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October 20, 2014 7:00 am ET

Phase III clinical study data presented at IDWeek in Philadelphia

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN and
NYSE:SNY), announced today that the Biologics License Application (BLA)
filed for the companies’ investigational pediatric hexavalent vaccine,
DTaP₅-IPV-Hib-HepB¹, has been accepted for review
by the U.S. Food and Drug Administration (FDA). If approved, it would be
the first pediatric combination vaccine in the United States designed to
help protect against six important diseases – diphtheria, tetanus,
pertussis (whooping cough), polio (poliovirus types 1, 2, and 3),
invasive disease caused by Haemophilus influenzae type b (Hib),
and hepatitis B.

“We are excited about reaching another key milestone in the development
of this investigational pediatric vaccine against six important
diseases,” said Robin Isaacs, M.D., Vice President, Vaccine Clinical
Research, Merck Vaccines.

“Leading organizations – the Advisory Committee on Immunization
Practices, the American Academy of Pediatrics, and the American Academy
of Family Physicians – generally recommend the use of combination
vaccines instead of individual injections,” said John Shiver, Ph.D.,
Senior Vice President, Research and Development, Sanofi Pasteur.

Phase III Clinical Study Data Presented at IDWeek

Data from a Phase III study for the investigational pediatric hexavalent
vaccine were recently presented at IDWeek in Philadelphia. This Phase
III study, a randomized, open-label, active-comparator controlled
clinical trial with more than 1,400 infants at multiple centers across
the United States, evaluated the safety and immunogenicity of the
investigational pediatric hexavalent vaccine versus licensed comparator
vaccines. The investigational and comparator vaccines were given at two,
four, and six months of age.

In the study, healthy infants were randomized in a 2:1 ratio to receive
either the investigational pediatric hexavalent vaccine (Group 1) or
Sanofi Pasteur’s Pentacel^{® 2} plus Merck’s Recombivax HB^®
3(Group 2). Antibody levels after the third infant doses were
measured, and from these measurements 19 primary comparisons between
Groups 1 and 2 were evaluated. For 18 of these 19 comparisons (all but
one pertussis comparison), the antibodies in the Group 1 infants were
non-inferior to those in the Group 2 infants. After the toddler dose of
licensed vaccines, antibodies were again measured; the Group 1
antibodies were non-inferior to those in Group 2 for all 8 pertussis
comparisons.

The most common, solicited, systemic adverse events following any dose
of the investigational hexavalent vaccine were irritability (83%),
crying (75%), and drowsiness (74%). Solicited systemic adverse event
rates after any dose were similar following administration of the
investigational pediatric hexavalent vaccine versus control with the
exception of increased rates of fever, which was mostly mild to moderate
in intensity and two days or fewer in duration.

“We are encouraged by the results of this Phase III trial,” said Gary S.
Marshall, M.D., professor of pediatrics, University of Louisville School
of Medicine, and lead investigator of the study. “This investigational
combination vaccine against six important diseases showed similar immune
responses against the antigens covered by licensed vaccines.”

The partnership between Merck and Sanofi Pasteur draws upon both
companies’ experience in the development, manufacturing and marketing of
individual and combination vaccines. This pediatric hexavalent vaccine
includes antigens for diphtheria, tetanus, pertussis (whooping cough),
and polio (poliovirus types 1, 2, and 3) from Sanofi Pasteur and
antigens for Haemophilus influenzae type b and hepatitis B
from Merck.

About Merck

Today’s Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
animal health products, we work with customers and operate in more than
140 countries to deliver innovative health solutions. We also
demonstrate our commitment to increasing access to healthcare through
far-reaching policies, programs and partnerships. For more information,
visit www.merck.com
and connect with us on Twitter,
Facebook
and YouTube.

About Sanofi

Sanofi, an integrated 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 Pasteur, the vaccines division of Sanofi, provides more than 1
billion doses of vaccine each year, making it possible to immunize more
than 500 million people across the globe. A world leader in the vaccine
industry, Sanofi Pasteur offers a broad range of vaccines protecting
against 20 infectious diseases. The company’s heritage, to create
vaccines that protect life, dates back more than a century. Sanofi
Pasteur is the largest company entirely dedicated to vaccines. Every
day, the company invests more than EUR 1 million in research and
development. For more information, please visit: www.sanofipasteur.com
or www.sanofipasteur.us.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; the exposure to litigation, including patent
litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2013 Annual Report on Form 10-K and the company’s other
filings with the SEC available at the SEC’s Internet site (www.sec.gov).

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 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, 2013. Other than as required by applicable
law, Sanofi does not undertake any obligation to update or revise any
forward-looking information or statements.

________________________________

¹ Known as V419 on the Merck pipeline chart and
DTaP-HepB-Polio-Hib (PR5I) Pediatric hexavalent vaccine on the Sanofi
and Sanofi-Pasteur pipeline charts. Also referred to as PR5I at
clinicaltrials.gov.

² Pentacel (Diphtheria and Tetanus Toxoids and Acellular
Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate
[Tetanus Toxoid Conjugate] Vaccine) is a registered trademark of Sanofi
Pasteur, the vaccines division of Sanofi, Paris, France.

³ Recombivax HB (Hepatitis B Vaccine [Recombinant]) is a
registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck
& Co., Inc., Whitehouse Station, N.J., USA.

Merck
Media:
Deb Wambold, (215) 652-2913
or
Investors:
Justin Holko, (908) 423-5088
or
Sanofi Pasteur
Media:
Susan Watkins, (570) 957-2563
susan.watkins@sanofipasteur.com
or
Investors:
George Grofik, (908) 981-5560
IR@sanofi.com