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Lyon, France – October 8, 2009
Panenza®* and Humenza®* Influenza A(H1N1) Vaccines Demonstrate Robust Immune Response After One Dose
Interim data from European studies confirm that one dose of Panenza®
or Humenza® pandemic influenza vaccines induces robust seroprotective antibody
response in children and adults.
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT:
SAN and NYSE: SNY), announced today that a single dose of influenza A (H1N1)
2009 monovalent vaccines, Panenza® (15mcg dose, non-adjuvanted) or Humenza®
(3.8mcg dose, adjuvanted), administered to children (3 years of age and older)
and adults induces a robust immune response, according to results from clinical
trials conducted in Europe.
One dose of Panenza or Humenza Influenza A (H1N1) 2009 monovalent vaccine induces
a robust antibody response that is considered protective in 93 percent or more
of adults 18 to 59 years old and in 83 percent or more of adults 60 years of
age and older. In children 3 years of age through 17 years of age, 94 percent
or more of study participants achieved seroprotective antibody response. Both
vaccines tested met the three European Medicines Agency’s (EMEA) criteria.
“These significant clinical data concerning Sanofi Pasteur’s pandemic influenza
vaccines will help build public confidence in the vaccine and will support efforts
by health authorities to face the challenge posed by pandemic influenza,” said
Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. “Humenza
and Panenza vaccines are effective answers to different public health needs.
Humenza, a low-dose adjuvanted vaccine, has the potential to expand pandemic
production capacities and to increase the number of doses of vaccine available,
making it possible to immunize more people; Panenza, standard-dose non-adjuvanted
vaccine, may be considered by European authorities as the vaccine of choice
to protect specific at-risk populations.”
Results announced today are based on interim analysis following the first vaccination
dose from clinical trials conducted in France and Finland. These data, from
serum samples taken from all participants 21 days after the first dose, indicate
that adjuvanted and non-adjuvanted vaccines administered in the trial induce
a strong immune response in most participants. No serious adverse events have
been observed to date in these clinical trials. Safety and tolerability profiles
were as expected. Local injection site (redness, swelling and pain) and systemic
complaints of mild fever, headache and fatigue were reported.
* Panenza® and Humenza® are registered trademarks of Sanofi Pasteur’s
influenza A (H1N1) vaccines in EU and other countries.
Sanofi Pasteur Clinical Trial Design
Sanofi Pasteur reported today on interim antibody response and safety results
following one dose of the company’s two influenza A (H1N1) 2009 monovalent vaccines
in children aged 3 years of age and older, and in adults.
Sanofi Pasteur began clinical trials in Europe on August 18, 2009 to test the
immunogenicity and safety of its influenza A (H1N1) 2009 monovalent vaccines.
Two multi-center, randomized controlled studies are being conducted in Finland,
involving 300 children 3 years of age through 17 years of age, and in France,
involving 450 adults divided into two age cohorts: 18 years of age through 59
years of age (300 volunteers) or 60 years of age and older (150 volunteers).
Both trials are continuing to evaluate the immunogenicity and safety of a second
dose of these vaccines. Final data from these clinical trials, following a second
dose of vaccine, will provide additional information on the human immune response
to this new influenza strain.
Study participants in each age cohort were randomly divided into three treatment
groups. Each group received a 0.5mL injection of either a non-adjuvanted 15mcg
dose vaccine, or an AF03-adjuvanted 7.5mcg dose vaccine or an AF03-adjuvanted
3.8mcg dose vaccine.
In the trials two doses of vaccine were administered; the second dose 21 days
after the first. Immunogenicity was measured at day 21 prior to administration
of the second dose and will be measured again 21 days after the second dose
at day 42. An antibody titer of 1:40 or greater is generally considered a marker
of seroprotection. A lower rise in antibody titers following vaccination may
minimize the occurrence of disease and its consequences but is not considered
seroprotective. Adverse events are being monitored throughout the clinical trial
and monitoring will continue for six months after the second dose of vaccine.
About Panenza and Humenza
Sanofi Pasteur’s influenza A (H1N1) 2009 monovalent inactivated influenza virus
vaccines, Panenza and Humenza, are manufactured at Sanofi Pasteur’s facility
in Val de Reuil, France, using the same process as Sanofi Pasteur’s seasonal
trivalent influenza virus vaccine licensed in Europe.
Panenza is a non-adjuvanted vaccine formulated to contain 15mcg hemagglutinin
(HA) of influenza A/California/07/2009 (H1N1) v–like virus.
Humenza vaccine is formulated to contain 3.8mcg hemagglutinin (HA) of influenza
A/California/07/2009 (H1N1) v–like virus and includes AF03-adjuvant, Sanofi
Pasteur’s proprietary adjuvant, aimed at stimulating the immune system to increase
its response.
Panenza and Humenza vaccines are not intended to be distributed in the U.S.
where Sanofi Pasteur produces another A (H1N1) pandemic vaccine licensed by the
F.D.A.
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur operates influenza vaccine production facilities in Val de Reuil,
France and in Swiftwater, Pa. (U.S.). All Sanofi Pasteur influenza vaccine facilities
have been designed and built to be able to switch from seasonal influenza vaccine
production to pandemic influenza vaccine production.
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines
distributed worldwide. For the 2008-2009 influenza season, the company produced
more than 45 percent of the influenza vaccines distributed in the U.S. More
information about Sanofi Pasteur’s pandemic preparedness efforts can be found
at www.pandemic.influenza.com.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops
and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis
is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more
than 1.6 billion doses of vaccine in 2008, 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 financial
projections and estimates and their underlying assumptions, statements regarding
plans, objectives, intentions and expectations with respect to future events,
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Forward-looking statements are generally identified by the words “expects”,
“anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions.
Although sanofi-aventis’ 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-aventis, 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
those discussed or identified in the public filings with the SEC and the AMF
made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report
on Form 20-F for the year ended December 31, 2008. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.