-----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, MPO0eqleQD2Hfqd+JL72i3mNT4uJHgIkYPMmzBuANFSOjanM1709rloVlR4WBwHB GR4a+8x6Y9/9edp1CqYrlQ== 0001144204-06-016899.txt : 20060426 0001144204-06-016899.hdr.sgml : 20060426 20060426162156 ACCESSION NUMBER: 0001144204-06-016899 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060426 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060426 DATE AS OF CHANGE: 20060426 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: 06781391 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 v041373.htm Unassociated Document
 
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):  April 26, 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
 
Cellegy Pharmaceuticals, Inc. announced today that The Food and Drug Administration’s Cardio-Renal Advisory Committee met on April 25, 2006 to review Cellegy’s New Drug Application relating to its Cellegesic™ (0.4% nitroglycerin ointment) product for reduction of pain associated with anal fissures. The Committee voted on three questions in connection with its review:

1.  
A majority of the Committee agreed that the quadratic model was the proper analysis for the purpose of decision-making.
2.  
A majority of the Committee found that, taking all three studies into consideration, the data is compelling that there is an effect of nitroglycerin ointment on the pain associated with anal fissures.
3.  
In its final vote, six members of the Committee voted for “Approval” of Cellegesic and six voted “Approvable pending another study of effectiveness.” There were no votes for “Not Approvable.”

The FDA may take this recommendation of the Advisory Committee under advisement as it deliberates on the review of the NDA. The FDA does not have a time period within which it must complete its review of the NDA. There are no assurances concerning the timing and outcome of FDA action following the Advisory Committee’s actions. Cellegy filed an NDA for the use of Cellegesic in June 2004. Cellegesic was the subject of an FDA Not Approvable letter in December 2004. Cellegy submitted an amended NDA, containing new analyses, to the FDA in April 2005, resulting in today’s review by the Cardio-Renal Advisory Committee.

A copy of the Company’s press release relating to the transaction is attached as Exhibit 99.1 and is incorporated by reference into this Item 1.01.


Item 9.01  Financial Statements and Exhibits.
 
(c) Exhibits
 
Exhibit Number
 
Description of Exhibit
 
 
 
99.1
 
Press Release dated April 26, 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: April 26, 2006
By:
/s/ Robert J. Caso
 
 
 
Robert J .Caso
 
 
 
Vice President, Finance and Chief Financial Officer
 
 
 
(Duly Authorized Officer)
 

 
EX-99.1 2 v041373_ex99-1.htm Unassociated Document


Exhibit 99.1

Cellegy Announces Results of the FDA’s Cardio-Renal Advisory Committee Meeting

Huntingdon Valley, PA - April 26, 2006 - Cellegy Pharmaceuticals, Inc. (OTC BB: CLGY.OB) announced today that The Food and Drug Administration’s Cardio-Renal Advisory Committee met on April 25, 2006 to review the Company’s New Drug Application relating to its Cellegesic™ (0.4% nitroglycerin ointment) product for reduction of pain associated with anal fissures. The Committee voted on three questions in connection with its review:

4.  
A majority of the Committee agreed that the quadratic model was the proper analysis for the purpose of decision-making.
5.  
A majority of the Committee found that, taking all three studies into consideration, the data is compelling that there is an effect of nitroglycerin ointment on the pain associated with anal fissures.
6.  
In its final vote, six members of the Committee voted for “Approval” of Cellegesic and six voted “Approvable pending another study of effectiveness.” There were no votes for “Not Approvable.”

The FDA may take this recommendation of the Advisory Committee under advisement as it deliberates on the review of the NDA. The FDA does not have a time period within which it must complete its review of the NDA. Cellegy filed an NDA for the use of Cellegesic in June 2004. Cellegesic was the subject of an FDA Not Approvable letter in December 2004. Cellegy submitted an amended NDA, containing new analyses, to the FDA in April 2005, resulting in yesterday’s review by the Cardio-Renal Advisory Committee.

“We are very pleased with the positive nature of the Advisory Committee’s recommendation and that the majority of the committee members agreed on the effectiveness of Cellegesic,” said Richard C. Williams, Chairman and Interim Chief Executive Officer. “We hope to hear soon from the FDA regarding the results of its deliberations. There are many people who are suffering from debilitating pain with this condition, and the quicker the action by the FDA, the quicker patient relief could be provided by a product manufactured in accordance with FDA Good Manufacturing Practices standards.”
 

 
 

 
 
 
Conference Call
 
The company will be hold a conference call today, April 26, 2006, at 12 pm Eastern Daylight Time to discuss the results of the Advisory Committee Meeting. Information on accessing the conference call will be presented in a release later today.

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 timing and outcome of FDA action following the Advisory Committee’s review and recommendation; completion, timing and outcome of clinical trials, including primarily the Savvy prevention and contraceptive Phase 3 studies; and the need and ability to complete corporate partnerships and additional financings. 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 Robert J. Caso   
Chairman and Interim CEO Vice President, Finance & CFO  
(650) 616-2200  (215) 914-0900 Ext. 603  
www.cellegy.com    
 
     
    
     
 


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