0001144204-11-012737.txt : 20110304 0001144204-11-012737.hdr.sgml : 20110304 20110303194117 ACCESSION NUMBER: 0001144204-11-012737 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20110224 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110304 DATE AS OF CHANGE: 20110303 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: 11662029 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 v213583_8k.htm Unassociated Document
 
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) February 24, 2011
 
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))
 
 
 
 
 
Item 1.01 Entry into Material Definitive Agreements.

On February 28, 2011, Novavax, Inc. (the “Company”) reported that it had entered into an agreement on February 25, 2011, effective as of December 9, 2010, to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to LG Life Sciences, Ltd. (LGLS). Under the agreement, LGLS received an exclusive license in South Korea and a non-exclusive license in certain other emerging-market countries, to manufacture, develop and commercialize influenza vaccines using Novavax technology.  Novavax is obligated to provide technology transfer and manufacturing support for LGLS’s new vaccine production facility.  Novavax will receive upfront and milestone payments from LGLS in addition to double-digit royalty rate payments from potential commercial sales.

On March 1, 2011, the Company announced that it has been awarded a contract dated as of February 24, 2011, from the Office of Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services (HHS). The contract is valued at up to $179 million for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. The contract has a 3-year base period, valued at $97 million, during which the Company will develop and produce novel, clinical-stage, recombinant VLP influenza vaccines. The contract has a 2-year period at BARDA’s option, valued at $82 million, to build on the work the Company accomplishes during the base period. The Company expects to conduct three (3) clinical trials for its pandemic influenza VLP vaccine candidate and two (2) clinical trials, a Phase 2 dose-ranging trial and a Phase 3 registration trial, for its seasonal influenza VLP vaccine candidate.

Item 9.01.  Financial Statements and Exhibits.
 
 
(d) 
Exhibits
 
Exhibits
 
 
99.1
Copy of LGLS Press Release
 
 
99.2
Copy of BARDA Press Release


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)
  
       
March 3, 2011
By:
/s/ John A. Herrmann III
  
 
Name:
John A. Herrmann III
  
 
Title:
Executive Director, Legal Affairs and Corporate Secretary
  
       
 
 
2
 
EX-99.1 2 v213583_ex99-1.htm Unassociated Document
 
Exhibit 99.1
 
       
Contact:  Frederick W. Driscoll Contact: Chulha Park
 
VP, CFO and Treasurer
Novavax, Inc. 
240-268-2000
  
Director, Public Relations
LG Life Sciences, Ltd.
+82-2-6924-3360
 

Novavax Licenses Recombinant VLP Influenza Vaccine to
LG Life Sciences for South Korea and Other Countries
 
 
·
15 million dose South Korean market
 
·
LG to build manufacturing facility with 30 million dose influenza vaccine capacity

Rockville, MD – February XX, 2011 – Novavax, Inc. (Nasdaq: NVAX) announced today an agreement to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to LG Life Sciences, Ltd. (LGLS). Under the agreement, LGLS receives an exclusive license to manufacture, develop and commercialize influenza vaccines using Novavax’s recombinant VLP technology in South Korea. LGLS also receives a non-exclusive license to manufacture, develop and commercialize influenza VLP vaccines in certain emerging market countries.

LGLS will be responsible for funding clinical development and licensure of influenza VLP vaccines in South Korea and other countries, and for construction of a new VLP vaccine manufacturing facility planned at LGLS’s Osong campus in South Korea.  Novavax will receive upfront and milestone payments from LGLS in addition to double-digit royalty rate payments from commercial sales. Novavax will provide VLP technology transfer and manufacturing support for LGLS’s new vaccine production facility.

Dr. Rahul Singhvi, CEO and President of Novavax, stated: “LGLS is an affiliate of LG, a global conglomerate. LGLS is a leading provider of vaccines to supranational health organizations such as UNICEF and the Pan American Health Organization (PAHO). We welcome this opportunity to develop a recombinant influenza vaccine solution for South Korea and other countries served by LGLS. This new partnership with LGLS is further validation of our VLP technology and, as we have done previously with our joint venture in India with Cadila Pharmaceuticals, further expands our development efforts into new territories. LGLS will help us advance our technology in Korea and other countries, consistent with our commercial strategy of developing regional partnerships and in-country manufacturing solutions with leading pharmaceutical companies around the world.”

Dr. Iljae Jung, CEO and President of LGLS, commented: “We look forward to working closely with Novavax in advancing the VLP influenza vaccines for people around the world. We anticipate that Novavax and LGLS together will make significant achievements in the field of influenza vaccines with our combined technology, expertise and resources.”

 
3
 
 
About LG Life Sciences, Ltd.

LG Life Sciences, Ltd. (LGLS), an LG affiliate, is a leading pharmaceutical company headquartered in South Korea.  LGLS is committed to developing a leading portfolio of drugs that prevent, treat and cure diseases across a broad range of therapeutic areas, including medicines to fight various infectious diseases, and improving the health and quality of life of patients around the world.   For additional information, please visit www.lgls.com.
 
