8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported):  December 23, 2004

Cellegy Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware	0-26372		82-0429727
(State or other jurisdiction of incorporation)	(Commission File Number)		(IRS Employer Identification No.)
349 Oyster Point Boulevard, Suite 200 South San Francisco, California		94080
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (650) 616-2200

Same

(Former name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01  Other Events.

On December 23, 2004, Cellegy Pharmaceuticals, Inc. (“Cellegy” or the “Company”) issued a press indicating that the U.S. Food and Drug Administration has issued a “not approvable” letter to the Company relating to the Company’s New Drug Application for its Cellegesic product candidate.  A copy of the press release is attached as Exhibit 99.1 and is incorporated by reference into this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(c) Exhibits

Exhibit Number	Description of Exhibit
99.1	Press Release dated December 23, 2004

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CELLEGY PHARMACEUTICALS, INC.
Date: December 27, 2004	By:	/s/ A. Richard Juelis
		A. Richard Juelis
		Vice President, Finance and Chief Financial Officer
		(Duly Authorized Officer)

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EX-99.1

Exhibit 99.1

FDA Issues Not Approvable Letter to Cellegy Pharmaceuticals
for Cellegesic^TM

SOUTH SAN FRANCISCO, CA – December 23, 2004 – Cellegy Pharmaceuticals, Inc. (Nasdaq:  CLGY) announced that it received late today a communication from the U.S. Food and Drug Administration in the form of a Not Approvable Letter for its product Cellegesic^TM (nitroglycerin ointment).  Cellegesic was the subject of an NDA that was filed with the FDA for the treatment of pain associated with chronic anal fissure.  In October the FDA granted the application a Priority Review status.

K. Michael Forrest, Cellegy’s President and CEO, stated, “We believe that our third Phase 3 trial achieved the requirements for approval of Cellegesic as agreed with the FDA under the provisions of a Special Protocol Assessment.  In addition, two previous Phase 3 trials included in the NDA were supportive of approval.  The FDA reached a different conclusion and has raised several issues that were not part of the agreed upon approval criteria.  We are evaluating the FDA’s letter and will carefully consider all of our options.”

“We are disappointed that the FDA chose to take this action on what we consider to be a safe and effective product that could provide relief to hundreds of thousands of people suffering from this very painful condition,” said David A. Karlin, M.D., Cellegy’s Vice President, Clinical Research.

About Cellegy Pharmaceuticals

Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of gastrointestinal disorders, women’s health care conditions, including sexual dysfunction and HIV prevention, and certain cancers.

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.

The Company is also pursuing the use of Cellegesic for the treatment of hemorrhoids, as well as dyspareunia, a painful condition that prevents or inhibits sexual intercourse in more than 5 million women in the United States.  Currently, there is no effective treatment for dyspareunia.

Cellegy recently enhanced its women’s healthcare product portfolio through the acquisition of Biosyn and its lead product Savvy^TM, a contraceptive gel to prevent HIV-AIDS in women.  Savvy is in advanced Phase 3 clinical trials for contraception and for

the prevention of HIV.  Cellegy is also developing Tostrelle^TM Gel for the treatment of sexual dysfunction (libido) in postmenopausal women and is planning to enter Phase 3 clinical trials during 2005.

Fortigel^TM, branded Tostrex^TM outside the United States, is currently undergoing regulatory review in Sweden for the treatment of male hypogonadism caused by testosterone deficiency.  ProStrakan has also licensed rights to Tostrex for the United Kingdom and other European markets.  Cellegy is in discussions with the FDA to determine the final design of a Phase 3 trial required for marketing approval of Fortigel in the United States.

Other products being developed by Cellegy researchers address a number of conditions including prostate cancer, Raynaud’s Disease and Restless Leg Syndrome.