Pfizer settles voriconazole (VFend) generic issue with Mylan, Matrix

Mylan Pharmaceuticals and Matrix Laboratories subsidiaries entered into a settlement and license agreement with Pfizer Inc relating to anti-fungal voriconazole generic tablets.

Mylan Matrix’ voriconazole is the generic version of Pfizer’s Vfend Tablets

VFend (voriconazole) is a triazole anti fungal agent. Voriconazole is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension.

Mylan’s Matrix was expecting generic approval for anti-fungal voriconazole generic tablets, 50 mg and 200 mg, with exclusive marketing rights for 180 days as the company was the first to submit an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification to the US. Food and Drug Administration (FDA).

Drug companies with first-to-file status seeking generic approval for patented products are eligible for 180 days of marketing exclusivity upon commercial marketing of the product, as provided under the provisions of the 1984 Hatch Waxman Act.

During this period no other generic of the approved drug would be allowed to be marketed in US.

As per the settlement reached between Pfizer and Mylan Matrix, Mylan will have the right to market voriconazole tablets in the U.S. in the first quarter of 2011.

Additional details of the agreement with Pfizer remain confidential.

The Mylan Matrix agreement with Pfizer is subject to the review by the U.S. Department of Justice and the Federal Trade Commission to ensure that the deal falls well within the domain ethical business practices and the companies concerned are not engaged in any sort of anti-competitive practices.

Clinical use of voriconazole was approved by FDA in May 2002. It was approved for primary treatment of acute invasive aspergillosis and salvage therapy for rare but serious fungal infections caused by the pathogens Scedosporium apiospermum and Fusarium spp.

In 2005, voriconazole was also approved for the treatment of invasive candidiasis.
Voriconazole tablets, 50 mg and 200 mg, had U.S. sales of $164 million for the 12 months ending June 30, according to IMS Health.

Mylan Inc. has has also received another USDFA for its ANDA for anti-convulsant topiramate capsules (Sprinkle), 15 mg and 25 mg.

Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil’s anticonvulsant Topamax Sprinkle Capsules, 15 mg and 25 mg. For the 12 months ending June 30, 2009,
Topiramate Capsules (Sprinkle) had U.S. sales of approximately $58 million for the same strengths, according to IMS Health. Mylan has launched topiramate in US.

Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales, according to IMS Health.

Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales, according to IMS Health.

Matrix Lab, which is controlled by the US generic major Mylan Inc, received tentative approval for efavirenz under the President’s Emergency Plan for AIDS Relief (PEPFAR).

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.

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.