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Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment
Date:1/27/2011

ame=news_56">Emcure Pharmaceuticals Ltd of India to broaden access to the medicines darunavir and etravirine in SSA and LDCs and to darunavir in India.

"We believe that voluntary licensing is an important mechanism by which to expand access to our HIV portfolio, including our newest medicines," said Will Stephens, Vice President of Global Access & Partnerships for Janssen Global Services, LLC. "Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the U.S. and Europe underscore the seriousness and speed with which we're working to ensure that all patients in need, not just those in Western markets, will have timely access to the most current regimens."

Tibotec will provide the generic manufacturers with the technical information and knowledge to allow them to manufacture the single agent product. The generic manufacturers will pay royalties ranging from two to five percent. The generic manufacturers will be responsible for timely regulatory filing for generic TMC278 and for seeking pre-qualification from the World Health Organization (WHO) and ANDA approvals. To keep medicines affordable, the generic manufacturers are required to limit their gross profit margin on the sale of TMC278. Prior to the signing of these agreements, Tibotec submitted TMC278 for regulatory approval in the U.S., Europe, Canada, Switzerland, Australia, Russia and South Korea. Upon approval, it is expected that TMC278, in combination with other antiretroviral medicinal products, will be indicated for the treatment of HIV-1 infection in treatment-naïve adult patients.

The agreements cover the manufacture of TMC278 as a single agent medicine and a license to develop an FDC product using TMC278 with 300 mg tenofovir disoproxil fumarate and 300 mg lamivudine.

In July 2009, Tibotec announced that it had entered into a license and collaboration agreement with Gilead Sciences
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SOURCE Tibotec Therapeutics
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