Genzyme’s Multiple Sclerosis Franchise Featured at AAN

PR Newswire/Les Echos/ 
         Genzyme's Multiple Sclerosis Franchise Featured at AAN 
 - Multiple Presentations Highlight Continuing Progress of AUBAGIO and LEMTRADA 
                                Programs - 
Paris, France - March 13, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its
subsidiary Genzyme announced today that data f rom its AUBAGIO(r)
(teriflunomide) and LEMTRADA(TM) (alemtuzumab) multiple sclerosis clinical
development programs will be presented during the 65th American Academy of
Neurology (AAN) Annual Meeting to be held in San Diego, Calif., March 16-23. 
"We are proud to present these results that offer important new insights into
Aubagio and Lemtrada," said Genzyme CEO and President, David Meeker, MD. "Our
robust clinical development pro grams underscore our steadfast commitment to
advancing our understanding of Multiple Sclerosis and its treatment, and to
providing new hope for people living with this devastating disease." 
Data from across the company's clinical development programs to be presented at
AAN during Pacific Time are as follows, along with details about the Genzyme
Corporate Therapeutic Update and Brain Health Fair sponsorship. 
Platform Presentations for AUBAGIO and LEMTRADA: 
* Pre-Defined Subgroups Analyses of TOWER, a Placebo-Controlled Phase 3 Trial 
  of Teriflunomide in Patients with Relapsing Multiple Sclerosis (Platform
  Presentation Session 41 - S41.006; March 21; 1:30 p.m.)
* Teriflunomide Efficacy and Safety in Patients with Relapsing Multiple
  Sclerosis: Results From TOWER, a Second, Pivotal, Phase 3 Placebo-Controlled
  Study (Platform Presentation Session 1 - S01.004; March 19; 1:45 p.m.)
* Pregnancy Outcomes From the Teriflunomide Clinical Development Program:
  Retrospective Analysis of the Teriflunomide Clinical Trial Database (Platform
  Presentation Session 30 - S30.005; March 20; 3:00 p.m.) 
* Durable Efficacy of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis
  Patients Who Participated in the CARE-MS Studies: Three Year Follow-Up
  (Platform Presentation Session 41 - S41 .001; March 21; 12:00 p.m.) 
Additional Presentations: 
Poster Presentations
* Immune Response to Seasonal Influenza Vaccination in Patients with Relapsing
  Multiple Sclerosis Treated with Teriflunomide: the TERIVA Study (Poster 
  Session I - P01.169; March 18; 2:00 p.m.)
* Frequency of Infections During Treatment with Teriflunomide: Pooled Data From
  Three Placebo-Controlled Teriflunomide Studies (Poster Session I - P01.171;
  March 18; 2:00 p.m.)
* Teriflunomide Reduces Relapse-Related Sequelae, Hospitalizations and
  Corticosteroid Use: A Post-Hoc Analysis of the Phase 3 TOWER Study (Poster
  Session VII - P07.109; March 21; 2:00 p.m.) 
Poster Presentations 
* Disability Improvement with Alemtuzumab vs. Interferon beta-1a in
  Relapsing-Remitting Multiple Sclerosis Patients Who Experienced Disease 
  Activity While on Prior Therapy (CARE-MS II) (Poster Session VII - P07.120; 
  March 21; 2:00 p.m.)
* Efficacy of Alemtuzumab vs IFNB-1a in Relapsing-Remitting Multiple Sclerosis
  Patients Who Experienced Disease Activity While on Prior Therapy 
  (CARE-MS II): Subgroup Analysis by Previous Disease Modifying Therapy (DMT) 
  Use (Poster Session VII - P07.111; March 21; 2:00 p.m.)
* Alemtuzumab Reduces MS Disease Activity in Active Relapsing-Remitting 
  Multiple Sclerosis Patients Who Had Disease Activity on Prior Therapy (Poster
  Session VII - P07.093; March 21; 2:00 p.m.)
