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Monday, September 15, 2014

Sanofi (France), Genzyme's Corporation Report Positive New Data From ...

9/11/2014 

At Four Years, Treatment Effect Maintained in More Than Two-Thirds of Patients Who Received Genzyme’s Lemtrada in Pivotal Studies

- In approximately 70 percent of patients, disability scores improved or remained stable for an additional two years beyond the two-year pivotal multiple sclerosis studies -


- Approximately 70 percent of patients treated with Lemtrada did not receive a third course of treatment through the second year of the extension –


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today positive interim results from the second year of the extension study of Lemtrada™ (alemtuzumab) for multiple sclerosis.

In this analysis, relapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada in either of the Phase III CARE-MS I and CARE-MS II studies. In these pivotal studies, Lemtrada was given as two annual courses, at the start of the study and 12 months later. Approximately 70 percent of patients who received Lemtrada in the pivotal studies did not receive further treatment with Lemtrada through the second year of the extension study. No new safety signals were identified. These data will be presented today at the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) meeting in Boston.

“These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability,” said Dr. Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge. “The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was three years earlier.”

Extension Study Results

The Phase III trials of Lemtrada were randomized, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with relapsing-remitting multiple sclerosis who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

More than 90 percent of the patients who were treated with Lemtrada in the Phase III trials enrolled in the extension study. These patients were eligible to receive additional treatment with Lemtrada in the extension study if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions.

The following interim results are from the second year of the extension study for patients who previously received Lemtrada in the two-year pivotal studies:

* In year four, the annualized relapse rates for patients who received Lemtrada in CARE-MS I and CARE-MS II were 0.14 and 0.23, respectively. These rates were comparable to the annualized relapse rates for those patients who received Lemtrada in the pivotal trials.

* Through year four, 74 percent of patients in CARE-MS I and 66 percent in CARE-MS II had improved or stable disability as measured by the Expanded Disability Status Scale (EDSS).
* Through year four, 83 percent and 76 percent of patients who received Lemtrada in the pivotal trials, respectively, did not experience six-month sustained accumulation of disability – meaning they did not experience a worsening of their disability that persisted for six continuous months in the four years of observation.

* Approximately 70 percent of patients treated with Lemtrada in the pivotal studies did not receive a third course of treatment in years three and four. 

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