ViiV Healthcare, Desano to offer China "competitive supply" of GlaxoSmithKline's HIV drug Tivicay

ViiV Healthcare entered into an agreement to allow China's Desano Pharmaceuticals to manufacture the active pharmaceutical ingredient (API) in GlaxoSmithKline's HIV drug Tivicay (dolutegravir), the companies announced Thursday. The move will provide an additional source for dolutegravir and allow ViiV Healthcare "to offer a competitive supply of the finished product…for China and a number of developing countries, subject to national approvals," the companies added.

Dominique Limet, chief executive of ViiV Healthcare, GlaxoSmithKline's joint venture with Pfizer and Shionogi, described the partnership as "a significant achievement to facilitate access to our medicines." Under the partnership, Tivicay is expected to be sold at a discounted price in China. The expected cost was not revealed by GlaxoSmithKline, but a company spokesman suggested that the drug’s price would be on par with the price level charged in developing countries. GlaxoSmithKline noted that the two companies are also exploring further options for the future manufacturing of finished drug product and fixed dose combinations of dolutegravir with APIs.

Meanwhile, industry insiders suggest that the partnership with Desano fits with GlaxoSmithKline’s strategy of working to revive its image in China after the UK drugmaker was fined a record 297 million pounds ($487 million) in September last year for bribing Chinese doctors to use its medications. At the time of the settlement, GlaxoSmithKline pledged to boost access to its medicines in the country by expanding local production and adopting flexible pricing. However, a ViiV spokesman said the negotiations with Desano predated this commitment.

Tivicay is approved in more than 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). The therapy is forecast by analysts to reach peak annual sales of up to 1.8 billion pounds ($2.8 billion) by 2020.

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