The Big Winner of the EU Drug Approval Bonanza

It looks like regulators at the European Medicines Agency's Committee for Medicinal Products for Human Use were looking to clear some paperwork off their desks. An early summer vacation, perhaps?

All told, regulators recommended six drugs for approval today.

Source: European Medicines Agency.

The CHMP recommendation is tantamount to an approval. It just requires the EMA to slap its rubber stamp on the forms. All six drugs are already approved in the U.S., so for the most part, the approvals weren't a major surprise.

Merck may benefit from the conspicuous absence of Vertex Pharmaceuticals (Nasdaq: VRTX) and Johnson & Johnson's hepatitis C treatment Incivek from the list. Merck's Victrelis will have a lead in the EU like it does stateside, although it isn't likely to have a major long-term effect on the market dynamics.

Fampyra was the undoubtedly the biggest winner of the approvals. The CHMP rejected Fampyra in January but seems to have reversed its decision, giving the drug a conditional approval. Acorda and Biogen will have to submit more information to gain a full approval, but at least Biogen will be able to begin selling the drug while they meet regulators' demands.

The surprise approval is a boon for Acorda, which will get a $25 million milestone payment and a double-digit percentage royalty on sales. After the jump in share price today, Acorda is sitting about where it was before the initial EU rejection. Further price appreciation will require increasing sales of the drug in the U.S.

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