GSK unit ViiV wins major dolutegravir tender in Botswana


ViiV Healthcare has won its largest ever national tender for HIV therapy dolutegravir (Tivicay) in Botswana. The company expanded access to the therapy under the Medicines Patent Pool, which includes China manufacture by Shanghai-based Desano Pharmaceuticals.

The therapy was recommended for patients with HIV late last year by the World Health Organization (WHO).

"This is the first time dolutegravir will be made available as part of a national health program in sub-Saharan Africa since the WHO recommended dolutegravir as alternative first line treatment in HIV patients in late 2015," parent company GlaxoSmithKline ($GSK) said in a release.

ViiV, a unit of a GSK venture formed with Pfizer ($PFE) and Osaka-based Shionogi to pool resources on HIV therapies, was approved by the China FDA earlier this year, following a July 2015 agreement with Desano to manufacture a "competitive supply" for Medicines Patent Pool countries.

The United Nations Medicines Patent Pool initiative allows royalty-free sales of generics of patented medicines in poor countries with the continent of Africa benefitting, according to GSK.

"Most recently, ViiV Healthcare also announced the extension of its license agreement with the Medicines Patent Pool for the adult formulation of dolutegravir to include all lower middle-income countries, a number of which are on the African continent," GSK said.

“This tender agreement is a great moment as part of our commitment to accelerating access to our treatments in Africa," Dominique Limet, CEO of ViiV, said in a release. "It is even more of an achievement for us as it happens less than three years after the product was first approved and less than one year after it was included in the WHO guidelines.”

It was not immediately clear if the dolutegravir tender for Botswana and other Medicines Patent Pool countries will come from Desano. But the July 2015 release said Desano will offer ViiV a "competitive supply" of the API for use in countries covered by the Medicines Patent Pool at a lower cost.

The branded product, Tivicay, can cost as much as $14,000 a year in the U.S.

Earlier this year, GSK CEO Andrew Witty radically changed policies on enforcing patents against generics in low-income and least-developed countries as well as a new effort in middle-income countries such as Vietnam where licenses would be granted to generics manufacturers to sell products in return for royalty payments.

- here's the release
- and a story from the Telegraph