NOVAVAX

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World Health Organization
7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials
Geneva, Switzerland
February 17-18, 2011

Presenter: Dr. Greg Glenn


NOVAVAX Presents Final Results from H1N1 Influenza Vaccine Trial at World Health Organization Meeting

Rockville, MD (February 18, 2011)¨C/PRNewswire-FirstCall/-Novavax, Inc. (NASDAQ:NVAX) a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle (VLP) pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting (WHO) on Evaluation of Pandemic Influenza Vaccines in Clinical Trials. The meeting was held at the WHO headquarters in Geneva, Switzerland where Dr. Gregory Glenn, Chief Medical Officer of Novavax, presented the findings at a session entitled: ¡°Pandemic and Potentially Pandemic Vaccines Developed Using New Technologies.¡± Dr. Glenn¡¯s presentation was entitled: ¡°Phase II randomized, double-blind, placebo-controlled trial of a novel (H1N1) influenza VLP vaccine¡± and is available at www.novavax.com under the Investors/Events tab.

In this randomized, double-blind, placebo-controlled Phase II trial, Novavax¡¯s H1N1 VLP vaccine was administered in a single-dose regimen to over 3,000 subjects. The study found that the vaccine exceeded the immunogenicity criteria for seasonal influenza vaccine licensure at all dose levels including the 5¦Ìg dose. Additionally, a single administration of the VLP vaccine induced high levels of hemaglutinin inhibition (HAI) titers in subjects without pre-existing detectable immunity to this pandemic influenza strain. Together, the data indicate that the H1N1 VLP vaccine was well-tolerated and immunogenic.

Dr. Glenn commented: ¡°This trial was an important milestone for our influenza vaccine program and demonstrated the potential of our recombinant vaccine technology. The data indicate that our VLP vaccine was well-tolerated and generated robust immunogenicity at all dose levels, including the 5¦Ìg dose. The single-dose seroprotection data in patients who had no pre-existing immunity (seronegatives) achieved protective titers in up to 85% of subjects which indicates that the VLP vaccine will be important in addressing future influenza pandemics. Novavax VLPs are unique as they are made in a non-egg-based, recombinant manufacturing system that produces particles resembling the influenza virus but which renders them more immunogenic than simple recombinant vaccines.¡±

Methods

This Phase II randomized, double-blind, placebo-controlled trial was conducted at a single study center in Mexico to evaluate the safety, tolerability, and immunogenicity of 3 dose levels (5¦Ìg, 15¦Ìg, and 45¦Ìg HA) of the novel (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults aged 18 to 64 years. The study was conducted in two parts: Part A was to evaluate
the safety and immunogenicity of the H1N1 influenza VLP vaccine over a dose range and to select a dose for an expanded safety evaluation in Part B. In Part A, 1,013 subjects were enrolled (760 active and 253 placebo). Based on an interim safety and immunogenicity analysis, an additional 3,547 (2,535 active and 1,012 placebo) subjects were enrolled in Part B of the study, a safety only study, and received 15¦Ìg of VLP vaccine or placebo as a single injection on Day 1 using a second lot of H1N1 VLP vaccine.

Safety

In Part A, adverse events (AEs) were similar for the placebo group and for the active vaccine groups, except that dose-related local injection site reactions were reported more frequently in the active vaccine groups. In Part B of the study, the incidence of AEs was consistent with that of Part A and was comparable between the VLP and placebo groups. The results for the 15¦Ìg vaccine in Part A and Part B of the study demonstrated that the different vaccine lots exhibited comparable safety profiles. Across all subjects in Part A and Part B, the majority of AEs were of mild or moderate severity and resolved without sequelae and all serious AEs were considered definitely not related to vaccine.

Immunogenicity

In Part A of the study, a single injection of the H1N1 Influenza VLP vaccine at doses of 5¦Ìg, 15¦Ìg, and 45¦Ìg induced immune responses against the H1N1 viral strain that met the Food and Drug Administration (FDA) immunogenicity criteria for licensure of seasonal inactivated influenza vaccines. A dose-response was observed as measured by the HAI assay. At Day 14, the rates of seroconversion for the 5¦Ìg, 15¦Ìg, and 45¦Ìg dosage groups were 48.3%, 65.0%, and 74.9%, respectively, as compared to 5.9% for the placebo group. Similarly, at day 14, the proportion of subjects who achieved an HAI titer ¡Ý1:40 (seroprotection) for the 5¦Ìg, 15¦Ìg, and 45¦Ìg dosage groups increased to 81.6%, 90.5%, and 91.6%, respectively. The second vaccine administration at day 21 did not significantly change the seroconversion and seroprotection rates.

Approximately 40% of all subjects had a baseline HAI titer ¡Ý1:40 to H1N1 at day 0, either due to exposure to the ongoing pandemic virus, or past exposure. Therefore, a sub-analysis was performed in subjects who were H1N1 seronegative at baseline. In this population, the seroconversion rates for the 5¦Ìg, 15¦Ìg and 45¦Ìg groups were, 64%, 79% and 85%, respectively, after the first dose.

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 particle (VLP) technology and unique disposable 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. For more information about Novavax, please visit www.novavax.com.

