-----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, AHbCkZRemeV+v1XNS/MpyjR8QhlGlmzHCImxm1MhDtd4gAi8KCYfEsA2rp0OrGPc JP0/OlL2WLeNMhvzkLtBTA== 0001144204-06-015300.txt : 20060414 0001144204-06-015300.hdr.sgml : 20060414 20060414150944 ACCESSION NUMBER: 0001144204-06-015300 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060411 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060414 DATE AS OF CHANGE: 20060414 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: 06760501 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 v040541_8-k.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):  April 11, 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 (“Cellegy”) announced that ProStrakan Group plc, Cellegy’s licensee for TostrexTM in Europe, reported today “the successful conclusion of the European Union Mutual Recognition Procedure for TostrexTM.” ProStrakan indicated that the procedure was completed successfully at the “day 90” target date of April 7, 2006. Tostrex is a 2% topical testosterone gel indicated for the treatment of male hypogonadism.

A copy of the Company’s press release relating to the amendment is attached as Exhibit 99.1 and is incorporated by reference into this Item.
 
Item 9.01  Financial Statements and Exhibits.
 
(c) Exhibits
 
Exhibit Number
 
Description of Exhibit
 
 
 
99.1
 
Press Release dated April 11, 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 11, 2006
By:
/s/ Robert J. Caso
 
 
 
Robert J .Caso
 
 
 
Vice President, Finance and Chief Financial Officer
 
 
 
(Duly Authorized Officer)
 
 

 
EX-99.1 2 v040541_ex99-1.htm Unassociated Document
Exhibit 99.1

Cellegy’s Licensee for TostrexTM in Europe has Reported the Successful Conclusion of EU MRP Process


Huntingdon Valley, PA - April 11, 2006 - Cellegy Pharmaceuticals, Inc. (OTC BB: CLGY.OB) announced that ProStrakan Group plc, Cellegy’s licensee for TostrexTM in Europe, reported today “the successful conclusion of the EU Mutual Recognition Procedure (MRP) for TostrexTM.” ProStrakan indicated that the procedure was completed successfully at the “day 90” target date of April 7, 2006. Tostrex is a 2% topical testosterone gel indicated for the treatment of male hypogonadism.

ProStrakan’s announcement continued, “The first EU launch of the product was into the Swedish market in September 2005. Following the successful conclusion of the MRP process, national licenses will be issued in due course in the 19 additional countries included in the MRP submission application. Launches in these other European territories will take place through the first half of 2007.” The completion of the MRP process is an initial step in receiving marketing regulatory approval in each country. Assuming successful commercial launch, Cellegy would receive up to $5.05 million in milestone payments, along with a royalty on net sales of Tostrex. Under Cellegy’s previous agreements with PDI, Inc., PDI may be entitled to receive one-half of these payments if the amounts owed to PDI under the settlement agreement have not already been satisfied.

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.

CellegesicTM (nitroglycerin ointment), branded Rectogesic outside the United States, is approved and is being marketed in the United Kingdom by ProStrakan, for the treatment of pain associated with chronic anal fissures. A similar formulation of Rectogesic is currently being sold in Australia, New Zealand, Singapore and South Korea.

 
 

 
 
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, obtaining regulatory approval for TostrexTM in Europe. PDI and Cellegy are currently in litigation regarding agreements between the two parties entered into in 2005, and PDI may contend that it is entitled to receive all milestone payments that may be received by Cellegy as described in this press release. 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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