Effect of Genzyme’s LEMTRADA Maintained in Patients Beyond Two-Year Pivotal MS Studies

PR Newswire/Les Echos/ 
PRESS RELEASE 
Effect of Genzyme's LEMTRADA Maintained in Patients Beyond Two-Year Pivotal MS 
                                 Studies 
-- In more than 70 percent of patients, disability scores improved or remained 
                        stable over three years -- 
-- More than 80 percent of patients treated with LEMTRADA did not receive a 
    third course of treatment in the first year of the extension -- 
Paris, France - March 21, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its
subsidiary Genzyme announced today interim results from the first year of the
extension study of LEMTRADA(TM) (alemtuzumab), being developed for the treatment
for multiple sclerosis (MS). 
In this analysis of the first year of the extension study, relapse rates and
sustained accumulation of disability remained low among patients who had
previously received LEMTRADA in either of the Phase III CARE-MS I or CARE-MS II
studies. In these pivotal studies, LEMTRADA was given as two annual courses, at
the start of the study and 12 months later. More than 80 percent of patients did
not receive further treatment with LEMTRADA during the first year of the
extension study. 
"These findings are important because they suggest that the benefits of LEMTRADA
as observed in the Phase III studies are maintained, even though most patients
did not receive further dosing," said Edward Fox, M.D., Director of the Multiple
Sclerosis Clinic of Central Texas, who presented the study results today at the
annual meeting of the American Academy of Neurology in San Diego, Calif. 
Extension Study Results 
The Phase III trials of LEMTRADA were randomized, two-year pivotal studies
comparing treatment with LEMTRADA to Rebif (subcutaneous interferon beta-1a 44
mcg) in patients with relapsing-remitting MS who were either new to treatment
(CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II). 
More than 90 percent of the patients who participated in the Phase III pivotal
trials enrolled in the extension study. Patients who originally received
LEMTRADA were eligible to receive additional treatment in the extension study if
they experienced at least one relapse or at least two new or enlarging brain or
spinal lesions. 
These interim results are from the first year of the extension study for
patients who previously received LEMTRADA in the two-year studies. Findings
stated below are based on patients who enrolled in the extension study: 
* More than half of patients (67 percent in CARE-MS I and 55 percent in CARE-MS
  II) who received LEMTRADA in the pivotal trials and enrolled in the extension
  study were still relapse-free through the first year of the extension study.
* In the first year of the extension phase, the annualized relapse rate for
  patients who received LEMTRADA in the pivotal trials was 0.24 and 0.25,
  comparable to the annualized relapse rate for those patients in CARE MS I and
  CARE-MS II, respectively.
* Through year three, 72.4 percent of patients in CARE MS I and 70.0 percent in
  CARE MS II had improved or stable disability as measured by EDSS.
* At three years, 88 percent and 80 percent of patients who received LEMTRADA in
  the pivotal trials, respectively, did not experience six-month confirmed
  sustained accumulation of disability.
* More than 80 percent of patients treated with LEMTRADA in the pivotal studies
  did not receive a third course of treatment within a year of entering the
  extension study. 
"These results underscore the tremendous promise that LEMTRADA holds for MS
patients," said David Meeker, M.D., Genzyme's President and Chief Executive
Officer. "We're pleased to be able to present these three-year results that
provide us with important new information about LEMTRADA and are consistent with
the published results from our Phase II extension study." 
Safety results from the first year of the extension study were reported for
patients who received LEMTRADA in the Phase III pivotal studies. No new risks
were identified. The frequency and type of common and serious adverse events in
the first year of the extension study were generally similar to those in the
Phase III pivotal studies. The most common adverse events during this period of
time were infections, including predominantly mild to moderate upper respiratory
and urinary tract infections. There were two deaths. One, as previously
reported, was from sepsis. The other was presumed accidental and deemed
unrelated to study treatment. The cumulative incidence of autoimmune thyroid
disease over three years was 29.9 percent, as expected based on the Phase II
study experience. Additionally, over three years, approximately 1 percent of
patients developed immune thrombocytopenia (ITP) and 0.3 percent developed
nephropathy, all of whom responded to treatment. These cases were detected early
through routine monitoring. Patient monitoring for autoimmune disorders is
incorporated in all Genzyme-sponsored trials of LEMTRADA. 
Genzyme's applications to market LEMTRADA for the treatment of MS are currently
being reviewed by the European Medicines Agency and the U.S. Food and Drug
Administration. The company expects action on both applications this year. 
About CARE-MS 
The CARE-MS trials are Phase III, global, randomized clinical trials designed to
evaluate whether the investigational MS therapy LEMTRADA could achieve
meaningful efficacy and safety improvements over the approved, active comparator
Rebif (subcutaneous interferon beta-1a 44 mcg), a standard treatment for
relapsing-remitting MS. The CARE-MS I study evaluated 581 patients naïve to
prior MS treatment, except for steroids. The CARE-MS II study evaluated 840
patients who have had at least one relapse occurring while on MS therapy,
including standard injectable disease modifying therapies. Genzyme announced
publication of results of these studies in The Lancet in November 2012. 
In the both trials, LEMTRADA was given as an IV administration a total of eight
times over the course of the two-year study. The first treatment course of
LEMTRADA 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 the third-year following initial
treatment, starting the extension phase of the trials, patients who experienced
resumed disease activity were retreated with LEMTRADA once daily for three days.
Patients who took Rebif in the pivotal study phase and crossed over to receive
LEMTRADA in the extension phase received LEMTRADA once daily for five days and
then once daily for three days one year later. 
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 co-promote alemtuzumab in multiple sclerosis.
Bayer HealthCare has notified Genzyme of its intention to copromote 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 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 reg istered trademark of Genzyme Corporation. All rights
reserved.  
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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results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
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"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
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- Mar/22/2013 09:07 GMT