Texas A&M System and GlaxoSmithKline receive U.S. Government approval to establish influenza vaccine facility in Texas

Tue Mar 26, 2013 11:00am EDT

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Team will develop and manufacture GSK's next generation influenza vaccines to
protect the nation against global pandemics
AUSTIN, Texas  and  PHILADELPHIA,  March 26, 2013  /PRNewswire/ --
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 

The TAMUS influenza vaccines manufacturing center will afford GSK the
capabilities to eventually manufacture influenza vaccine based on a proprietary
cell-culture line, [1]EB66. 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.   

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 led 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

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 emergency situations.

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.

Patricia Haigwood

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/

[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).

SOURCE  GlaxoSmithKline

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