WASHINGTON, Feb. 1 (UPI) -- Cellegy has granted a licensing agreement to CONRAD to research and develop its patented microbicides for the prevention of HIV, including Savvy, which is in phase 3, and a treatment dubbed "UC781," which is in phase 2.
The move appears to signal Cellegy's desire to get out of the HIV microbicide field, an area that big pharma has largely shied away from, preferring instead to focus on vaccines.
But experts said that microbicides could be available sooner than inoculations and could play a significant role in slowing down the spread of the HIV/AIDS epidemic.
"It's like the tortoise and the hare whether we'll have an effective microbicide before we have a vaccine," Kenneth Mayer, a professor of medicine and community health at Brown University who has conducted clinical research with microbicides, told United Press International.
"But the vaccine field is not moving forward so quickly, and even a modestly effective microbicide could have a big impact on slowing down the HIV epidemic around the world," he said.
In addition, there are indications that some companies, such as Gilead, are becoming interested in pursuing development of microbicides, which are products that can be applied vaginally to reduce the chance of HIV infection during sexual intercourse.
Cellegy did not return a phone call from United Press International requesting comment, but Henry Gabelnick, executive director of CONRAD, said, "Cellegy is not so interested anymore and that's why they've asked us to get involved."
Gabelnick said he did not know whether Savvy was showing promise in the phase 3 studies because the data is still blinded, but he noted that it has been reviewed by a safety monitoring board and they have not raised any significant issues about the product.
"I really think Savvy is on the track to success," he told UPI.
Gabelnick said the agreement will also help accelerate the development of two other microbicide candidates: UC781, which is in phase 2 trials in the United States and Thailand, and Cyanovirin-N, which is still in preclinical testing. Cellegy's subsidiary Biosyn holds the patent on all three compounds.
Gabelnick said he thinks microbicides will ultimately prove effective at preventing HIV infection, and the first one could reach the market as early as 2009.
For Savvy, he said he would like to partner with a big pharmaceutical company, or at least a medium-sized firm, for distribution and production. The problem, he said, is that the predominant market for microbicides will be developing nations, and without a clear demonstration of an audience in developed countries, big pharma will likely remain reticent.
However, he said, CONRAD communicates regularly with some Indian companies, and that could be an option.
"I'm convinced we could get it manufactured in India, South Africa or Brazil, if no U.S. or European country gets interested," he said. Many brand-name manufacturers in India already meet the FDA's requirements for manufacturing pharmaceuticals and shipping them into the United States, "so it's just a problem of getting the right match," he added.
Brown University's Mayer told UPI he thinks the compounds "are an extremely exciting approach" that could reach the market before an effective vaccine and could significantly curtail HIV transmission.
Mayer, who also serves as an infectious-disease specialist at Miriam Hospital, said a phase 1 study he helped conduct that focused on a vaginal gel supplied by Gilead that incorporates their oral HIV medication Viread indicates the product is safe and well-tolerated.
The results will be coming out at the end of this month, he said, adding that a phase 2 study of the gel is being planned in high-risk populations under the auspices of the HIV Prevention Trials Network.
Currently, there are approximately 5 or 6 microbicide compounds in phase 3 of phase 2b, so "we really have the possibility to see whether these are effective in the next 2, 3, 4 or 5 years," Mayer said.
Contrasting that with the vaccine field, he noted the only inoculation that is that far along in development is Merck's, which is in phase 2b.
"What might help increase market interest is the fact that there will be an audience in the developed world as well," Mayer said. This could include use of microbicides during anal sex by men who have sex with men or in other high-risk populations, he said.
In addition to Gilead, Mayer said there is an emerging model of public/private partnerships springing up around microbicide development.
This includes the recent announcement by the International Partnership for Microbicides that two pharmaceutical giants -- Merck and Bristol-Myers Squibb -- had granted IPM a royalty-free license to develop and manufacture their anti-retroviral compounds as microbicides for use in developing nations.
