CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced
that the company has submitted a supplemental Biologics License
Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a
marketing authorization application (MAA) to the European Medicines
Agency (EMA) seeking approval of LEMTRADA™ (alemtuzumab) for treatment
of relapsing multiple sclerosis (RMS). Genzyme is developing LEMTRADA in
MS in collaboration with Bayer HealthCare.
“There remains a large unmet treatment need for patients living with
active disease and we believe that LEMTRADA, given its efficacy and
unique dosing schedule, has the potential to transform the lives of
patients with MS”
Genzyme’s clinical development program for LEMTRADA included two Phase
III studies in which results for LEMTRADA were superior to Rebif®
(high dose subcutaneous interferon beta-1a) on clinical and imaging
endpoints, including a reduction in relapse rate. In addition, as
presented last month at the American Academy of Neurology meeting, some
patients with pre-existing disability treated with LEMTRADA in the
CARE-MS II trial were more than twice as likely to experience a
sustained reduction in disability over two years than patients treated
with Rebif.
“There remains a large unmet treatment need for patients living with
active disease and we believe that LEMTRADA, given its efficacy and
unique dosing schedule, has the potential to transform the lives of
patients with MS,” said Genzyme President and CEO, David Meeker.
The regulatory submissions for LEMTRADA include two-year controlled
efficacy and safety data from both treatment-naïve patients and those
who relapsed while on therapy, with greater than five years of safety
follow-up. Common adverse events associated with alemtuzumab were
consistent across the Phase III program and included infusion-associated
reactions and infections, which were generally mild to moderate in
severity. Autoimmune adverse events were observed in some patients with
cases being detected early through a monitoring program and managed
using conventional therapies.
In addition to LEMTRADA, Genzyme’s clinical development program for
relapsing multiple sclerosis includes the once-daily oral treatment,
AUBAGIOTM (teriflunomide), which is currently under review by
the FDA and EMA.
About Alemtuzumab/LEMTRADA™
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.
In both CARE-MS I and CARE-MS II 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.
LEMTRADATM and AubagioTM are the proprietary names
submitted to health authorities for the company’s investigational
multiple sclerosis agents alemtuzumab and teriflunomide respectively.
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.
Forward Looking Statements
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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
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Rebif® is a
registered trademark of EMD Serono, Inc. or affiliates.