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
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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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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
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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
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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.
MerckMedia:Deb Wambold, (215) 652-2913orInvestors:Justin
Holko, (908) 423-5088orSanofi PasteurMedia:Susan Watkins,
(570) 957-2563susan.watkins@sanofipasteur.comorInvestors:George
Grofik, (908) 981-5560IR@sanofi.com
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