Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today
that Argentina’s National Administration of Drugs, Food and Medical
Technology (ANMAT) has approved LemtradaTM (alemtuzumab) for
adult patients with relapsing remitting multiple sclerosis (RRMS) with
active disease defined by clinical or imaging features.
“The Lemtrada clinical trial data demonstrating the treatment’s
positive impact on relapse rates and disability progression support its
potential as a transformational new treatment for relapsing-remitting
multiple sclerosis,” said Norma Deri, M.D., Hosptial Fernandez,
Buenos Aires, Argentina. “The approval of Lemtrada is good news for
people living with active MS, who are in need of additional treatment
options that may offer greater efficacy.”
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. In addition to Argentina, Lemtrada is
approved in the European Union, Australia, Canada, Mexico, Brazil and
Guatemala. Lemtrada is currently not approved in the United States.
Genzyme recently announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the company’s resubmission of its
application seeking approval of Lemtrada. Genzyme expects FDA action on
the application in the fourth quarter.
More than 2.3 million people worldwide have been diagnosed with MS,
including approximately 8,000 people in Argentina.
Lemtrada 12 mg has a novel dosing and administration schedule of two
annual treatment courses. The first treatment course of Lemtrada is
administered via intravenous infusion on five consecutive days, and the
second course is administered on three consecutive days, 12 months later.
"We are pleased by the continued global support for Lemtrada,"
said Genzyme President and CEO, David Meeker. "We are launching the
treatment in more than 30 countries this year, and look forward to
additional approvals where Lemtrada is still under review."
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.
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 lymphopenia.
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
support early detection and management of these identified risks.
About LemtradaTM (alemtuzumab)
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
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expectations with respect to future financial results, events,
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regarding future performance. Forward-looking statements are generally
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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.
Copyright Business Wire 2014