SOUTH SAN FRANCISCO, Calif. and GALASHIELS, United Kingdom, Dec. 30 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. and ProStrakan Group Limited today announced that the Medical Products Agency (MPA) in Sweden has approved Tostrex(R) (testosterone gel) 2% for the treatment of male hypogonadism. Approvals of Tostrex by the other member states of the European Union will be sought through the Mutual Recognition Procedure.
Tostrex is a proprietary transdermal testosterone gel product developed by Cellegy to treat male hypogonadism, a condition that results in diminished libido and other signs of aging. ProStrakan has licensed the rights to commercialize the product in Europe.
"The approval of Tostrex in Sweden represents the second Cellegy product approval granted in Europe this year," said K. Michael Forrest, Cellegy's President and CEO. "We look forward to working with our partner in supporting the launch of Tostrex in Sweden. The Mutual Recognition Procedure to obtain regulatory approval for Tostrex in other European territories will be initiated by ProStrakan as soon as possible."
Commenting, ProStrakan CEO, Dr Wilson Totten, said: "ProStrakan's commercial operations in Europe are expanding rapidly. We believe that the testosterone market is one with major growth potential and Tostrex will, therefore, form a significant addition to our range of marketed products."
About Tostrex(R) Gel
Tostrex, called 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 to individual patient requirements. Hypogonadism is frequently characterized by reduced libido, loss of muscle mass, bone density and diminished energy levels.
About Cellegy
Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops and commercializes prescription drugs for the treatment of gastrointestinal disorders, women's health care conditions, including sexual dysfunction and HIV prevention, and certain cancers.
In September, the Cellegesic(TM) (nitroglycerin ointment, branded Rectogesic(R) outside of the United States) was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for sale in the U.K. The product is expected to be launched in that country during the second quarter of 2005. A similar formulation of Rectogesic is currently being sold in Australia, New Zealand and South Korea.
About ProStrakan
ProStrakan was established in 2004 through the merger of UK-based Strakan Pharmaceuticals Ltd and France-based ProSkelia SAS. Employing approximately 275 people, the company is headquartered in Scotland with expanding commercial operations throughout the rest of the UK and Europe. The company's principal R&D site is in Romainville near Paris.
Prior to the merger, Strakan (founded in 1995) specialised in the research, development and commercialisation of novel prescription medicines in the women's health, ageing male and oncology therapeutic areas. ProSkelia (founded in 2002 from the spin-out of the specialist bone research unit of Aventis) was a leading European R&D company focused on skeletal diseases and related therapeutic areas such as hormone-related cancers and women's/men's health.
The merger of the two companies has created an integrated specialty pharmaceutical company with leading edge research and development capabilities coupled to an expanding European commercial operation which is generating significant and growing revenues. ProStrakan's therapeutic focus is primarily on steroid chemistry, hormonal disorders and bone biology, areas which represent significant unmet need and high growth potential.
In July 2004, Strakan acquired the European marketing rights to Cellegy's transdermal testosterone gel product, Tostrex(R) (known as Fortigel(TM) in the US). In January 2004, Strakan acquired Paris-based OTL Pharma, a company specialising in the commercialisation of high value niche products across the European Union.
In September 2004, ProStrakan acquired Spain-based Devon Farmaceutica in a move which gave the company a commercial presence in the EU's fifth largest pharmaceutical market. This was followed in November 2004 by the acquisition of Elfar SA (also based in Madrid), a company with a portfolio of marketed products serviced by an established sales and marketing infrastructure in Spain.
In December 2004, ProStrakan acquired the European rights to Cellegy's Cellegesic(TM) (branded as Rectogesic(R) outside of the US). Rectogesic is a 0.4% topical nitroglycerin ointment indicated for the treatment of the pain associated with chronic anal fissures. The deal covers 38 European territories in total. The product was approved for sale in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA) in September 2004.
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: completion, timing and the outcome of regulatory review of Cellegesic in the United States and of the Mutual Recognition Procedure in other countries in the European Union; the outcome of clinical trials including the Savvy prevention and contraceptive Phase 3 studies, the outcome and timing of discussions with the FDA, particularly with regard to additional clinical trial requirements for marketing approval of Tostrelle and Fortigel; and the timing and subsequent success of the planned launch of Tostrex in Europe.
Cellegy Pharmaceuticals, Inc.CONTACT: Richard Juelis, Vice President, Finance & CFO, orK. Michael Forrest, President & CEO, both of Cellegy Pharmaceuticals, Inc.,+1-650-616-2200; or Bruce Voss or Ina McGuinness, imcguinness@lhai.com, bothof Lippert/Heilshorn & Associates, +1-310-691-7100, for CellegyPharmaceuticals, Inc.; or David Watt, Corporate Communications of ProStrakanGroup Ltd, +44 (0) 1896 668078
Web site: http://www.prostrakan.com/
Web site: http://www.cellegy.com/