Novavax Launches Pivotal Clinical Study Of Novel 2009 H1n1 Vlp Flu Vaccine In Mexico

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20th October 2009, 11:11pm - Views: 836

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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


    -- GE Healthcare Provides Support with its Novel Disposable Bioprocessing


    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


    "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


    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

Community Health Novavax, Inc. 3 image

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


    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

Community Health Novavax, Inc. 4 image

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 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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