Starpharma, SSL International To Produce Condoms With Microbicide VivaGel
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 (AAP/Age, 10/16).
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 and also was effective in preventing the spread of genital herpes. 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 NIH and involved 40 sexually active, HIV-negative women between ages 18 and 24 (Kaiser Daily HIV/AIDS Report, 7/11). VivaGel also has undergone testing in Kenya and still is in clinical trials (AAP/News.com, 10/17).
The companies will create a development program for the VivaGel-coated condoms and negotiate a commercial license under the agreement (Starpharma release, 10/16). Starpharma 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, 10/16). According to the AAP/News.com, the condoms are expected to be available worldwide in about one year (AAP/News.com, 10/17).
"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 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 (Starpharma release, 10/16).