DGAP-News: Novavax to Initiate Seasonal and Pandemic Influenza Trials in Collaboration With BARDA
(firmenpresse) - Novavax, Inc.
24.09.2013 14:00
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-- Quadrivalent Seasonal Influenza Clinical Trial to start in 1Q2014
-- Pandemic Influenza Clinical Trial to start in the U.S. in 1H2014
-- Proprietary Adjuvant Matrix-M to be used in the Pandemic Clinical Trial
ROCKVILLE, Md., 2013-09-24 14:00 CEST (GLOBE NEWSWIRE) -- Novavax, Inc.
(Nasdaq:NVAX) a clinical-stage vaccine company, announced today that it is
finalizing details on costs and timelines for their next round of clinical
studies with the U.S. Department of Health and Human Services, Biomedical
Advanced Research and Development Authority (BARDA) following successful
completion of process improvement studies. Novavax is preparing to move forward
with these next clinical trials for its quadrivalent seasonal influenza vaccine
candidate and its pandemic influenza vaccine candidate, both under U.S. INDs.
The pandemic study will include the use of Novavax' proprietary saponin-based
adjuvant, Matrix-M(tm).
'Novavax is committed to moving these two vaccine candidates through to
licensure. The clinical trials we have planned for 2014 are important steps in
the completion of that goal,' said Stanley C. Erck, President and Chief
Executive Officer, 'Given the shift in the global disease focus from the H5N1
avian influenza strain to the H7N9 avian influenza strain we have expanded our
pandemic program to include H7N9. We are especially pleased with BARDA's
interest in the development of both of our pandemic vaccine candidates with the
Matrix-M adjuvant, along with our seasonal vaccine program.'
About the Novavax BARDA Contract
In February 2011, Novavax was awarded a contract valued at up to $179 million
by BARDA for the advanced development of recombinant influenza vaccine products
and manufacturing capabilities for pandemic preparedness. Throughout the
contract's 3-year base period, valued at $97 million, Novavax has been
developing and testing its novel recombinant virus-like particle (VLP)
influenza vaccines to address BARDA's commitment to advancing recombinant-based
technology as a component of pandemic preparedness. Upon satisfaction of
established milestones, the contract can expect to be extended for an
additional 24 months, upon execution by BARDA of an Option One period, valued
at $79 million in additional funding. The milestones under the Option One
period would focus on completion of the pathway to product licensures from the
U.S. Food and Drug Administration (FDA), including support for manufacturing
scale-up. There is an additional contract option for vaccine production ($3
million).
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company
creating novel vaccines and vaccine adjuvants to address a broad range of
infectious diseases worldwide. Using innovative proprietary recombinant protein
nanoparticle vaccine technology, the company produces vaccine candidates to
efficiently and effectively respond to both known and newly emergent diseases.
Novavax is involved in several international partnerships, including
collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea,
PATH and recently acquired Isconova AB, a leading vaccine adjuvant company
located in Sweden. Together, Novavax' network supports its global
commercialization strategy to create real and lasting change inthe
biopharmaceutical and vaccinology fields. Additional information about Novavax
is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development
of its vaccine and adjuvant products are forward-looking statements. Novavax
cautions that these forward looking statements are subject to numerous risks
and uncertainties, which could cause actual results to differ materially from
those expressed or implied by such statements. These risks and uncertainties
include those identified under the heading 'Risk Factors' in the Novavax Annual
Report on Form 10-K for the year ended December 31, 2012,and Form 10-Q for the
period ended June 30, 2013, both filed with the Securities and Exchange
Commission (SEC). We caution investors not to place considerable reliance on
the forward-looking statements contained in this press release. You are
encouraged to read our filings with the SEC, available at sec.gov, for a
discussion of these and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this document,
and we undertake no obligation to update or revise any of the statements. Our
business is subject to substantial risks and uncertainties, including those
referenced above. Investors, potential investors, and others should give
careful consideration to these risks and uncertainties.
CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
News Source: NASDAQ OMX
24.09.2013 Dissemination of a Corporate News, transmitted by DGAP -
a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Novavax, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US6700021040
WKN:
End of Announcement DGAP News-Service
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Datum: 24.09.2013 - 14:00 Uhr
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