VIVALIS : VIVALIS: EXPANDED DEVELOPMENT OF EB66® AS PART OF THE
GLAXOSMITHKLINE INFLUENZA PROGRAM IN US
VIVALIS: THE EXPANDED DEVELOPMENT OF EB66® CELL LINE AS PART OF THE
GLAXOSMITHKLINE (GSK) - TEXAS A&M UNIVERSITY SYSTEM INFLUENZA VACCINE PROGRAM
IN THE UNITED STATES
Nantes & Lyon (France) - Vivalis (NYSE Euronext : VLS) is pleased to announce
the following press release distributed by GSK detailing their continued
efforts with the Texas A&M University System (TAMUS) for the development of an
EB66® cell culture based influenza vaccine funded by the U.S. Department of
Health and Human Services (HHS). Under this program, the HHS has approved the
development of a $91 million influenza vaccine manufacturing facility to be
located in Bryant-College Station, Texas.
A full copy of the GSK press release is presented herein.
Texas A&M System and GlaxoSmithKline receive U.S. Government approval to
establish influenza vaccine facility in Texas
GlaxoSmithKline plc (GSK) and The Texas A&M University System announced today
that the U.S. Department of Health and Human Services (DHHS) has approved the
establishment of a $91 million influenza-vaccines manufacturing facility as
the anchor of the Center for Innovation in Advanced Development and
Manufacturing (CIADM) in Bryan-College Station, Texas.
The announcement was hosted by Governor Rick Perry at the Texas State Capitol,
and was attended by a number of dignitaries including Texas A&M System
Chancellor John Sharp, Dr. Robin Robinson, DHHS Deputy Assistant Secretary and
Director of the Biomedical Advanced Research and Development Authority
(BARDA), and Antoon Loomans, Senior Vice President, GSK Vaccines.
"Today's announcement is a huge win for Texas and for the nation," Governor
Perry said. "The Texas A&M Center, anchored by this facility, is expected to
bring more than $41 billion in expenditures within the State of Texas over the
next 25 years, and will add more than 6,800 direct and related jobs to Texas."
The TAMUS influenza vaccines manufacturing center will afford GSK the
capabilities to eventually manufacture influenza vaccine based on a
proprietary cell-culture line, ^1EB66®. Most existing influenza vaccine is
manufactured using fertilized chicken eggs. The cell-culture process will
supplement the vaccine supply from eggs, and facilitate a rapid national
vaccine response in the event of a pandemic.
^1 *EB66® exclusively licensed from Vivalis by GSK Biologicals S.A. for the
field of Influenza and sublicensed use at the Texas A&M Center for Innovation
in Advanced Development and Manufacturing (CIADM).
GSK Vaccines produces 30 vaccines worldwide, eleven of which are licensed by
the FDA. The Texas A&M-GSK venture will complement and support the company's
existing influenza vaccines operations, based in Quebec, Canada, and Dresden,
Germany. GSK's operations hub in Marietta, Pennsylvania will package, inspect
and distribute influenza vaccine manufactured at the Texas A&M Center. In
2012, GSK provided more than 20 million flu shots for the U.S. market and
recently became the first major U.S. vaccines provider to gain FDA-approval
for a broader-protection, four-strain (quadrivalent) influenza vaccine shot
that will be available in time for the 2013-14 flu season.
"GSK is privileged to deepen our commitment to U.S. public health, as part of
this unprecedented public-private collaboration to protect against pandemics
and bio-threats," noted Loomans. "In Texas A&M we have found a partner with a
rich tradition of service, and with pioneering technologies that will benefit
the entire pharmaceutical industry in making vaccines available and accessible
to all in need."
One of only three CIADMs to be developed in the U.S., the Texas A&M Center is
at the vanguard of U.S. pandemic-preparedness efforts and represents
unprecedented public-health collaboration among state and federal governments,
academia and private industry. Once constructed and operational, the Center's
influenza manufacturing facility will be able to supply 50 million doses of
pandemic influenza vaccine within four months of an outbreak. BARDA conceived
the public-private formula to assure a strong biosecurity product development
and manufacturing base on U.S. soil, ensuring that the nation would have rapid
access to vaccines and therapeutics in the advent of influenza pandemics, or
chemical, biological, radiological, and nuclear attacks.
"We are honored to welcome GSK to Texas A&M as a key partner in the Center for
Innovation," said Sharp. "GSK's dedication to public service is well-aligned
with the Texas A&M tradition of serving the nation and defining its future
through research and scholarship. Equally important is the cultural and
philosophical match between GSK and the A&M System, as reflected by GSK's
desire to collaborate with academia and the U.S. government, and their ongoing
commitment to helping address global health scourges such as pandemic
influenza and malaria."
The Texas A&M Center for Innovation is lead by Dr. Brett Giroir, Vice
Chancellor for Strategic Initiatives at the Texas A&M System, and a core team
of A&M experts in biotechnology, infectious diseases, facilities planning and
construction, federal acquisitions/contracting, and government affairs. The
partnership with GSK was founded on a long, collaborative relationship between
Texas A&M and the Wallonia Region of Belgium, with specific planning for this
project beginning in the spring of 2010.
"GSK's decision to partner with Texas A&M and bring their vaccine
manufacturing to our state is a testament to the investments that the A&M
System and the State of Texas have made in the people, infrastructure and
technologies, much of which came from critical state programs such as the
Emerging Technology Fund," Giroir said. "GSK brings unequaled influenza
vaccine development, manufacturing, and regulatory expertise to our Center.
Equally important, GSK brings its cell based influenza vaccine development
program, which we have assessed to be the most promising near term influenza
vaccine technology to improve upon current egg based vaccines."
