Australian Therapeutic Goods Administration approves Genzyme's Lemtrada for multiple sclerosis

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Australian Therapeutic Goods Administration (TGA) has approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

"Multiple Sclerosis is a highly complex and often devastating disease that can lead to significant disability in patients, despite availability of standard therapies," said Associate Professor John King, Senior Neurologist, Royal Melbourne Hospital. "Lemtrada represents a significant advance in the way physicians and patients can think about treating multiple sclerosis. The efficacy data supporting Lemtrada highlight its strong potential to impact disease progression in patients with relapsing forms of MS."

Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. Approval in Australia follows the recent approval of Lemtrada in Canada and the European Union. Marketing applications for Lemtrada are also under review in other countries.

More than 2.3 million people worldwide have been diagnosed with MS, including approximately 20,000 people in Australia.

Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.

"The approval of Lemtrada in Australia reinforces the significance of this treatment and is an important milestone in Genzyme's commitment to bring this potentially transformative therapy to patients globally," said David Meeker, President and CEO, Genzyme. "We're very pleased with the TGA's approval and look forward to working with the reimbursement authorities to make Lemtrada available to patients in Australia."

The Lemtrada clinical development program included two pivotal randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif^®) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.

The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Autoimmune conditions and serious infections can occur in patients receiving Lemtrada. A comprehensive risk management program incorporating education and monitoring will support early detection and management of these identified risks.