Genzyme’s Once-daily, Oral AUBAGIO® (teriflunomide) Approved in Argentina for the Treatment of Relapsing Multiple Sclerosis

  Genzyme’s Once-daily, Oral AUBAGIO® (teriflunomide) Approved in Argentina
  for the Treatment of Relapsing Multiple Sclerosis

  Approval Expands Footprint of AUBAGIO Across Three Continents and Further
                    Advances Genzyme’s Global MS Franchise

Business Wire

CAMBRIDGE, Mass. -- April 08, 2013

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today
Argentina’s National Administration of Drugs, Food and Medical Technology
(ANMAT) has approved once-daily, oral AUBAGIO^® 14 mg as a new treatment
indicated for patients with relapsing forms of multiple sclerosis (MS).

“Studied in one of the largest clinical trial programs of any MS treatment,
AUBAGIO has had consistent effects across all the important measures of MS
disease activity including slowing the progression of disability, reducing the
number of brain lesions as detected by MRI and reducing relapses. The clinical
data supporting AUBAGIO confirm its importance as a new treatment option for
MS patients,” said Dr. Jorge Correale, Head of Neuroimmunology and
Demyelinating Diseases, Raul Carrea Institute for Neurological Research FLENI,

The decision by ANMAT represents the first approval for once-daily, oral
AUBAGIO in Latin America. AUBAGIO is also approved in both the United States
and Australia, with additional marketing applications under review by
regulatory authorities around the world.

“The approval in Argentina of once-daily, oral AUBAGIO represents another
important advancement for the Genzyme MS Franchise,” said Bill Sibold, SVP,
Head of MS Business, Genzyme.“Genzyme is committed to becoming leaders in MS
and developing differentiated treatments that can address the diverse needs of
the MS community. Now approved on three continents, AUBAGIO’s established
efficacy and convenient dosing can provide many patients with an attractive
alternative to frequent and potentially burdensome injections.”

The ANMAT approval of AUBAGIO was based on safety and efficacy data from the
TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO
clinical development program, involving more than 5,000 patients in 36
countries, is amongst the largest of any MS therapy. Some patients in
extension trials have been treated for up to 10 years.

“AUBAGIO, in its clinical studies, has shown favorable efficacy and a
well-characterized safety profile. With its once-daily oral administration and
tolerability, AUBAGIO should contribute positively to the care of patients
with Multiple Sclerosis,” said Dr. Edgardo Cristiano, Head of the Neurology
Department of the Hospital Italiano de Buenos Aires, Argentina.


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 U.S. 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 greater than 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.

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 of 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).

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Genzyme Media Relations
Erin Walsh, +1-617-768-6881
Sanofi Investor Relations
Kristen Galfetti, +1-908-981-5560
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