-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, ROH7jZ94rTG8qIBE+o5ROJzG3S7s9CmQdZUZhEI4bIZ3U+9Y+2qme4YF+0CptUeM r/RHm6yOq2nd4zczWFseig== 0001144204-10-021600.txt : 20100422 0001144204-10-021600.hdr.sgml : 20100422 20100422090032 ACCESSION NUMBER: 0001144204-10-021600 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100422 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100422 DATE AS OF CHANGE: 20100422 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVAVAX INC CENTRAL INDEX KEY: 0001000694 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 222816046 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26770 FILM NUMBER: 10763258 BUSINESS ADDRESS: STREET 1: 9920 BELWARD CAMPUS DRIVE CITY: ROCKVILLE STATE: MD ZIP: 20850 BUSINESS PHONE: 240-268-2000 MAIL ADDRESS: STREET 1: 9920 BELWARD CAMPUS DRIVE CITY: ROCKVILLE STATE: MD ZIP: 20850 8-K 1 v181874_8-k.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 8-K
 
CURRENT REPORT
 
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 
Date of Report (Date of earliest event reported) April 22, 2010
 
NOVAVAX, INC.

(Exact name of Registrant as specified in its charter)
 
Delaware
 
0-26770
 
22-2816046
(State or other jurisdiction of
incorporation or organization)
 
(Commission File Number)
 
(I.R.S. Employer Identification No.)
 
9920 Belward Campus Drive
Rockville, Maryland
 
20850
(Address of principal executive offices)
 
(Zip Code)
 
Registrant’s telephone number, including area code:
 
(240) 268-2000
 

(Former name or former address, if changed since last report.)

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 
 
On April 22, 2010, Novavax, Inc. (“Novavax”) issued a press release announcing that it was notified by the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) that its Proposal for a contract award is in the “competitive range” for the advanced development of its recombinant influenza vaccine.  A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
 
 
 
(d) 
Exhibits
 
Exhibits
 
 
99.1
Press Release of Novavax, Inc. dated April 22, 2010
 
 
 

 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized

 
Novavax, Inc.
(Registrant)
 
     
       
April 22, 2010
By:
/s/ John A. Herrmann III
 
 
Name:
John A. Herrmann III
 
 
Title:
Executive Director, Legal Affairs and Corporate Secretary
 


 

EX-99.1 2 v181874_ex99-1.htm
Exhibit 99.1
 

Contact:
Fred Driscoll
 
Chief Financial Officer
 
Novavax, Inc.
 
1 240-268-2000

NOVAVAX Notified by Department of Health and Human Services that its
Proposal for a Contract Award is in the Competitive Range for the Advanced
Development of its Recombinant Influenza Vaccine

Rockville, MD (April 22, 2010) –/PRNewswire-FirstCall/-Novavax, Inc. (NASDAQ:NVAX) announced today that the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), has determined the Company’s proposal to provide recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness is in the competitive range for award of an advanced development contract. Novavax submitted its proposal in September 2009 in response to Solicitation No. HHS-BARDA-09-32 for development of a new influenza vaccine in a U.S. based manufacturing facility.

The BARDA solicitation states that contracts will be awarded to vaccine manufacturers that satisfy several specific requirements.  BARDA’s notification indicated that Novavax’s proposal is in the competitive range, which consists of the most highly rated proposals. BARDA has proposed to conduct a pre-award site visit to inspect Novavax’s manufacturing facility in Rockville, Maryland.

“Novavax is pleased that its response to BARDA’s request for proposal (RFP) is within the competitive range for award consideration and we look forward to working with BARDA during the next stages of the process,” said Dr. Rahul Singhvi, President and CEO of Novavax. “We have made significant progress over the past several years in the development of our recombinant Virus-Like Particle (VLP) vaccine candidates for both seasonal and pandemic influenza (H5N1 and H1N1) and have now vaccinated over 4,200 subjects demonstrating both safety and immunogenicity of our vaccine candidates. In addition, last year, in the midst of the H1N1 pandemic, we were able to successfully demonstrate that we could manufacture under cGMP, an H1N1 VLP vaccine candidate within 11 weeks after receiving the viral gene sequences from the CDC.”

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 biopharmaceutical 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 the award by HHS BARDA of a contract for the advanced development of recombinant influenza vaccine, the development of our vaccine products, vaccine safety and efficacy, and the ability to quickly produce a vaccine product during a pandemic and any other future financial or business performance or matters 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 include HHS BARDA may not award any contract to Novavax, even though it has notified Novavax that it is in the competitive range; the agency will perform an on-site inspection which may prove to be unsatisfactory to the agency; safety or efficacy issues not seen to date may be encountered before the agency makes its decision which could have a negative impact on the receipt of a contract award; the company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale which could have a negative impact on the receipt of a contract award; historical and current results may not be predictive of future trial results for the seasonal vaccine or any other vaccine that we are developing or may develop; further testing is required before regulatory approval can be applied for and the FDA may not approve a vaccine even if the results are similar or better than the results reported to date; uncertainties related to the initiation, enrollment, progress and completion of clinical trials; and whether Novavax could repeat the 11-week production of a vaccine in a future pandemic could depend on many factors outside the company’s control including the virus itself. Further information on the factors and risks that could affect Novavax’s receipt of a contract award or its 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.



 

 

 

 
 
 

 
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