CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi company (EURONEXT: SAN and NYSE: SNY), reports today that the
Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse
rate and sustained accumulation (worsening) of disability (SAD) were
significantly reduced in multiple sclerosis patients receiving
alemtuzumab (LEMTRADA™) as compared with Rebif® (44 mcg
subcutaneous interferon beta-1a). Results for both of these co-primary
endpoints were highly statistically significant. CARE-MS II is the
randomized Phase III clinical trial comparing the investigational drug
alemtuzumab to interferon beta-1a in patients with relapsing-remitting
multiple sclerosis (RRMS). Patients were required to have experienced a
relapse while on a prior therapy to be eligible for CARE-MS II. Genzyme
is developing alemtuzumab in MS in collaboration with Bayer HealthCare.
“The superior efficacy results for alemtuzumab, particularly the
slowing of disability, are very promising since this was a head-to-head
comparison trial with high dose subcutaneous interferon beta-1a”
In this randomized trial involving 840 patients, a 49 percent reduction
in relapse rate was observed in patients treated with alemtuzumab 12 mg
compared to interferon beta-1a over two years of study (p<0.0001).
Importantly, there was also a 42 percent reduction in the risk of
sustained accumulation (worsening) of disability as measured by the
Expanded Disability Status Scale (EDSS) (p=0.0084). Analysis of the full
CARE-MS II data is ongoing and results will be presented at a
forthcoming scientific meeting.
"CARE-MS ll represents the culmination of many years of clinical and
laboratory research aimed at demonstrating the potential for alemtuzumab
as a highly effective treatment for MS and understanding mechanisms
involved in the complex natural history of the disease," said
Professor Alastair Compston, Chair of the Steering Committee overseeing
the conduct of the study and head of the Department of Clinical
Neurosciences at the University of Cambridge, United Kingdom. "Taken
together, the Phase ll and lll clinical trial data illustrate the
promise that alemtuzumab holds as a transformative treatment for people
with relapsing MS."
The CARE-MS II trial compared treatment with alemtuzumab 12 mg given
daily as an IV administration for 5 days, and then again for 3 days one
year later, to treatment with interferon beta-1a 44 mcg administered by
injection three times per week throughout the two years of study.
"The superior efficacy results for alemtuzumab, particularly the
slowing of disability, are very promising since this was a head-to-head
comparison trial with high dose subcutaneous interferon beta-1a," said
Dr. Jeffrey Cohen, Professor of Medicine (Neurology), Cleveland Clinic
Lerner College of Medicine; Director of Experimental Therapeutics,
Mellen Center for MS Treatment and Research; and a member of the
Steering Committee overseeing the conduct of the study. “These
results suggest alemtuzumab's potential to offer patients with MS a new
and effective treatment option.”
The safety profile observed in the trial was consistent with previous
alemtuzumab use in MS and adverse events continued to be manageable. The
most common types of adverse events associated with alemtuzumab in the
CARE-MS II study were infusion-associated reactions, the symptoms of
which most commonly included headache, rash, nausea, hives, fever,
itching, insomnia, and fatigue. Infections were common in both groups
with a higher incidence in the alemtuzumab group. The most common
infections in patients receiving alemtuzumab included upper respiratory
and urinary tract infections, sinusitis and herpes simplex infections.
Infections were predominantly mild to moderate in severity and there
were no treatment-related life-threatening or fatal infections.
Approximately 16 percent of alemtuzumab-treated patients developed an
autoimmune thyroid-related adverse event and approximately one percent
developed immune thrombocytopenia during the two-year study period.
These cases were detected early through a monitoring program and managed
using conventional therapies. Patient monitoring for immune cytopenias
and thyroid or renal disorders is incorporated in all Genzyme-sponsored
trials of alemtuzumab for the investigational treatment of MS.
“We are very pleased with the results of the CARE-MS II study which
are unprecedented,” said David Meeker, M.D., President and Chief
Executive Officer, Genzyme. “We believe that LEMTRADA™, with
its impressive efficacy, novel dosing regimen and manageable safety
profile, could make a very important contribution to the MS treatment
landscape, where a significant unmet need still exists for many
patients. Based on these positive results, we are on track to submit
LEMTRADA™ for review to US and EU regulatory authorities
in the first quarter of 2012.”
