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

CORK, Ireland, Jan. 27, 2011 /PRNewswire/ -- Tibotec Pharmaceuticals today announced that it has granted multiple non-exclusive licenses to generic manufacturers including Hetero Drugs Limited, Matrix Laboratories Limited (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naive HIV-1 infected adults.  The generic pharmaceutical manufacturers in India will have rights to market the product in sub-Saharan Africa (SSA), Least Developed Countries (LDCs) and India. Aspen will have rights to market the product in SSA including South Africa. Under the agreement, the generic manufacturers will be entitled to manufacture once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product. Fixed-dose combinations contain multiple medicines formulated into one tablet helping to simplify HIV therapy and are preferred by public health treatment programs. Tibotec has chosen to collaborate with multiple manufacturers in order to ensure the widespread and sustainable access to, and supply of, TMC278 in areas of high HIV burden and to support generic competition.    

Tibotec specializes in the research and development of new medicines for infectious diseases including HIV. It plays a key role in the Johnson & Johnson Global Access & Partnerships Program, which is committed to improving and saving lives by addressing unmet medical needs and ensuring the availability of HIV medicines to patients in need. The Program is already working, through existing agreements with generic manufacturers Aspen of South Africa and

SOURCE Tibotec Therapeutics
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2. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
3. Tibotec Therapeutics Debuts Innovative Web Portal for HIV/AIDS Front-Line Service Providers
4. Tibotec Therapeutics Launches GRACE Campaign for Women and People of Color Living With HIV/AIDS
5. Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
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8. Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008
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10. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
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