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Genzyme shocked by FDA's rejection of Lemtrada

US regulator refuses to approve MS drug on safety grounds

GenzymeSanofi's Genzyme unit has suffered a major setback after the US FDA rejected a marketing application for multiple sclerosis (MS) treatment Lemtrada on safety grounds.

Given that Lemtrada (alemtuzumab) is already available for MS in the EU and a number of other world markets the company has indicated it plans to appeal the decision, and is hoping to meet with the regulator in the coming weeks to discuss its options.

Alemtuzumab is already available in the US under the Campath trade name as a treatment for B-cell chronic lymphocytic leukaemia (CLL), although it is no longer sold commercially and provided only under a compassionate-use programme.

Genzyme was seeking approval for the drug as a treatment for relapsing forms of MS, which are associated with progression of the disease, but the FDA has concluded that the company "has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects".

Sanofi said the FDA is asking for additional clinical trials of the drug in MS, which could delay US approval by two years or more. The regulator has been very wary of approving Lemtrada and initially refused to accept Genzyme's marketing application for MS when it was submitted in 2012, asking for changes to the way the data were presented.

The development is a blow for Sanofi, given that Lemtrada is one of the key assets that drove its $20bn takeover of Genzyme in 2011, and also for Genzyme's shareholders who had stood to gain a financial windfall from Lemtrada's approval.

Sanofi said it now has no expectation of securing approval for Lemtrada before March 31, a deadline linked to contingent value rights (CVRs) held by Genzyme shareholders that could have entitled them to a payout of around $14 per share. The CVRs trade just like shares and lost two-thirds of their value on news of the Lemtrada delay.

Lemtrada - which had been predicted to achieve sales upwards of $500m a year with US approval - is seen as a critical pillar of Sanofi's aspirations in MS. The company also has oral therapy Aubagio (teriflunomide) that was cleared for marketing in the US in 2012 and in Europe at the end of August 2013.

Article by
Phil Taylor

3rd January 2014

From: Sales, Regulatory

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