schizophrenia patients with a meaningful and much needed therapeutic option," stated Dr. Marc Rubin, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Titan Pharmaceuticals, Inc. "Iloperidone may offer advantages to patients in need of alternative therapies," stated Dr. Louis R. Bucalo, Chairman of Titan Pharmaceuticals, Inc. "We are pleased with the continued progress of this development program." About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. (AMEX: TTP) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , cardiovascular disease, bone disease and other disorders. Titan's products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with government institutions and other leading pharmaceutical development companies. For more information, please visit the Company's website at www.titanpharm.com. The press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company's development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets, and the Company's ability to obtain additional financing. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. |
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