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PITTSBURGH — A Mylan subsidiary has inked a nonexclusive license agreement with Tibotec Pharmaceuticals to manufacture, market and distribute a generic version of an HIV treatment.
Pending the regulatory approval of TMC278 (rilpivirine hydrochloride), Matrix Labs will have the right to manufacture once-daily 25-mg TMC278 as a single-agent medicine and a fixed-dose combination product, Mylan said. Matrix also will be able to market the drug in sub-Saharan Africa, certain developing countries and India.
Prior to the signing of license agreements, TMC278 was submitted for regulatory approval in the United States, 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-naive adult patients.
"This agreement represents additional recognition for Mylan's Matrix in the antiretroviral market, in which Matrix is a leader," Mylan president Heather Bresch said. "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."