Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
that the Australian Therapeutic Goods Administration (TGA) has approved
Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple
sclerosis for patients with active disease defined by clinical or
imaging features to slow the accumulation of physical disability and
reduce the frequency of clinical relapses.
“Multiple Sclerosis is a highly complex and often devastating disease
that can lead to significant disability in patients, despite
availability of standard therapies,” said Associate Professor John
King, Senior Neurologist, Royal Melbourne Hospital. “Lemtrada
represents a significant advance in the way physicians and patients can
think about treating multiple sclerosis. The efficacy data supporting
Lemtrada highlight its strong potential to impact disease progression in
patients with relapsing forms of MS.”
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. Approval in Australia follows the recent
approval of Lemtrada in Canada and the European Union. Marketing
applications for Lemtrada are also under review in other countries.
More than 2.3 million people worldwide have been diagnosed with MS,
including approximately 20,000 people in Australia.
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.
“The approval of Lemtrada in Australia reinforces the significance of
this treatment and is an important milestone in Genzyme’s commitment to
bring this potentially transformative therapy to patients globally,”
said David Meeker, President and CEO, Genzyme. “We’re very pleased
with the TGA’s approval and look forward to working with the
reimbursement authorities to make Lemtrada available to patients in
Australia.”
The Lemtrada clinical development program included two pivotal
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, infections (upper respiratory tract and urinary tract),
lymphopenia and leukopenia. Autoimmune conditions 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 Lemtrada™ (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 Lemtrada™ is a
trademark of Genzyme Corporation, a Sanofi company. Rebif® is
a registered trademark of EMD Serono, Inc.
About Sanofi
Sanofi, an integrated 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
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“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, 2012. 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 2013