Mylan Inc. announced that its subsidiary Matrix Laboratories Limited has signed an agreement with Tibotec Pharmaceuticals for a non-exclusive license to manufacture, market and distribute a generic version of the non-nucleoside reverse transcriptase inhibitor Rilpivirine Hydrochloride (TMC278), pending its regulatory approval for the treatment of treatment-naive HIV-1-infected adults. Matrix will have the right to market the product in sub-Saharan Africa, certain developing countries and India.

Mylan president 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 toward the future access of this important new product being developed by Tibotec Pharmaceuticals for patients living with HIV/AIDS. By obtaining this license at this time, we can now begin our research and development phase for our formulation to ensure that a generic version will be available in developing countries as quickly as possible. This was an important step in ensuring that novel ARV treatments available in more fortunate countries are accessible to patients in need all over the world.”

Under the agreement, Matrix 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.

Prior to the signing of license agreements, TMC278 was submitted 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 ARV medicinal products, will be indicated for the treatment of HIV-1 infection in treatment-naive adult patients.

The agreement covers the manufacture of TMC278 as a single agent medicine and a license to develop a FDC product using TMC278 with 300 mg Tenofovir Disoproxil Fumarate and 300 mg Lamivudine, products which are already part of Matrix's ARV portfolio.

Matrix 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.
Mylan Inc maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.