US FDA Accepts for Review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine


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®
(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

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,
and connect with us on Twitter,
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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:

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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

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.

Deb Wambold, (215) 652-2913
Justin Holko, (908) 423-5088
Sanofi Pasteur
Susan Watkins, (570) 957-2563
George Grofik, (908) 981-5560

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