Pfizer settles with Mylan over generic Vfend; gets US/Canadian OK for Wyeth buy

Global drugs behemoth Pfizer says that it has entered into an agreement with two subsidiaries of US firm Mylan relating to a generic version of Vfend (voriconazole), an antifungal agent. The agreement is limited to the tablet form of the compound and does not cover Pfizer's Vfend products for intravenous use or oral suspension.

As a result, Mylan will have the right to market voriconazole tablets in the USA in the first quarter of 2011. Additional details of the agreement with Mylan, which is subject to review by the US Department of Justice and the Federal Trade Commission, remain confidential.

Mylan's Matrix was the first company to submit a substantially complete Abbreviated New Drug Application containing a Paragraph IV certification to the Food and Drug Administration and therefore believes it will be eligible for 180 days of marketing exclusivity upon commercial marketing of the product, as provided under the provisions of the 1984 Hatch Waxman Act.

Voriconazole tablets, 50mg and 200mg, had US sales of $164 million for the 12 months ending June 30, 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.

Pfizer/Wyeth deal to close today

Meantime, Pfizer has received the final regulatory clearances from the US Federal Trade Commission and regulators in Canada to complete its $68 billion acquisition of fellow USA-based Wyeth. The FTC approval came after Pfizer and Wyeth agreed last month to sell certain animal health assets t Germany's Boehringer Ingelheim. Pfizer now expects to close the deal today (October 15).