-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, L44wI6Zvu9jAQhiFL0fPup2wcH7UDzSv1fq7DZHuNKNYKWdSR7w5YJ2nVvpghO8W hOlM7mpTL2Xdz7RjXRN7Ng== 0001144204-06-027861.txt : 20060710 0001144204-06-027861.hdr.sgml : 20060710 20060710092435 ACCESSION NUMBER: 0001144204-06-027861 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060707 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060710 DATE AS OF CHANGE: 20060710 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELLEGY PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000887247 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820429727 STATE OF INCORPORATION: CA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26372 FILM NUMBER: 06952609 BUSINESS ADDRESS: STREET 1: 1800 BYBERRY ROAD, BLDG. #13 CITY: HUNTINGDON VALLEY STATE: PA ZIP: 19006 BUSINESS PHONE: 2159140900 MAIL ADDRESS: STREET 1: 1800 BYBERRY ROAD, BLDG. #13 CITY: HUNTINGDON VALLEY STATE: PA ZIP: 19006 8-K 1 v047243_8k.htm
 
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):  July 7, 2006
 

 
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.)
 
1800 Byberry Road, Bldg 13
Huntingdon Valley, Pa
 
19006
(Address of Principal Executive Offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code: (215) 914-0900
 
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 July 10, 2006, Cellegy Pharmaceuticals, Inc. issued a press release announcing that it received late afternoon on Friday, July 7, 2006 a communication from the U.S. Food and Drug Administration in the form of an Approvable Letter for its product, Cellegesic® (nitroglycerin ointment). The letter stated, however, that before the company’s New Drug Application (“NDA”) may be approved and the product approved for marketing, Cellegy must conduct another clinical trial to demonstrate efficacy at a level deemed statistically significant by the agency. The letter indicated that the agency was requiring an additional study because it believed the results of the three trials conducted to date did not provide substantial evidence that the drug is effective, and provided a number of comments on the results previously presented by Cellegy and recommendations concerning the design and protocol of the additional required study. Cellegesic, for reduction of pain associated with anal fissures, was the subject of an FDA Not Approvable letter in December 2004. An amended NDA, containing new analyses, was resubmitted to the FDA in April 2005, which resulted in a review by the FDA’s Cardio-Renal Advisory Committee on April 25, 2006. As previously reported, the Advisory Committee’s final vote was six members of the Committee for “Approval” of Cellegesic and six for “Approvable pending another study of effectiveness.” There were no votes for “Not Approvable.” Cellegesic has been under review at the FDA since then.

In the press release, Richard C. Williams, Cellegy’s Chairman and Interim Chief Executive Officer, stated, “We believe that we achieved the requirements for Cellegesic to be approved. The FDA reached a different conclusion that the product was approvable, but requires another trial to demonstrate efficacy. We are carefully considering all of our options and will be scheduling a meeting with the FDA.”

A copy of the Company’s press release relating to the transaction is attached as Exhibit 99.1.

Item 9.01       Financial Statements and Exhibits.
 
(c) Exhibits
 
Exhibit
Number
 
Description of Exhibit
 
 
 
99.1
 
Press Release dated July 10, 2006
 
 
 

 
 
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: July 10, 2006 By:   /s/ Robert J. Caso
 
Robert J .Caso
 
Vice President, Finance and Chief Financial Officer
(Duly Authorized Officer)
 
 
 

 
EX-99.1 2 v047243_ex99-1.htm
 
FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic® 

Conference Call Scheduled for Today at 1:00 p.m. Eastern/10:00 a.m. Pacific

Huntingdon Valley, PA - July 10, 2006 - Cellegy Pharmaceuticals, Inc. (OTC BB: CLGY.OB) announced that it received late afternoon on Friday, July 7 a communication from the U.S. Food and Drug Administration in the form of an Approvable Letter for its product, Cellegesic® (nitroglycerin ointment). The letter stated, however, that before the company’s New Drug Application (NDA) may be approved and the product approved for marketing, Cellegy must conduct another clinical trial to demonstrate efficacy at a level deemed statistically significant by the agency. The letter indicated that the agency was requiring an additional study because it believed the results of the three trials conducted to date did not provide substantial evidence that the drug is effective, and provided a number of comments on the results previously presented by Cellegy and recommendations concerning the design and protocol of the additional required study. Cellegesic, for the treatment of anal fissures, was the subject of an FDA Not Approvable letter in December 2004. An amended NDA, containing new analyses, was resubmitted to the FDA in April 2005, which resulted in a review by the FDA’s Cardio-Renal Advisory Committee in April 2006. As previously reported, the Advisory Committee’s final vote was six members of the Committee for “Approval” of Cellegesic and six for “Approvable pending another study of effectiveness.” There were no votes for “Not Approvable.” Cellegesic has been under review at the FDA since then.

Richard C. Williams, Cellegy’s Chairman and interim CEO, stated, “We believe that we achieved the requirements for Cellegesic to be approved. The FDA reached a different conclusion that the product was approvable, but requires another trial to demonstrate efficacy. We are carefully considering all of our options and will be scheduling a meeting with the FDA.”

Conference Call Information
Cellegy will be hosting a conference call beginning at 1:00 p.m. Eastern Daylight Time (10:00 a.m. Pacific Daylight Time) today, Monday, July 10, 2006. Richard C. Williams, Chairman and interim CEO, will provide an update. To participate in the live call by telephone, please dial (866) 700-5192 from the United States, or for international callers, please dial (617) 213-8833, entering the Passcode, 11193554.

A replay will be available on Cellegy’s website for one week. A telephone replay will be available for one week by dialing (888) 286-8010 from the United States, or (617) 801-6888 for international callers, and entering Passcode 30080567.

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, HIV prevention and gastrointestinal disorders. Savvy® (C31G vaginal gel), a novel microbicide gel product for contraception and the reduction in transmission of HIV in women, is currently undergoing Phase 3 clinical studies in the United States and Africa.
 

 
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 company’s cash position and need and ability to complete corporate partnerships and additional financings; market acceptance and the level of future sales of Rectogesic® markets outside the United States; and completion, timing and outcome of clinical trials, including primarily the Savvy prevention and contraceptive Phase 3 studies. For more information regarding risk factors, refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2005 and other filings with the Securities and Exchange Commission.
 
Cellegy Pharmaceuticals, Inc.:
Richard C. Williams
Chairman and Interim CEO
(650) 616-2200
www.cellegy.com
Robert J. Caso
Vice President, Finance & CFO
(215) 914-0900 Ext. 603
###
 

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