Bristol-Myers Squibb Company, Gilead Sciences, Inc. and Merck & Co., Inc. has announced the submission of a Marketing Authorisation Application (MAA) for Atripla (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) in the European Union to the European Medicines Agency (EMEA).
The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), subject to validation by the EMEA.
The MAA for Atripla in the European Union was filed jointly by the three companies through a newly established three-way joint venture based in Ireland, Bristol-Myers Squibb Gilead Sciences And Merck Sharp & Dohme Limited. Review of the MAA will be conducted by the EMEA under the centralized licensing procedure, which, when finalized, provides one marketing authorization in all member states of the European Union. Discussions among the three companies regarding agreements for manufacturing, commercialization and distribution of Atripla in the European Union are ongoing.
Atripla was approved by the US Food and Drug Administration (FDA) on July 12, 2006. In the United States, 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-coloured tablet to distinguish it from the salmon-coloured version currently available in the United States. Gilead and Merck established a separate agreement in August 2006 for distribution of the product in developing countries.
"Bristol-Myers Squibb is committed to delivering effective HIV therapies to patients worldwide and is pleased to work with Gilead and Merck to realize this goal with Atripla," said Lamberto Andreotti, president, Worldwide Pharmaceuticals, Bristol-Myers Squibb. "With the filing of Atripla in Europe, we are one step closer to making available another effective treatment option for European adult patients living with HIV/AIDS."
"As the first and only once-daily single tablet regimen, Atripla may help to simplify therapy for many HIV-infected adults. Gilead is pleased to have established this partnership with Bristol-Myers Squibb and Merck, and we look forward to working with colleagues at both companies to make this product available to people living with HIV in Europe as quickly as possible," said Kevin Young, Executive Vice President, Commercial Operations, Gilead Sciences.
"Atripla has the potential to offer an important new tool to patients and physicians in Europe for treating HIV infection in adults," said Stefan J. Oschmann, President, Europe, Middle East, Africa, Canada, Merck & Co., Inc. "This new single tablet regimen exemplifies our commitment to putting patients first. We look forward to collaborating with BMS, Gilead and national health authorities to deliver Atripla to those who need it as soon as possible."