Novavax Launches Pivotal Clinical Study of Novel 2009 H1N1 VLP Flu Vaccine in Mexico

Rockville, Maryland (ots/PRNewswire) -

-- 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 audio webcast of the
conference call will be available at www.novavax.com 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.

ots Originaltext: Novavax, Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Tricia J. Richardson of Novavax, Inc., +1-240-268-2031