ViiV Healthcare, the HIV specialty drug company of GlaxoSmithKline (GSK), Pfizer, and Shionogi, and Desano Pharmaceuticals, a Chinese pharmaceutical company, have formed a strategic manufacturing agreement to enable production in China of dolutegravir the active pharmaceutical ingredient in ViiV’s Tivicay. The agreement will offer an additional source of the dolutegravir API and will allow ViiV Healthcare to offer a competitive supply of the finished product (dolutegravir 50 mg, marketed under the name Tivicay) for China and a number of developing countries, subject to national approvals.

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.

Tivicay (dolutegravir) 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. 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 considered essential in the HIV replication cycle and is also responsible for establishing chronic infection.

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK and Pfizer for delivering advances in treatment and care for people living with HIV. Shionogi joined in October 2012.

Founded in 1996, Desano Pharmaceutical is vertically integrated pharmaceuticals company, based in Shanghai, specializing in developing and manufacturing of generic antiviral (ARv) APIs and formulations with four manufacturing sites located in China.

Source: Viiv Healthcare