Genzyme’s Lemtrada Approved in Argentina for Treatment of Multiple Sclerosis

  Genzyme’s Lemtrada Approved in Argentina for Treatment of Multiple Sclerosis

Business Wire

CAMBRIDGE, Mass. -- June 30, 2014

Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that
Argentina’s National Administration of Drugs, Food and Medical Technology
(ANMAT) has approved Lemtrada^TM (alemtuzumab) for adult patients with
relapsing remitting multiple sclerosis (RRMS) with active disease defined by
clinical or imaging features.

“The Lemtrada clinical trial data demonstrating the treatment’s positive
impact on relapse rates and disability progression support its potential as a
transformational new treatment for relapsing-remitting multiple sclerosis,”
said Norma Deri, M.D., Hosptial Fernandez, Buenos Aires, Argentina. “The
approval of Lemtrada is good news for people living with active MS, who are in
need of additional treatment options that may offer greater efficacy.”

Lemtrada is supported by a comprehensive and extensive clinical development
program that involved nearly 1,500 patients and 5,400 patient-years of
follow-up. In addition to Argentina, Lemtrada is approved in the European
Union, Australia, Canada, Mexico, Brazil and Guatemala. Lemtrada is currently
not approved in the United States. Genzyme recently announced that the U.S.
Food and Drug Administration (FDA) has accepted for review the company’s
resubmission of its application seeking approval of Lemtrada. Genzyme expects
FDA action on the application in the fourth quarter.

More than 2.3 million people worldwide have been diagnosed with MS, including
approximately 8,000 people in Argentina.

Lemtrada 12 mg has a novel dosing and administration schedule of two annual
treatment courses. The first treatment course of Lemtrada is administered via
intravenous infusion on five consecutive days, and the second course is
administered on three consecutive days, 12 months later.

"We are pleased by the continued global support for Lemtrada," said Genzyme
President and CEO, David Meeker. "We are launching the treatment in more than
30 countries this year, and look forward to additional approvals where
Lemtrada is still under review."

The Lemtrada clinical development program included two randomized Phase III
studies comparing treatment with Lemtrada to high-dose subcutaneous interferon
beta-1a (Rebif^®) in patients with RRMS who had active disease and were either
new to treatment (CARE-MS I) or who had relapsed while on prior therapy
(CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada
was significantly more effective than interferon beta-1a at reducing
annualized relapse rates; the difference observed in slowing disability
progression did not reach statistical significance. In CARE-MS II, Lemtrada
was significantly more effective than interferon beta-1a at reducing
annualized relapse rates, and accumulation of disability was significantly
slowed in patients given Lemtrada vs. interferon beta-1a.

The most common side effects of Lemtrada are infusion associated reactions
(headache, rash, pyrexia, nausea, fatigue, urticaria, insomnia, pruritus,
diarrhea, chills, dizziness, and flushing), infections (upper respiratory
tract and urinary tract), and lymphopenia. Autoimmune conditions (including
immune thrombocytopenia, other cytopenias, glomerulonephritis and thyroid
disease) and serious infections can occur in patients receiving Lemtrada. A
comprehensive risk management program incorporating education and monitoring
will support early detection and management of these identified risks.

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 holds the right to co-promote alemtuzumab in MS in
the United States. Upon commercialization, Bayer will receive contingent
payments based on global sales revenue.

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.

Genzyme^®is a registered trademark and Lemtrada^TM is a trademark of Genzyme
Corporation. Rebif^®is a registered trademark of EMD Serono, Inc.

About Sanofi

Sanofi, a global 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).

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
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Sanofi’s management believes that the expectations reflected in such
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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, 2013. Other than as
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or revise any forward-looking information or statements.

Contact:

Genzyme Media Relations
Erin Pascal , + 1 617 768 6864
erin.pascal@genzyme.com
or
Sanofi Investor Relations
Kristen Galfetti, +1 908 981 5560
ir@sanofi.com
 
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