Mylan Inc. on Friday announced that its subsidiary Matrix Laboratories Ltd (MLL) has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive licence to manufacture, market and distribute a generic version of a HIV drug.

The non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), is pending its regulatory approval for the treatment of HIV-1-infected adults. Matrix will have the right to market the product in sub-Saharan Africa, certain developing countries and India.

Agreement terms

Under the agreement, MLL 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 programmes.

Prior to the signing of licence agreements, TMC278 was submitted for regulatory approval in the US, Europe, Canada, Switzerland, Australia, Russia and South Korea. At present, Matrix has 300 mg Tenofovir Disoproxil Fumarate and 300 mg Lamivudine, products which are part of the Anti-Retroviral (ARV) portfolio.

Matrix Laboratories, which has a manufacturing base in Hyderabad and was acquired by Mylan a few years back, ranks among the world's leading producers of ARV products. Its ARV franchise includes active pharmaceutical ingredients and 34 first- and second-line finished doses, eight of which are paediatric products, a Mylan release said.

The President of Mylan, Ms Heather Bresch, said: “This agreement represents additional recognition for Mylan's Matrix in the antiretroviral (ARV) market, in which Matrix is a leader. It also marks a significant step towards the future access of this important new product being developed by Tibotec Pharmaceuticals for patients living with HIV/AIDS”.

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