Merck & Co is seeking to register its three-in-one fixed dose combination Atripla in 66 developing countries, in addition to seeking World Health Organization prequalification for the product, the company announced on Friday.
Atripla, which is a single tablet containing a daily dose of efavirenz, tenofovir and emtricitabine, will be priced at $613 a year for least developed countries and higher prevalence middle income countries (>1% HIV prevalence), and $1032 a year for other middle-income countries that qualify for a discounted price.
Atripla will be sold in developing countries as a white tablet in order to differentiate it from the salmon-pink tablet sold in the United States, in order to reduce the risk of diversion of product from developing countries.
Atripla is a collaboration between Merck, the license holder for efavirenz outside the US and western Europe, and Gilead, the license holder of tenofovir and emtricitabine. In contrast to Gilead's policy with tenofovir, where the company has granted voluntary licenses in India and South Africa, Atripla commercialisation will remain in the hands of the patent holders. This is likely to prevent any significant competitive pressure on the price of the product, since once licenses are granted, competition from generic versions of this fixed dose combination will be impossible without the granting of compulsory licenses for rival versions.
Although Merck will be able to import Atripla into eleven countries on the basis of US Food and Drug Administration registration, licensing in other countries may take several years in some cases owing to lack of regulatory agency capacity. Tenofovir, one of the components of Atripla, remains unlicensed in South Africa despite the grant of a voluntary license for the product to South African manufacturer Aspen in 2004. According to the Treatment Action Campaign, Aspen’s version of tenofovir was already under fast track review by South Africa’s Medicines Control Council in June 2006.
The combination of efavirenz, tenofovir and emtricitabine has been recommended by the World Health Organization as a preferred first-line combination wherever it is available, because of the reduced risk of toxicity when compared to a stavudine (d4T)-based regimen.