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MARCH 2011

6th Latin America Clinical Trials Conference
Miami, FL
March 1–2, 2011
Examination of a Clinical Trial Conducted in Mexico City which Enrolled 4,550 Subjects During the Pandemic of 2009 Preventing the Spread of H1N1
Keynote Speaker: Kathy Lenhard



2011 Citi Global Healthcare Conference
New York, NY
March 1–3, 2011
Speaker: Dr. Rahul Singhvi
Webcast: click here.

NOVAVAX to Present at Citi 2011 Global Health Care Conference

ROCKVILLE, Md., Feb. 24, 2011 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) a clinical-stage vaccine company, announced today that Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax will be presenting at the Citi 2011 Global Health Care Conference on March 3rd, 2011 at 8:30 am local time at the Hilton New York Hotel, New York, NY. A live audio-only webcast link for the presentation can be accessed via the Company website at www.novavax.com under Investors/Events, and a replay will be available for 90 days after the presentation.

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.



Roth Growth Stock Conference
Dana Point, CA
March 13 – 16, 2011
Presenter: Dr. Rahul Singhvi
Webcast: click here.



BIT’s Life Science’s Vaccines Congress (WCV 2011): The Future of Global Vaccines
Beijing, China
March 23-25, 2011
Commercialization Strategies for Vaccines in the Emerging Markets
Keynote Speaker: Dr. Rahul Singhvi

CLICK HERE FOR WEBCAST:

www.novavax.com/go.cfm?do=Page.View&pid=36

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“The 2009 H1N1 pandemic demonstrated the need for technologies that can provide vaccines more rapidly”


February 28, 2011 03:53 PM Eastern Time

HHS Awards Contracts to Develop New Flu Vaccine Technology
Two contracts support advanced development of next-generation recombinant vaccine

WASHINGTON--(BUSINESS WIRE)--U.S. Department of Health and Human Services awarded two contracts today to help make vaccine available more quickly for seasonal flu outbreaks and pandemics. The contracts for advanced development of new types of vaccine and new ways to make flu vaccine known as next-generation recombinant influenza vaccine total $215 million.

“The 2009 H1N1 pandemic demonstrated the need for technologies that can provide vaccines more rapidly,” HHS Secretary Kathleen Sebelius said. “These next-generation flu vaccines hold the potential to be even more effective and to make the first and last doses of vaccine available sooner than existing flu vaccines by weeks and months which can save more lives during a pandemic as well as during seasonal flu outbreaks.”

HHS awarded one contract to Novavax, Inc., of Rockville, Md., for $97 million over the first three years, which can be extended for an additional two years, for a total contract value of $179.1 million. HHS awarded a separate contract to VaxInnate, Inc. of Cranbury, N.J., for $117.9 million over the first three years, which can be extended for two additional years, for a total contract value of $196.6 million.

Under its contract, Novavax is to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate a strong immune response in humans.

VaxInnate is developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate strong immune response to protect against the flu.

Through these contracts, both companies will conduct clinical safety and efficacy studies and optimize and validate their manufacturing processes, which are needed to obtain licensing from FDA in order to use the new technologies in manufacturing flu vaccine in United States.

These next-generation recombinant influenza vaccines were supported in early stages by the National Institutes of Health and will complement currently available and other new influenza vaccines. Today’s contracts for advanced development are supported by the HHS Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response.

The contracts are part of a national pandemic vaccine preparedness strategy, which includes the advanced development of new types influenza vaccines as well as expanding and diversifying domestic influenza vaccine production, and establishing and testing stockpiles of pre-pandemic vaccine. In addition, the recombinant flu vaccine may enhance pandemic vaccine manufacturing surge capacity in the United States.

The contracts use the federal government’s new approach to producing medical countermeasures – the medications, vaccines, medical equipment and supplies needed for a health emergency. On Aug. 19, HHS Secretary Kathleen Sebelius released an examination of the federal government’s system to produce medical countermeasures, along with recommendations for a better approach. The recommendations included developing flexible, robust, nimble and innovate technologies to increase capacity and produce vaccines for pandemic influenza and other threats in a much shorter timeframe. These recommendations were consistent with a report by the President’s Council of Advisors on Science and Technology, titled “Report to the President on Reengineering the Influenza Production Enterprise to Meet the Challenges of Pandemic Influenza.” Both reports are available at
www.phe.gov/preparedness/mcm/enterprisereview/Pages/default.aspx.

BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases. For more information, visit www.phe.gov. Note: All HHS press releases, fact sheets and other press materials are available at

www.hhs.gov/news.


Contacts
HHS Press Office
202-690-6343

Permalink:
www.businesswire.com/news/home/20110228007038/en/HHS-Awards-Contracts-Develop-Flu-Vaccine-Technology.

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DOW JONES NEWSWIRES


Novavax Inc. (NVAX) won a flu-vaccine contract with the U.S. government worth $97 million over three years, according to the Department of Health and Human Services Monday.

Shares in the biopharmaceutical company climbed 12% after hours to $2.90 on the news.

The HHS, which awarded another contract to a privately held company, said the deals are for advanced development of new types of seasonal flu vaccine and news ways to make the vaccine. It means to help make the vaccines available more quickly for seasonal flu outbreaks or pandemics.

"The 2009 H1N1 pandemic demonstrated the need for technologies that can provide vaccines more rapidly," HHS Secretary Kathleen Sebelius said in a release.

Novavax's contract can be extended for another two years, which would raise its total value by $82.1 million. Under its contract, Novavax has been asked to develop new technology to produce vaccines using insect cells to express influenza proteins and create virus-like particles that stimulate the immune system.

The other company, VaxInnate Inc., is developing a recombinant influenza vaccine technology based on combining influenza and bacteria proteins to stimulate a strong immune response to protect against the flu.

Both companies will conduct clinical safety and efficacy studies and "optimize and validate" their manufacturing processes, the HHS said, which are necessary for Food and Drug Administration approval to use the new technologies.


