CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme,
a Sanofi Company (EURONEXT: SAN and NYSE: SNY), announced that
the U.S. Food and Drug Administration (FDA) has accepted for review the
company’s supplemental Biologics License Application (sBLA) file seeking
approval of LEMTRADA (alemtuzumab) for the treatment of relapsing
multiple sclerosis (RMS). The company also reported key highlights from
the U.S. launch of once-daily, oral AUBAGIO (teriflunomide).
“Genzyme is making a difference for people living with MS and
realizing its vision of being leaders in MS”
LEMTRADA sBLA Accepted by FDA
The FDA has accepted for standard review the company’s sBLA file seeking
approval of LEMTRADA. Genzyme expects FDA action on the application in
the second half of 2013. Genzyme has already submitted its marketing
authorization application for LEMTRADA to the European Medicines Agency
(EMA) and the review process is underway. The Committee for Medicinal
Products for Human Use (CHMP) opinion for LEMTRADA is expected in Q2
The LEMTRADA clinical development program includes CARE-MS I and CARE-MS
II (Comparison of Alemtuzumab
and Rebif® Efficacy
in Multiple Sclerosis),
randomized Phase III studies comparing LEMTRADA to a standard of care MS
treatment, Rebif, in patients with relapsing-remitting MS who
were naïve to prior treatment or who had relapsed while on prior
therapy, respectively. Genzyme announced publication of results of these
studies in The Lancet in November 2012.
AUBAGIO Early Launch Indicators in the U.S.
Since its launch in October, once-daily, oral AUBAGIO has shown very
encouraging early launch indicators among U.S. prescribers.1
Key highlights from the launch include:
More than 80 percent of MS specialists in the U.S. have prescribed
Approximately 1 in 5 patients prescribed AUBAGIO were treatment-naïve;
More than 50 percent of AUBAGIO patients were most recently on Copaxone®
“Genzyme is making a difference for people living with MS and
realizing its vision of being leaders in MS,” said Genzyme President
and CEO, David Meeker, M.D. “The initial uptake of AUBAGIO by U.S.
prescribers shows the importance of a once-daily oral option in MS. In
addition, the acceptance of the LEMTRADA file in the U.S. marks another
important milestone in bringing this potentially transformative therapy
to MS patients. We look forward to a series of product launches in 2013
in Europe and other major markets.”
AUBAGIO is approved for use in both the U.S. and Australia.
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 retains an option to co-promote alemtuzumab
in multiple sclerosis. Bayer HealthCare has notified Genzyme of its
intention to co-promote under this option. Upon regulatory approval and
commercialization, Bayer would receive contingent payments based on
LEMTRADATM is the proprietary name submitted to health
authorities for the company’s investigational multiple sclerosis agent
AUBAGIO is an immunomodulator with anti-inflammatory properties.
Although the exact mechanism of action for AUBAGIO is not fully
understood, it may involve a reduction in the number of activated
lymphocytes in the central nervous system (CNS).
Indications and Usage
AUBAGIO (teriflunomide) is a once-daily, oral treatment indicated for
patients with relapsing forms of multiple sclerosis (MS). AUBAGIO 14 mg
has shown significant efficacy across key measures of MS disease
activity, including reducing relapses, slowing the progression of
physical disability, and reducing the number of brain lesions as
detected by MRI.
Important Safety Information About AUBAGIO
The AUBAGIO label includes a boxed warning citing the risk of
hepatotoxicity and, teratogenicity (based on animal data).
In MS clinical studies with AUBAGIO, the incidence of serious adverse
events were similar among AUBAGIO and placebo-treated patients. The most
common adverse events associated with AUBAGIO in MS patients included
increased ALT levels, alopecia, diarrhea, influenza, nausea and
Teriflunomide is the principal active metabolite of leflunomide, which
is indicated in the U.S. for the treatment of rheumatoid arthritis.
Severe liver injury including fatal liver failure has been reported in
patients treated with leflunomide.
Leflunomide has an estimated 2.1 million years of patient exposure in
rheumatoid arthritis globally since its launch.
AUBAGIO is contraindicated in pregnant women and women of childbearing
potential who are not using reliable contraception.
AUBAGIO is supported by a robust clinical program with more than 5,000
trial participants in 36 countries and is amongst the largest of any MS
therapy. Some patients in extension trials have been treated for up to
10 years. The AUBAGIO approvals were based on efficacy data from the
TEMSO (TEriflunomide Multiple
For full prescribing information and more information about AUBAGIO,
please visit www.genzyme.com.
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.
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
Genzyme® is the registered trademark of Genzyme Corporation.
All rights reserved.
Copaxone® is a trademark of Teva Pharmaceuticals Industries.
Avonex® is a trademark of Biogen Idec.
Rebif® is a registered trademark of EMD Serono, Inc. or
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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1 Based on data collected at Genzyme's MS One to One Patient
and Provider Support Center, September 2012-January 2013.