Matrix Lab, in which the US generic major Mylan Inc owns a controlling stake, has received tentative approval under the President’s Emergency Plan for AIDS Relief (PEPFAR).
USFDA approved Matrix’ abbreviated new drug application (ANDA) for a fixed-dose combination (FDC) of efavirenz, emtricitabine, tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg.
Matrix Lab’s efavirenz, emtricitabine and tenofovir combination pill is the generic version of Gilead Sciences’ Atripla tablets.
Atripla is indicated for the treatment of HIV-1 infection in adults.
Single combination pills containing several drugs into a once daily dose can dramatically reduce pill burden, and improve patient compliance with complex AIDS treatment regimens.
“Matrix’s generic fixed-dose combination will dramatically improve access to this more patient-friendly medication while reducing the cost of treatment,” said Mylan president Heather Bresch in the press release
Atripla, which combines three anti-AIDS medicines – efavirenz, emtricitabine and tenofovir – into a single daily dose for either first- or second-line treatment and is one of the best-selling AIDS products in developed countries
Atripla registered approximately $1.6 billion in U.S. sales alone for the twelve months ending June 30, according to IMS Health. Until now, a generic version of this product has not been available in any market.
Matrix’ efavirenz, emtricitabine and tenofovir combination pill is the first and only generic version of this product and will be eligible for purchase outside the U.S. in many developing countries, Mylan said in a press release.
FDA’s tentative approval under PEPFAR means that Matrix’s product meets all of the US regulator’s manufacturing quality, safety and efficacy standards.
But Matrix Lab’s efavirenz, emtricitabine and tenofovir combination pill cannot be sold in US because the individual components are still patent protected for marketing exclusivity.
However, USFDA approval under PEPFAR make the product eligible for purchase outside the U.S. in many developing countries.
Hyderabad, south India=based Matrix Lab has a wide range of antiretroviral (ARV) products that includes active pharmaceutical ingredients (API) and first- and second-line finished doses.
In 2007, Matrix signed an agreement with the Clinton HIV/AIDS Initiative (CHAI) that significantly lowers the price of AIDS treatment for second-line anti-retroviral drugs (ARVs), as well as a new, once-a-day pill that is currently cost prohibitive in the developing world.
This deal made Matrix one of the key suppliers of affordable second-line Antiretroviral (ARV) drugs into 66 low- and middle-income countries in Africa, Asia, Latin America and the Caribbean. Second-line treatment is required in patients who develop resistance to first-line treatment and typically costs 10 times the price of first-line therapy. Nearly half a million patients will require these drugs by 2010.
Approximately 30% of HIV/AIDS patients in developing countries depend on at least one Matrix ARV product.
Matrix Laboratories has API manufacturing facilities at four locations in and around Hyderabad and Visakhapatnam, India. Matrix Lab’s solid oral dosage forms facility is located near Nashik, about 150 km from Mumbai. All of Matrix Lab’s facilities are USFDA approved. The facilities also have ISO 9000, ISO 14000 Certifications.