Shire Supports Generic HIV Drug Plan

Shire’s Canadian subsidiary, Shire BioChem, announced recently that it has agreed to a compulsory license that would go toward allowing Apotex to manufacture a generic combination HIV drug for export to Rwanda under Canada’s Access to Medicines Regime.

Rwanda notified the World Trade Organization (WTO) last month that it plans to import 260,000 packs over two years of a fixed-dose combination product containing zidovudine, lamivudine and nevirapine that will be manufactured by Apotex. Shire holds Canadian patent rights for 3TC (lamivudine).

Canada’s Access to Medicines Regime is based on a 2003 WTO decision to allow countries with public health problems to import generic drugs if they are unable to manufacture the medicines themselves.

Shire said it agrees that the compulsory license will be royalty-free, and that the drug will be sold to Rwandan authorities on a no-profit basis.

Previously, GlaxoSmithKline, which holds Canadian rights to products containing zidovudine and lamivudine, announced that it consented to the plan.