Australian pharmaceutical company Starpharma and SSL International, which owns the Durex condom brand, have signed an agreement to develop condoms coated with Starpharma's microbicide VivaGel, the drug maker announced on Tuesday, the AAP/Age reports.
In July, at the International AIDS Society conference in Sydney, the vaginal microbicide, VivaGel, was reported as preventing HIV and genital herpes in animal and human studies.
Designed to prevent STIs by stopping viruses from entering cells and thus avoiding infection, VivaGel's active ingredient is dendrimer, a molecule that binds itself to the viruses preventing them from infectng healthy cells. Early results from research also places VivaGel as a potent contraceptive.
US Food and Drug Administration (FDA) in January 2006 granted an accelerated review of VivaGel. The agency also announced that it will become more involved in further human trials of the gel. VivaGel did not cause any harmful side effects in trials of 35 women in Australia. The University of South Florida and the University of Puerto Rico in July ran a two-week clinical trial of VivaGel that was funded by National Institutes of Health (NIH) and involved 40 sexually active, HIV-negative women between ages 18 and 24. VivaGel also has undergone testing in Kenya and still is in clinical trials there.
The companies will create a development program for the VivaGel-coated condoms and negotiate a commercial license under the agreement according to a Starpharma release. The drug company will be paid undisclosed fees under the deal, which also includes the start of regulatory and market development activities by the two companies AAP/Age reports. According to the AAP/News.com, the condoms are expected to be available worldwide in about one year.
"We are delighted to be working with SSL, whom we believe will be an excellent co-development partner for VivaGel as a condom coating," Starpharma CEO Dr. Jackie Fairley said. She added, "Our development and commercialization activities for VivaGel are gathering momentum with this SSL agreement," which is the second condom-coating deal signed by Starpharma during the past three months.
This is a much-needed option for prevention, and Farley expounded saying, "We feel the health sector has focused on finding a cure or treatment to disease, whereas we believe very strongly that prevention is a preferable option in curbing the disturbing increase in STIs in both the developed and developing worlds".
Reproduced in part, with permission from: www.kaisernetwork.org/daily_reports/