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news.Tibotec Pharmaceuticals has signed licensing agreement with Hetero Drugs, Matrix Laboratories (a Mylan company) of India and Aspen Pharmacare of South Africa to manufacture, market and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278).
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The agreements cover the manufacture of TMC278 as a single agent medicine and a license to develop an FDC product using TMC278 with 300mg tenofovir disoproxil fumarate and 300mg lamivudine.
Tibotec Pharma has licensed marketing rights to the Indian manufacturers in sub-Saharan Africa (SSA), Least Developed Countries (LDCs) and India; however Aspen got license to market the product in SSA including South Africa.
As per the agreement, the generic manufacturers will be responsible to manufacture once-daily 25mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product.
Tibotec said it will offer the generic manufacturers with the technical information and knowledge to allow them to manufacture the single agent product.
The company is entitled to get royalties ranging from 2 to 5%.
Janssen Global Services Global Access & Partnerships vice president Will Stephens said they believe that voluntary licensing is an important mechanism by which to expand access to their HIV portfolio, including their newest medicines.
"Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the US 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," Stephens said.