Genzyme’s LEMTRADA™ (alemtuzumab) Application for MS Accepted for Review by the FDA

PR Newswire/Les Echos/ 
PRESS RELEASE 
 Genzyme's LEMTRADA(TM) (alemtuzumab) Application for MS Accepted for Review by 
                                 the FDA 
-- Genzyme also Reports Very Encouraging Early Launch Indicators for AUBAGIO(r) 
                          (teriflunomide) in U.S. - 
Paris, France -- January 28, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its
subsidiary Genzyme 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(TM) (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). 
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 2013. 
The LEMTRADA clinical development program includes CARE-MS I and CARE-MS II
(Comparison of Alemtuzumab and Rebif(r)  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 AUBAGIO; 
 *  Approximately 1 in 5 patients prescribed AUBAGIO were treatment-naïve; 
 *  More than 50 percent of AUBAGIO patients were most recently on Copaxone(r) 
and Avonex(r) 
"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. 
(1) Based on data collected at Genzyme's MS One to One Patient and Provider
Support Center, September 2012-January 2013. 
About Alemtuzumab/LEMTRADA(TM)
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 sales revenue. 
Lemtrada is the proprietary name submitted to health authorities for the
company's investigational multiple sclerosis agent alemtuzumab. 
About AUBAGIO(r)
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 s 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 paresthesia. 
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
Sclerosis Oral) trial.  
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. 
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). 
Genzyme(r) is the registered trademark of Genzyme Corporation. All rights 
reserved.  
Copaxone(r) is a trademark of Teva Pharmaceuticals Industries 
Avonex(r) is a trademark of Biogen Idec 
Rebif(r) is a registered trademark of EMD Serono, Inc. or affiliates. 
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. 
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
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intentions and expectations with respect to future financial results, events,
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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, 2011.
Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements. 
Contacts:
Sanofi Media Relations                           Sanofi Investor Relations
Marisol Péron                                    Sébastien Martel
Tel: +33 (0) 1 53 77 46 46                       Tel: +33 (0) 1 53 77 45 45
E-mail: mr@sanofi.com                            E-mail: ir@sanofi.com 
Genzyme Media Relations                          Sanofi Investor Relations
Erin Walsh                                       Kristen Galfetti
Tel: 617-768-6881                                Tel: +1 908 981 5560
E-mail: Erin.Walsh@genzyme.com                   E-mail: ir@sanofi.com 
                  
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-0- Jan/28/2013 07:37 GMT
 
 
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