-----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, Eoa/6HdILRDnIUoLEVX5AORyJJvZ8SPt6scL46ju6p1avEV/AZOn9xkkLky8yAoi luEUoLCmQnYYcHNbj0wa5g== 0000950133-07-004816.txt : 20071210 0000950133-07-004816.hdr.sgml : 20071210 20071210151410 ACCESSION NUMBER: 0000950133-07-004816 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20071210 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071210 DATE AS OF CHANGE: 20071210 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: 071295557 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 w44040e8vk.htm FORM 8-K e8vk
 

 
 
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) December 10, 2007
NOVAVAX, INC.
 
(Exact name of Registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of incorporation or
organization)
  0-26770
(Commission File Number)
  22-2816046
(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))
 
 

 


 

Item 8.01 Other Events.
On December 10, 2007, Novavax, Inc. (the “Company”) announced that it has entered into a collaboration agreement with GE Healthcare, a unit of General Electric Company, to develop and co-market a pandemic influenza vaccine manufacturing solution for selected international countries. The collaboration will incorporate GE Healthcare’s bioprocess solutions and design expertise with the Company’s virus-like particle and manufacturing platform. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
     (d) Exhibits
Exhibits
     99.1 Press release dated December 10, 2007

2


 

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)
 
 
December 10, 2007  By:   /s/ Len Stigliano    
  Name:   Len Stigliano    
  Title:   Chief Financial Officer, Vice President and Treasurer   
 

3

EX-99.1 2 w44040exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
         
(LOGO)
      (NOVAVAX LOGO)
GE Healthcare and Novavax Establish Collaboration
To Develop and Market Pandemic Influenza Solution
    Collaboration aimed at enabling vaccine production facility commissioning in half the time of a traditional egg-based facility.
 
    Once established, such a vaccine facility could allow manufacturing of pandemic flu vaccine to commence within 12 weeks of the strain isolation
Chalfont St Giles, UK and Rockville, MD, USA: December 10, 2007 GE Healthcare, a unit of General Electric Company (NYSE: GE), and Novavax Inc. (NASDAQ: NVAX), today announced a collaboration agreement to develop and market a pandemic influenza vaccine manufacturing solution for selected international countries. This collaboration leverages GE Healthcare’s bioprocess solutions and design expertise and Novavax’s virus-like particle (VLP) and manufacturing platform.
Health planners around the world are looking to increase manufacturing capacity and vaccine stockpiles to counter the threat of a global avian flu pandemic: the global demand for pandemic influenza vaccine has been reported as possibly approaching 13 billion doses, with current world capacity at best 2.4 billion doses.
“This collaboration is a great first example of GE Healthcare realizing its strategy of enabling affordable and safe vaccine production for countries that need to better prepare for emerging infectious diseases,” said Peter Ehrenheim, President and CEO, GE Healthcare Life Sciences.
Novavax’s VLP-based H5N1 pandemic flu vaccine is currently in Phase I/IIa clinical trials. The goal is that any required recombinant vaccine could be produced in cell culture within 12 weeks of identification of a pandemic strain, without using eggs or live influenza virus — as little as half the time compared with currently available processes.
Commenting on the collaboration, Dr. Rahul Singhvi, President and CEO of Novavax said, “This collaboration is a critical milestone in addressing one of the most pressing global healthcare issues of the 21st century. We believe the combination of these technologies will enable the creation of a country’s rapid response supply and self-sufficiency in pandemic flu vaccine.”
GE Healthcare’s new ReadyToProcess portfolio of ready-to-use systems and devices is designed to increase speed, simplicity and safety for all areas of bioprocessing, including the time it takes to build and validate a facility. With Novavax’s VLP and manufacturing platform, the intention is that it could enable commissioning of a new facility from scratch in approximately two and a half years, half the time for a traditional egg-based vaccine production facility, and at a potential capital reduction of approximately 60 per cent.

 


 

About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.
About Novavax Inc
Novavax Inc. is a clinical stage vaccine company committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company’s proprietary virus-like particle (VLP) and Novasome® adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax’s particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs. 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 Statements
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding product sales, operating expenses, and clinical developments are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax and GE Healthcare caution 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 ability of Novavax and GE Healthcare to successfully market a pandemic influenza vaccine solution; the ability of Novavax to integrate GE Healthcare’s devices into its manufacturing process; the terms and conditions of a definitive agreement with one of the selected countries, if such an agreement is reached; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Novavax’s proposed

 


 

product candidates; dependence on the efforts of third parties; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. 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.
# # #
     
Contact:
   
 
   
GE Healthcare
  Novavax, Inc:
Conor McKechnie
  Tricia J. Richardson
International Media Relations
  Investor Relations Manager
conor.mckechnie@ge.com
  trichardson@novavax.com
+44 771 751 7028
  + 1 240-268-2031
 
   
Arvind Gopalratnam
   
Americas Media Relations
   
arvind.gopalratnam@ge.com
   
+1 414-721-2429
   

 

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-----END PRIVACY-ENHANCED MESSAGE-----