Yesterday, Mylan Inc. (MYL) announced that its Indian subsidiary, Matrix Laboratories, received tentative approval from the US Food and Drug Administration (FDA) under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its generic version of a fixed-dose combination of Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate tablets in 600 mg/200mg/300 mg dosage strengths.
The decision is in response to an Abbreviated New Drug Application filed by the Indian subsidiary. The tentative approval under PEPFAR is indicative of the fact that the product satisfies all the manufacturing quality, safety and efficacy standards laid down by the agency.
The Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate combination is the generic version of Gilead Sciences’ (GILD) Atripla tablets used for the treatment of HIV-1 infection in adults. It combines three anti-AIDS medicines into a single, daily dose for either first- or second-line treatment and is one of the best-selling AIDS products in developed countries.
The combination of the three anti-AIDS drugs into a single daily dose is not only patient friendly but also cost effective. Existing patents prevent the marketing of the generic product in the U.S. However, the Atripla generic can be purchased in many developing countries outside the U.S.
This tentative nod by regulators strengthens the efforts of Mylan and Matrix to provide increased access to life-saving, affordable AIDS treatments in developing countries. It will also boost Matrix’s wide range of ARV (antiretroviral) products. At least one Matrix ARV product is used to treat nearly 30% HIV/AIDS patients in developing countries.
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