India, China to produce generic of Gilead's TAF

Currently 5.4 million people are receiving Gilead HIV medicines in low and middle-income countries through the company's access initiatives

Singapore: Gilead have allowed generic manufacturers in India and China to produce generic versions of its HBV and HIV drug, tenofovir alafenamide (TAF).

The company is in agreement with the Medicines Patent Pool allowing generics manufacturers from both the Asian nations to produce TAF.

Making the announcement at the 20th International AIDS Conference in Melbourne, Australia, Gilead said that its agreement with MPP is mainly to expand access to their investigational drug tenofovir alafenamide (TAF) for HIV and hepatitis B, contingent on the medicine's US regulatory approval.

Reports added that under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries.

"The Medicines Patent Pool plays a critical role in efforts to expand access to HIV treatment in the developing world," Mr Gregg H. Alton, Executive Vice President for Corporate and Medical Affairs at Gilead Sciences explained.

He added, "By expanding our partnership to include TAF today, we hope to lay the groundwork for the rapid introduction of generic versions should it receive regulatory approval."

The new agreement expands on Gilead's previous licensing partnership with the MPP. In July 2011, Gilead became the first pharmaceutical company to join the MPP. Today, six Indian pharmaceutical companies hold MPP sub-licenses for Gilead HIV medicines, a news report pointed out.

"As the Medicines Patent Pool's first pharmaceutical industry partner, Gilead has played a vital role in increasing treatment access for people living with HIV in the developing world," said Mr Greg Perry, executive director of the MPP.

"We welcome this expansion of our partnership, and we look forward to working with our sub-licensees to provide access to low-cost, high-quality versions of TAF and other Gilead antiretroviral medicines," he added.

Currently 5.4 million people are receiving Gilead HIV medicines in low and middle-income countries through the company's access initiatives, more than half of all people on HIV therapy in these countries. Ninety-nine percent of these people receive versions produced by generic partners.

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