Navigation Links
Next steps for Tenofovir gel: CONRAD and TIA sign license agreement
Date:6/14/2011

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
alarkin@conrad.org
703-772-6427
CONRAD
Source:Eurekalert

Related medicine news :

1. New Lumension Webcast Highlights Key Steps to Prepare Healthcare Firms and Business Associates to Comply with New HITECH Act
2. UAB-led study shows simple steps could reduce stillbirths by up to 1 million
3. KID HEALTHY-Steps to Healthy Living Kicks Off 2010 Campaign to Make Southern California Kids and Families Healthier
4. New York Medical Malpractice Attorney Recommends Cancer Patients Take Precautionary Steps Before Undergoing Radiation Therapy
5. Consumers over age 50 should consider steps to cut copper and iron intake
6. B. Eliot Cole, MD, Steps Down as Executive VP at Aventine Healthsciences and Executive Director of American Society of Pain Educators
7. Strep steps up in urinary tract infections
8. Attain Fertility Offers 3 Steps to Protect Emotional Well-being While Trying to Get Pregnant
9. More Steps a Day Lead to Better Health
10. Khannna Institute to offer Crystalens in Quarter Diopter Steps
11. Five Essential Steps to Choosing Toning Footwear
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San ... Society and the Road To Recovery® program to drive cancer patients to and from ... adults to ensure the highest quality of life and ongoing independence. Getting to ...
(Date:6/24/2016)... New York, NY (PRWEB) , ... June 24, ... ... lifestyle publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as ... believes that “the most beautiful women in the world, and the most handsome ...
(Date:6/24/2016)... ... ... Venture Construction Group (VCG) sponsors Luke’s Wings 5th Annual ... Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event raised funds ... been wounded in battle and their families. Venture Construction Group is a 2016 Silver ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
Breaking Medicine Technology: