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Cellegy Announces 50% Enrollment in Phase 3 HIV Prevention Trial in Ghana

Posted on: Thursday, 3 March 2005, 09:00 CST

SOUTH SAN FRANCISCO, Calif., March 3 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. announced today that 50% enrollment has been achieved in the Savvy(R) (C31G vaginal gel) Phase 3 HIV prevention trial in Ghana based on current projected enrollment. This is a significant milestone reflecting the rapid accrual of a large number of trial participants. Over 1,500 women have enrolled in the trial which first commenced enrollment in March 2004.

Cellegy's Biosyn subsidiary is conducting two Phase 3 HIV prevention trials in Africa (Ghana and Nigeria). The trials are placebo controlled double blind studies that compare Savvy with a placebo gel in women using the gels for 12 months. Women in both groups are strongly cautioned on safe sex practices and encouraged to have their partners use condoms. The primary endpoint of the studies is a 50% reduction in the rate of transmission of HIV in the Savvy group compared with the control. Cellegy is currently on track to have both trials completed in late 2006.

In addition to the two trials taking place in Africa, a Phase 3 contraceptive trial is underway in the United States with over 200 patients enrolled to date. The United States Food and Drug Administration (FDA) was previously consulted on the protocol design of all three trials and has granted a "Fast Track" designation for HIV prevention.

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 prevention of HIV in women, expands Cellegy's near term product pipeline and complements Cellegy's women's health focus.

Savvy is a contraceptive gel for use by women to protect against the possible contraction of HIV/AIDS. The gel, part of a class of drugs known as microbicides, is acknowledged to be the most advanced product in the race to demonstrate efficacy of microbicides in the prevention of HIV. In addition to HIV, Savvy has also shown activity that suggests protection against other sexually transmitted diseases (STDs), including those caused by herpes simplex virus (HSV), chlamydia, trichomonas, gonorrhea and syphilis. Two other promising anti-HIV product candidates with different modes of action are also in the Biosyn pipeline.

Certain costs relating to the Phase 3 trials for HIV prevention and contraception, and other clinical and preclinical development costs are funded by approximately $50 million in grant and contract commitments from the United States Agency for International Development (USAID), the International Partnership for Microbicides (IPM), which receives grants from the Bill and Melinda Gates Foundation, the National Institute for Child Health and Development (NICHD), the National Institute for Allergy and Infectious Disease (NIAID), CONRAD and other government and philanthropic organizations.

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 and HIV prevention, gastrointestinal disorders and certain cancers.

Cellegesic(TM) (nitroglycerin ointment), branded Rectogesic(R) outside the United States, is approved in the United Kingdom for the treatment of pain associated with chronic anal fissures. Launch of Rectogesic in the United Kingdom through ProStrakan Group Limited, Cellegy's corporate partner, is expected in the first half of 2005. A similar formulation of Rectogesic is currently being sold in Australia, New Zealand and South Korea. In December 2004, the Medical Products Agency (MPA) in Sweden approved Fortigel(TM) (testosterone gel), branded Tostrex(R) outside the United States, for the treatment of male hypogonadism. ProStrakan will also distribute Tostrex in the European Union. Approvals of Rectogesic and Tostrex by the other member states of the European Union will be sought through the Mutual Recognition Procedure.

Cellegy is developing two transdermal testosterone gel products: Fortigel, a testosterone replacement therapy for male hypogonadism and Tostrelle(R) (testosterone gel) for the treatment of female sexual dysfunction in postmenopausal women. Cellegesic, for the treatment of anal fissures, was the subject of an FDA Not Approvable letter in December 2004. The Company is evaluating the FDA's letter, intends to have further discussions with the FDA concerning the letter and is considering alternatives with respect to the product.

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, 2003 and other filings with the Securities and Exchange Commission.

Cellegy Pharmaceuticals, Inc.

CONTACT: Richard Williams, Chairman and Interim CEO, or Anne-MarieCorner, Senior Vice President, Women's Preventive Health, +1-215-914-0900, orRichard Juelis, Vice President, Finance & CFO, +1-650-616-2200, all forCellegy Pharmaceuticals, Inc.

Web site: http://www.cellegy.com/

Source: PRNewswire-FirstCall

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