-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; [e-mail]


Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary: www.djnewsplus.com/access/al?rnd=dpnnmY5Rdt%2Bwnk9ngXOGVg%3D%3D. You can use this link on the day this article is published and the following day.



(END) Dow Jones Newswires

February 28, 2011 17:08 ET (22:08 GMT)

Copyright (c) 2011 Dow Jones & Company, Inc.- - 05 08 PM EST 02-28-11

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News for 'NVAX' - (Novavax Licenses Recombinant VLP Influenza Vaccine to LG Life Sciences for South Korea and Other Countries -- 15 million dose South Korean market)


ROCKVILLE, Md., Mar 01, 2011 (PR Newswire Europe via COMTEX) -- Novavax, Inc.
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 technology,
expertise and combined resources."

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. , 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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NOVAVAX Special Investor Conference Call and Webcast
Rockville, Maryland

March 1, 2011 10:00 am

Real time Dial-in: 1-877-212-6076 (domestic) or 1-707-287-9331 (international)

Replay dial-in: 1-800-642-1687 (domestic) or 1-706-645-9291 (international), conference ID: 48683057

Webcast:

www.novavax.com/go.cfm?do=Page.View&pid=36

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Novavax Inc

(NVAX: News ) shares surged more than 24% in after hours after the company received a contract worth up to $179.1 million from the U.S. Department of Health and Human Services to develop new flu vaccine technology.

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www.rallymonkey.com/oldvideo.php



www.novavax.com/download/releases/02-28-11%20NOVAVAX%20LGLS%20Press%20Release_FINAL.pdf

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Special Investor Conference Call
Tuesday March 1, 2011 at 10:00 AM ET

This broadcast is available in the following formats. Please select your preference.


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ir.novavax.com/eventdetail.cfm?eventid=93502



www.shareholder.com/visitors/event/build2/mediapresentation.cfm?companyid=NVAX&mediaid=46691&mediauserid=5110744&TID=982286350:6b8f14d7c8fa7820ada8657c50b46c1b&popupcheck=0&shexp=201103011031&shkey=80da7e5b79ddb90a7dac765b9a5926c9&player=1

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Roth Capital: two grand slams for Novavax
March 1, 2011 by leonardzehr · Leave a Comment

Roth Capital Partners says that Novavax’s (NASDAQ:NVAX) new BARDA vaccine contract and agreement to license its VLP vaccine technology to LG Life Sciences of South Korea represents “two grand slams that place Novavax on a new playing field.”

Analyst Edward Nash writes that contract from the Biomedical Advanced Research and Development Authority (BARDA), valued at up to $179.1 million over five years, bolsters the balance sheet and allows for Phase 3 development of the VLP vaccine without equity dilution.Additionally, it puts Novavax in a “strong negotiating position with regard to partnership discussions,” he added.

Under the LG accord, Novavax will receive undisclosed upfront and milestone payments, and double-digit royalties from commercial sales, while LG will be responsible for clinical development costs in South Korea and construction of a VLP vaccine plant, with an annual capacity of 30 million doses.

“Both of these news events significantly change the Novavax story,” Mr. Nash said. “We believe investors still have a ground floor opportunity to buy into shares of Novavax at a reasonable valuation, given that we believe additional clinical data points will continue to drive the story.”

He reiterated his “buy” rating on Novavax and 12-month price target of 8. The stock jumped 33% or 85 cents to $3.45 in early trading Tuesday.

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WHY NOVAVAX DIDN'T HIT $4/$5 TODAY!


4:30 pm : A spike in oil prices amid percolating geopolitical tension in the Middle East prompted participants to pare their positions. Their steady selling effort left stocks to settle at session lows with sharp losses.

The tone of trade in the early going was actually positive, but buyers began to lose interest as Europe's major bourses drifted lower, even though Germany, France, the United Kingdom, and the broader eurozone all posted solid PMI Manufacturing data. A jump in oil prices before the open of pit trade also undermined early strength.

Oil prices rallied 2.7% to settle at $99.63 per barrel, a two-year closing high. Even after the close oil prices flirted with $100 per barrel in electronic trade. Oil's strength started with morning reports that Saudi Arabia sent tanks into neighboring Bahrain, where social unrest continues to be of concern in a region largely responsible for the world's oil supply. Indicative of the tensions surrounding the region, Saudi Arabia's stock market slumped 7%.
As oil prices pushed higher, participants pressed stocks lower, eventually spurring a broad-based sell-off that left more than 90% of the S&P 500 in the red. That took the Volatility Index up close to 15%.

Precious metals rallied as many sought safety. Silver settled with a 2.0% gain at $34.41 per ounce and gold gained 1.4% to close at $1431.20 per ounce. Silver extended its climb after the close of pit trade so that the continuous contract hit a new 30-year high above $34.60 per ounce. Gold prices hit a record high above $1434 per ounce after pit trade ended.

