Amgen Inc. (MM) (NASDAQ:AMGN)
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Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) and Amgen Inc. (AMGN) have reached a settlement agreement that would allow Teva to launch copycat versions of Neupogen and Neulasta, used to prevent infections in patients receiving chemotherapy, by November 2013 at the latest.
Amgen reported $3.6 billion in U.S. sales of the two drugs last year, almost a quarter of its total revenue of $15.1 billion.
Teva already sells a biosimilar--the closest thing to a generic for a complex biologic drug--of Neupogen in Europe under the name TevaGrastim and had been seeking to sell the drug as Neutroval in the U.S.. Teva had planned to file for U.S. approval for Neugranin, which is similar to Neulasta, in the U.S. later this year. It hasn't disclosed its plans for the drug in Europe.
Amgen had filed a patent-infringement claim in federal court to block Teva's attempt to sell Neutroval and had been widely expected to request an injunction to block any launch by Teva if the Food and Drug Administration approved the drug.
The settlement of the suit was filed in court. Amgen officials weren't immediately available for comment. A Teva spokeswoman confirmed the settlement, but declined to comment.
Under the agreement, Teva can launch Neutroval and Neugranin on Nov. 10, 2013, at the latest. Certain provisions, including the launch of similar products by a third party, could allow the drugs to be on the market earlier.
Although a regulatory pathway for biosimilars' approval in the U.S. was included in last year's health-care overhaul, the FDA has yet to issue formal guidance on that pathway.
Rather than wait, Teva filed for approval of Neutroval using a traditional application route with supporting clinical data and planned to do the same with Neugranin.
The main European patents on Neupogen expired in 2006, allowing the sale of biosimilars, but Amgen has U.S. patents covering the drug until 2013.
Like biosimilars in Europe and those expected in the U.S., Neutroval and Neugranin would be branded generics. That means they couldn't be substituted like a traditional generic and would be actively marketed by Teva.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; email@example.com