About Novavax
 
Novavax, Inc. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary virus-like particles (VLPs) technology and single-use bioprocessing system enables rapid vaccine development and production where and when it’s needed, worldwide. 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 licensure by LGLS of Novavax’s recombinant influenza vaccine technology and other future financial or business performance or matters are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax and LGLS 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 include: neither Novavax nor LGLS have yet manufactured, or relied on third parties to manufacture, any recombinant vaccines at a commercial scale; historical and current results may not be predictive of future trial results for influenza vaccines; further testing is required before regulatory approval can be applied for and regulatory agencies may not approve a vaccine even if the results are similar or better than the results reported to date; there are uncertainties related to the initiation, enrollment, progress and completion of clinical trials; production of a vaccine could depend on many factors outside Novavax’s or its licensee’s control. 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 neither Novavax nor LGLS assume a duty to update forward-looking statements.

# # #

 
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Exhibit 99.2
 
 
       
Contact:  Frederick W. Driscoll    
 
VP, Chief Financial Officer and Treasurer
Novavax, Inc. 
240-268-2000
  
 
 
 

NOVAVAX Awarded HHS-BARDA Contract Valued at up to $179 Million to Develop Pandemic and Seasonal Influenza Vaccines for U.S. Government Using Recombinant VLP Technology

 
·
Contract Includes $97 Million 3-year Base Period and $82 Million 2-year Option Period

 
·
Base Period Will Fund Seasonal Influenza Vaccine through Phase 3 and Potential FDA Licensure; Pandemic Influenza Vaccine Candidates through Phase 1/2 Clinical Trials

 
·
Includes Development of Manufacturing Plan to Establish a U.S.-based Facility with Surge Manufacturing Capacity of 50 Million Doses within Six Months of Influenza Pandemic

Company to Hold Investor Conference Call 10:00 am ET Today

ROCKVILLE, Md. – (March 1, 2011) – Novavax, Inc. (Nasdaq: NVAX) announced today that it has been awarded a contract valued at up to $179 million by the Office of Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS) for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza. During the contract’s 3-year base period, valued at $97 million, Novavax will continue to develop and manufacture its novel, clinical-stage, recombinant virus-like particle (VLP) influenza vaccines to address BARDA’s commitment to advancing recombinant-based technology and pandemic preparedness. The contract could be extended for an additional 24-month option period with $82 million in additional funding to build on the work Novavax accomplishes during the base period and to support manufacturing scale-up and licensure by the U.S. Food & Drug Administration (FDA).

During the contract’s base period, funded activities would include:

 
·
three (3) clinical trials utilizing Novavax’s pandemic influenza VLP vaccine candidate with adjuvants (including Novavax’s proprietary adjuvant);
 
·
Phase 2 dose-ranging trial and Phase 3 registration trial utilizing Novavax’s seasonal influenza VLP vaccine candidate; and
 
·
development of a manufacturing facility plan that has the capability to produce finished vaccine within twelve (12) weeks and at least 50 million doses within six (6) months of an influenza pandemic declaration.

Novavax’s manufacturing facility plan will outline the design, construction, commissioning, qualification and validation of such a U.S.-based facility to produce recombinant seasonal and pandemic vaccines.  Additional funded base period activities include vaccine product characterization, process development and scale–up of recombinant vaccine manufacturing including consistency lot manufacturing and lot-release assay development in support of the Phase 3 trial.

 
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“We are thrilled to work with BARDA to accelerate the development of a recombinant influenza vaccine solution and help the U.S. government prepare for potential influenza pandemics,” said Novavax’s President and CEO, Dr. Rahul Singhvi.  “This is a unique opportunity for our company to apply the knowledge we have gained over the past five years to address a critical public health need.  We thank the team at HHS-BARDA for this contract to advance this important new technology, which will ultimately help our nation and the world to be better prepared to respond quickly to influenza pandemics and emerging diseases.  This is a particularly satisfying day for all employees at Novavax to see the fruits of their labor over the past 5 years go toward such an important cause.”
 
“Biotechnology is a key part of the global innovation economy -- this vaccine program shows that Maryland is leading the way in innovation,” U.S. Senator Barbara A. Mikulski (D-MD) said. “Making vaccines available faster and to more people is important to our health, and this development will also contribute to jobs of the future. It’s a win-win for Maryland.”
 
Novavax is currently developing vaccines to prevent pandemic (H5N1) and seasonal influenza using its novel VLP technology, which enables more rapid vaccine production than traditional egg-based methods.  The BARDA contract award follows the August 2010 Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza by the President’s Council of Advisors on Science and Technology, which analyzed current influenza vaccine production processes and identified ways the U.S. federal government could support improvements in relevant technologies to reduce the time required to supply vaccine to the U.S. population when the next influenza pandemic occurs.

Conference Call Information
Novavax’s senior management will host a conference call at 10:00 am Eastern time today to discuss this announcement.  You may listen to the call on Novavax’s website at www.novavax.com under “Investor/Events” or by telephone at 1-877-212-6076 (domestic) or 1-707-287-9331 (international). To access a replay of the conference call, dial 1-800-642-1687 (domestic) or 1-706-645-9291 (international) and enter pass code 48683057.

About VLPs and Novavax’s Vaccine Program
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. (Nasdaq: NVAX), a clinical-stage biopharmaceutical company, employs its cutting-edge technology to create next-generation vaccines to prevent serious infectious diseases, such as pandemic and seasonal influenza and respiratory syncytial virus (RSV). The company’s proprietary virus-like particles (VLPs) technology and single-use bioprocessing system enables rapid vaccine development and production where and when it’s needed, worldwide. 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.

 
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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 an influenza pandemic and 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 or may not award any option period funding to Novavax; the Company has not yet manufactured, or relied on third parties to manufacture, any vaccines at a commercial scale; 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 12-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 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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