* Adverse Event Profile of Alemtuzumab Over Time in Active Relapsing-Remitting
  Multiple Sclerosis Patients Who Experienced Disease Activity While on Prior
  Therapy (CARE-MS II) (Poster Session I - P01.174; March 18; 2:00 p.m.)
* Detection, Incidence, and Management of Thyroid Autoimmunity in Comparison of
  Alemtuzumab and Rebif(r) in Multiple Sclerosis (CARE-MS I and II) (Poster
  Session I - P01 .173; March 18; 2:00 p.m.)
* Comparison of Infection Risk with Alemtuzumab and SC IFNB-1a in Patients with
  Multiple Sclerosis Who Experienced Disease Activity While on Prior Therapy
  (CARE-MS II) (Poster Session I - P01.172; March 18; 2:00 p.m.)
* Anti-IFNB-1a Antibody Status Was Not a Factor Influencing Efficacy of
  Alemtuzumab vs IFNB1a in Relapsing-Remitting Multiple Sclerosis Patients Who
  Experienced Disease Activity While on Prior Therapy (CARE-MS II) (Poster 
  Session VII - P07.125; March 21; 2:00 p.m.)
* Immunogenicity of Alemtuzumab Treatment in Relapsing-Remitting Multiple
  Sclerosis (RRMS) Patients in the CARE-MS II Study (Poster Session VII - 
  P07.101; March 21; 2:00 p.m.)
* Relapse Outcomes with Alemtuzumab vs IFNB-1a in Active Relapsing-Remitting
  Multiple Sclerosis Patients Who Experienced Disease Activity on Prior Therapy
  (CARE-MS II) (Poster Session VII - P07.098; March 21; 2:00 p.m.) 
Abstracts are available on the AAN website. 
Corporate Therapeutic Update 
"Evolving Standards in MS Care"
When: Tuesday, March 19; 7:00 - 10:00 p.m.
Location: Hilton San Diego Bayfront Hotel (1 Park Boulevard, San Diego, CA) 
Brain Health Fair
Genzyme is proud to serve as a platinum sponsor of this year's AAN Brain Health
Fair, taking place on Saturday, March 16, 2013. The Brain Health Fair is a free
event that is open to the public and designed to help connect patients, 
families and caregivers affected by neurologic disorders. Genzyme has invited 
Children's Hope for Understanding Multiple Sclerosis (CHUMS) to host an 
interactive exhibit, where visitors can experience what it's like to have MS 
through techniques that simulate common MS symptoms. 
About LEMTRADA(TM) (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 retains an option to copromote 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(TM) 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
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 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 has an estimated 2.1 million patient years of 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
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 
one of the world's largest pharmaceutical companies, with a shared commitment 
to improving the lives of patients. Learn more at 
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
AUBAGIO(r) is the registered trademark of Genzyme Corporation. All rights
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 
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 identified by the words "expects", "anticipates", 
"believes", "intends", "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. 
Contacts : 
Sanofi Media Relations             Sanofi Investor Relations
Jean-Marc Podvin                   Sébastien Martel
Tel: +33 (0) 1 53 77 46 46         Tel: +33 (0) 1 53 77 45 45
E-mail:              E-mail:  
Genzyme Media Relations            Sanofi Investor Relations
Erin Walsh                         Kristen Galfetti
Tel: +1 617-768-6881               Tel: +1 908 981 5560
E-mail:     E-mail: 
The content and accuracy of news releases published on this site and/or 
distributed by PR Newswire or its partners are the sole responsibility of the 
originating company or organisation. Whilst every effort is made to ensure the 
accuracy of our services, such releases are not actively monitored or reviewed 
by PR Newswire or its partners and under no circumstances shall PR Newswire or 
its partners be liable for any loss or damage resulting from the use of such 
information. All information should be checked prior to publication. 
-0- Mar/13/2013 07:49 GMT
Press spacebar to pause and continue. Press esc to stop.