Monday, November 14, 2011

Genzyme MS drug candidate meets Phase 3 goals

By Michelle Lang

Sanofi subsidiary Genzyme reported positive Phase 3 trial results for its multiple sclerosis drug candidate alemtuzumab, also known as Lemtrada, as it inches closer toward FDA approval.

The Cambridge biotech said that Lemtrada met its two primary endpoints – reduced relapse rate and lower sustained accumulation of disability in MS patients taking Lemtrada, compared to Rockland-based EMD Serono’s MS drug Rebif (interferon beta-1a). Genzyme is working with Bayer Healthcare to develop Lemtrada, which was given fast track status for a quicker review process by the U.S. Food and Drug Administration.

The Phase 3 trial involved 840 patients with relapsing-remitting multiple sclerosis (RRMS). The results showed a 49 percent reduction in relapse and a 42 percent reduction in the worsening of MS related disability, compared to Rebif, Genzyme noted in a news release. Of the side effects listed, the patients taking the Genzyme drug candidate did have a higher rate of infections – mainly upper respiratory and urinary tract infections, sinusitis and herpes simplex infections – compared to the EMD Serono drug. Genzyme categorized the side effects of Lemtrada as “manageable” with other potential side effects including headache, rash, nausea, hives, fever, itching, insomnia and fatigue.

Genzyme announced in April that five years after a Phase 2 clinical trial, about two-thirds of its patients with multiple sclerosis (MS) taking the company’s drug candidate alemtuzumab did not experience relapse or sustained disability increases.