Catalytica Pharmaceuticals to Provide Clinical Trial Material for CV Therapeutics' Ranolazine Phase III Angina Studies.MOUNTAIN VIEW, Calif.--(BW HealthWire)--August 4, 1998-- Catalytica Pharmaceuticals, Inc., a subsidiary of Catalytica, 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 :CTAL CTAL Confederacion de Trabajadores de America Latina (Confederation of Latin American Workers) CTAL Canadian Tire Acceptance Limited CTAL Computer Technology Application Lab, Inc. CTAL Confidentially Typed Assembly Language ), today announced a new agreement with CV Therapeutics (NASDAQ:CVTX) for supply of a sustained release Sustained-release (SR), extended-release (ER, XR, or XL), time-release or timed-release, controlled-release (CR), or continuous-release (CR or Contin tablet form of Ranolazine, which is currently in Phase III clinical trials in the U.S. for the treatment of angina. Under the agreement, Catalytica Pharmaceuticals will manufacture specified quantities of Ranolazine tablets for use in human clinical trials. Catalytica Pharmaceuticals will also work with CV Therapeutics to define the commercial scale tablet manufacturing process and to support the filing of the 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 for Ranolazine with the U.S. Food and Drug Administration. The two parties intend to negotiate a commercial supply agreement for Ranolazine, provided the 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. has approved the product for marketing. This agreement with CV Therapeutics is part of Catalytica's strategy to provide its partners with its full-service capabilities from clinical trials through full-scale manufacturing of the final drug. CV Therapeutics is an emerging pharmaceutical company that relies on strategic support in clinical trials operation, manufacturing and other key areas fundamental to its business growth. Ranolazine (piperazine piperazine /pi·per·a·zine/ (-zen) an anthelmintic used against Ascaris lumbricoides and Enterobius vermicularis; used as the citrate salt. pi·per·a·zine n. acetamide a·cet·a·mide n. The crystalline amide of acetic acid, CH3CONH2, used as a solvent and wetting agent and in lacquers and explosives. ) is an oral compound currently under investigation by CV Therapeutics for its effectiveness in treating chronic stable angina chronic stable angina Cardiology The most common form of angina, characterized by chest discomfort due to myocardial ischemia, and unaccompanied by myocardial necrosis; the cause of pain is uncertain, possibly substances released during transient ischemia–eg, , a condition affecting approximately seven million U.S. patients. Ranolazine is believed to represent a new class of anti-angina therapeutics that enables the heart to work more efficiently by burning relatively more glucose for energy. According to Gabriel R. Cipau, President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of Catalytica Pharmaceuticals, Inc., the agreement with CV Therapeutics is part of Catalytica's strategic plan to serve a mix of established and emerging customers in the pharmaceutical industry. "Both large and emerging pharmaceutical companies are seeking new kinds of partners that can provide the full spectrum of expertise required to help bring potential new therapies from the research lab to the consumer more quickly and more efficiently than ever before," Cipau said. "The new development agreement for Ranolazine and similar agreements we have established with our pharmaceutical industry partners emphasize the unique, fully-integrated technology and manufacturing support Catalytica provides throughout the pharmaceutical development cycle." CV Therapeutics becomes the latest pharmaceutical company to work with Catalytica. Earlier this year, Catalytica Pharmaceuticals entered into a development agreement with Pfizer, Inc. Catalytica has also announced manufacturing and technology agreements with other partners in the pharmaceutical and biotech industries, including Astra USA, Monarch Pharmaceuticals, and Amgen. CV Therapeutics, headquartered in Palo Alto, Calif., is a biopharmaceutical company focused exclusively on the application of molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . Catalytica Pharmaceuticals, Inc., a majority-owned subsidiary majority-owned subsidiary A firm in which more than 50% of outstanding voting stock is owned by the parent company. of Catalytica, Inc., provides process and formulation development and manufacturing for business partners in the pharmaceutical and biotech industries. Catalytica, Inc., through its subsidiaries, provides catalytic technologies and advanced products that improve manufacturing processes and solve environmental problems economically. The three subsidiaries are Catalytica Pharmaceuticals, Inc., which is a full-service provider to the healthcare industry; Catalytica Combustion Systems, Inc., which produces XONON for the energy market; and Catalytica Advanced Technologies, Inc., which creates new catalytic technologies. Find Catalytica on the world wide web at www.catalytica-inc.com. This news release contains forward-looking statements regarding Catalytica's future operation of the manufacture of Ranolazine for CV Therapeutics and Catalytica's competitive position in its markets. These statements involve risks and uncertainty, including without limitation, the ability to complete negotiations for a commercial supply agreement for Ranolazine if the FDA approves the product for market, the ability to operate the manufacturing, research and development facilities efficiently, the ability to perform cost-effectively and in a timely manner, product development delays, changes in the company's competitive position, and the impact of FDA and other regulations on pharmaceutical and biotech manufacturing. Investors are encouraged to review Catalytica's Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ending December 31, 1997 and Form 10-Q Form 10-Q See 10-Q. for the period ending March 31, 1998, for a more complete discussion of factors that could affect Catalytica's future performance.
CONTACT: Catalytica, Inc.
Lloyd Baylis, 650/960-3000
|
|
||||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion