ViiV Healthcare, a global specialist HIV company, and Desano Pharmaceuticals (Desano), a leading vertically integrated pharmaceuticals company, announced a strategic manufacturing agreement to enable production of dolutegravir in China. The agreement will offer an additional source of the dolutegravir active pharmaceutical ingredient (API), and will allow ViiV Healthcare to offer a competitive supply of the finished product (dolutegravir 50mg, marketed under the name Tivicay) for China and a number of developing countries, subject to national approvals. This strengthens ViiV Healthcare’s commitment to improve access to its treatments for people living with HIV, especially in countries hardest hit by the disease.
“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.” said Dr Dominique Limet, chief executive officer, ViiV Healthcare.
Based in Shanghai, Desano is a high quality manufacturer, therefore well suited to partner with ViiV Healthcare. Under the agreement, Desano will manufacture the API of dolutegravir to feed in to the GSK/ViiV Healthcare supply chain for onward sale in China and developing countries covered by the agreement. ViiV Healthcare and Desano are also exploring further options for future manufacture of finished drug product and fixed dose combinations of dolutegravir with APIs.
“As one of the leading Chinese pharmaceutical companies dedicated to developing, manufacturing and supplying antiretroviral (ARV) APIs for HIV and finished pharmaceutical products, Desano is honored to cooperate with ViiV Healthcare to manufacture a high quality, competitive supply of dolutegravir and its combinations,” said Ying Kan, president of Desano Pharmaceuticals. “We believe that working together with ViiV Healthcare we can better contribute to the global goal of making treatment options available to patients across the globe.”
Dolutegravir is an integrase strand transfer inhibitor (INSTI) for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Tivicay is approved in over 70 countries across North America, Europe, Asia, Australia, Africa and Latin America. A regulatory application for dolutegravir is currently 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. With more than 40,000 new HIV infections and over 25,000 deaths reported in 2011. People living with HIV/ AIDS in China who meet the national treatment criteria are referred to receive care through the China National Free Antiretroviral Treatment Programme (CNFATP). Still, only an estimated 126,000 people with HIV were receiving antiretroviral treatment, with an estimated 76% of adults and children who met the criteria receiving antiretroviral treatment.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Shionogi joined in October 2012.
Founded in 1996, Desano Pharmaceutical is a leading vertically integrated pharmaceuticals company specialising in developing and manufacturing of generic ARV APIs and formulations with 4 manufacturing sites located in China approved by the agencies of CFDA, USFDA and WHO.