- 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 –
Company Website:
http://www.genzyme.com
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.
“MS is a devastating disease and patients remain in need of new
treatment options that may offer greater efficacy. These new data
reinforce the transformative potential of Lemtrada,” said Genzyme
President and CEO, David Meeker, M.D. “It is encouraging to see the
durable efficacy and manageable safety of Lemtrada maintained two years
into the extension study.”
Safety results from the second year of the extension study were
reported. No new risks were identified. As previously reported, there
were two deaths in the extension study. One was from sepsis and the
other was presumed accidental and deemed unrelated to study treatment.
Over four years, approximately 2 percent of patients treated with
Lemtrada in the pivotal trials developed immune thrombocytopenia (ITP),
all of whom responded to treatment. Patient monitoring for autoimmune
disorders is incorporated in all Genzyme-sponsored trials of Lemtrada.
The most common side effects of Lemtrada are infusion associated
reactions (headache, rash, pyrexia, nausea, fatigue, urticaria,
insomnia, pruritus, diarrhea, chills, dizziness, and flushing),
infections (upper respiratory tract and urinary tract), and thyroid
disorders. Autoimmune conditions (including immune thrombocytopenia,
other cytopenias, glomerulonephritis and thyroid disease) and serious
infections can occur in patients receiving Lemtrada. A comprehensive
risk management program incorporating education and monitoring will help
support early detection and management of these identified risks.
About CARE-MS
The Lemtrada clinical development program included two 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.
About LemtradaTM (alemtuzumab)
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. Lemtrada 12 mg has a novel dosing and
administration schedule of two annual treatment courses. The first
treatment course is administered via intravenous infusion on five
consecutive days, and the second course is administered on three
consecutive days, 12 months later.
Lemtrada is approved in the European Union, Australia, Canada, Mexico,
Brazil, Argentina, Chile and Guatemala. Lemtrada is currently not
approved in the United States. The U.S. Food and Drug Administration
(FDA) has accepted for review the company’s resubmission of its
application seeking approval of Lemtrada, and Genzyme expects FDA action
on the application in the fourth quarter. Marketing applications for
Lemtrada are also under review in other countries.
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.
Genzyme holds the worldwide rights to alemtuzumab and has primary
responsibility for its development and commercialization in multiple
sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in
MS in the United States. Upon commercialization, Bayer will receive
contingent payments based on global 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.
Genzyme® is a registered trademark and LemtradaTM
is a trademark of Genzyme Corporation. Rebif® is a registered
trademark of EMD Serono, Inc.
About Sanofi
Sanofi, a global 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).
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and
expectations with respect to future financial results, events,
operations, services, product development and potential, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects”, “anticipates”, “believes”, “intends”,
“estimates”, “plans” and similar expressions. Although Sanofi’s
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks
and uncertainties, many of which are difficult to predict and generally
beyond the control of Sanofi, that could cause actual results and
developments to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include among other things, the uncertainties
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, 2013. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.
Contacts:
Contacts:
Genzyme Media Relations
Erin Pascal,
Tel: +1 617 768 6864
erin.pascal@genzyme.com
or
Sanofi
Media Relations
Jack Cox, Tel.: +33 (0)1 53 77 46 46
mr@sanofi.com
or
Sanofi
Investor Relations
Sébastien Martel, Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Source: Genzyme
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