BRISBANE, Calif., Nov. 22 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. announced today that it has licensed the rights to develop, manufacture and market a nitric oxide donor product for the treatment of anal disorders to New Harbor Corporation (NHC) under Cellegy's issued patent in China. NHC will work through PUMC Pharmaceuticals Co., Ltd. (PUMC) to bring products to market in China that are protected by the Cellegy patent. PUMC will pay all development, regulatory, manufacturing and marketing costs. In exchange for rights under the patent, Cellegy will receive a royalty on sales. Cellegy's patent issued in China in May 2003 and expires in April 2015. The issuance of a license to NHC and the marketing of products developed under the license by PUMC optimize Cellegy's potential earnings in China. China, currently the second largest market in Asia after Japan, is expected to become the world's largest market in unit volume for the consumption of pharmaceutical products.
"Cellegy chose NHC and its associate company PUMC from a number of Chinese companies that indicated strong interest in the Cellegy's products for the treatment of anal fissures," said Richard C. Williams, Cellegy's Chairman and interim CEO. "PUMC will handle all aspects of registration, insurance reimbursement, manufacturing and marketing in China and their MD and Pharm.D.- dominated sales force sells into more than 500 major teaching hospitals throughout China."
PUMC will develop its own nitric oxide donor products in China. The formulation of these products may be different than Rectogesic(R), nitroglycerin ointment 0.2% or 0.4%, Cellegy's products for the treatment of anal fissures, which are successfully marketed by Cellegy in Australia, and by Cellegy's marketing partners in Korea, New Zealand, Singapore and the UK.
About Cellegy
Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of women's health care conditions, including sexual dysfunction, HIV prevention and gastrointestinal disorders. In October 2004, Cellegy acquired Biosyn, Inc., a privately held biopharmaceutical company in Huntingdon Valley, Pennsylvania. The addition of Biosyn, a leader in the development of novel microbicide gel products for contraception and the reduction in transmission of HIV in women, expands Cellegy's near term product pipeline and complements Cellegy's women's health care focus. Cellegy believes that Savvy(R) (C31G vaginal gel), currently undergoing Phase 3 clinical studies in the United States and Africa, is one of the most clinically advanced products in development for the reduction in transmission of HIV.
Fortigel(TM) (testosterone gel), branded Tostrex(R) outside the United States, is marketed in Sweden for the treatment of male hypogonadism also by ProStrakan. Approvals of Rectogesic and Tostrex by the other member states of the European Union are being sought through the Mutual Recognition Procedure. Cellegesic, for the treatment of anal fissures, which was the subject of an FDA Not Approvable letter in December 2004, was resubmitted to the FDA in April 2005 and is currently under review at the FDA.
Forward Looking Statements
This press release contains forward-looking statements. Investors are cautioned that these forward-looking statements are subject to numerous risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such risks and uncertainties relate to, among other factors: completion, timing and outcome of clinical trials, including primarily the Savvy prevention and contraceptive Phase 3 studies; and the need and ability to complete corporate partnerships and additional financings. For more information regarding risk factors, refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2004 and other filings with the Securities and Exchange Commission.
Cellegy Pharmaceuticals, Inc.CONTACT: Richard C. Williams, Chairman and Interim CEO, +1-650-616-2200,or Robert J. Caso, Vice President, Finance & CFO, +1-215-914-0900, ext.603, both of Cellegy Pharmaceuticals, Inc.
Web site: http://www.cellegy.com/
