CELLEGY PHARM Inc. (OTC:CLGY)
Industry: Healthcare
Cellegy Pharmaceuticals, Inc. (Cellegy), incorporated in 1989, is a development-stage specialty biopharmaceutical company engaged in the development and commercialization of prescription drugs targeting women's health care, including the reduction in transmission of human immunodeficiency virus (HIV), and gastrointestinal conditions using topical formulations and nitric oxide (NO) donor technologies. The Company develops the products Cellegesic, a nitroglycerin ointment for the treatment of anal fissures and hemorrhoids; Savvy, a contraceptive vaginal gel for women designed to prevent HIV/Acquired Immune Deficiency Syndrome (AIDS); Fortigel, a testosterone replacement therapy for male hypogonadism, and Tostrelle, testosterone gel for female hormone replacement therapy. Cellegy markets Cellegesic as Rectogesic and Fortigel as Tostrex in Europe. In December 2005, the Company divested its skin care business. Cellegesic Cellegesic is a topical, nitroglycerin-based prescription product being developed for the treatment of anal fissures and dyspareunia. Nitroglycerin is a drug that has safely and effectively been used for many years to treat cardiac conditions, primarily angina pectoris. In January 2004, the results of preliminary analysis of the third Phase III clinical trial for Cellegesic showed a reduction in anal fissure pain, compared with a placebo control, the primary efficacy endpoint of the study. The Company submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) in June 2004. The FDA issued a Not Approvable letter for Cellegesic in December 2004. The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) approved Cellegesic (branded Rectogesic in Europe) for sale in the United Kingdom in August 2004 and the product was launched by European marketing partner ProStrakan Group Limited (ProStrakan) in May 2005. ProStrakan is seeking additional approvals of Rectogesic by other member states of the European Union through the Mutual Recognition Procedure. In November 2005, Cellegy renegotiated its marketing agreement with ProStrakan. Under the terms of the amended agreement, ProStrakan will assume responsibility for all manufacturing and other product support functions and will purchase the product directly from the manufacturer rather than from Cellegy. Rectogesic was approved by the Australian Therapeutic Goods Administration, has been marketed in Australia, and is also marketed in New Zealand, Singapore and South Korea. On March 24, 2006, Cellegy announced that its European marketing partner ProStrakan had completed the European Union Mutual Recognition Procedure for Rectogesic. Savvy Cellegy obtained rights to the late-stage product candidate, Savvy, with its acquisition of Biosyn. Savvy, a microbicidal gel, is one of the product candidates in development for the reduction in transmission of HIV, and has also shown promising results in the prevention of other sexually transmitted diseases (STDs), including those caused by herpes simplex virus and Chlamydia. Savvy has also shown activity against gonorrhea and syphilis. Savvy is undergoing a Phase III trial for reduction of HIV transmission in Nigeria in populations of women at risk for HIV infection. The primary endpoint of the study is a 50% reduction in the rate of transmission of HIV in the Savvy group compared with the placebo. In November 2005, the Company discontinued its Phase III trial for reduction of HIV transmission in Ghana, which had enrolled approximately 2,100 women. The Data Monitoring Committee reviewing interim data from the Savvy Ghana Phase III HIV prevention trial made the recommendation in November 2005 that continuing the trial would not allow the effect of Savvy (C31G vaginal gel) on HIV to be determined because of a lower than expected rate of HIV seroconversion in the trial. The active compound in Savvy is C31G, a broad-spectrum compound with antiviral, antibacterial and antifungal activity. Its mechanism of action is via immediate membrane disruption and
As Of: 10/07 00:00 ET
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