I've got this one already. I suggest you keep it on your watch list. It dropped sharply last year due to an FDA non-Approval for a drug important to the company.
This is Cellegy's chance to make a comeback. I'm hoping for the best of course. Do your research, put on your watch list, and cross your fingers!
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Cellegy Reports New FDA Target Response Date of June 15, 2005 for Amended Cellegesic(TM) 0.4% Ointment NDA Thursday May 5, 7:30 am ET New Date Part of Continued Review by FDA of Cellegesic NDA
BRISBANE, Calif., May 5 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY - News) today announced that it has received a letter from the U.S. Food and Drug Administration indicating that the FDA is reviewing the Company's recently submitted amended New Drug Application (NDA) for Cellegesic(TM) (0.4% nitroglycerin ointment), for the treatment of pain associated with chronic anal fissure. The Company expects the agency to respond after its review by the FDA's target date of June 15, 2005. As part of an ongoing dialog with the FDA following receipt of a Not Approvable letter in December 2004, the Company submitted a written response in April 2005 containing new analyses of data from its three Cellegesic Phase 3 trials.
The FDA's most recent letter indicated that under the Agency's procedural rules, the Company's resubmission is being accepted by the agency as a "complete, Class 1" response to the Agency's Not Approvable letter. A "Class 1 resubmission" is a resubmission that includes a minor re-analysis of data previously submitted to the application.
"We are very pleased with this action and look forward to the response by the FDA by June 15, 2005," said Richard C. Williams, Chairman and interim Chief Executive Officer of the Company.
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 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(TM) 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(TM) 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® (testosterone gel) for the treatment of female sexual dysfunction in postmenopausal women.
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: 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. The FDA letter referenced in the above press release expresses no views concerning the outcome of the agency's review of the Company's additional submission or whether the agency will reconsider its Not Approvable letter and grant marketing approval for Cellegesic.
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.
-------------------------------------------------------------------------------- Source: Cellegy Pharmaceuticals, Inc.
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