Pfizer and GlaxoSmithKline (GSK) joint venture ViiV Healthcare and Shanghai-based Desano Pharmaceuticals have signed a manufacturing agreement to produce a new HIV drug Tivicay (dolutegravir 50mg) in China.
Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). The drug is used in combination with other antiretroviral agents for the treatment of HIV.
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The deal strengthens ViiV Healthcare commitment to improving access to HIV treatments in the country and several other developing nations.
ViiV Healthcare chief executive officer Dr Dominique Limet said: "This manufacturing agreement with Desano for dolutegravir is a significant achievement to facilitate access to our medicines.
"With our recent agreement with the Medicines Patent Pool and our other access initiatives this deal is aligned with our ongoing commitment to improve access to our medicines in countries where the need is greatest."
As part of the agreement, Desano will manufacture the active pharmaceutical ingredient (API) of dolutegravir to feed into the GSK/ViiV Healthcare supply chain for onward sale in China and developing countries covered by the agreement.
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By GlobalDataIn addition, both companies are also exploring further options to manufacture finished drug product and fixed dose combinations of dolutegravir with APIs in future.
Tivicay is approved in more than 70 countries across North America, Europe, Asia, Australia, Africa and Latin America, while a regulatory application for the drug is being evaluated by the China Food and Drug Administration (CFDA).
UNAIDS estimates that approximately 780,000 (620,000 to 940,000) people are infected with HIV/AIDS in China. In 2011, more than 40,000 new HIV infections and over 25,000 deaths were reported.
Only an estimated 126,000 people with HIV are currently receiving antiretroviral treatment, with an estimated 76% of adults and children meeting the criteria receiving antiretroviral treatment.
Image: HIV-1 particles assembling at the surface of an infected macrophage. Photo: © 2006 Public Library of Science.
