GlaxoSmithKline's HIV unit ViiV Healthcare announced that it has finalized a deal with Shanghai-based Desano Pharmaceuticals to allow the production in China of an active ingredient needed for its HIV treatment.
The strategic manufacturing agreement enables Desano to co-produce dolutegravir, an integrase strand transfer inhibitor that is used along with other antiretroviral agents to manufacture ViiV Healthcare's Tivicay.
The collaboration between the two companies is viewed as way to introduce a competitive supply of the finished HIV treatment for the Chinese market and several other developing countries, dependent on nation approvals.
This move also serves to strengthen ViiV Healthcare's commitment to help improve access to its treatments for HIV patients, especially those living in countries that have been affected by the disease the most.
"This manufacturing agreement with Desano for dolutegravir is a significant achievement to facilitate access to our medicines," ViiV Healthcare Chief Executive Officer Dr. Dominique Limet said.
"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."
According to the agreement, Desano will be allowed to locally manufacture the active pharmaceutical ingredient (API) dolutegravir in China to feed in to ViiV Healthcare's chain of supply. ViiV Healthcare and Desano are also exploring the possibility for the future manufacture of finished treatment product as well as fixed dose combinations dolutegravir with APIs.
Desano Pharmaceuticals president Ying Kan said the company welcomes the opportunity to collaborate with ViiV Healthcare to produce competitive yet high quality supplies of dolutegravir and its combinations.
The Desano chief added that the agreement will allow both companies to contribute to the international goal of making HIV treatment options more readily available to patients around the world.
Dolutegravir
As an integrase strand transfer inhibitor, Dolutegravir serves to block the replication of HIV during treatment by stopping its viral DNA from integrating into the genetic composition of human immune cells (T-cells). This process is important in the replication cycle of the virus and also leads to the establishment of chronic infection in HIV patients.
ViiV Healthcare's Tivicay treatment has been approved for use in 70 different countries around the world, including those in Africa, Asia, Australia, Europe, Latin America and North America.
The China Food and Drug Administration (CFDA) is currently evaluating a regulatory application for the API dolutegravir.
Photo: Wheeler Cowperthwaite | Flickr