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Pharmaceuticals to Experience Wide Changes - In-Depth

Research Featuring Novavax and Radient PharmaceuticalsLast update: 3/3/2011 8:59:00 AMHONG KONG, March 3, 2011 /PRNewswire via COMTEX/ --

Today, released its industry report highlighting Novavax, Inc. (NVAX) and Radient Pharmaceuticals Corporation (RPC). Investors from around the world are invited to view fundamental and technical analysis at . The global pharmaceutical market is expected to experience wide changes, with trends growing towards the Asia-Pacific region. A favorable regulatory environment has started to emerge in India, China, Malaysia, South Korea and Indonesia; drawing the attention of larger API product providers. This new competition within an already fast-paced economy has closed the gap between product cost and disposable income of consumers - a change that is expected to drive long-term growth within the global marketplace. Global pharmaceutical market sales are expected to grow at a 4 - 7% compound annual growth rate (CAGR) through 2013, largely driven via growing access to health-care in emerging economic regions. Short-term growth within the sector will be fueled by the US market, as it remains the largest pharmaceutical market in the world. A large focus on R&D in biotechnology, special drugs and generic drugs will remain a strong catalyst to meet 2011 targets of $315 billion dollar in sales volume within the United States alone. World Street Fundamentals has highlighted Novavax for its recently awarded contract for $97 Million dollars by the U.S. Department of Health and Human Services (HHS). The company's technology platform is based on virus-like particles (VLPs) using insect cells for production, rather than mammalian eggs, resulting in a low-cost disposable system with quick-response deployment potential. To read the report on Novavax, Inc. (NVAX), click here: . World Street has recognized Radient Pharmaceuticals for its lead product, a FDA approved cancer test kit marketed as Onko-Sure. Recently, Radient has begun repositioning itself in order for it to become solely focused on distributing its cancer test to market. Estimated market projections for cancer test kits are as high as $1.45 billion annually. To read the report on Radient Pharmaceuticals Corporation (RPC), click here: . About World Street World Street Fundamentals is an online portal for professionals, investors and new-comers to the markets to find in depth comprehensive research and research tools to help guide you through the ever changing financial markets around the world. Covering the top performers in the hottest sectors and providing clarity to investors around the world. SOURCE World Street Fundamentals

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Maryland Governor Martin O'Malley to Visit Novavax in Celebration of HHS-BARDA Contract Award


-- BARDA contract valued at up to $179 Million to Develop Pandemic and Seasonal Influenza Vaccines for U.S. Government Using Recombinant VLP Technology



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


Press Conference at 9:15 a.m. ET, Monday, March 7
ROCKVILLE, Md., March 3, 2011 /PRNewswire/ --

ovavax, Inc. (Nasdaq: NVAX) announced today that Maryland State Governor Martin O'Malley will visit the company's headquarters in Rockville, Maryland, on Monday, March 7, to celebrate the recently announced contract valued at up to $179 million. 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) awarded the contract to Novavax for the advanced clinical and manufacturing development of recombinant vaccines for the prevention of seasonal and pandemic influenza.

"The Governor's recognition of our award is a tremendous honor to the employees of Novavax and an acknowledgement of the importance of both this contract award and the company's contribution to the State of Maryland," said Novavax's President and CEO Dr. Rahul Singhvi. "We are thrilled to formally celebrate our partnership with BARDA, which will accelerate the development of a recombinant influenza vaccine solution and help the U.S. government prepare for potential influenza pandemics."

During the contract's 3-year base period, valued at $97 million, Novavax will continue its development of 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 has a 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 and Drug Administration (FDA).

"On behalf of all Marylanders, I am so proud to congratulate Novavax on their federal award," said Governor O'Malley. "Their leadership in innovation and discovery is exactly what we need to compete and win in the new economy and their contributions are proof of what biotechnology and life sciences can mean to the future of our State and our nation. I'd like to thank Dr. Singhvi and all of the Novavax employees for their commitment and dedication to this important healing and lifesaving work."

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.

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 production 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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Maryland Governor Martin O’Malley to Visit Novavax in Celebration of HHS-BARDA Contract Award

BARDA contract valued at up to $179 Million to Develop Pandemic and Seasonal Influenza Vaccines for U.S. Government Using Recombinant VLP Technology

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

Press Conference at 9:15 a.m. ET, Monday, March 7

www.novavax.com/go.cfm?do=Press.List&Year=2011

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VIDEO: O'Malley Tours NovavaxRockville biotech firm recently landed federal contract for influenza vaccine.

Gov. Martin O'Malley made a quick swing through Rockville on Monday morning, touring Novavax, a biotechnology company that recently landed a federal contract to develop an influenza vaccine.

The three-year contract, awarded by the U.S. Department of Health and Human Services, is valued at up to $170 million. It charges Novavax with advanced clinical and manufacturing development of seasonal and pandemic influenza vaccines.


VIDEO AND ARTICLE CONTINUED:

rockville.patch.com/articles/video-omalley-tours-novavax

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Wedbush Analysts Begin Coverage on Novavax, Inc. (NVAX)
March 16th, 2011

Equities research analysts at Wedbush initiated coverage on shares of Novavax, Inc. (NASDAQ: NVAX) in a research note to investors on Tuesday. The analysts set an “outperform” rating and a $6.00 price target on the stock.

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News for 'NVAX' - (NOVAVAX Announces Release Date of 2010

Year-End Financial Results and Investor Conference Call)


ROCKVILLE, Md., March 23, 2011 /PRNewswire via COMTEX/ -- Novavax, Inc.
(Nasdaq: NVAX) today announced that it will report its 2010 year-end financial
results in a press release to be issued after 8:00 a.m. local time Monday, March
28, 2011 and will then hold an investor conference call at 10:00 a.m. The call
will be hosted by Novavax's President and Chief Executive Officer, Dr. Rahul
Singhvi and other members of senior management. The dial-in number for the
conference call is 1 (877)-212-6076 (U.S. or Canada) or 1 (707)-287-9331
(International).

A live audio webcast of the conference call will be available at www.novavax.com
under Investors/Events. A replay of the conference call will be available on
Novavax's website approximately one-hour after the event for 90 days and a
replay will also be available by telephone beginning March 28, 2011. To access
the replay, dial 1-(800)-642-1687 and enter pass code 54520344.

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.

SOURCE Novavax, Inc.

