|Genzyme Announces Publication of LEMTRADA (alemtuzumab) Pivotal Studies in The Lancet.|
|CAMBRIDGE, Mass. - October 31, 2012 - Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today the publication of results from the LEMTRADA ™ (alemtuzumab) CARE-MS I and CARE-MS II pivotal studies in patients with relapsing- remitting multiple sclerosis (MS) in the November 1, 2012, online issue of The Lancet. interferon beta-1a), and more patients on LEMTRADA were relapse-free for two years. In addition, in CARE-MS II, accumulation of disability was significantly slowed in patients given LEMTRADA vs. Rebif. Further, patients treated with LEMTRADA were significantly more likely to experience improvement in disability scores than those treated with Rebif, suggesting a reversal of disability in some patients. "There is a tremendous unmet need for treatments that address the progression of disability that people living with multiple sclerosis can experience, ”said Genzyme President and CEO, David Meeker, MD. “Genzyme sets a new standard by comparing LEMTRADA exclusively to approved treatment in all of our studies. Publication of these findings by The Lancet highlights the importance of these results to the MS community. "CARE-MS I and CARE-MS II Efficacy Results
CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis) are randomized Phase III studies comparing the investigational treatment alemtuzumab to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively. The results of these trials for LEMTRADA were superior to Rebif on clinical and imaging endpoints, including a reduction in relapse rate and are published in full in The Lancet. "The observed efficacy in these and earlier clinical studies indicates the potential, following regulatory approval, for alemtuzumab to become a transformative therapy among the various MS treatment options currently available, "Said Professor Alastair Compston, Chair of the Steering Committee overseeing the conduct of the study, senior author of both manuscripts, and Professor of Neurology, University of Cambridge, UK. In both studies, LEMTRADA was significantly superior to Rebif in reducing relapses. In CARE-MS I, 78 percent of patients treated with LEMTRADA remained relapse-free for two years, providing statistically significant improvement over Rebif (77.6 percent vs. 58.7 percent, p <0.0001). In the CARE-MS II trial, 65 percent of patients treated with LEMTRADA were relapse-free at two years, compared to 47 percent with Rebif (p <0.0001). In addition, in CARE-MS II, LEMTRADA reduced relapse rate to a greater extent than Rebif in all subgroups defined by previous therapy, including: with or without any interferon therapy, and those previously treated with Rebif or Copaxone® (glatiramer acetate injection) .
Study data also showed a strong clinical benefit by reducing the risk of sustained accumulation of disability in patients taking LEMTRADA in CARE-MS ll by 42 percent as compared to Rebif (p = 0.008), with significant improvement in disability scores that suggested a reversal of pre-existing disability in some patients. In the trial, the mean disability score for patients treated with LEMTRADA decreased over a two-year period, indicating an improvement in their physical disability, while the mean score for patients given Rebif increased, indicating a worsening of disability (p <0.0001).
CARE-MS I and II Safety Results
In both CARE-MS I and CARE-MS II, the incidence of serious adverse events was similar between the two treatment arms. As previously reported, autoimmune disorders were more common on patients treated with LEMTRADA, primarily autoimmune thyroid disease. Approximately 1 percent of LEMTRADA-treated patients in each study developed immune thrombocytopenia (ITP) over the two-year study period. There were no cases of anti-GBM disease reported during the study period with one case of glomerulonephritis during the follow-up period as has been previously reported. The percentage of LEMTRADA-treated patients reported to have malignant neoplasms was <1 percent. The overall safety profile was similar for the LEMTRADA 12 mg and 24 mg groups.
In both trials, the autoimmune disorders were detected early through a monitoring program and managed using conventional therapies. Patient monitoring for autoimmune disorders is incorporated in all Genzyme-sponsored trials of LEMTRADA for the investigative treatment of multiple sclerosis.
Since it is not yet approved for the treatment of MS, LEMTRADA must not be used in MS patients outside of a formal, regulated clinical trial setting in which appropriate patient monitoring measures are in place.
About the CARE-MS Trials
About LEMTRADA ™ (alemtuzumab) LEMTRADA is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with LEMTRADA results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. LEMTRADA has minimal impact on other immune cells. The acute anti-inflammatory effect of LEMTRADA is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to LEMTRADA and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare retains an option to co-promote LEMTRADA in multiple sclerosis. Bayer HealthCare has notified Genzyme of its intention to co-promote under this option. Upon regulatory approval and commercialization, Bayer would receive contingent payments based on sales revenue. LEMTRADA ™ is the proprietary name submitted to health authorities for the company's investigative multiple sclerosis agent alemtuzumab.
About Genzyme, and Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We achieve our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme's portfolio of transformative therapies, marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
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