Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
- Company responds to FDA recommendation for influenza virus strain change supplement -
LYON, France and SWIFTWATER, Pa., Aug. 7 /PRNewswire/ -- Sanofi
Pasteur, the vaccines division of the sanofi-aventis Group
(EURONEXT: SAN and NYSE: SNY), announced today the company has
submitted to the U.S. Food and Drug Administration (FDA) a
supplemental application for licensure of its influenza A(H1N1)
2009 monovalent vaccine. Responding to recent recommendations by
the FDA, the company's supplemental application requests the FDA's
evaluation of the influenza A(H1N1) 2009 strain change, which is
expected to expedite the licensure process for the pandemic
vaccine.
"Filing this application is consistent with our commitment to
work collaboratively with public health officials in producing a
vaccine against the influenza A(H1N1) 2009 virus," said Wayne
Pisano, President and Chief Executive Officer of Sanofi Pasteur.
"It is essential that we pursue the vaccine licensure pathway made
available to us, while at the same time, continue the important
clinical studies of our vaccine."
The supplemental application follows recent recommendations by
the FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines
using the same regulatory process by which it approves new viral
strains contained in the annual seasonal influenza vaccines. Sanofi
Pasteur's influenza A(H1N1) 2009 monovalent vaccine supplemental
application specifies the evaluation of a non-adjuvanted
vaccine.
While these strain change supplements are not required to be
supported by new clinical data, immunogenicity and safety data will
be made available through clinical studies. Sanofi Pasteur will
test the immunogenicity and safety of its influenza A(H1N1) 2009
monovalent vaccine through clinical trials in the U.S., which began
August 6. The planned clinical trials will consist of approximately
2,000 subjects and will also evaluate the safety and potential
benefits of adding an adjuvant to the pandemic vaccine. More
information on the influenza A(H1N1) 2009 vaccine clinical trials
is available at www.clinicaltrials.gov.
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, operations, products and services, 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-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.
Contacts Global Media Relations US Media Relations Pascal Barollier Donna Cary T. +33-(0)4-37-37-50-38 T. +1-570-957-0717 pascal.barollier@sanofipasteur.com donna.cary@sanofipasteur.com www.sanofipasteur.com www.sanofipasteur.us
Source: Sanofi Pasteur
CONTACT: Global Media Relations, Pascal Barollier,
+33-(0)4-37-37-50-38,
pascal.barollier@sanofipasteur.com;
or US Media Relations, Donna Cary,
+1-570-957-0717, donna.cary@sanofipasteur.com
Web Site: http://www.sanofipasteur.com/
http://www.sanofipasteur.us/
Posted: August 2009
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