The Texas A&M Center for Innovation represents the largest commitment of a
global biopharmaceutical company to partner within Texas, and will be an
important catalyst to the future growth of this industry within the State.
U.S. Government Funding
Efforts highlighted in this release have been funded in whole or in part with
Federal Funds from the DHHS/ASPR/BARDA, under contract numbers
HHSO100200600011C, HHSO100200700029C and HHSO100201200002I.
About the A&M System
The A&M System is one of the largest systems of higher education in the
nation, with a budget of $3.5 billion. Through a statewide network of 11
universities, seven state agencies and a comprehensive health science center,
the A&M System educates more than 120,000 students and makes more than 22
million additional educational contacts through service and outreach programs
each year. Externally funded research expenditures exceed $780 million and
help drive the state's economy.
Steven B. Moore
Texas A&M University System
About the Texas A&M Center for Innovation
The Texas A&M Center for Innovation in Advance Development and Manufacturing
(CIADM) is one of three centers established in June, 2012 by the US Department
of Health and Human Services to enhance the nation's emergency preparedness
against emerging infectious diseases, including pandemic influenza, and
chemical, biological, radiological and nuclear threats. The Center is founded
on an initial $285.6 million investment, including a $176.6 million
contribution from the US Department of Health and Human Services, with the
remainder cost-shared by commercial and academic proposal partners.
The Center will perform research and advanced development to accelerate
vaccines and other medical products through pre-clinical and clinical
development and produce these products in cases of pandemics or other national
emergencies. Through these activities, the Center will address a recognized
shortcoming in preparedness and response to known and unknown threats, and
will improve our nation's ability to protect the health of its citizens in
With GSK and other partners, TAMUS also will utilize CIADM capabilities to
develop and transition platform technologies to accelerate new treatments for
conditions as diverse as cancer and cardiovascular disease.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For further
information please visit http://us.gsk.com/
US Media Inquiries: Rob Perry +1
Sarah Alspach +1 202
715 1048 (Washington, DC)
Sally Ferguson +44 (0) 20 8047 5543 (London)
Lucy Budd +44 (0) 20 8047 2248 (London)
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies + 44 (0) 20 8047 5503 (London)
James Dodwell + 44 (0) 20 8047 2406 (London)
Jeff McLaughlin + 1 215 751 7002 (Philadelphia)
Ziba Shamsi + 44 (0) 20 8047 3289 (London)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Factors that may affect GSK' s operations are described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
Next financial press release: 2012 Results
March, 26, 2013, after market closing
About VIVALIS (www.vivalis.com)
March 7, 2013 - VIVALIS SA (NYSE Euronext: VLS) and Intercell AG (VSE: ICLL)
announced that the Extraordinary General Meeting of both companies approved
the proposed merger of equals between Intercell AG and Vivalis SA to create
Valneva SE. The merger should be effective in May 2013
Vivalis (NYSE-Euronext: VLS) is a biopharmaceutical company that provides
innovative cell-based solutions to the pharmaceutical industry for the
manufacture of vaccines and recombinant proteins, and develops monoclonal
antibodies for the prevention and treatment of pathologies with unmet medical
needs. Vivalis' expertise and intellectual property are leveraged in two main
EB66^® Cell Line
Vivalis offers research and commercial licenses for its EB66^® cell line,
derived from duck embryonic stem cells, to pharmaceutical and biotechnology
companies for the production of therapeutic and prophylactic viral vaccines,
virosomes, VLPs and recombinant proteins, with a focus on monoclonal
antibodies having enhanced cytotoxic activity. Clinical trials of EB66^®
produced vaccines are currently on-going in the USA and Japan. Through these
programs, Vivalis receives upfront payments, clinical stage milestone
payments, and royalties on licensees' net sales.
VIVA|Screen(TM) Human Antibody Discovery Platform
Customized solutions for the discovery, development and production of rare,
fully human monoclonal antibodies are offered by Vivalis. Through these
programs, Vivalis receives payments associated with the funding of discovery
phase, upfront payments, clinical stage milestone payments, and royalties on
net sales of licensed antibodies that are commercially developed and sold by
Based in Nantes and Lyon (France) and in Toyama (Japan), Vivalis was founded
in 1999 by the Grimaud Group (ca. 1,700 employees), one of the worldwide
leaders in animal genetic selection. Vivalis has established more than 30
partnerships and licenses with world leaders in this sector, including Sanofi
Pasteur, GlaxoSmithKline, Transgene, Zoetis, Kaketsuken, Kitasato Daiichi
Sankyo Vaccine, Merial, Merck Animal Health and SAFC Biosciences. Vivalis is a
member of the French ATLANTIC BIOTHERAPIES and LYON BIOPOLE bio-clusters and a
member of the Japanese HOKURIKU INNOVATION CLUSTER FOR HEALTH SCIENCE in
Listed on Euronext Paris - Compartment B of NYSE Euronext
Reuters: VLS.PA - Bloomberg: VLS FP
Included in NYSE Euronext's SBF 250, CAC Small 90 and Next Biotech indexes
This document contains forward-looking statements and comments on the
company's objectives and strategies. No guarantee can be given to any of the
events anticipated by the forward-looking statements contained in this
document, which are subject to inherent risks, including risk factors
described in the company's Document E, changes in economic conditions, the
financial markets or the markets in which the company operates.
Franck Grimaud, CEO Financial
Axelle Vuillermet / PierreLaurent
Tel.: +33 (0) 1 44 71 94 91
This announcement is distributed by Thomson Reuters on behalf of Thomson
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: VIVALIS via Thomson Reuters ONE
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