BRISBANE, Calif., April 18 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. reported today that it has submitted a written response containing new analyses of data from its Cellegesic(TM) (0.4% nitroglycerin ointment) phase 3 trials. The new analyses were submitted in response to an FDA request resulting from an ongoing dialogue with the FDA following receipt of a "Not Approvable" letter in December 2004. Cellegy filed an NDA for the use of Cellegesic for the treatment of pain associated with chronic anal fissures in June 2004. While there is no deadline for a reply from the FDA, the company hopes to hear the results of the FDA's deliberations in the near future.
Richard C. Williams, Chairman and Interim CEO, said, "Our discussions with the FDA have been very productive and we believe that we have addressed their inquiries in this submission. The submission is one more step forward for Cellegy and emphasizes a number of recent accomplishments that include progress on Savvy(R) Phase 3 clinical trials, reduction in expenses, the relocation of the Cellegy headquarters, the settlement of litigation with PDI, Inc. and the appointment of new members to the management team. We have begun discussions to license Fortigel(TM) which we recently reacquired and are continuing licensing efforts for our European approvals of Rectogesic(R) and Tostrex(TM) with prospective partners in Latin America and the Far East."
Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of women's health care conditions, including reduction in the transmission of HIV and sexual dysfunction, gastrointestinal disorders and certain cancers.
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 (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.
Cellegesic, branded Rectogesic 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, Singapore and South Korea. Fortigel, branded Tostrex outside the United States, for the treatment of male hypogonadism, was approved by the Medical Products Agency (MPA) in Sweden in December 2004. ProStrakan will also distribute Tostrex in Sweden and the European Union. Approvals of Rectogesic and Tostrex by the other member states of the European Union will be pursued by Cellegy and ProStrakan 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.
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: the timing and outcome of clinical trials, including reduction in transmission of HIV and contraception Phase 3 trials for Savvy. In addition, there is no certainty as to the timing and outcome of discussions with the FDA, particularly regarding additional requirements for clinical trials and marketing approval of Fortigel, Cellegesic and Tostrelle, or the Company's ability to complete corporate partnerships and additional financings.
Readers are cautioned not to place undue reliance on forward-looking statements, and we undertake no obligation to update or revise statements made herein. For more information regarding risk factors, refer to the Company's Annual Report on Form 10-K for the year ending December 31, 2004, and to its other Securities and Exchange Commission filings.
Cellegy Pharmaceuticals, Inc.