Currently approved MS drugs, like blockbusters Tysabri (natalizumab) and Copaxone (glatiramer acetate), are disease-modifiers that slow the progress of MS. Ampyra is a different beast -- it addresses one of the symptoms, not the underlying disease. Some analysts have argued physical therapy achieves the same thing, and sales estimates have been all over the map, ranging from $300 million to more than $1 billion.
The FDA seemed uncertain about Ampyra at first, too. Last fall, the agency issued briefing documents saying the drug's benefit was "of small magnitude and uncertain clinical significance," according to the Wall Street Journal's Health Blog.
But a panel of expert reviewers disagreed. The noted that Ampyra had met its endpoints in two Phase III trials, helping MS patients walk faster, and they voted 12-to-1 in favor of the drug's efficacy. The FDA went along with its advisors, and it did not smack the drug with a black box warning as some had feared, according to Reuters.
What I wonder now is whether or not the approval -- which takes significant risk off the table -- will pave the way for an acquisition.
Raghuram Selvaraju, analyst with Hapoalim Securities, wrote in a recent research note that Ampyra is the only MS drug that can be prescribed to all classes of MS patients, with or without other MS drugs. As such, he predicted that firms with an interest in MS -- e.g., Biogen Idec (BIIB), Merck-Serono (MKGAF.PK), Novartis (NVS), Sanofi-Aventis (SNY), and Teva Pharmaceutical Industries (TEVA) -- may aim to acquire Acorda.
Acorda's investors have long been hoping for an acquisition. In fact, when Acorda licensed ex-U.S. Ampyra rights to Biogen last summer, dashed acquisition hopes caused investors to push the stock down 15 percent, despite the good deal terms.
So will Biogen now step up to the plate and finish what it started? Will another MS player step in? Or will Acorda launch the drug on its own?