The three microbicides covered under the agreement are in various stages of development and work under different mechanisms of action. They include: Savvy, which is currently in Phase III clinical trials in the U.S. and Africa; UC781 which is in expanded Phase II trials in the U.S and Thailand and Cyanovirin-N which is in preclinical testing. Henry Gabelnick, Ph.D., executive director of CONRAD says, "This agreement is great news for everyone interested in developing an effective microbicide. The more partnerships we have like this one, the better our potential is for getting an effective product ready for distribution."
"I am delighted for our two organizations to enter into this agreement. We have collaborated for many years on all aspects of our microbicide development programs, and we have a deep respect for each other's knowledge and expertise. With CONRAD, we feel we have a capable and experienced partner to work with us toward approval of these critically important products," said Anne-Marie Corner, Senior Vice President of Cellegy Pharmaceuticals.Currently, the highest rates of infection in women are in sub-Saharan Africa and rates are increasing in women in South and Southeast Asia.
CONRAD has been involved in the research of nearly every microbicide currently in clinical trials. They are currently managing a second Phase III trial of a microbicide called Ushercell in Uganda and South Africa, Benin, Burkina Faso and two centers in India. The trials will evaluate Ushercell for the prevention of HIV infection among 2,574 adult women at high risk of acquiring HIV. This study will also assess incidence of genital gonorrhea and chlamydia.
CONRAD is a cooperating agen cy of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases. CONRAD is administered through the Department of Obstetrics and Gynecology at Eastern Virginia Medical School (EVMS) in Norfolk, VA, with the main office located in Arlington, VA. www.conrad.org
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. Biosyn, Inc is a wholly owned subsidiary of Cellegy Pharmaceuticals.
CellegesicTM (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.
FortigelTM (testosterone gel), branded Tostrex® outside the United States, is marketed in Sweden for the treatment of male hypogonadism also by ProStrakan. Approvals of Rectogesic and Tostrex by the other member states of the European Union are being sought through the Mutual Recognition Procedure.