LYON, France, Aug. 26, 2013 /PRNewswire/ -- Sanofi
Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE:
SNY), today announced topline results of a large-scale,
multi-center efficacy trial in people 65 years of age and older
showing a superior clinical benefit of Fluzone®
High-Dose (Influenza Virus Vaccine) relative to the standard dose
of Fluzone vaccine in preventing influenza.
Today's announcement reflects the positive findings related to
the primary endpoint for the study population. Further data
analyses of secondary endpoints are ongoing, including an
evaluation of the relative efficacy based on the match of the
vaccine strains to circulating influenza virus strains. Sanofi
Pasteur anticipates submitting the full clinical study report to
the FDA for review by early 2014 and will seek a modification to
the label for Fluzone High-Dose vaccine reflecting the superior
efficacy data in adults 65 years of age and older.
"We are pleased that this study demonstrates the superior
relative efficacy of Fluzone High-Dose vaccine compared to Fluzone
vaccine in preventing influenza in older adults," said
David P. Greenberg, M.D., Vice
President, U.S. Scientific and Medical Affairs, Sanofi Pasteur.
"This efficacy trial complements the previous evidence of
superior immune responses for Fluzone High-Dose vaccine compared to
Fluzone vaccine and reaffirms the Phase III safety data in this
population that were the basis for FDA licensure of Fluzone
High-Dose vaccine in 2009."
In the study, Fluzone High-Dose vaccine was 24.2 percent more
effective in preventing influenza in adults 65 years of age and
older than Fluzone vaccine. The results met the pre-specified
primary objective of the study, demonstrating statistically
superior efficacy for Fluzone High-Dose vaccine. Additionally, the
study results suggested consistent clinical benefit across the
study years, influenza virus types, clinical illness definitions,
and laboratory methods of influenza confirmation. This large,
multi-year trial also reaffirmed the safety of Fluzone High-Dose
vaccine as demonstrated in previous studies.
"Influenza vaccines have been shown to offer public health
benefits in preventing influenza and its complications in all age
groups; however, older adults still have the highest rates of
influenza-related hospitalization and death despite having high
immunization rates," said John
Shiver, Senior Vice President, Research and Development,
Sanofi Pasteur. "This led Sanofi Pasteur to develop Fluzone
High-Dose vaccine, which this trial has confirmed provides better
protection against influenza compared to Fluzone vaccine in people
65 years of age and older."
Fluzone High-Dose vaccine was licensed in the United States by the Food and Drug
Administration (FDA) in December 2009
based on the vaccine's safety profile and superior immunogenicity
compared to Fluzone vaccine. Immunogenicity (the ability of a
vaccine to trigger the body to produce antibodies against an
infectious agent) is commonly used to evaluate vaccines in clinical
trials. Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin
antigen per strain of influenza virus in the vaccine as compared to
15 mcg of influenza virus hemagglutinin antigen per strain of
influenza virus in standard dose Fluzone vaccine. Fluzone High-Dose
vaccine was licensed by the FDA under an accelerated approval
process to address the medical need in older adults. As a
requirement of the accelerated approval pathway, Sanofi Pasteur
embarked on this large-scale, two-season, confirmatory efficacy
trial, involving more than 30,000 participants 65 years of age and
older, to evaluate the clinical benefit of Fluzone High-Dose
vaccine compared to Fluzone vaccine in the prevention of influenza
disease.
About Influenza Disease in People 65+ Years of Age
Research has shown that the immune system weakens as people age.
Older adults are not only more susceptible to infections, but also
less responsive to vaccination. When infected with the influenza
virus, they are less able to mount an effective immune response to
neutralize the attack. Compared to younger adults, people 65 years
of age and older suffer disproportionately from seasonal influenza
disease and its complications, including severe illness leading to
hospitalization and death. Although this group comprises only 15
percent of the U.S. population, on average it accounts for 65
percent of the estimated 226,000 hospitalizations and 90 percent of
the 3,000 to 49,000 deaths attributed to seasonal influenza and its
complications each year. The first baby boomers began to turn 65 in
2011 and, by the year 2030, the number of adults 65 years of age
and older is anticipated to double and surpass 70 million people,
comprising 20 percent of the U.S. population. Thus, better
prevention of influenza in older adults can have a significant
impact on public health, quality of life, and healthcare
costs.
About Fluzone High-Dose Vaccine
Indication
Fluzone High-Dose vaccine is an
inactivated influenza virus vaccine given for active immunization
in persons 65 years of age and older against influenza disease
caused by influenza virus subtypes A and type B contained in the
vaccine. Approval of Fluzone High-Dose vaccine is based on superior
immune response relative to Fluzone vaccine. Data demonstrating a
decrease in influenza disease after vaccination with Fluzone
High-Dose vaccine relative to Fluzone vaccine have not yet been
reviewed by FDA.
Safety Information
The most common side effects to Fluzone High-Dose vaccine
include pain, swelling, and redness at the injection site; fever,
headache, fatigue, and muscle aches. Other side effects may occur.
Fluzone High-Dose vaccine should not be given to anyone with a
severe allergic reaction to any vaccine component, including eggs
or egg products, or to a previous dose of any influenza
vaccine.
The decision to give Fluzone or Fluzone High-Dose vaccine should
be based on the potential benefits and risks if Guillain-Barre
syndrome has occurred within six weeks of receipt of a prior
influenza vaccine. Vaccination with Fluzone or Fluzone High-Dose
vaccine may not protect all individuals.
Before administering Fluzone High-Dose vaccine or Fluzone
vaccine, please see full Prescribing Information available at
www.sanofipasteur.us or www.vaccineshoppe.com.
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 health care 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 the broadest
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.
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, 2012. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.
SOURCE Sanofi Pasteur