The HIV-oriented joint venture of Pfizer ($PFE), GlaxoSmithKline ($GSK) and Japan's Shionogi is turning to a Chinese manufacturer for a cheap supply of dolutegravir, the active ingredient in its Tivicay. The deal is seen as a way to cut the cost in China and some other developing countries of the JV's newest HIV fighter.
ViiV Healthcare said today that it has struck a deal with Shanghai-based Desano Pharmaceuticals, a Chinese company with experience making HIV meds in China. Desano will offer ViiV a "competitive supply" of the API for use in countries covered by ViiV's agreement forged last year with the Medicines Patent Pool to offer the drug in some countries at a lower cost. The patent pool announced a year ago that it had a sublicense with Desano to manufacture dolutegravir, a drug brought to the JV by Shionogi.
Tivicay, which came with a retail cost of $14,000 a year in the U.S. when it was approved in 2013, is expected to hit peak sales of $5 billion a year.
|Viiv CEO Dominique Limet|
"This manufacturing agreement with Desano for dolutegravir is a significant achievement to facilitate access to our medicines," ViiV CEO Dr. Dominique Limet said in a statement.
ViiV said it is also talking with Desano about manufacturing the finished form of the drug and fixed-dosed combinations of dolutegravir with APIs. Last year, ViiV got FDA approval for Triumeq, a three-way combination pill that adds Tivicay (dolutegravir) to two commonly used treatments, abacavir and lamivudine.
Founded in 1996, Desano Pharmaceutical has four manufacturing sites in China that are approved by the FDA, the WHO and China's regulator, the CFDA. It says it specializes in developing and manufacturing of generic antiretroviral APIs and formulations.
ViiV has had issues with manufacturing Tivicay. In August 2014, it recalled 1,056 bottles from the U.S. and Puerto Rico because tablets had been cross-contaminated with Promacta (eltrombopag), a GSK drug approved for treating chronic immune thrombocytopenia.
- here's the release