Overnight success proves elusive for oral MS drugs

Novartis' Gilenya pill hampered by safety review; Sanofi's Aubagio is just now testing the waters
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Theoretically, the advent of oral MS treatments was supposed to drain sales away from less-convenient injectables--and quickly. In practice, patients and doctors have proven more cautious about the newer drugs, The Wall Street Journal reports.

The ease of taking a pill isn't seen as much of an advantage, at least not yet. Deciding which type of treatment to use is "all about safety and efficacy, not oral versus needle," Lawrence Steinman, a Stanford University neurologist, told the WSJ.

That's not what Novartis ($NVS) expected when it launched Gilenya in October 2010. But then again, the company probably didn't expect a safety debate--and regulatory review--so early in its lifespan. Late last year, the FDA and the European Medicines Agency said they were investigating 11 deaths among Gilenya patients. In April, Novartis said it had agreed to new FDA-approved labeling on the drug that advises electrocardiograms for potential Gilenya patients.

To judge from the WSJ's report, doctors are getting the message that Gilenya isn't for heart patients. According to previous reports, some doctors pulled around a tenth of their patients off the drug after safety concerns arose. And analysts downgraded their sales estimates on the drug by around 10%, to around $2 billion by 2017.

Now, Sanofi ($SNY) has introduced an oral competitor to Gilenya. Aubagio reduced the relapse rate by about 36% in a clinical trial--less than Gilenya's 54%, per the WSJ--but its side-effect profile is seen as more favorable. Some analysts think it can hit around €1.5 billion (about $1.92 billion) by 2018, though others figure on much less.

The upshot is this: Oral MS drugs aren't the instant slam-dunk they were hoped to be. Many doctors are sitting back, waiting for early adopters to show how they work in the real world. But while they may not fill those patent-cliff gaps as quickly as Novartis and Sanofi wished, they're still on their way to becoming blockbusters--provided no other big safety signals or efficacy questions arise.

- read the WSJ story

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