GlaxoSmithKline Receives New HHS Order For H5N1 Bulk Antigen

GlaxoSmithKline (NYSE:
GSK), one of the world's largest vaccine manufacturers, today announced
that HHS has placed another order to purchase bulk H5N1 antigen for the US
national stockpile of pre-pandemic vaccines. The company also announced the
start of the first North American pre-pandemic vaccine trials in the
company's global pre-pandemic influenza program.



HHS Order



The company has received a second task order for 22.5 million doses of
15 mcg H5N1 bulk vaccine antigen from the U.S. Department of Health and
Human Services (HHS) under a contract [HHS100200700027I] awarded in
November 2007. This is in addition to the 5 million doses of H5N1 clade 2
bulk antigen at 15 mcg HA/dose ordered in November 2006. The additional
task order procures an additional 9 million doses of H5N1 clade 2 bulk
vaccine produced in the 2006 manufacturing campaign and 13.5 million doses
of H5N1 clade 2 bulk vaccine expected to be produced in the 2007
manufacturing campaign.



Under the terms of the contract, GSK will manufacture the bulk vaccine
product at the GSK manufacturing site in Ste. Foy, Canada and store bulk
H5N1 antigen at the GSK site in Marietta, PA. Terms of the contract also
state that GSK may be directed by HHS to formulate this bulk antigen at
some point in the future. Additionally, HHS also has the option to purchase
pre-pandemic vaccines together with one of GSK's proprietary adjuvant
systems, which could mean that less antigen would be needed per dose to
achieve a protective immune response. Funding for this contract is provided
through the Office of Biomedical Advanced Research and Development
Authority (BARDA) in the Assistant Secretary for Preparedness and Response
(ASPR).



David Stout, President, Pharmaceutical Operations, GlaxoSmithKline
said: "We applaud the US government's proactive steps in protecting
American citizens against this potential public health threat. We are
committed to helping governments and public health officials around the
world effectively respond to the global threat of a flu pandemic and we are
pleased to be working with the US government in its preparedness efforts."



Initiation of H5N1 clinical trials



Today also marked the start of the first pre-pandemic vaccine trials
involving GSK's proprietary adjuvanted H5N1 vaccine in North America. The
vaccine used in these trials will be produced at the company's North
American manufacturing facility in Quebec, Canada. These U.S. studies are
supported by a contract [HHS100200700029C] from BARDA/ASPR/HHS awarded in
January 2007 for the advanced development of antigen-sparing pandemic
influenza vaccines towards U.S.-licensure with a commitment to U.S.
production of 150 million doses of pandemic vaccine within six months of a
pandemic onset.
















The trials highlight the company's continuing commitment to its global
pre-pandemic influenza vaccine development program. Data from earlier
European studies, using a pre-pandemic vaccine produced at GSK's Dresden,
Germany facility, showed that the influenza candidate vaccine may be able
to induce immune responses that might protect against different strains of
H5N1.



GSK's first North American pre-pandemic vaccine trial will be a Phase
I/II study that evaluates its H5N1 antigen alone and in combination with
one of its proprietary Adjuvant Systems, in 675 subjects. This Phase I/II
study is expected to lead into a larger, multi-center, Phase III trial -
one of the largest in North America - which is expected to enroll
approximately 4,400 subjects later in 2007.



Ripley Ballou, Vice President of Clinical Development for Flu at
GlaxoSmithKline said: "The goal of our North American clinical development
program is to establish GSK's second manufacturing facility as a source for
H5N1 vaccine, further strengthening our efforts to support governments'
pandemic preparedness strategies. The initiation of these trials
underscores the importance of GSK's $2 billion investment in 2005 to create
a new influenza vaccine infrastructure in North America."



This Phase I/II study, which will be conducted in seven states in the
United States and two provinces in Canada, is an observer-blind,
randomized, active-controlled trial that will evaluate the safety and
immunogenicity of two consecutive doses of H5N1 pre-pandemic vaccine. The
vaccine containing H5N1 antigen alone will be evaluated against a vaccine
containing H5N1 antigen in combination with the Adjuvant System, in 675
adult volunteers aged between 18 and 64 years. Results from this study will
be available in early 2008.



GSK is actively pursuing research into ways to make vaccines more
effective through the use of Adjuvant Systems, combinations of compounds
that are designed to enhance a vaccine's ability to elicit a strong,
durable and protective immune response in the human body.



GSK's candidate pre-pandemic split antigen H5N1 vaccine induced a
substantial level of cross-reactive immune response against a 'drifted'
strain of H5N1 virus in a clinical trial conducted in 2006. A drifted
strain is one that has undergone evolution in its protective antigens
relative to the vaccine; the process of 'drift' is the same phenomenon that
allows new strains of seasonal flu virus to circulate and cause disease
year after year. This GSK candidate vaccine was accepted for review by the
Committee for Medicinal Products for Human Use (CHMP) in Europe in January
2007.



In 2005, GSK invested approximately $2 billion in expanding its vaccine
manufacturing and development activities in North America, primarily
through the acquisition of the Canadian company, ID Biomedical (IDB). GSK's
FluLaval(R) and Fluviral(R) seasonal influenza vaccines for use in North
America and Canada are currently produced in IDB's former facility in
Quebec, Canada and Dresden, Germany respectively. Additionally, GSK is
modernizing its facility in Marietta, PA, to develop and manufacture
cell-culture based seasonal and pandemic influenza vaccines. These cell
culture vaccine candidates are not approved in the US.



About GlaxoSmithKline



GSK is one of the world's leading research-based pharmaceutical and
health care companies. GSK is committed to improving the quality of human
life by enabling people to do more, feel better and live longer. For
company information visit: gsk.



About GSK Biologicals



GSK Biologicals, based in Rixensart, Belgium, is the vaccine division
of GlaxoSmithKline. As one of the world's leading vaccine manufacturers,
GSK Biologicals employs more than 1,500 scientists devoted to discovering
new vaccines and developing more cost-effective and convenient combination
products to prevent infections that cause serious medical problems.



FluLaval and Fluviral are registered trade marks of the GlaxoSmithKline
group of companies.


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