Matrix Laboratories, a subsidiary of Mylan Inc, has received final approval didanosine delayed-release capsules from the US FDA under the President’s Emergency Plan for AIDS Relief (PEPFAR).
US FDA has approved Mylan Matrix’ abbreviated new drug application (ANDA) for didanosine delayed-release capsules in 125 mg, 200 mg, 250 mg and 400 mg in strengths.
Matrix’s didanosine is the generic version of Bristol Myers Squibb’s HIV treatment Videx EC.
Didanosine delayed-release capsules had US sales of approximately US$ 29 million for the 12 months ending December 31, 2009, according to IMS Health.
Matrix expects to begin marketing of didanosine in the US during the current quarter. The pills will be sold under the Mylan Pharmaceuticals brand. The product will also be sold outside the US in a number of developing countries.
Currently, Mylan has 140 ANDAs pending US FDA approval representing US$ 98.3 billion in annual brand sales. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing US$ 19.8 billion in annual brand sales, for the 12 months ending December 31, 2009, according to IMS Health.
In September 2009, Matrix Laboratories won tentative approval from US FDA for its AIDS drug combination containing the generic versions of efavirenz, emtricitabine and tenofovir in a single pill under 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.
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.
In November, Matrix Laboratories received final approval for lansoprazole delayed-release capsules from the US Food and Drug Administration.
Lansoprazole delayed-release capsules are the generic version of Tap Pharmaceuticals’ proton pump inhibitor Prevacid DR capsules.
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.