CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), reports
today additional data from the Phase III CARE-MS II trial. Accumulation
of disability was significantly slowed in patients with multiple
sclerosis (MS) who were treated with alemtuzumab versus Rebif® (high
dose subcutaneous interferon beta-1a), as measured by the Expanded
Disability Status Scale (EDSS), a standard assessment of physical
disability progression. In addition, significant improvement in
disability scores was observed in some patients treated with alemtuzumab
from baseline and compared to patients treated with Rebif, suggesting a
reversal of disability in these patients. In the trial, patients with
pre-existing disability treated with alemtuzumab were more than twice as
likely to experience a sustained reduction in disability than patients
given Rebif. Genzyme is developing alemtuzumab in MS in collaboration
with Bayer HealthCare.
“We are
on track to submit alemtuzumab for review to U.S. and EU regulatory
authorities in the second quarter of this year and are excited about the
potential of bringing this important therapy to people living with MS
who have unmet treatment needs.”
CARE-MS II was a randomized Phase III clinical trial comparing the
investigational drug alemtuzumab to Rebif in patients with
relapsing-remitting multiple sclerosis (RRMS) who had relapsed while on
prior therapy. The company announced in November that results for the
co-primary endpoints of the trial were highly statistically significant.
Key disability data from the CARE-MS II trial presented today at the
64th Annual Meeting of the American Academy of Neurology include:
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The mean EDSS score for patients treated with alemtuzumab 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 (-0.17 vs. 0.24; p < 0.0001).
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At two years, 29 percent of patients treated with alemtuzumab had
experienced a six-month sustained reduction in disability, meaning
their level of disability improved, as compared to only 13 percent
with Rebif (p=0.0002).
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There was a 42 percent reduction in the risk of six-month sustained
accumulation (worsening) of disability (SAD) as measured by EDSS in
patients treated with alemtuzumab compared to Rebif over two years of
study (p=0.0084), as previously reported. This was a highly
statistically significant result for this co-primary endpoint.
Key relapse data from the trial presented at AAN include:
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65 percent of patients treated with alemtuzumab were relapse-free at
two years, meaning they did not experience any relapses in the trial,
compared to 47 percent with Rebif (47 percent risk reduction;
p<0.0001).
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A 49 percent reduction in relapse rate was observed in patients
treated with alemtuzumab 12 mg compared to Rebif over two years of
study (p<0.0001), a highly significant result for this co-primary
endpoint, as previously reported.
“To date, a key goal for MS treatment has been to delay the worsening
of disability,” said Jeffrey Cohen, M.D., Director of Experimental
Therapeutics, Cleveland Clinic Mellen Center for MS Treatment and
Research; and a member of the Steering Committee overseeing the conduct
of the study. “Patients in the study whose prior MS treatment was
inadequate at preventing relapses and received alemtuzumab in the
CARE-MS ll trial experienced a slowing or reversal of their disability."
In the CARE-MS II trial, alemtuzumab 12 mg was given as an IV
administration a total of eight times over the course of the two-year
study. The first treatment course of alemtuzumab was administered on
five consecutive days, and the second course was administered on three
consecutive days 12 months later. Rebif 44 mcg was administered by
subcutaneous injection three times per week, each week, throughout the
two years of study.
“Alemtuzumab is the first disease modifying therapy to show a
significant effect both on relapse and disability endpoints over and
above those of Rebif in a comparative trial,” said Professor
Alastair Compston, Chair of the Steering Committee overseeing the
conduct of the study, principal investigator on the Phase II and III
clinical trials of alemtuzumab, and Head of the Department of Clinical
Neurosciences at the University of Cambridge, United Kingdom. “The
efficacy data from the CARE-MS trial program suggest that, if approved,
alemtuzumab will be an important new treatment for relapsing MS patients
with active disease.”
Additional new data from the CARE-MS II study suggest that alemtuzumab
provided significant improvement over Rebif across a number of imaging
endpoints, consistent with the effects observed in the clinical
endpoints. In MS, imaging can be used to track the development of
lesions, or patches of inflammation in the central nervous system (CNS).
Statistically significant improvement was observed for alemtuzumab over
Rebif in the percentage of patients with new or enlarging
T2-hyperintense lesions (46 vs. 68; p<0.0001) and with
gadolinium-enhancing lesions (19 vs. 34; p<0.0001). The change in
T2-hyperintense lesion volume from baseline to year two, a secondary
endpoint, was not significantly different (p=0.14). In the trial,
patients treated with alemtuzumab experienced less change in brain
parenchymal fraction (BPF), a measure of brain atrophy or loss of
neurons and the connections between them, compared to Rebif (-0.62 vs.
-0.81) median percent change from baseline (p=0.012), a significant
result.
“We believe these ground-breaking results from CARE-MS ll, including
reversal of disability accumulation in some patients, achieved over the
standard therapy Rebif, provide a message of hope for people living with
MS,” said David Meeker, M.D., President and CEO, Genzyme. “We are
on track to submit alemtuzumab for review to U.S. and EU regulatory
authorities in the second quarter of this year and are excited about the
potential of bringing this important therapy to people living with MS
who have unmet treatment needs.”
