FDA approves generic version of Teva's Copaxone, the most-used MS drug in the world

Markets Associated Press

Two drugmakers are preparing to sell a lower-cost version of Copaxone, the world's most-widely used drug for multiple sclerosis.

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The generic, called Glatopa, is made by Sandoz, a unit of Swiss drug company Novartis AG, and U.S.-based Momenta Pharmaceuticals. The Food and Drug Administration approved the drug Thursday. Momenta shares jumped 6.1 percent Thursday and reached their highest price in almost five years. Shares of Teva, which have been trading around all-time highs, fell 3.8 percent on the day.

The companies did not say when Glatopa will go on sale. But Teva Pharmaceutical Industries, which makes Copaxone, has said it expects generic versions of the drug to go on sale in the U.S. in September. That's when a key patent on Copaxone will expire, although Teva has introduced a newer formulation of the drug to extend its patent protection.

Momenta Pharmaceuticals Inc. will get a $10 million payment based on the approval of Glatopa, and says it could get up to $140 million in payments based on the drug's approval and sales.

Teva is the world's biggest seller of generic drugs, but Copaxone is by far its best-selling product. In the fourth quarter, almost a third of all MS drug prescriptions were written for Copaxone, which has been on the market for nearly 20 years. It is taken by injection three times a week. In the last two years, it's faced tough competition from Tecfidera, a twice-per-day pill made by Biogen that got FDA approval in March 2013.

Teva, based in Israel, reported $4.24 billion in revenue from Copaxone in 2014, down 2 percent from the previous year. That was 20 percent of its overall revenue. U.S. sales totaled $3.11 billion.

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Biogen Inc. has reported that revenue from Tecfidera more than tripled last year to $2.91 billion.

Teva says that if a generic version of Copaxone reaches the market before September, it could cut its sales by up to $50 million a month. The company expects overall sales of Copaxone to fall to between $3.5 billion and $3.7 billion in 2015.

With stocks slumping at midday Friday, shares of Teva Pharmaceutical Industries Ltd. were down 56 cents to $62.93, Novartis shares fell $1.18 to $102.13, and Momenta shares rose 38 cents, or 2.2 percent, to $17.46.