Cellegy's Licensee for Rectogesic(TM) in Europe Has Reported the Successful Conclusion of EU MRP Process Friday March 24, 1:42 pm ET
HUNTINGDON VALLEY, Pa., March 24 /PRNewswire-FirstCall/ -- Cellegy Pharmaceuticals, Inc. (OTC Bulletin Board: CLGY.OB - News) announced that ProStrakan Group plc, Cellegy's licensee for Rectogesic in Europe, reported today "the successful conclusion of the EU Mutual Recognition Procedure (MRP) for Rectogesic(TM)." ProStrakan indicated that the procedure was completed successfully shortly after the "day 90" target date of March 20, 2006. Rectogesic(TM) is a 0.4% topical nitroglycerin ointment indicated for the relief of pain associated with chronic anal fissures.
ProStrakan's announcement continued, "The first EU launch of the product was into the UK market in May 2005. Month-on-month in-market sales demonstrate significant growth. 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. Under Cellegy's license agreement with ProStrakan, Cellegy is entitled to receive $250,000 for each marketing regulatory approval obtained in the first of any three countries out of France, Italy, Germany or Spain up to a maximum total amount payable of $750,000. Under Cellegy's previous agreements with PDI, Inc., PDI is entitled to receive one-half of these payments.
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.
Cellegesic(TM) (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: completion, timing and outcome of clinical trials, including primarily the Savvy prevention and contraceptive Phase 3 studies; the timing and outcome of the FDA Advisory Committee that will review the Cellegesic NDA and the timing and outcome of FDA action following that review; and the need and ability to complete corporate partnerships and additional financings. 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, 2004 and other filings with the Securities and Exchange Commission.
-------------------------------------------------------------------------------- Source: Cellegy Pharmaceuticals, Inc.
[ March 24, 2006, 14:25: Message edited by: Peaser01 ]
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