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J Virol Methods. 2011 Mar 15. [Epub ahead of print]

INFLUENZA VIRUS-LIKE PARTICLES AS A NEW TOOL FOR VACCINE IMMUNOGENICITY TESTING: VALIDATION OF A NEURAMINIDASE NEUTRALIZING ANTIBODY ASSAY.
Gavrilov V, Orekov T, Alabanza C, Porika U, Jiang H, Connolly K, Pincus S.

Novavax, Inc., 9920 Belward Campus Drive, Rockville, MD 20850, USA.

Abstract
Detection of neutralizing antibody to viral neuraminidase (NA) by testing for enzyme inhibition has been recognized as an important part of the immunogenicity of influenza vaccines. However, the absence of a well characterized standard source of active NA and validated assays has significantly limited clinical studies of NA immunity. Influenza virus-like particles (VLPs) containing hemagglutinin (HA), NA, and M1 proteins were produced from insect cells infected with a recombinant baculovirus and used as the NA source for the NA inhibition (NAI) assay. The NA activity of 6 different VLP strains varied from 0.43 to 1.61 (x 10(-3)) enzyme units per ìg of HA and was stable over 6months of storage at 2-8°C. The NAI assay using 2'-(4-Methylumbelliferyl)-á-D-N-acetylneuraminic acid as a substrate was modified for testing the antibody titer in clinical samples and validated. The advantages of the assay include: 1) stable, reproducible, and standardized source of NA; 2) testing the antibody titer specific to each subtype of NA in serum from subjects immunized with trivalent vaccines (H1N1, H3N2, B) with no interference from antibodies specific to the HA and to heterologous subtypes of the NA; 3) suitability for conducting long-term clinical trials as a result of low intra- and inter-assay variability, and 4) a wide analytical range due to 25% inhibition cut-off value for the NAI titer estimation.

[dothedd]

NOVAVAX Announces Release Date of 2010 Year-End Financial Results and Investor Conference Call

NOVAVAX to Present at BIT Life Science’s 3rd World Congress of Vaccine

NOVAVAX to Present at the ROTH 23rd Annual OC Growth Stock Conference

Maryland Governor Martin O’Malley to Visit Novavax in Celebration of HHS-BARDA Contract Award

LINK:

www.novavax.com/

[dothedd]

Journal of Virological Methods
Article in Press, Corrected Proof - Note to users

2011.03.011

Influenza virus-like particles as a new tool for vaccine immunogenicity testing: Validation of a neuraminidase neutralizing antibody assay

Victor Gavrilova, Tatyana Orekova, Casper Alabanzaa, Udayasree Porikaa, Hua Jianga, Kevin Connolly1, a and Steven Pincus

Novavax, Inc., 9920 Belward Campus Drive, Rockville, MD 20850, USA
Received 9 September 2010;
revised 3 March 2011;
accepted 9 March 2011.
Available online 16 March 2011.

Abstract
Detection of neutralizing antibody to viral neuraminidase (NA) by testing for enzyme inhibition has been recognized as an important part of the immunogenicity of influenza vaccines. However, the absence of a well characterized standard source of active NA and validated assays has significantly limited clinical studies of NA immunity. Influenza virus-like particles (VLPs) containing hemagglutinin (HA), NA, and M1 proteins were produced from insect cells infected with a recombinant baculovirus and used as the NA source for the NA inhibition (NAI) assay. The NA activity of 6 different VLP strains varied from 0.43 to 1.61 (¡Á10−3) enzyme units per ¦Ìg of HA and was stable over 6 months of storage at 2¨C8 ¡ãC. The NAI assay using 2¡ä-(4-methylumbelliferyl)-¦Á-d-N-acetylneuraminic acid as a substrate was modified for testing the antibody titer in clinical samples and validated. The advantages of the assay include: (1) stable, reproducible, and standardized source of NA; (2) testing the antibody titer specific to each subtype of NA in serum from subjects immunized with trivalent vaccines (H1N1, H3N2, B) with no interference from antibodies specific to the HA and to heterologous subtypes of the NA; (3) suitability for conducting long-term clinical trials as a result of low intra- and inter-assay variability, and (4) a wide analytical range due to 25% inhibition cut-off value for the NAI titer estimation.
Keywords: Neuraminidase neutralizing antibody; Influenza virus-like particle; Assay validation; Vaccine immunogenicity
Abbreviations: NA, neuraminidase; NAA, neuraminidase activity; NAI, neuraminidase inhibition; NIT, neuraminidase inhibition titer; VLP, virus-like particle

[dothedd]

3/29/11

Analyst Recommendations
First Call Mean (FC): Buy (5 firms)
Buy
FC
First Call Mean (FC) is the mean recommendation of all
analysts covering the stock.

[dothedd]

4th International Conference on Immunopotentiators in Modern Vaccines (IMV)
Porto, Portugal
April 6 -8, 2011
Presenter: Dr. Greg Glenn

World Vaccine Congress
Washington, DC
April 11-14, 2011
Collaborations and Co-development between Start-up Biotech and Big Pharma
Presenter: Dr. Rahul Singhvi

Skin Vaccination Summit
Washington, DC
October 12-14, 2011
Panel Speaker: Dr. Greg Glenn

[dothedd]

Novavax's VLP Influenza Vaccine Named One of Top 100 Drugs in Development Today

ROCKVILLE, Md., April 5, 2011 /PRNewswire/ -- Novavax, Inc. (NASDAQ: NVAX) announced that its virus-like particle (VLP) influenza vaccine has been named by the editors of R&D Directions magazine as one of the top "100 great investigational drugs in development" today. In its tenth annual list of promising clinical compounds, R&D Directions cited Novavax's virus-like-particle technology as a promising new approach to producing vaccines to prevent seasonal, H1N1 and avian influenza. The list reflects the current interests of industry observers and analysts and is described in the magazine's March 2011 issue.

