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:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical ... Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. ... honor of Morris F. Collen, a pioneer in the field of medical informatics, this ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the ... medical article to the newly revamped Cosmetic Town journal section, featuring ... transplant procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi ...
(Date:10/12/2017)... Chapel, FL (PRWEB) , ... October 12, 2017 , ... ... is holding a treadmill relay – Miles by Moonlight to raise money for the ... donating $300 or more. , Teams will work together to keep their treadmills ...
(Date:10/12/2017)... ... 2017 , ... In the United States, single-family home owners ... New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average is $7,000 ... property-tax rates, which contributes to the relatively lower cost of living in places ...
Breaking Medicine News(10 mins):
(Date:10/12/2017)... -- AVACEN Medical , Inc. (AVACEN) announced that Frost ... Product Innovation Award for Its fibromyalgia pain management device. ... device market research by Frost & Sullivan,s industry experts. ... relief product, the AVACEN 100, offers a safe and effective ... ...
(Date:10/11/2017)...  True Health, a leader in integrated diagnostics ... National Breast Cancer Awareness month to educate doctors ... Research recently published in ... than 10 million American women are at significant ... BRCA2 and have not had testing. These mutations can ...
(Date:10/5/2017)... , Oct. 5, 2017  In response ... of Oral and Maxillofacial Surgeons (AAOMS) released prescribing ... – to be used as a first-line therapy ... Recognizing the ... AAOMS White Paper "Opioid Prescribing: Acute and Postoperative ...
Breaking Medicine Technology: