Developing countries to benefit from MPP and Gilead HIV drug licensing agreement

Upon approval for use by the US, a generic version of Gilead’s HIV drug TAF will be made available to low- and middle-income countries

drugs & pills in mans hand image

Medicine Patent Pool (MPP), a not-for-profit organization, has partnered with pharmaceutical company Gilead Sciences to produce a generic version of a new HIV treatment drug in India and China that will be distributed in 112 countries. The partnership was announced last week at the AIDS 2014 conference in Melbourne.

One of the most contentious issues in HIV treatment is the price of antiretrovirals and other drugs that can save lives. Patented drugs by pharmaceutical companies are often far beyond the reach of many of the world’s poorest. Though many developing nations may receive the drugs at a cheaper price, this does not apply to middle income countries like Mexico and India, which still have a very large population of the extremely poor.

Earlier this year, pharmaceutical company Gilead came under fire for releasing a Hepatitis C vaccine that costs US$1,000 per pill, or $84,000 for an entire course. Even in the developed world, there is concern that health insurers might shy away from covering the cost of such expensive drugs and instead force patients back to older and less effective drug treatments.

The licensing agreement between Gilead, one of the sponsors of the AIDS 2014 conference, and the MPP will allow India and China to manufacture a cheap, generic version of the company’s new HIV drug tenofovir alafenamide (TAF). The drug is currently undergoing Phase III clinical trials and, shortly after its approval is the US, will be sold in 112 nations that are said to be home to 92 percent of the developing world’s HIV sufferers, including 65 so-called middle income nations.

“This continues MPP’s novel approach of licensing promising new medicines in advanced stages of development or soon after registration to speed delivery to countries most affected by the HIV epidemic,” said Greg Perry, Executive Director of the MPP.

At an AIDS 2014 press conference, Linda Gail-Bekker, president-elect of the International AIDS Society and a doctor with over 20 years treating the disease in South Africa, expressed her gratitude that the five percent royalty paid to Gilead will not include pediatric treatments, which will be free. This has been key feature of previous agreements between MPP and Gilead. She also sees TAF as a worthy alternative to current treatments, with potentially lower side effects.

TAF itself seems to be notable for a few reasons in itself. Doses of TAF may need to be 10 times lower than tenofovir disoproxil fumarate (TDF), a current widely-used HIV drug. According to the MPP and Gilead, the lower dose will eventuate in lower production costs and also possible greater ease in delivering fixed single tablet treatments.

It is also positively associated with bone density and renal safety markers, according to Phase II tests conducted last year and is being studied as a standalone treatment for chronic Hepatitis B, which like Hepatitis C can be a problematic co-infection for many of those living with HIV.

Source: MPP

Henry Sapiecha

Tags: , , , , ,

Leave a Reply