Sanofi : BARDA Grants $43.2 million USD to Sanofi Pasteur for Zika
(Thomson Reuters ONE) -
BARDA Grants $43.2 million USD to Sanofi Pasteur for Zika
- Funds will be used for phase II development and manufacturing -
Paris, France - September 26, 2016 - Sanofi and its vaccines global business
unit Sanofi Pasteur announced today that the Biomedical Advanced Research and
Development Authority (BARDA) within the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and Human Services
has agreed to a proposal to fund the manufacture of an inactivated Zika vaccine
for phase II development. Sanofi Pasteur committed to researching and
developing a vaccine to prevent Zika in February, shortly after the World Health
Organization declared an emergency.
In July 2016, Sanofi Pasteur announced a Cooperative Research and Development
Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-
development of a Zika vaccine candidate. The BARDA funding is to take WRAIR's
Zika purified inactivated virus (ZPIV) vaccine into phase II development with
manufacturing and characterization of the vaccine product as well as
optimization of the upstream process to improve production yields.
Sanofi Pasteur is in the process of creating a clinical development and
regulatory strategy while WRAIR and the National Institute of Allergy and
Infectious Diseases (NIAID)--part of the U.S. National Institutes of Health
(NIH)-are conducting a series of phase I ZPIV trials. Beyond the funding
provided by BARDA for the two phase I/II clinical trials, there is an option in
the contract that BARDA can exercise for continuing support through Phase III
industrial and clinical development.
"Given the devastating effects that this infectious disease can have on babies
of infected mothers and the fact that the disease appears to rapidly spread,
Sanofi Pasteur decided to get involved early on" said David Loew, Sanofi
Executive Vice President and Head of Sanofi Pasteur. "We are very pleased that
the U.S. government is committed to working with us to develop a Zika vaccine.
Based on this collaboration, we can bring together resources and expertise which
are essential in fighting this public-health concern."
The Biomedical Advanced Research and Development Authority (BARDA), within the
Office of the Assistant Secretary for Preparedness and Response in the U.S.
Department of Health and Human Services, provides an integrated, systematic
approach to the development and purchase of the necessary vaccines, drugs,
therapies, and diagnostic tools for public-health medical emergencies. The
project has been funded with Federal funds from BARDA under Contract HHSO100201-
6000039C.
Sanofi Pasteur has developed and provides several vaccines against flaviviruses,
such as yellow fever, dengue, and Japanese encephalitis. It developed its first
yellow fever vaccine in 1979 and has since sold more than 400 million doses; it
is licensed in more than 100 countries around the world. In 2010 Sanofi Pasteur
licensed its first vaccine against Japanese encephalitis, which is now licensed
in 14 countries with more than 1.5 million doses sold to date. Both yellow
fever and Japanese encephalitis vaccines are licensed in endemic countries as
well as other countries for travelers. Sanofi Pasteur's newest flavivirus
vaccine is licensed for the prevention of dengue fever in several endemic
countries; Dengvaxia(®) was first licensed in Mexico, the Philippines and Brazil
late last year and picked up six more licensures so far this year in El
Salvador, Costa Rica, Paraguay, Guatemala, Peru and Indonesia.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients' needs. Sanofi has core strengths in
diabetes solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and 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
produces a portfolio of high quality vaccines that matches its areas of
expertise and meets public-health demand. 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, Sanofi's ability to benefit from external growth opportunities
and/or obtain regulatory clearances, risks associated with intellectual property
and any related pending or future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest rates, volatile
economic conditions, the impact of cost containment initiatives 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, 2015. Other than as required by applicable law,
Sanofi does not undertake any obligation to update or revise any forward-looking
information or statements.
--------------------------------------------------------------------------------
Contacts:
Global Media Relations Investor Relations
Flore Larger George Grofik
Tel. +33 (0)1 53 77 46 46 Tel. +33 (0)1 53 77 45 45
mr(at)sanofi.com ir(at)sanofi.com
Global Sanofi Pasteur Communications Sanofi Pasteur Communications- US
Alain Bernal Susan Watkins
Tel. +33 (0)4 37 37 50 38 Tel. +570 957 2563
alain.bernal(at)sanofipasteur.com susan.watkins(at)sanofipasteur.com
www.sanofipasteur.com
Press Release (PDF):
http://hugin.info/152918/R/2044231/763346.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 26.09.2016 - 17:00 Uhr
Sprache: Deutsch
News-ID 497041
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