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 rilpivirinehydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults
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.
Rilpivirine is new drug (in pre-registration stage) which is from class of non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz.
Rilpivirine seems to be protected by WO 2003/016306 and its indian equivalent is granted as 222987 (00265/DELNP/2004)