SOUTH SAN FRANCISCO, Calif., March 9 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. announced today it has granted exclusive distribution rights for Tostrex(TM) (testosterone gel) to PT Kalbe Farma located in Jakarta, Indonesia (http://www.kalbefarma.com/) for parts of the Far East. Tostrex is indicated for the treatment of male hypogonadism. In December 2004, the product was approved by the Medical Products Agency (MPA) in Sweden.
Under the terms of the agreement, Cellegy will provide PT Kalbe Farma the Tostrex regulatory dossier, recently granted approval by the MPA. PT Kalbe Farma will be responsible for all regulatory filings, sales, marketing and distribution of Tostrex in various regions in the Far East. PT Kalbe Farma has been granted distribution rights in 11 countries in the Far East, including Indonesia and Thailand. Cellegy will be responsible for supplying finished product to PT Kalbe Farma through its contract manufacturer.
"Cellegy is pleased that Tostrex, one of its two European-approved products, has attracted a quality commercialization partner for regions in the Far East. We look forward to working with PT Kalbe Farma. We are confident that they will maximize the commercial potential for Tostrex in their territory," said Richard C. Williams, Chairman and interim CEO.
PT Kalbe Farma is very optimistic that this cooperation will strengthen their position as a major player in the Indonesian market and will be a driving force for growth in international markets, particularly in the Far East. Tostrex will add value to PT Kalbe Farma's product portfolio in their anti-aging pipeline, which provides superior treatment options for male hypogonadism. This cooperation with Cellegy will enhance PT Kalbe Farma's reputation as a reliable partner for possible strategic alliances with other companies from around the world.
About Tostrex(TM) (testosterone gel)
Tostrex, branded Fortigel(TM) in the United States, is a patented transdermal testosterone gel that utilizes a proprietary metered dose delivery system for the treatment of male hypogonadism. The metered dose delivery system permits dose adjustment for individual patient requirements. Hypogonadism is frequently characterized by reduced libido, loss of muscle mass, bone density and diminished energy levels.
About Cellegy Pharmaceuticals, Inc.
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 and HIV prevention, gastrointestinal disorders and certain cancers.
Cellegesic(TM) (nitroglycerin ointment), branded Rectogesic(R) 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. A similar formulation of Rectogesic is currently being sold in Australia, New Zealand and South Korea. In December 2004, the Medical Products Agency (MPA) in Sweden approved Fortigel(TM) (testosterone gel), branded Tostrex(TM) outside the United States, for the treatment of male hypogonadism. ProStrakan will also distribute Tostrex in the European Union. Approvals of Rectogesic and Tostrex by the other member states of the European Union will be sought through the Mutual Recognition Procedure.
Cellegy is also another transdermal testosterone gel product: Tostrelle(R) (testosterone gel) for the treatment of female sexual dysfunction in postmenopausal women. Cellegesic(TM), for the treatment of anal fissures, was the subject of an FDA Not Approvable letter in December 2004. The Company is evaluating the FDA's letter, intends to have further discussions with the FDA concerning the letter and is considering alternatives with respect to the product.
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: completion, timing and outcome of clinical trials; 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, 2003 and other filings with the Securities and Exchange Commission.
Cellegy Pharmaceuticals, Inc.