NOVAVAX Completes Enrollment in Phase IIa Study of Seasonal Influenza Vaccine
in Older Adults
- Dose-ranging study to compare Novavax's trivalent virus-like-particle (VLP)
vaccine to currently marketed flu vaccine, Fluzone(R)
ROCKVILLE, Md., Nov. 30 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX)
announced today it has completed enrollment in the Phase II clinical study of
its trivalent seasonal influenza (2008/2009 recommended strains) VLP vaccine
candidate in healthy adults 60 years of age or older (older adults). This
randomized, double-blind, active-controlled study is comparing the safety,
tolerability and immunogenicity of two different doses (15 mcg and 60 mcg) of
Novavax's trivalent seasonal influenza VLP vaccine to a commercially available
trivalent inactivated vaccine, TIV (Fluzone®).
This study enrolled 467 older adults in a three-arm study at six different
sites located within the United States. In addition to evaluating
hemagglutinin inhibition (HAI) responses, anti-neuraminidase and cell-mediated
immune responses are also being examined. Previous studies have shown that
VLP-based flu vaccines drive strong neuraminidase inhibition (NAI) antibody
titers and T-cell responses, indicating the potential for broader immunologic
responses particularly in older adults.
"With the rapid completion of enrollment in this clinical trial as well as the
first part of our H1N1 vaccine study in Mexico announced previously, we are on
track to report results from our two most advanced clinical programs during
the first quarter of next year," said Dr. Rahul Singhvi, President and Chief
Executive Officer of Novavax. "If results from the seasonal flu vaccine study
are positive, we will be able to advance this program into Phase III clinical
testing as early as 2010."
Seasonal Influenza
Seasonal influenza infects between 5 percent and 20 percent of the world's
population and kills between 250,000 and 500,000 people each year. In the
United States, the Centers for Disease Control and Prevention estimates that
15 to 60 million people contract influenza each year leading to over 200,000
hospitalizations and 36,000 deaths. The Advisory Committee on Immunization
Practices (ACIP) currently recommends seasonal influenza vaccination for
children six months through 18 years of age, pregnant women, and adults over
50 years of age, and individuals of any age with chronic health conditions or
who are at high risk of influenza disease. Based on the expanding
recommendation of vaccination to new age groups, the growing worldwide
population to be vaccinated, and the need of an improved influenza vaccine for
the elderly, global market projections of seasonal influenza are estimated to
increase from $2.8 billion in 2007 to $6.5 billion by 2013.
About VLPs
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 more rapidly than egg-based vaccines by using
proprietary, portable, recombinant cell-culture technology.
About Novavax
Novavax, Inc. 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. The company has
formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to
develop and manufacture vaccines, biological therapeutics and diagnostics in
India. Additional information about Novavax is available on the company's
website: www.novavax.com.
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 seasonal
influenza vaccine 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 trials are positive, the data may
not be accepted by regulatory bodies or the seasonal influenza vaccine may not
be approved by the United States government or additional clinical trials may
be required; the Company has not yet manufactured, or relied on third parties
to manufacture, any vaccines at a commercial scale; competition from already
approved vaccines for seasonal influenza; the cost of filing, prosecuting,
defending and enforcing any patent claims and other intellectual property
rights; the Company's ability to obtain rights to technology; competition for
clinical resources and patient enrollment from drug candidates in development
by other companies with greater resources and visibility; the Company's
ability to enter into future collaborations with industry partners and the
terms, timing and success of any such collaboration; the cost, timing and
success of regulatory filings and approvals; the Company's ability to obtain
adequate financing in the future through product licensing, co-promotional
arrangements, public or private equity or debt financing or otherwise; general
business conditions; competition; business abilities and judgment of
personnel; 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.
Tricia J. Richardson, Senior Manager, Investor Relations of Novavax, Inc.,
+1-240-268-2031