Alemtuzumab has been granted Fast Track designation by the U.S. Food and
Drug Administration (FDA). The FDA's Fast Track program is designed to
expedite the review of new drugs that are intended to treat serious or
life-threatening conditions and demonstrate the potential to address
unmet medical needs. Under Fast Track designation, alemtuzumab for MS is
eligible for Priority Review. Since it is not yet approved for the
treatment of MS, alemtuzumab must not be used in MS patients outside of
a formal, regulated clinical trial setting in which appropriate patient
monitoring measures are in place.
*LEMTRADA™ is the proprietary name submitted to health authorities for
the company’s investigational multiple sclerosis agent alemtuzumab.
About the CARE-MS II Trial
CARE-MS II (The Comparison of Alemtuzumab and Rebif® Efficacy
in Multiple Sclerosis) trial was designed to evaluate whether the
investigational MS therapy alemtuzumab could achieve meaningful efficacy
and safety improvements over the approved, active comparator interferon
beta-1a, a standard treatment for relapsing MS.
CARE-MS II was a Phase III, global, randomized clinical trial comparing
treatment with alemtuzumab to treatment with subcutaneous interferon
beta-1a (44 mcg administered by injection three times per week) in 840
patients who relapsed despite receiving prior MS treatment. Patients
enrolled in the trial had to have experienced at least two relapses
within the two years prior to entering the trial, with at least one of
these relapses occurring within one year prior to enrollment and at
least one relapse occurring while on MS therapy.
The CARE-MS II trial had two co-primary endpoints: reduction in relapse
rate and six months sustained accumulation of disability (SAD)**.
Secondary outcome measures include: Percentage of relapse-free patients
at year two; Expanded Disability Status Scale (EDSS) change from
baseline; percent change in magnetic/resonance imaging
(MRI)-T2-hyperintense lesion volume at year two; and Multiple Sclerosis
Functional Composite (MSFC) change from baseline. Disability assessments
were performed at regularly scheduled visits by independent, evaluating
neurologists who were blinded to the patients’ treatment assignments.
Relapse was determined by a blinded committee.
**Sustained Accumulation of Disability – Clinical
representation of the worsening of a patient’s level of disability;
CARE-MS ll monitored this endpoint over the course of six months.
Alemtuzumab is a humanized monoclonal antibody being studied as a
potential therapy for relapsing MS. Alemtuzumab targets the cell-surface
glycoprotein CD52, which is highly expressed on T- and B-lymphocytes.
Preliminary research suggests that alemtuzumab initially depletes the T-
and B-cells that may be responsible for the cellular damage in MS. This
depletion of T- and B-cells is followed by a distinctive pattern of
lymphocyte repopulation. Alemtuzumab appears to have little or no effect
on other cells of the immune system. In addition to the completed
CARE-MS II study, another Phase III trial, CARE-MS I, evaluated
alemtuzumab against interferon beta-1a in relapsing-remitting MS
patients naive to prior treatment and found a statistically significant
reduction in relapse rate with alemtuzumab.
Genzyme has the worldwide rights to alemtuzumab and has primary
responsibility for the development and commercialization of alemtuzumab
in MS. Bayer HealthCare has been co-developing alemtuzumab in MS with
Genzyme. Bayer HealthCare retains an option to co-promote alemtuzumab in
MS and upon regulatory approval and commercialization would receive
contingent payments based on sales revenue.
About Genzyme, a 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 accomplish 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, which are 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.
Sanofi, a global and diversified healthcare leader, discovers, develops
and distributes therapeutic solutions focused on patients’ needs. Sanofi
has core strengths in the field of healthcare with seven growth
platforms: diabetes solutions, human vaccines, innovative drugs, rare
diseases, consumer healthcare, emerging markets and animal health.
Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the
fields of health care, nutrition and high-tech materials. Bayer
HealthCare, a subgroup of Bayer AG with annual sales of more than EUR
16.913 billion (2010), is one of the world’s leading, innovative
companies in the healthcare and medical products industry and is based
in Leverkusen, Germany. The company combines the global activities of
the Animal Health, Consumer Care, Medical Care and Pharmaceuticals
divisions. Bayer HealthCare’s aim is to discover and manufacture
products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55.700 employees and is represented
in more than 100 countries. Find more information at www.bayerhealthcare.com.
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Genzyme® is a registered trademark and LEMTRADA™ is a trademark of
Genzyme Corporation. All rights reserved.
Rebif® is a registered trademark of EMD Serono, Inc. or affiliates.