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Tibotec grants HIV licenses to generics

Tibotec Pharmaceuticals of Cork, Ireland has granted multiple non-exclusive licences 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 preferred by public health treatment programmes.

Tibotec has chosen to collaborate with multiple manufacturers in order to ensure the widespread and sustainable access to, and supply of, TMC278 in areas with high evidence of HIV and to support generic competition. The company 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 US, 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 licence 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 licence and collaboration agreement with Gilead Sciences Inc. for the development and commercialisation of a new, once-daily, fixed-dose antiretroviral product containing Tibotec's investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine hydrochloride) and Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate). Tibotec and Gilead are committed to working together to make the fixed-dose combination of TMC278 and Truvada available in the developing world and are working towards a separate agreement for these countries.

 
   
 
 
 
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