Genzyme MS portfolio clears two hurdles abroad

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Sanofi biotech unit Genzyme received two pieces of good news for its MS treatments in European markets late last week.

The European Commission's CHMP (Committee for Human Medicinal Products) issued a “positive opinion for approval” of Genzyme's pipeline drug Lemtrada for relapsing-remitting multiple sclerosis. CHMP also gave oral MS treatment Aubagio a recommendation toward “new active substance designation,” which would grant eligibility for up to 10 years of patent protection.

News of Lemtrada's recommendation for earlier use came as a surprise to some analysts, who expected the drug to fall to a second- or third-line indication due to safety concerns. Leerink Swann analyst Seamus Fernandez, in a research note Friday, called the recommended indication a “slight upside surprise.”

But the analyst still expects use to remain limited to patients who are resistant to other therapies. A Lemtrada decision is expected in the next 70 days in the EU, and by the end of year in the US from FDA.

Sanofi appealed CHMP's original decision in March that Aubagio was unworthy of the new active substance designation. Last week's reversal removes a pretty significant overhang for the drug.

The decision could also pave the way for Biogen Idec's Tecfidera. Biogen had asked European regulators for a delay on approval of its MS pill, whose launch got off to a very strong start in the US, as it continues to try and secure data exclusivity in the EU. Tecfidera, or dimethyl fumarate, has a chemical cousin, Fumiderm, which is already in use in Germany for psoriasis.

ISI Group analyst Mark Schoenebaum conceded in an investor note that “it's very hard to responsibly read-across from this news to [Biogen Idec],” but that the “headline reads favorably and could signal general flexibility in thinking on the part of Europeans. Perhaps most important it signals that Europeans do not intend to stifle innovation in drug development despite cost containment pressures."

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