Gilead and Merck ink Atripla deal

Atripla contains 600mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 200mg of emtricitabine and 300mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs). Efavirenz is marketed by Merck under the tradename Stocrin in all territories outside of the US, Canada and certain European countries (where it is commercialized by Bristol-Myers Squibb under the tradename Sustiva).

Emtricitabine and tenofovir disoproxil fumarate are commercialized by Gilead Sciences under the tradenames Emtriva and Viread, respectively. The compounds are commonly prescribed together as a once-daily, fixed-dose tablet, marketed under the tradename Truvada for use as part of combination therapy.

Atripla was approved by the FDA in July. In the US, the product is commercialized by Bristol-Myers Squibb and Gilead Sciences through a joint venture. The FDA also granted approval of an alternate tradedress of Atripla for developing countries, where Atripla will be made available as a white-colored tablet to distinguish it from the salmon-colored version currently available in the US.

Gilead and Merck plan to pursue registration of the product with individual country health authorities. The component therapies are already registered, or in the process of being registered, in many of these countries.

Under the terms of the agreement, Gilead will manufacture Atripla using efavirenz supplied by Merck. Merck, in turn, will handle distribution of the product in the countries covered by the agreement.

In other news, Gilead announced that it has completed its acquisition of Corus Pharma and received regulatory clearance by the US Federal Trade Commission. Gilead expects to retain Corus’ Seattle-based operations, establishing a center of expertise in respiratory therapeutics for the company.

Gilead said that it will provide updated full-year 2006 expense guidance reflecting the impact of the Corus acquisition in October.