"We are honored to be recognized by editors and analysts who follow the pharmaceutical industry and gratified by their interest in our technology and vaccine candidates," said Dr. Rahul Singhvi, President and CEO of Novavax. "Our recent BARDA contract award and new partnership with LG Life Sciences demonstrate the progress we are making and reflect the potential of our technology to revolutionize the development and production of influenza vaccines. It is a very exciting time for our company and we appreciate this recognition of our work to prevent the spread of infectious diseases around the world."

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 VLP 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.

[dothedd]

World Vaccine Congress
Washington, DC
April 11-14, 2011
Collaborations and Co-development between Start-up Biotech and Big Pharma
Presenter: John Trizzino

[dothedd]

Management Team


President and Chief Executive Officer
Rahul Singhvi, Sc.D., M.B.A.

Senior Vice President, Chief Medical Officer
Gregory M. Glenn, M.D.

Senior Vice President, Business Development
John J. Trizzino, B.S., M.B.A.

Vice President, Chief Financial Officer and Treasurer
Frederick W. Driscoll

Vice President, Strategy
Thomas S. Johnston, B.S., M.B.A

Vice President, Vaccine Development
Gale Smith, Ph.D.

Executive Director of Legal Affairs & Corporate Secretary
John A. Herrmann III, J.D.

Head, Process and Manufacturing Operations
John Madsen, Ph.D.

Head of Analytical and Quality Operations
Steven Pincus, Ph.D.


President and Chief Executive Officer
Rahul Singhvi, Sc.D., M.B.A.

Dr. Singhvi is a recognized vaccine specialist, manufacturing expert and business leader in the pharmaceutical industry. Since assuming his current position, Dr. Singhvi has restructured Novavax to focus on product innovation and development, in particular influenza vaccine development using the company’s novel virus-like particle and Novasome® paucilamellar vesicle technologies.

Before joining Novavax, Dr. Singhvi headed vaccine manufacturing operations at Merck & Co., where production increased by 25 percent at the two plants he oversaw.

Dr. Singhvi received his M.S. and Sc.D. degrees in Chemical Engineering from the Massachusetts Institute of Technology. He also holds an M.B.A. from the Wharton School. Dr. Singhvi also serves on the Board of Directors for the TechCouncil of Maryland .


Senior Vice President, Chief Medical Officer
Gregory M. Glenn, M.D.

Dr. Glenn is a pioneer in vaccine delivery and adjuvants, and has brought several products from concept into clinical development including the travelers' diarrhea vaccine patch, and an adjuvant patch for a pandemic influenza vaccine, developed under U.S. government contracts. He provided the scientific and technical leadership that led to the acquisition of IOMAI by Intercell in 2008. He has co-authored more than 150 research publications, scientific abstracts and presentations, and successful grant applications, and holds multiple U.S., European and other international patents. In addition, he is an associate editor of the journals Expert Review of Vaccines, and Human Vaccine, and was a board-certified pediatrician. Dr. Glenn received his bachelor of arts degree in biology and chemistry from Whitman College and his doctor of medicine degree from Oral Roberts University School of Medicine and completed the Medical Research Fellowship at the Walter Reed Army Institute of Research.


Senior Vice President of Business Development
John J. Trizzino, B.S., M.B.A.

Mr. Trizzino is responsible for business development at Novavax and joins Novavax with more than 28 years of broad industry experience. Having worked closely with public and private partners including the U.S. Centers for Disease Control (CDC) and Prevention and the Department of Health and Human Services (HHS) he has an extensive background in vaccines. Mr. Trizzino served as Vice President, Vaccine Franchise at MedImmune, Inc., and was responsible for the FluMist® brand and public health sales teams, including the strategic planning and early execution of its international launch. Before taking on vaccine franchise responsibilities Mr. Trizzino had responsibility for all trade activities for the $1 billion plus MAb RSV business. Prior to joining MedImmune, Mr. Trizzino held positions at ID Biomedical (now GSK), including Senior Vice President, Business Development, and was in charge of the US launch of Fluviral® (GSK’s FluLaval®) and responsible for their bio defense vaccine business and government relations. During his time at ID Biomedical, Mr. Trizzino also negotiated a $2.3 billion U.S. influenza vaccine distribution agreement for the company.

Mr. Trizzino obtained his M.B.A. from New York University, Leonard N. Stern School of Business, New York and his B.S. from Long Island University, NY.


Vice President, Chief Financial Officer and Treasurer
Frederick W. Driscoll

Frederick W. Driscoll joined Novavax in August 2009 as Chief Financial Officer after more than 30 years of financial management and operational experience in the biotechnology and medical device sectors. In 2007, he joined Genelabs, Inc., a publicly traded biotechnology company developing novel small molecules targeted at infectious diseases, where he served as Chief Financial Officer and became Chief Executive Officer prior to the company’s acquisition by GlaxoSmithKline. From 2000 to 2006, Mr. Driscoll was employed by OXiGENE, Inc., initially as Chief Financial Officer and subsequently as Chief Executive Officer. Mr. Driscoll has also served in senior financial positions at Collagenesis, Inc. and Instrumentation Laboratory.


Vice President of Strategy
Thomas S. Johnston, B.S., M.B.A.

