Arlington, VA, USA and Pretoria, South Africa -- CONRAD and the South African Government's Technology Innovation Agency (TIA) today announced a license agreement that grants TIA the rights to manufacture and distribute Tenofovir1% gel in Africa. TIA will in turn set up a joint venture for the manufacturing and distribution of the gel in South Africa and other licensed territory, which includes the African continent. The gel will be registered, manufactured and distributed by ProPreven, a joint venture involving TIA, Cipla Medpro and iThemba Pharmaceuticals.
Dr. Henry Gabelnick, Executive Director of CONRAD stated, "Although confirmatory results are necessary to secure regulatory approval, this license agreement creates a process to move approval and access forward. It's important to prepare for success in order to get this prevention tool to women who need it the most, as soon as possible."
Women who used Tenofovir 1% gel in a South African study called CAPRISA 004 had 39% fewer HIV infections and 51% fewer genital herpes infections compared to women who used a placebo gel. These results provided the first evidence that an antiretroviral drug delivered in a gel form can reduce sexually transmitted infections of HIV and herpes in women. Gilead Sciences licensed the drug royalty-free to CONRAD, who manufactured and supplied the gel for the trial.
"TIA has agreed to help facilitate the manufacture of this product so that it will be affordable and accessible to women, not only in South Africa, but the entire continent of Africa. While we have an enormous amount of work to accomplish before the product is available, we are creating a
mechanism to expedite the process to the market," said Pontsho Maruping, Group Executive: Sectors at TIA. "We hope this can be accomplished in the next three years," Ms. Maruping added.
CONRAD is spearheading regulatory work toward registration in the U.S., South Africa and Europe. The FDA has granted Fast Track approval designation for Tenofovir1% gel, which facilitates the development and expedites the review of drugs that are intended for treating serious diseases and fill an unmet medical need. CONRAD's clinical team is currently working on expanded studies that will compare various dosing regimens and clinical trials requested by the FDA, including safety in adolescents and drug-drug interaction studies.
|Contact: Annette Larkin|