CollaGenex Pharmaceuticals Completes Manufacturing Agreement for Periostat.NEWTOWN, Pa.--(BUSINESS WIRE)--June 25, 1998--CollaGenex Pharmaceuticals Inc. (Nasdaq: CGPI CGPI Corporate Goods Price Index (Japan) CGPI Capital Goods Price Index (New Zealand) ) announced Thursday that it has finalized an agreement with Applied Analytical Industries Inc. (AAI AAI American Association of Immunologists. ) (Nasdaq: AAII AAII See: American Association of Individual Investors ) to manufacture Periostat(R), the company's lead drug for the treatment of periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where . 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 ) for Periostat is currently under review by the U.S. Food and Drug Administration. AAI is a leading contract research organization which provides an extensive range of product development and support services support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other services to the worldwide pharmaceutical and biotechnology industries. AAI conducted extensive development work to support the Periostat NDA, including the creation and validation of manufacturing processes in its state-of-the-art facilities. Under the terms of the agreement, AAI will manufacture Periostat for future sale in the United States. Product manufacturing will begin immediately to ensure that an adequate inventory is available for sale upon regulatory approval. "We are pleased that AAI has committed to be our supplier for Periostat in the United States," said Brian Gallagher, PhD, president and chief executive officer of CollaGenex." AAI supported Periostat throughout the development process and is uniquely qualified to ensure a reliable supply of high quality product to the market if Periostat is approved by 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. ." "AAI has been committed to the development of Periostat for the last four years," noted Frederick Sancilio, PhD, AAI's chairman and chief executive officer. "We are delighted to be a commercial partner of CollaGenex and are excited by Periostat's prospects as a unique and innovative pharmaceutical treatment for periodontal disease." CollaGenex Pharmaceuticals is an emerging pharmaceutical company that is developing and commercializing innovative proprietary medical therapies for the treatment of periodontal disease and other pathologies. The company's core technology involves inhibiting the activity of certain enzymes that destroy the connective tissues of the body. In addition to periodontal disease, CollaGenex and its collaborators are researching and developing other potential applications of its core technology, including cancer metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to , wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by , osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. , osteoporosis, rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. and diabetic nephropathy. Metastat(R), the company's lead anti-cancer drug, entered Phase I clinical trials in January 1998 under the sponsorship of the National Cancer Institute. Founded in 1992, the company completed an initial public offering of common stock in June 1996. AAI is a leading contract research and development organization providing pharmaceutical product development and support services to the worldwide pharmaceutical and biotechnology industries. AAI offers seamless outsourcing as well as an integrated broad spectrum of pharmaceutical services, both clinical and non-clinical. Additionally, AAI leverages its drug development expertise to generate licensing and royalty revenues by licensing internally developed drugs and drug technologies to pharmaceutical client companies worldwide. To receive additional information on CollaGenex, please visit the company's web site at www.collagenex.com, which is not a part of this press release. This news release contains certain forward-looking statements within the meaning of section 21E of the Securities and Exchange Act of 1934, as amended. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including without limitation the requirement for regulatory approval of products by the FDA, the uncertainty in obtaining such approval and uncertainties relating to clinical trials, all as discussed in the company's periodic filings with the U.S. Securities and Exchange Commission.
CONTACT: CollaGenex Pharmaceuticals
Nancy Broadbent, CFO, 215/579-7388
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