With Lemtrada's EU nod, Sanofi preps for dual MS drug launches

Sanofi now has not one, but two big multiple sclerosis launches to get under way in Europe. Two weeks after nabbing EU approval for its new MS pill Aubagio, Sanofi ($SNY) got regulatory clearance for Lemtrada.

It's the latter drug that's most promising for Sanofi. Thanks to some impressive data, including its prevailing in a head-to-head study against Merck KGaA's Rebif, the company has some high expectations. Lemtrada, in fact, is one of the reasons why the French drugmaker bought Genzyme. (It's also the reason why the deal included contingency value rights, because at the time Sanofi wasn't 100% sure Lemtrada would pay off, but that's another story.)

Now, the company will have to wait for the payoff because it's still lacking approval by the FDA, which accepted its application in January. And the payoff may not be as big as previously expected because, thanks to Biogen Idec's ($BIIB) Tecfidera launch, the market has changed significantly.

Sanofi says it's preparing to launch both drugs in Europe soon. And the EU approvals are a definite boost for the company's MS ambitions. But launches in Europe tend to be slow. Approvals may be centralized, but reimbursement decisions are not. Drugmakers have to make a case for their new products country by country, at least in major markets.

That's why Lemtrada can't fully rev up until it wins the FDA's blessing. In the U.S., as soon as a drug wins approval, it can roll right out to the pharmacy. Payers may slot new meds into their formularies at varying prices, and Medicare might choose to review reimbursement, as it recently did with Eli Lilly's ($LLY) Alzheimer's imaging agent. But by and large, FDA approval equals payment.

Aubagio has been for sale in the U.S. since last year, when it brought in €7 million. For the first half of 2013, it jacked sales up to €53 million. Where it will end up in the MS market remains to be seen, but its launch was quickly overshadowed by Tecfidera, which generated a whopping $192 million for its first quarter on the market.

ALSO: European regulators also blessed Provenge, the prostate cancer treatment from Dendreon ($DNDN). Launched in 2010 in the U.S., the drug came to market to high expectations, but so far it has failed to deliver. But the U.S. rollout was hampered by reimbursement questions and a manufacturing ramp-up. With manufacturing in place--and different reimbursement rules--perhaps the European launch will be more successful. Release | Story

- here's the release from Sanofi (PDF)

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