MEDIA RELEASE PR36672
Novavax Launches Pivotal Clinical Study of Novel 2009 H1N1 VLP Flu Vaccine in Mexico
ROCKVILLE, Md., Oct. 20 /PRNewswire-AsiaNet/ --
-- Pivotal Clinical Study to Evaluate H1N1 VLP Vaccine Safety,
Immunogenicity and Efficacy in Mexico
-- Novavax forms Alliance with Avimex Laboratories to support the
Clinical Trial and Potential Commercial Distribution of the H1N1 vaccine in
Mexico
-- GE Healthcare Provides Support with its Novel Disposable Bioprocessing
Technologies
Novavax, Inc. (Nasdaq: NVAX) announced today that it has initiated a
two-stage clinical study of its virus-like-particle (VLP) H1N1 influenza
vaccine in Mexico in collaboration with Avimex Laboratories (Avimex) and GE
Healthcare. Avimex distributes biological and pharmaceutical products for use
in Mexico and more than 25 other countries around the world. Avimex is
providing financial support for the trial and is expected to distribute the
H1N1 VLP vaccine in Mexico in 2010 if it is approved for commercial sale. In
addition, Novavax also announced today that GE Healthcare (a unit of General
Electric Company (NYSE: GE)) has agreed to support this program by providing
its single-use bioprocessing technologies for vaccine production. GE
Healthcare and Novavax have worked together since December 2007 to develop
innovative vaccine production solutions using GE Healthcare's manufacturing
technologies.
"This clinical study represents a unique opportunity to accelerate the
development of our pandemic 2009 H1N1 flu VLP vaccine and address an
important public health problem in Mexico. Conducting this clinical trial
during a pandemic, when the attack rate of the H1N1 virus is expected to be
very high, provides the company with an invaluable opportunity to demonstrate
field efficacy of its VLP-based H1N1 vaccine and the utility of the VLP
vaccine platform for influenza as a whole," said Dr. Rahul Singhvi, President
and CEO of Novavax. "Our new alliance with Avimex is another example of our
regional strategy and will provide valuable assistance toward the successful
completion of this important clinical study within a remarkably short
horizon. The fast spread of H1N1 worldwide has caused a significant strain on
vaccine supply in countries with limited indigenous vaccine capabilities. We
are grateful to the Mexican health authorities for their rapid clinical
protocol clearance and enabling our potential solution for this escalating
unmet medical need," Dr. Singhvi added.
"We are delighted to support Novavax as they move into this exciting
clinical trial," said Catarina Flyborg, Enterprise Solutions Leader, GE
Healthcare. "Alongside growing interest from organizations in India and
Spain, this trial lends further credence to the combination of Novavax's
vaccine technology with GE Healthcare's ReadyToProcess bioprocessing
solutions."
Novavax and Avimex are initiating the blinded, placebo-controlled
clinical trial in Mexico City to evaluate the safety, immunogenicity and
efficacy of Novavax's 2009 H1N1 VLP vaccine in healthy adults. The first
stage will evaluate the vaccine's safety, immunogenicity and efficacy among
1,000 subjects, including 750 VLP recipients and 250 placebo recipients.
Pending favorable results from the first stage, the second stage of the study
will be initiated to evaluate the safety of the vaccine in a larger cohort of
3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The primary
safety and immunogenicity results are expected within 3 months of the start
of this study in January 2010. If the results are clinically acceptable, they
will be used to seek registration of Novavax's 2009 H1N1 pandemic flu vaccine
in Mexico. These data are also expected to support development of the
company's pandemic and seasonal flu VLP vaccines in other countries,
including the United States.
"We are pleased to be working with GE Healthcare, Avimex and the leading
health officials in Mexico to launch the first and largest clinical trial to
date using the 2009 H1N1 influenza VLP-based vaccine," said Thomas Johnston,
Vice President of Strategy at Novavax. "This study is a continuation of our
efforts to respond quickly to this current pandemic by leveraging our
proprietary recombinant VLP technology and our innovative manufacturing
solution. We appreciate having the opportunity and support to demonstrate the
H1N1 vaccine's safety, immunogenicity and efficacy in Mexico and thereby help
with ongoing pandemic response efforts. Similar to our previous announcements
regarding our ongoing work in the countries of India and Spain, where we plan
to establish in-border production, our planned clinical work in Mexico, if
successful, could lead to rapid availability of the vaccine and advance
Novavax's regional strategy to assist countries around the globe with such
critical needs."
