Biovail Completes Development of New Celexa Formulation; Lundbeck to Initiate Phase III Studies.Business Editors, Health/Medical Writers TORONTO--(BW HealthWire)--June 29, 2000 Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) announced today the successful completion of the development of a novel controlled release formulation of Celexa(R) citalopram citalopram /ci·tal·o·pram/ (si-tal´o-pram) 1. an antidepressant compound used in the treatment of major depressive disorder, administered orally as the hydrobromide. 2. . H. Lundbeck, the developer of the original version of citalopram, and the owner of the new formulation, is expected to begin Phase III clinical trials in compliance with TPP TPP thiamine pyrophosphate. Thiamine pyrophosphate (TPP) The coenzyme containing thiamine that is essential in converting glucose to energy. Mentioned in: Beriberi TPP 1. total plasma protein. 2. guidelines. Citalopram is an anti-depressant which belongs to a class of drugs known as SSRIs ("Selective Serotonin Reuptake Inhibitors Selective Serotonin Reuptake Inhibitors Definition Selective serotonin reuptake inhibitors are medicines that relieve symptoms of depression. Purpose "), is the best selling anti-depressant in 8 countries and has been introduced in more than 70 countries worldwide under several trade names including Celexa(R), Cipramil and Seropram. The worldwide market for such anti-depressants is estimated to be in excess of U.S. $10 billion annually, growing at a rate of more than 10%. Compared to many other SSRIs, Citalopram has a better side effect profile and a lower incidence of drug to drug interactions. The successful completion of the technical phase of the development was demonstrated by the results of Phase I pivotal bio-availability studies conducted on commercial scale clinical batches. Biovail's controlled release formulation has been designed to provide further improvements in patient tolerability and features a unique pharmacokinetic profile. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting 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. approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. |
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