Acorda's (ACOR) MS Drug Gets Nod From the FDA

Late Friday, the Food and Drug Administration approved a pill from Acorda Therapeutics (NASDAQ: ACOR) that is designed to help walking for patients multiple sclerosis, a potentially disabling disease that affects the nervous system.

The drug named Ampyra is the first pill of its kind to be approved, and has the potential to help the 400,000 patients in the U.S. that have the disease with the affects of loss of balance, muscle spasms and other motor functions.

Officials at Acorda say that the drug could help between 260,000 and 340,000 of the patients that are affected by the disease, after the company conducted two clinical trials to track the ability of patients to complete a 25-foot walking drill. Both of the studies showed improvements in the time needed for subjects to complete the exercise.

Ron Cohen, CEO of Acorda, said that patients taking the drug showed on average showed a 25 percent improvement in the time taken to complete the course after taking Ampyra.

The FDA did say that the drug can cause seizures in patients who take larger-than-recommended doses of the medication. The dose recommended will be 10 mg, as the studies have shown that higher doses do not increase the drug’s effectiveness and does increase the risk of seizures.

According to the FDA other side effects include insomnia, urinary tract infections, dizziness, headache, throat pain and nausea.

The drug is being manufactured under a license with Irish pharmaceutical company Elan Corp. (NYSE: ELN), but will be distributed in the U.S. by Acorda. Ampyra is set to launch in the U.S. in March.

Analysts at Piper Jaffray were happy that the label on the drug was relatively clean, with no black box warning, but downgraded the shares from Overweight to Neutral anyway saying the commercial potential is largely reflected in ACOR shares.

Robert W. Baird's analyst covering Acorda were more positive and reiterated their Outperform rating and raised their price target to $32, saying "the label will likely accelerate launch and support premium pricing, perhaps even beyond the $10,000/year upper boundary outlined by management."

Shares of Acorda are down 1 percent to $27.83 in midday market movement on Monday.

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