Mr. Johnston is responsible for managing Novavax’s corporate strategic planning process, evaluating potential strategic opportunities and managing select initiatives, including the GE Healthcare collaboration, for development through to proof of concept. Prior to joining Novavax, Mr. Johnston served as an executive level strategic consultant in a number of industries including biotech, financial services, and electronic security, with clients such as Novavax, RBC Bank and the U.S. Department of Homeland Security. Earlier in his career, Mr. Johnston held varying senior-level positions with a number of organizations such as Comcast, Microsoft, and Schlumberger. In each role he was able to apply a unique combination of corporate strategy, marketing and finance skills with product level and often technical skills. Tom holds an M.B.A. from The Wharton Business School and a Bachelor of Science degree in Computer Science from Arcadia University.

Vice President of Vaccine Development
Gale Smith, Ph.D.

Dr. Smith is a leader in vaccine technology and holds numerous patents for the baculovirus-insect cell expression system, influenza vaccines and adjuvants. At Novavax, Dr. Smith has developed the first known commercial, scalable process for the manufacture of virus-like particle vaccines for influenza. He also has collaborated with the U.S. Centers for Disease Control and Prevention in testing a virus-like particle vaccine to protect animals against the H9N2 influenza. Prior to joining Novavax, Dr. Smith led a team at Protein Sciences Corp. that developed the first experimental vaccine for HIV approved by the U.S. Food and Drug Administration for testing in the United States . Dr. Smith also collaborated with the National Institute of Allergy and Infectious Diseases and the National Institute of Health to produce the first experimental vaccine tested in man against the H5N1 avian influenza.

Dr. Smith did graduate work at the Baylor College of Medicine and has a Ph.D. in Microbiology from Texas A&M University.


Executive Director of Legal Affairs & Corporate Secretary
John A. Herrmann III, J.D.

Mr. Herrmann is responsible for managing all of Novavax’s legal affairs including its patent portfolio, various transactional matters, and public securities filings, as well as attending to all the duties of Corporate Secretary. Prior to joining Novavax, Mr. Herrmann was general counsel and secretary for Ore Pharmaceuticals and deputy general counsel to Gene Logic before it became Ore Pharmaceuticals. In addition, he has held senior level in-house counsel roles at Celera Genomics and Baxter Healthcare. Mr. Herrmann holds a J.D. from the University of Illinois and a Bachelor of Arts degree in Political Science and History from Brown University.


Head, Process and Manufacturing Operations
John Madsen, Ph.D.

Dr. Madsen is responsible for overseeing the process and manufacturing operations at Novavax. His team is credited for dramatically increasing vaccine production capacity, resulting in full scale manufacturing in our pilot manufacturing facility. Before coming to Novavax, Dr. Madsen was Director of Manufacturing for the Vaccine Clinical Materials Program at SAIC-Frederick, Inc., where he was part of the core team that designed, constructed and operated the 130,000 sq.ft. NIAID/Vaccine Research Center Vaccine Pilot Plant in Frederick, Maryland, and was responsible for developing and executing manufacturing processes for clinical plasmid DNA vaccines against various disease targets. As Director of Pharmaceutical Science at Entremed, Inc., he was responsible for production, technology transfer and scale-up.

Dr. Madsen received his Ph.D. in Biomedical Sciences from the University of Texas Health Science Center, Houston/MD Anderson Cancer Center. He conducted his post-doctoral work at Albert Einstein/Montefiore Medical Center, and subsequently, at Walter Reed Army Institute of Research, Department of Membrane Biochemistry.


Head of Analytical and Quality Operations
Steven Pincus, Ph.D.

Dr. Pincus is biochemist with 25 years of experience in the field of recombinant vaccines and immunotherapeutics. In his role at Novavax, Dr. Pincus oversees preparation of all quality operations for Phase III studies and product manufacturing, and leads efforts in product characterization toward well-characterized biologic status. With his broad expertise in virology, molecular biology, biochemistry and immunology, he contributes to immunological assay development and testing for preclinical and clinical studies. Additionally, Dr. Pincus provides insight to understanding immunological responses to Novavax's vaccines. Before joining Novavax, Dr. Pincus was Senior Director of Virology and Animal Biology at Elusys Therapeutics, where he helped develop monoclonal-based therapeutics to treat infectious diseases, and Senior Research Scientist with Virogenetics, where he developed a number of poxvirus recombinant vaccines and served on project teams that evaluated these candidates in Phase I clinical trials.

Dr. Pincus received his B.S. and Ph.D. in biochemistry from the State University of New York at Buffalo.

[jarhead1976]

Looking over the proxy and some of the numbers... doing some research , The price of the stock is right!

[dothedd]

Greetings JH:

I will be very interested in your analysis of Novavax when your DD is completed. I am on a fast track getting ready to leave town for a few weeks, but will get back to the board in couple of days.

Enjoy your weekend....

dothedd

[dothedd]

JH:

The following quote is of importance when doing Novavax DD.

"As you might already know, the overwhelming majority of licensed flu vaccines contain only hemagglutinin or HA. The Novavax VLP vaccine is different and unique. Our VLP is made up of not only the viral surface protein HA, but it contains another surface protein, neuraminidase, or NA, and a core protein, matrix M1. We believe that including all three key proteins and presenting them as the influenza virus presents itself in nature offers potential key immunological advantages. The antibody to the HA component blocks the virus from entering a cell; the antibody to the NA prevents spread down the respiratory track; and the M1 response kills the cells that are already infected. We believe that this unique design forms a basis of a potentially more effective vaccine and the clinical results today are evidence of that."

An early day tomorrow!

[dothedd]

JH:

A good article from Seeking Alpha...

This article was written by my colleague, Reef Anderson ( See bio on Seeking Alpha), Head of Research at the hedge fund I manage. This article should be published tomorrow under his profile.

