-----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, HS8iXbRZrAt9yyiYryghqa7Qsz+bmJcB3KXqx9X6gTP/ER6Z6tlK+OyriXRWu47t ndOKvIb7YH+jKOfa1RuJxA== 0000950005-03-001227.txt : 20031215 0000950005-03-001227.hdr.sgml : 20031215 20031215172946 ACCESSION NUMBER: 0000950005-03-001227 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20031211 ITEM INFORMATION: Changes in registrant's certifying accountant ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031215 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: 031055524 BUSINESS ADDRESS: STREET 1: 349 OYSTER POINT BLVD. STREET 2: SUITE 200 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 BUSINESS PHONE: 6506262200 MAIL ADDRESS: STREET 1: 349 OYSTER POINT BLVD. STREET 2: SUITE 200 CITY: SO. SAN FRANCISCO STATE: CA ZIP: 94080 8-K 1 p18018_8k.txt CURRENT REPORT 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 11, 2003 CELLEGY PHARMACEUTICALS, INC. - -------------------------------------------------------------------------------- (Exact name of Registrant as specified in its charter) California ------------------------------------------------------ (State or other jurisdiction of incorporation) 0-26372 82-0429727 - ---------------------------- -------------------------- (Commission (IRS Employer File Number) Identification No.) 349 Oyster Point Boulevard, Suite 200 South San Francisco, CA 94080 - ------------------------------------------------------------ ------------------- (Address of principal executive offices) (Zip Code) (650) 616-2200 - -------------------------------------------------------------------------------- (Registrant's telephone number, including area code) - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) ITEM 4: OTHER EVENTS Filed with this report as Exhibits 99.01, 99.02 and 99.03, respectively, are: (i) a press release issued by Cellegy Pharmaceuticals, Inc. (the "Company") dated December 11, 2003 announcing the resignation of Dr. Ronald J. Saldarini from its board of directors; (ii) a press release issued by the Company on December 12, 2003, announcing that the Company has filed a declaratory judgement action in federal district court in San Francisco against PDI, Inc.; and (iii) a press release announcing that the Board of Opposition of the European Patent Office has rendered a verbal decision revoking Cellegy's European patent relating to its Cellegesic(TM) (nitroglycerin ointment) product and related compounds for the treatment of anal disorders. ITEM 7: FINANCIAL STATEMENTS AND EXHIBITS. (a) Exhibits. 99.01 Press Release issued by the Registrant dated December 11, 2003. 99.02 Press Release issued by the Registrant dated December 12, 2003. 99.03 Press Release issued by the Registrant dated December 12, 2003. 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. Date: December 15, 2003 CELLEGY PHARMACEUTICALS, INC. By: /s/ A. Richard Juelis --------------------- A. Richard Juelis Vice President, Finance and Chief Financial Officer EX-99.01 3 p18018_ex99-01.txt PRESS RELEASE Exhibit 99.01 Cellegy Pharmaceuticals Announces Retirement of Director, Dr. Ronald J. Saldarini South San Francisco, California, December 11, 2003 - Cellegy Pharmaceuticals, Inc. (Nasdaq NM: CLGY) announced today that one of its directors, Dr. Ronald J. Saldarini has resigned from its board. Cellegy's Chief Executive Officer K. Michael Forrest said, "Dr. Saldarini has been on our Board since 1999 and has made many significant contributions over the years. His retirement is well-earned. While we regret that he will no longer be active with the Company, we would like to thank him for his dedication and service to Cellegy and its shareholders. We will miss him as a colleague and a friend." Cellegy Pharmaceuticals is a specialty biopharmaceuticals company engaged in the development and marketing of prescription drugs for the treatment of gastroenterology disorders, sexual dysfunction, and nitric oxide donors for the treatment of certain cancers. For More Information: Richard Juelis K. Michael Forrest Vice President, Finance & CFO President & CEO www.cellegy.com EX-99.02 4 p18018_ex99-02.txt PRESS RELEASE Exhibit 99.02 Cellegy Pharmaceuticals Files Declaratory Judgment Action Against PDI, Inc. Concerning Fortigel(TM) License Agreement South San Francisco, California, - December 12, 2003 - Cellegy Pharmaceuticals, Inc. (Nasdaq NM: CLGY) announced today that it filed a declaratory judgment action in federal district court in San Francisco against PDI, Inc. relating to the exclusive License Agreement between PDI and Cellegy entered into in December 2002 concerning Cellegy's product Fortigel(TM) (testosterone gel). Cellegy's lawsuit follows required mediation over PDI's recent assertions that Cellegy breached several provisions of the License Agreement and failed to disclose relevant facts, and its claim that it is entitled to several kinds of alleged damages, including return of the initial license fee that PDI paid to Cellegy when the agreement was signed. Cellegy seeks, among other things, a declaration that it has fully complied with the License Agreement and that PDI's claims are without merit. Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development and marketing of prescription drugs for the treatment of gastroenterology disorders, sexual dysfunction, and the use of nitric oxide donors for the treatment of certain cancers. 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 outcome of ongoing clinical trials; the outcome and timing of discussions with the FDA, particularly with regard to additional requirements for marketing approval of Fortigel; and the need and ability to complete corporate partnerships and financings. Although Cellegy has initiated legal proceedings relating to the License Agreement, there can be no assurances regarding the outcome of any such proceedings, or any potential counterclaims by PDI, and the Company could be required to devote significant time and resources to the proceeding. An adverse outcome in any such proceeding could have a material financial impact on Cellegy. For more information regarding risk factors, refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2002. For More Information: Richard Juelis K. Michael Forrest Vice President, Finance & CFO President & CEO www.cellegy.com EX-99.03 5 p18018_ex99-03.txt PRESS RELEASE Exhibit 99.03 Cellegy Pharmaceuticals Announces Decision of European Patent Opposition Board Regarding European Patent South San Francisco, California, December 12, 2003 - Cellegy Pharmaceuticals, Inc. (Nasdaq NM: CLGY) announced today that the Board of Opposition of the European Patent Office has rendered a verbal decision revoking Cellegy's European patent relating to its CellegesicTM (nitroglycerin ointment) product and related compounds for the treatment of anal disorders, including fissures and various hemorrhoidal conditions. Oppositions to the issued patent had previously been filed with the European Patent Office, and the verbal decision followed an oral proceeding before the Board. The Opposition Board will issue a written decision at a future date. Cellegy disagrees with the verbal decision and is evaluating issues available for appeal. Cellegy Pharmaceuticals is a specialty biopharmaceutical company engaged in the development and marketing of prescription drugs for the treatment of gastroenterology disorders, sexual dysfunction, and nitric oxide donors for the treatment of certain cancers. 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 outcome of ongoing clinical trials; the outcome and timing of discussions with the FDA, particularly with regard to additional requirements for marketing approval of Fortigel; and the need and ability to complete corporate partnerships and financings. There can be no assurances that Cellegy will appeal the decision of the Board of Opposition regarding Cellegy's patent referred to in this press release, or that any such appeal, if pursued, will be successful. An adverse outcome in the European Patent Office proceedings could have a material impact on Cellegy business and financial position. For more information regarding risk factors, refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2002. For More Information: Richard Juelis K. Michael Forrest Vice President, Finance & CFO President & CEO www.cellegy.com -----END PRIVACY-ENHANCED MESSAGE-----