Monday, July 11, 2011

Sanofi/Genzyme MS drug meets mostly positive data results

By Boston Business Journal staff

The first results are in for a hotly anticipated Genzyme Corp. multiple sclerosis drug trial: Data show the drug candidate offers a 55 percent reduction in relapses, versus an already-approved therapy.

However, the Cambridge-based biotech company’s potential treatment, which would be called Lemtrada if approved, failed to meet a second endpoint in the Phase 3 trial. Patients taking Lemtrada had only a slightly slower advancement of disability than those taking the other therapy, Rebif, marketed by Rockland-based EMD Serono.

But the overall positive results are good news to Genzyme’s parent, French drug maker Sanofi (NYSE: SNY), which raised its offer for the company ahead of the February acquisition deal on the promise of Lemtrada.

In the midst of fierce negotiations over the sale of Genzyme Corp. to Sanofi, former Genzyme CEO Henri Termeer said when data became available from this trial, it would prove Sanofi’s $69 per share offer was too low. Termeer has said that if approved, Lemtrada could bring in $3 billion per year in sales.

In the end, the two sides agreed on $74 per share, plus so-called contingent value rights that give shareholders additional payments based on performance measures – including the approval of Lemtrada – worth up to $14 per share by 2020.

Sanofi expects to file for U.S. Food and Drug Administration and EU approval for Lemtrada in early 2012. The drug candidate has been granted fast-track designation by the FDA, meaning that the regulatory agency will make an approval decision within six months versus the usual 10 months.