U.S. Court Permits Generic Version of Teva MS Drug a Year Sooner

Teva Pharmaceutical Industries' $4 billion-a-year multiple sclerosis drug Copaxone will lose its patent protection in 2014 rather than 2015.

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Teva Pharmaceutical Industries' $4 billion-a-year multiple sclerosis drug Copaxone will lose its patent protection in 2014 rather than 2015 following a ruling from a U.S. appeals court on Friday, making it potentially prey to cheaper generics next May.

The U.S. Court of Appeals for the Federal Circuit issued its decision in a patent fight that pits Teva against two teams developing cheaper generic forms of Copaxone: one with Novartis AG and Momenta Pharmaceuticals Inc and another between Mylan Inc and Natco Pharma Ltd.

The court upheld some claims, or portions, of nine patents involved in the drug but declared several invalid, shortening patent protection for the drug.

"We are very pleased with today's ruling and we expect that it will allow Mylan to launch its generic version of Copaxone on May 25, 2014," Mylan Chief Executive Heather Bresch said in a statement.

Teva said in a release that it plans to appeal the court decision. Novartis did not immediately comment on the ruling.

The lawsuit was filed after the Sandoz generic division of Novartis and Mylan notified the U.S. Food and Drug Administration that they wanted to bring out generic versions of Copaxone. Teva sued to block them and protect its patents.

Patents on Copaxone, which accounts for about 20% of Teva's sales and about 50% of its profit, had been set to expire in September 2015.

The ruling affects 72% of Teva's global Copaxone sales. U.S. sales of the drug totaled $2.9 billion in 2012. Teva has said that its gross profit on Copaxone equals 89% of sales, which means the ruling endangers 25% of its total gross profit.

In total, losing exclusivity over Copaxone 16 months earlier could cost Teva $1.9 billon in sales, given that the drug will face competitors that will eat away at its market share and also force down prices. Analysts believe that U.S. sales of the drug could be halved.

Shares of Teva closed down 1% on the New York Stock Exchange on Friday, after falling by more than 3.5% immediately after the ruling. Mylan shares rose 1.7% on the Nasdaq. Momenta shares rose 11% on the Nasdaq. Novartis shares slipped 0.7%.

Morningstar analyst Michael Waterhouse said Teva shares were little affected by the unfavorable court ruling because many analysts and investors had already assumed that Copaxone, which had sales of $4 billion last year, would face competition from at least one generic in 2014.

"So a lot of that pessimism was priced into the stock," Waterhouse said.

Waterhouse said one or both generics could be introduced by 2014 or 2015. But he said there is a good chance neither generic will be ready for launch next year because of difficulty making the complicated molecule.

In any case, the analyst said he expects Copaxone sales to fall to about $3.8 billion this year because of competition from new oral treatments for multiple sclerosis, including Biogen Idec's Tecfidera and Sanofi SA's Aubagio, and to fall to $3.4 billion in 2014 for the same reason, even if no generics are introduced.

Once one or more generics arrive, either in 2014 or later, Waterhouse said they could be expected to quickly erase 40% of Copaxone sales.

Teva's facility in Jerusalem.Credit: Lior Mizrahi / BauBau

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