June 15, 2011
www.conrad.org
 

CONRAD News UPDATE

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NEXT STEPS FOR TENOFOVIR GEL: CONRAD AND TIA SIGN LICENSE AGREEMENT

Terms of deal to make gel affordable and accessible in Africa following regulatory approval

CONRAD and the South African Government’s Technology Innovation Agency (TIA) announced a license agreement that grants TIA the rights to manufacture and distribute tenofovir 1% 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 tenofovir 1% 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. 

FACTS Trial

On June 14th, Prof. Helen Rees, the Director of the Wits Reproductive Health and HIV Institute (WRHI), Derek Hanekom, the South African Deputy Minister of Science and Technology, and U.S. Ambassador Donald Gips announced a follow-on trial to test the safety and effectiveness of tenofovir 1% gel.   The Follow-on African Consortium for Tenofovir Studies (FACTS) will conduct the Phase III trial to be known as FACTS 001.

The study is being funded by the South African Departments of Science and Technology and Health, and the United States government through USAID. CONRAD is providing the gel for the study and TIA will fund the technical support and monitoring carried out by the African Clinical Research Organisation (ACRO).

Dr. Henry Gabelnick Wins CAPRISA – DST Award

On 5th June 2011,  South African Deputy Minister Hanekom presented Dr. Henry Gabelnick with the CAPRISA – Department of Science and Technology Award "for exceptional contributions to the CAPRISA 004 trial for HIV prevention in women.”

In his speech, Deputy Minister Hanekom said, "As the Executive Director of CONRAD, Dr. Gabelnick, has the extraordinary ability of using science as a landmark in uniting dynamic individuals to achieve the goal of providing contraceptives to men and women in under-resourced parts of the world.

Dr. Gabelnick received his undergraduate and post-graduate degrees from the Massachusetts Institute of Technology and his Ph.D. in 1966, from Princeton University. Committed to global health with a focus on women’s health, Dr. Gabelnick joined CONRAD at its inception in 1986 and became the Director in 1990.

Dr. Gabelnick has devoted more than 20 years to directing contraceptive research and serves on the editorial boards of several journals. Dr. Gabelnick has envisaged innovative research for contraceptive development and was at the forefront of advocating for microbicide development when the idea was first envisaged.  Dr. Gabelnick is an acknowledged leader in the field of microbicide development and as such currently serves or has previously served on several microbicide boards including the Alliance for Microbicide Development, International Partnership for Microbicides and Biosyn, Inc.  Dr. Gabelnick was recognised for his unparalleled commitment and dedication to the development of microbicides and was awarded his second lifetime achievement award at the 6th International Microbicides 2010 Conference.

Today, we recognise and award Dr Gabelnick for his critical contributions and leadership role in the CAPRISA 004 trial."