Novartis MS Pill Wins EU Backing as Acorda Rejected

Novartis AG won European Union regulatory backing for its multiple sclerosis drug Gilenya, beating Merck KGaA in a race to sell a pill to slow the crippling disease. Shares of MS drugmaker Acorda Therapeutics Inc. declined the most in 15 months after its competing medicine was rejected.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Novartis be granted approval to market its drug for patients with the relapsing-remitting form of MS, the London-based agency said in a statement today. The European Commission usually adopts the panel’s advice.

Gilenya won U.S. approval in September, raising hopes for some patients who suffer from the disease and rely on injections for symptom relief. The Food and Drug Administration extended a review of Merck’s rival pill, cladribine, by three months in November. European regulators rejected cladribine in September, saying the drug’s benefits didn’t outweigh its risks, and affirmed that decision today.

“Novartis is committed to providing innovative medicines like Gilenya to patients with multiple sclerosis, and we look forward to working with countries across Europe towards this goal,” David Epstein, the head of Novartis’s pharmaceuticals division, said in a statement. A decision by the commission is likely in about three months, the Basel, Switzerland-based company said.

Novartis was unchanged at 54.20 Swiss francs at the close of Zurich trading. Merck rose 60 cents, or 1 percent, to 60.41 euros in Frankfurt.

Cladribine’s Chance

Merck can’t appeal today’s European ruling without new clinical data, Gangolf Schrimpf, a spokesman for the Darmstadt, Germany-based company, said by telephone today. “If the data is good, we still have a chance to apply,” Schrimpf said. Cladribine was approved for sale in Russia in July.

The agency also recommended against approving the MS pill Fampyra, developed by Acorda, based in Hawthorne, New York, and sold by Biogen Idec Inc. outside the U.S. Fampyra is approved in the U.S. to improve walking ability in MS patients. Weston, Massachusetts-based Biogen said it intends to appeal the European opinion.

Acorda shares fell $3.86, or 14 percent, to $23.97 at 4 p.m. New York time in Nasdaq Stock Market composite trading, the biggest single-day decline since October 2009. Biogen declined $2.10, or 2.9 percent, to $66.77, the biggest single- day fall in four months.

Sales Estimate

Gilenya may generate as much as $5.3 billion a year for Novartis by 2016, according to Fabian Wenner, an analyst at UBS AG in Zurich.

MS causes the body to attack nerve cells through the immune system. Gilenya and cladribine blunt the attack by targeting white blood cells that harm the protective coating of nerve cells. Gilenya keeps lymphocytes, a type of white blood cell, from being released into the immune system.

The disease affects about 2.5 million people worldwide, many of whom have trouble sticking with current therapies because they’re difficult to use or have side effects, according to the National Multiple Sclerosis Society, a New York-based patient group.

To contact the reporters on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net; Naomi Kresge in Frankfurt at nkresge@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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