The most common adverse events associated with alemtuzumab in the
CARE-MS Il study were infusion-associated reactions, which were
generally mild to moderate. Infections were common in both groups, with
a higher incidence in the alemtuzumab group. The most common infections
included upper respiratory and urinary tract infections, cutaneous
fungal infections and oral herpes. Serious infections occurred in 3.7
percent of the alemtuzumab group as compared to 1.5 percent of the Rebif
group. Infections were predominantly mild to moderate in severity and
none were fatal.
In the trial, 15.9 percent of alemtuzumab-treated patients developed an
autoimmune thyroid-related adverse event compared to 5.0 percent with
Rebif, and 0.9 percent of alemtuzumab-treated patients developed immune
thrombocytopenia (ITP) during the two-year study period. These cases
were detected early through a monitoring program and managed using
conventional therapies. Patient monitoring for ITP and thyroid or renal
disorders is incorporated in all Genzyme-sponsored trials of alemtuzumab
for the investigational treatment of MS. All data reported above pertain
to patients in the trial who received alemtuzumab 12 mg or Rebif 44 mcg.
Alemtuzumab is a monoclonal antibody that selectively targets CD52, a
protein abundant on T and B cells. Treatment with alemtuzumab results in
the depletion of circulating T and B cells thought to be responsible for
the damaging inflammatory process in MS. Alemtuzumab has minimal impact
on other immune cells. The acute anti-inflammatory effect of alemtuzumab
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.
The company is on track to file for U.S. and EU approval of alemtuzumab
in relapsing MS in the second quarter of 2012. 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.
*LemtradaTM is the proprietary name submitted to health
authorities for the company’s investigational multiple sclerosis agent
alemtuzumab.
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Sanofi will host a conference call for the financial community
during the upcoming
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American Academy of Neurology Annual Meeting,
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including the results of the CARE - MS II study.
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It will take place on Wednesday 25th April, 2012 at:
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15:00 Paris CEST / 14:00 London BST / 9:00 New York EDT
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The conference call will include a presentation followed by a Q&A
session.
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It will be accessible through audio webcast at www.sanofi.com
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and via the following telephone numbers.
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CALL IN NUMBERS
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France +33 (0) 1 70 77 09 38
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UK +44 (0) 203 367 9457
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USA +1 866 907 5925
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AUDIO REPLAY
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An audio replay of the call will be available through the numbers
below.
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The replay will be available approximately 2 hours after the end of
the call.
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France +33 (0) 1 72 00 15 00
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UK +44 (0) 203 367 9460
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USA +1 877 642 3018
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Access code 276606#
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***
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About CARE-MS
CARE-MS II (Comparison of Alemtuzumab
and Rebif Efficacy
in Multiple Sclerosis
II) trial was designed to evaluate whether the investigational MS
therapy alemtuzumab could achieve meaningful efficacy and safety
improvements over the approved, active comparator Rebif (subcutaneous
interferon beta-1a 44 mcg), a standard treatment for relapsing-remitting
MS. Patients enrolled in the trial had to have active MS, with at least
one relapse occurring while on MS therapy, including standard injectable
disease modifying therapies.
CARE-MS II was a Phase III, global, randomized clinical trial comparing
treatment with alemtuzumab to treatment with Rebif in 840 patients who
relapsed while receiving prior MS treatment. The 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.
In addition to the completed CARE-MS II study, another Phase III trial,
CARE-MS I, evaluated alemtuzumab against Rebif in relapsing-remitting MS
patients naive to prior treatment and found a statistically significant
reduction in relapse rate with alemtuzumab. In both trials, alemtuzumab
12 mg was given as an IV administration for a total of eight times over
the course of the two-year study. The first treatment course of
alemtuzumab was administered on five consecutive days, and the second
course was administered on three consecutive days 12 months later. Rebif
44 mcg was administered by subcutaneous injection three times per week,
each week, throughout the two years of study. In CARE-MS II, a third
group of patients received alemtuzumab 24 mg (n=170), given on the same
dosing schedule as the patients receiving alemtuzumab 12 mg (n=426).
Genzyme has the worldwide rights to alemtuzumab and has primary
responsibility for its development and commercialization 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.
About Sanofi
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,
consumer healthcare, emerging markets, animal health and the new
Genzyme. 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 EUR 17.2 billion
(2011), 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, develop, manufacture and market
products that will improve human and animal health worldwide. Bayer
HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and
is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
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the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
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and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
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inherent in research and development, future clinical data and analysis,
including post marketing, decisions by regulatory authorities, such as
the FDA or the EMA, regarding whether and when to approve any drug,
device or biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential of
such product candidates, the absence of guarantee that the product
candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives, the Group’s
ability to benefit from external growth opportunities, trends in
exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number
of shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including those
listed under “Risk Factors” and “Cautionary Statement Regarding
Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for
the year ended December 31, 2011. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
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Genzyme® is a registered trademark. All
rights reserved.
Rebif® is a
registered trademark of EMD Serono, Inc. or affiliates.
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