Teva Gains U.S. Approval for Higher-Dose Copaxone Therapy

Teva Pharmaceutical Industries Ltd. gained U.S. approval for a longer-acting version of the Copaxone multiple-sclerosis drug, bolstering the company’s effort to defend its best-selling product as competitors seek to introduce cheaper copies this year.

Teva can now market Copaxone for use as a 40-milligram shot three times a week, the Petach Tikva, Israel-based company said yesterday in a statement. Teva sells a 20-milligram daily injection, which last year generated $4.2 billion in sales, based on analysts’ estimates compiled by Bloomberg.

The approval “is a significant advancement for patients as they now have the option of effective and safe treatment with Copaxone, while reducing the number of injections by 60 percent,” Omar Khan, chairman of the Department of Neurology at Wayne State University School of Medicine in Detroit, said in the statement. “Patients in the U.S. can now benefit from an improved dosing regimen without compromising the known benefits of Copaxone.”

Finding new sources of revenue to offset an expected drop in Copaxone sales will be one of the challenges for Erez Vigodman, who takes over as Teva’s chief executive officer on Feb. 11. His predecessor, Jeremy Levin, left last year after a dispute with the board over how to overhaul Teva.

Teva rose 1.7 percent to 157.30 shekels, the highest level in a week, as of the close in Tel Aviv. The shares are down about 34 percent from their March 2010 peak.

Delivery Schedule

Teva will seek to move as many as half of the patients taking daily Copaxone injections to the newer version, which would have patent protection until 2030, the company has said. Momenta Pharmaceuticals Inc. of Cambridge, Massachusetts, is among the companies that plan to introduce generic versions of the daily shot as soon as May.

The new higher-dosage formulation will be available immediately for shipping to distribution outlets and patients should be able to get the therapy within days, Teva said.

Copaxone already faces competition from new branded drugs that come in pill form, allowing patients to avoid injections. They include Biogen Idec Inc.’s Tecfidera, Novartis AG’s Gilenya and Sanofi’s Aubagio. Teva’s oral MS drug, Nerventra, failed to win backing from the European Medicines Agency this month and the company is conducting an additional clinical trial before it seeks approval in the U.S.

A U.S. Court of Appeals in July invalidated a 2015 patent protecting Copaxone, shortening the time Teva has to convert patients to the longer-acting version. Teva says the FDA should require lengthy clinical trials for the copy, because of the complexity of the molecule in the injection. Such trials usually aren’t required for a generic drug.

Analysts estimate that sales of Copaxone will fall 56 percent by 2016 as the relative ease of oral pills lures patients from Teva’s older injected product. At the same time, Teva is facing a slowdown in its own generic-drug business as competition intensifies and fewer blockbuster products lose patent protection.

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