Virus-like particles (VLPs) mimic the external structure of viruses but
lack the live genetic material that causes viral replication and infection.
VLPs can be designed quickly to match individual viral strains and be
produced efficiently using portable cell-culture technology. Novavax's
VLP-based vaccine candidates are produced significantly more quickly than
egg-based vaccines by using proprietary, portable, recombinant cell-culture
technology.
The company will hold an investor conference call to discuss this
clinical study at 9:00 a.m. Eastern Time on Tuesday, October 20, 2009. The
call will be hosted by Novavax President and Chief Executive Officer Dr.
Rahul Singhvi and other members of the company's senior management team. A
question and answer session will follow. The dial-in number for the
conference call is 1 (866) 206-5917 (International: 1 (703) 639-1106). A live
under Investors/Events. Please connect to this website at least 15 minutes
prior to the conference call to ensure adequate time for any software
download that may be needed to hear the webcast.
A replay of the webcast will be available on the website for 90 days
after the call and a replay of the conference call will also be available by
telephone beginning October 20, 2009 at 1:00 p.m. Eastern Time through
October 22, 2009 at 11:59 p.m. To access the replay, dial 1 (888) 266- 2081
and enter pass code 1405084.
About Novavax
Novavax is a clinical-stage biotechnology company creating novel vaccines
to address a broad range of infectious diseases worldwide, including H1N1,
using advanced proprietary virus-like-particle (VLP) technology. The company
produces potent VLP -based, recombinant vaccines utilizing new and efficient
manufacturing approaches. Novavax is committed to using its VLP technology to
create country-specific vaccine solutions. It recently launched a joint
venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and
manufacture vaccines, biological therapeutics and diagnostics in India.
Forward-Looking Statements
Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters, including
expectations regarding clinical trials and development of the 2009 H1N1
vaccine, the potential use of any data from clinical trials and other
anticipated milestones are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act. Novavax cautions that these
forward-looking statements are subject to numerous assumptions, risks and
uncertainties, which change over time. Factors that may cause actual results
to differ materially from the results discussed in the forward-looking
statements or historical experience include risks and uncertainties,
including clinical trial results, which may not be sufficient for regulatory
approval or may indicate safety concerns not yet encountered; even if the
results of the planned clinical trial are positive, the data may not be
accepted by regulatory bodies in other countries or the 2009 H1N1 vaccine may
not be approved by the Mexican government or additional clinical trials may
be required; if approved, approval of the 2009 H1N1 vaccine may not be timely
and thus may not be granted until after the 2009/2010 flu season has ended;
sales of the 2009 H1N1 vaccine are not scheduled begin until late in the
2009/2010 flu season which could result in poor sales; Avimex is expected to
be responsible for sales of the 2009 H1N1 vaccine in Mexico, thus, the
Company would be dependent on Avimex's sales effort; the Company has not yet
manufactured, or relied on third parties to manufacture, any vaccines at a
commercial scale; the 2009 H1N1 vaccine must be manufactured in a short
period of time and will be subject to scale-up, validation and inspection;
competition from already approved vaccines for the 2009 H1N1 flu; business
abilities and judgment of personnel and corporate partners; and the
availability of qualified personnel. Further information on the factors and
risks that could affect Novavax's business, financial conditions and results
of operations, is contained in Novavax's filings with the U.S. Securities and
Exchange Commission, which are available at www.sec.gov. These
forward-looking statements speak only as of the date of this press release,
and Novavax assumes no duty to update forward-looking statements.
SOURCE Novavax, Inc.
CONTACT: Tricia J. Richardson of Novavax, Inc., +1-240-268-2031
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