Spanish Government Selects Novavax's VLP Technology for Comprehensive Flu Vaccine...

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Tue Jun 30, 2009 11:38am EDT

Spanish Government Selects Novavax's VLP Technology for Comprehensive Flu
Vaccine Solution in Spain

ROCKVILLE, Md., June 30 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX)
announced today its initial agreement to license its proprietary, recombinant
virus-like-particle (VLP) vaccine technology to ROVI Pharmaceuticals (Madrid:
ROVI) of Spain.  ROVI will use the VLP technology to create a comprehensive
influenza vaccine solution for the Spanish government under a new 60
million-euro program sponsored and led by the Spanish Ministry of Health and
other government groups to develop pandemic and seasonal flu vaccines and
establish its only in-border facility.  This program, which was announced
today by Spanish health officials, is being launched to develop safe and
effective flu vaccines to serve the entire population of Spain.  

Under separate agreements that are in the process of being negotiated by both
companies, ROVI will receive exclusive licenses to Novavax's portable VLP
vaccine technology to commercialize flu vaccines in Spain and Portugal, and
non-exclusive licenses in Europe, Latin America and Africa.  Furthermore,
under a stock purchase agreement executed today, ROVI has committed to make a
$3 million (US) equity investment in Novavax at $2.74 per share, a 10% premium
to the June 29, 2009 closing bid price on the NASDAQ Global Market.  A
non-profit Foundation, jointly sponsored by ROVI and the Spanish authorities,
will be formed and initially funded with a 25 million euro credit line from
the Spanish government, to support Phase III clinical development and other
studies necessary to achieve marketing authorization of the VLP influenza
vaccines in the European Union in 2012.  Additional clinical development funds
will be contributed by ROVI if required.  In addition, the State of Andalucia
will support ROVI in building a new VLP vaccine plant in the city of Granada
and bring it on-line in 2012 at a cost of approximately 20 million euro.  The
plant, with certain licensed manufacturing rights from Novavax, is expected to
have enough manufacturing capacity to service Spain and other parts of Europe,
Latin America, and Africa.  Details of the commercial terms between ROVI and
Novavax will be announced after the definitive agreements are finalized and
are expected to include milestones and royalties. 

Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, stated:
"We are honored to be selected by the Spanish Health Ministry and ROVI
Pharmaceuticals to help develop pandemic and seasonal flu vaccine solutions
for Spain, the world's eighth largest economy with more than 43 million
people.  We are pleased to have found a superb partner in ROVI that has deep
knowledge of the local vaccine markets as well as significant vaccine
manufacturing experience.  This is the first opportunity to export our
technology to Europe, following the recent joint venture with Cadila
Pharmaceuticals in India, and is further validation of our unique in-border
vaccine supply offering.  This influenza vaccine supply solution consisting of
our VLP technology and portable manufacturing avoids the use of chicken eggs,
creates vaccines for emerging strains faster, and promises less expensive,
in-border manufacturing capacity.  We continue to discuss opportunities with
other pharmaceutical companies and governments to implement this compelling
influenza vaccine technology around the globe."

"Today's contemplated partnership with ROVI and the Spanish government will
enable funding to support development and registration of VLP-based influenza
vaccines in the European Union and possibly other countries, including the
United States.  Through this partnership, the goal to supply influenza
vaccines for all Spanish citizens from domestic production should be achieved
in year 2012," Dr. Singhvi continued.

Juan Lopez-Belmonte Encina, ROVI CEO, commented: "The pandemic flu vaccine
business is currently a key part of the strategy of ROVI, and we are committed
to the business as one of the future growth drivers for the company. We are
entering a new world of high technology and complex processes, but we are
confident that our knowledge in this area along with Novavax's extensive
experience will enable us to fight on the front line against the devastating
effects of influenza virus infection." 

ABOUT ROVI
ROVI is a fully integrated, profitable Spanish specialty pharmaceutical
company engaged in the research, development, in-licensing, manufacturing and
marketing of small molecule and specialty biologic drugs. The Company has a
diversified portfolio of products that it markets in Spain through its
specialized sales force, calling on specialist physicians, hospitals and
pharmacies. ROVI's portfolio of 23 principal marketed products is currently
anchored by the internally-developed, second generation low molecular weight
heparin, bemiparin. ROVI's research and development pipeline is focused
primarily on addressing currently unmet medical needs by developing new
LMWH-based products and expanding applications for its existing LMWH-based
products. ROVI manufactures the active biological ingredient (bemiparin) for
its principal proprietary product and product candidates and the injectable
pharmaceutical products developed by its in-house research team, and utilizes
its state-of-the-art filling and packaging capabilities to provide a broad
array of toll manufacturing services to leading international pharmaceutical
companies, primarily in the area of pre-filled syringes. 

ABOUT NOVAVAX
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company
creating novel vaccines, including H1N1, to address a broad range of
infectious diseases worldwide using advanced proprietary virus-like-particle
(VLP) technology. The company produces these VLP-based, potent, recombinant
vaccines utilizing new and efficient manufacturing approaches.  VLPs are
designed to induce protective immune responses without generating infection
since they are not made from a live virus and contain no genetic material in
their inner core.  The Company is currently conducting Phase II clinical
studies of a seasonal flu vaccine and recently announced a research agreement
with the National Institutes of Health to evaluate a VLP-based vaccine against
the novel H1N1 influenza strain.  The company also plans to initiate a
seasonal flu vaccine study in elderly subjects later this year.  Additional
information about Novavax is available at www.novavax.com and in the company's
various filings with the Securities and Exchange Commission.

Forward Looking Statement
Statements herein relating to future financial or business performance,
conditions or strategies and other financial and business matters, including
expectations regarding revenues, operating expenses, cash burn, and clinical
developments and 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
the Company's ability to progress any product candidates in preclinical or
clinical trials; the scope, rate and progress of its preclinical studies and
clinical trials and other research and development activities; clinical trial
results; current results may not be predictive of future results; even if the
data from preclinical studies or clinical trials is positive, the product may
not prove to be safe and efficacious; Novavax's pilot plant facility is
subject to extensive validation and FDA inspections, which may result in
delays and increased costs; our ability to enter into future collaborations
with industry partners and the government and the terms, timing and success of
any such collaboration; the cost of filing, prosecuting, defending and
enforcing any patent claims and other intellectual property rights; our
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; our ability to obtain adequate financing in
the future through product licensing, co-promotional arrangements, public or
private equity or debt financing or otherwise;  the maturity of the
convertible notes on July 15, 2009; 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 of Novavax, Inc., +1-240-268-2031
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