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Tostrelle Study Findings to Be Presented at the International Society for the Study of Women's Sexual Health Annual Meeting October 28

Posted on: Wednesday, 27 October 2004, 21:00 CDT

SOUTH SAN FRANCISCO, Calif., Oct. 27 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. today announced that the lead investigator of its Tostrelle(R) Phase 2 study, Andre Guay, M.D., of the Center for Sexual Function at the Lahey Clinic, will present the interim findings of the Tostrelle(R) study at the ISSWSH Annual Meeting, to be held in Atlanta tomorrow, in the Scientific Selected Paper Presentation #1 session.

The interim findings to be presented indicate that Tostrelle(R) testosterone gel is a promising alternative for the treatment of Female Sexual Dysfunction (FSD). Specifically, the study found that following 4-month daily application of Tostrelle(R) testosterone gel, patients experienced a 95% increase in frequency of satisfactory sexual activity over baseline and a 45% increase over the placebo group of menopausal women distressed with sexual dysfunction. Daily topical application of Tostrelle(R) testosterone gel achieved serum bioactive testosterone and free testosterone levels in the normal range, comparable to the levels achieved with a transdermal testosterone patch product. This was achieved with no application site reactions reported, and no difference in acne or hirsutism scores between the Tostrelle(R)-treated and placebo gel-treated subjects. The study included naturally and surgically menopausal women distressed with sexual dysfunction, who were administered oral or transdermal estrogen (progesterone required in women with intact uterus) with screening serum bioactive testosterone concentrations at the lower quartile of normal.

About Tostrelle(R) (testosterone gel)

Tostrelle(R) testosterone gel currently is under clinical investigation for the treatment of hypoactive sexual desire disorder (HSDD) in women. Testosterone therapy also can be useful in treating other testosterone deficiency conditions including the loss of bone mineral density and muscle mass, decline in energy, and an overall low sense of well being. While generally regarded as a male hormone, testosterone plays an important role in women's hormonal balance in addition to the two dominant sex hormones, estrogen and progesterone. Produced in small amounts by the ovary and adrenal glands, production of testosterone and other androgens is associated with increasing energy, appetite, sex drive, muscle mass, bone density, and assertiveness. Testosterone production in women declines with age. Women in their 40's produce approximately 50% less testosterone than women in their 20's. Decline in testosterone levels also can be caused by surgery (e.g. ovariectomy) and illness; a decline in free testosterone can be caused by drug use (e.g. oral estrogen). Published clinical results provide strong evidence that testosterone treatment improves libido, and increases muscle mass and bone density in women. In addition, researchers credit testosterone treatment with an increased general sense of well being in women.

About ISSWSH

The International Society for the Study of Women's Sexual Health is a multidisciplinary, academic and scientific organization whose purposes include providing opportunities for communication among scholars, researchers, and practitioners about women's sexual function and sexual experience; supporting the highest standards of ethics and professionalism in research, education, and clinical practice of women's sexuality; and to provide the public with accurate information about women's sexuality and sexual health.

About Cellegy

Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of gastrointestinal disorders, sexual dysfunction, women's health care conditions and certain cancers. For more information about Cellegy, visit the Company's website at http://www.cellegy.com/.

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, completion, timing and the outcome of clinical trials, including the Tostrelle Phase 2 trial for Female Sexual Dysfunction and timing of discussions with the FDA with regard to additional requirements for marketing approval and the need and ability to complete corporate partnerships and additional financings. For more information regarding Cellegy's risk factors, refer to the Company's Annual Report on Form 10-K for the year ending 2003, its quarterly filings and other documents filed with the Securities and Exchange Commission.

Cellegy Pharmaceuticals, Inc.

CONTACT: Richard Juelis, Vice President, Finance & CFO, orK. Michael Forrest, President & CEO, both of Cellegy Pharmaceuticals, Inc.,+1-650-616-2200; or Ina McGuinness, or Bruce Voss, both of Lippert/Heilshorn &Associates, +1-310-691-7100, for Cellegy Pharmaceuticals, Inc.

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

Source: PRNewswire-FirstCall

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