J&J unit Tibotec signs multiple deals with generic drugmakers for access to new HIV treatment rilpivirine pre-approval

Ireland-based Tibotec Pharmaceuticals, a subsidiary of US health care major Johnson & Johnson (NYSE: JNJ), has granted multiple non-exclusive licenses to generic manufacturers including India’s Hetero Drugs, US generics major Mylan’s (Nasdaq: MYL) Matrix Laboratories India and Aspen Pharmacare (APN: SJ) 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 25mg 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.

"We believe that voluntary licensing is an important mechanism by which to expand access to our HIV portfolio, including our newest medicines," said Will Stephens, vice president of Global Access & Partnerships for Janssen Global Services (another J&J company). "Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the USA and Europe underscore the seriousness and speed with which we're working to ensure that all patients in need, not just those in Western markets, will have timely access to the most current regimens," he added.