MS drugs get yeas, nays and price increases

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Lots of news about the multiple sclerosis market today. Two companies raised prices, Novartis received good Gilenya news, while Merck KGaA and Biogen Idec/Acorda Therapeutics suffered setbacks related to their therapies. The developments underscore the ongoing shake-up in MS meds, as new products come to market--or fail to--and entrenched products scramble to compete.

Novartis' Gilenya pill, the first oral MS treatment, won the nod from European Medicines Agency's Committee for Medicinal Products for Human Use, putting it one step closer to European marketing approval. And in another boost for Gilenya, the committee rejected cladribine, Merck KGaA's experimental MS pill that had been expected to give the Novartis drug a run for its money. It's the company's second setback; the FDA in November extended its review of the drug.

Gilenya won approval in the U.S. in September, and Novartis has said that sales are exceeding its initial expectations. Sales of the drug are expected to grow to as much as $5.3 billion by 2016, Bloomberg reports.

The busy regulators also recommended against approving Fampyra, which was developed by Acorda and sold by Biogen outside the U.S. The drug is sold in the U.S. by Acorda under the trade name Ampyra extended release tablets. Biogen says intends to appeal and request a re-examination of the decision, according to an Acorda statement. "We and most of the Street were expecting approval given the unmet need in Europe and the fact that it has been approved in the U.S. last year with a robust uptake," said Geoff Meacham, an analyst at J.P. Morgan, as quoted by Reuters.

Meanwhile, Biogen and Elan are looking to collect more from their profitable MS meds. Biogen has hiked the price of Avonex, its first-line MS treatment, and its Tysabri partner Elan raised the cost of that drug, too. The price increases are six percent and seven percent, respectively, and come on top of other price hikes not more than eight months ago. Avonex prices were raised three times in 2009, analysts said.

With the increases, Dow Jones says, annual Avonex treatment runs about $37,500, while Tysabri is $42,800. Other MS drugmakers have hiked prices recently, too. And Novartis has set the price of Gilenya at $48,000.

"Gilenya, which is widely regarded as a more convenient and effective alternative, will provide heavy competition for Biogen in the market and will lead to a decline in sales for the company," says Datamonitor's Trung Huynh in a statement. "In the sort term though, Biogen will still see sales figures grow as a result of recent price rises on its leading therapies Avonex and Tysabri"

- read Acorda's statement
- get Novartis' release
- check out Merck KGaA's statement
- read the analysis from Datamonitor
- see the Bloomberg news
- check out the story and report from Reuters
- read the Dow Jones article
- get more from the Wall Street Journal

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Novartis aims Gilenya at advanced MS--and $5.4B
Analysts expect Gilenya to storm MS market