Getting HIV Drugs to Poor Nations

Johnson & Johnson’s Tibotec Pharmaceuticals is engaging three overseas generic drugmakers in licensing agreements to help speed up the delivery of one of its AIDS drugs. A novel aspect to the agreements is that the non-nucleoside reverse transcriptase inhibitor, rilpivirine, has not yet been approved by the Food and Drug Administration.

However, Tibotec hopes to hasten access to the antiretroviral in resource-constrained, high-prevalence countries. Through agreements with India-based Matrix Laboratories and Hetero Drugs and South Africa’s Aspen Pharmacare, Tibotec may get rilpivirine into sub-Saharan and Indian markets earlier. The generic producers would pay royalties of 2 percent to 5 percent.

Under the agreements, Tibotec provides manufacturing technical information to the generics firms, which are responsible for gaining regulatory approval and pre-qualification from the World Health Organization. With WHO pre-qualification, the generic drugmakers can start selling to some public health agencies ahead of approvals by each individual government.

Tibotec’s approach may help cut years of lag-time common in many of the markets covered, said Jeff Sturchio, CEO of the Global Health Council. “Most of the people affected by the disease live in the countries covered by these agreements,” he said.

“We want to expand access to the drug as quickly as we can where Johnson & Johnson doesn’t have reach, in terms of logistics and manufacturing capability, and doing it at a price that’s more affordable,” said Will Stephens, vice president of global access and partnerships with Titusville, N.J.-based Johnson & Johnson subsidiary Janssen Pharmaceutica.

Aspen is licensed to distribute rilpivirine throughout sub-Saharan Africa and South Africa, while Hetero and Matrix will cover India and parts of the sub-Saharan region.

The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.


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