Recent news for Novavax (NVAX) was big, but as investors know, the bigger news is yet to come. Novavax is extremely undervalued and the recent pull back from the $3.50 level represents an extraordinary entry opportunity. By the end of summer, I expect Novavax to easily double and I expect to see $11 per share in 2012, returning to its 2002 stock price levels. The details of my analysis will be presented later in this article, but first, I will address the key drivers that make Novavax a compelling “buy and buy more” proposition.

Novel, Patented Technology and Recent Developments

Novavax, Inc. (Novavax) is a biopharmaceutical company focused on developing recombinant vaccines. Recombinant protein-based vaccines are widely used and accepted. Examples of vaccines currently available that use recombinant protein particle technology include Recombivax® HB (Merck: MRK) and Engerix® (GlaxoSmithKline: GSK), which protect against Hepatitis B, and Gardasil® Merk and Cervarix® GlaxoSmithKline which protect against human papillomavirus.

However, the key difference of NVAX is the production technology which uses insect cells rather than chicken eggs or mammalian cells. The technology platform is based on proprietary virus-like particles (VLPs). VLPs are not made from a live virus and have no genetic nucleic material in their inner core, which renders them incapable of replicating and causing disease. This platform offers several potential significant advantages over traditional vaccine production methods, including: (1) higher yields than traditional mammalian or egg-based system, (2) faster facility commissioning time, (3) significantly lower capital expenditures on infrastructure, (4) competitive cost of goods, (5) shorter lead time to produce vaccine than egg-based technology, and (6) a scalable production process that can respond rapidly to pandemic outbreaks, which is a key concern for the U.S. and other Governments.

There are some notable facts and recent developments which attest to the viability, efficacy and superiority of Novavax’s Technology and Pipeline:

1) BARDA Contract Award – In February, 2011, the U.S. Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) awarded Novavax a contract valued at $97 million for the first 36 month base-period, with an option period of 24 months valued at $82 million, for a total contract value of up to $179 million. The HHS BARDA contract award provides significant funding for the continued ongoing clinical development and product scale-up of seasonal and pandemic influenza vaccine candidates. This is a cost-plus-fixed-fee reimbursement contract in which HHS BARDA will reimburse Novavax for direct contract costs incurred plus allowable indirect costs and a fee earned in the further development of seasonal and pandemic H5N1 influenza vaccines. This award eliminated a significant overhang for the company in that they achieved a significant source of funding and a tremendous increase to its top line revenue. The key to the award is that Novavax’ technology meets HHS’ goals for increasing the capacity to produce flu vaccine in a much shorter time frame, in particular, the ability to enhance pandemic vaccine manufacturing surge capacity. I do not believe Novavax will have any problems achieving the extension of the contract into the second period which will allow them to receive the additional $82 million. The following two examples highlight the company’s ability to achieve shorter time frames and hence increase the probability of the second award:

a. In 2009, using VLP technology, NVAX manufactured an H1N1 VLP vaccine candidate under cGMP at their vaccine manufacturing facility in Rockville, MD within eleven weeks after receiving the gene sequence from the CDC. The company’s named above (Merk and GlaxoSmithKline) typically take over 6 months to ramp up production.

b. Per the company’s form 10-K filed March 28, 2011, “The agreement with Xcellerex expired by its own terms on February 15, 2010. Although the H1N1 manufacturing campaign with Xcellerex did not result in the manufacturing of acceptable vaccine to Novavax, we did achieve proof of concept by scaling-up to a commercial grade bioreactor. The success in scaling-up our VLPs in stir tank bioreactors using single-use disposables potentially provides an additional path to large-scale, commercially viable vaccine production. During 2010, we manufactured multiple large-scale VLP production runs using our 1,000 liter bioreactor in our Rockville, MD facility and have successfully demonstrated that we can produce VLPs at high-yields, a competitive cost per dose of manufactured vaccine at acceptable quality standards.”

2) First Licensing Deal for VLP Vaccine Technology – On March 1, 2011, Novavax announced an exclusive license of its VLP vaccine technology to manufacture, develop and commercialize influenza vaccines in South Korea and certain emerging market countries. Novavax will provide technology transfer and manufacturing support and in return receive upfront and milestone payments from LGLS as well as double-digit royalty rate payments from commercial sales. Dr. Rahul Singhvi, CEO and President of Novavax, commented, “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. 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.”

3) The company has announced excellent pandemic and seasonal flu vaccine Phase II results.- The Center for Disease Control and Prevention (CDC) has indicated that currently approved seasonal influenza vaccines have shown to be as little as 30% effective in preventing hospitalization for pneumonia and influenza in older adults (CDC link)However, per Dr. Rahul Singhvi, “Data from our Phase IIa trial in healthy adults showed that 50 to 73% of the volunteers immunized with our VLP vaccine had a 4-fold increase in the antibody that blocks NA activity.” This is a marked improvement that increases the probability of FDA approval and subsequent market acceptance.

4) Competing technology remains Egg-based. Below is a table of Novavax’s competitors from the company’s 10-k filed March 28, 2011


Company

Competing Technology Description

sanofi pasteur, Inc.

Inactivated sub-unit (egg-based)

MedImmune, LLC (a subsidiary of AstraZeneca PLC)(AZN)

Nasal, live attenuated (egg-based)

GlaxoSmithKline plc

Inactivated (egg-based)

Novartis, Inc. (NVS)

Inactivated sub-unit (cell and egg-based)

Merck & Co., Inc. (MRK)

Inactivated sub-unit (egg-based)

Cash availability and cash burn

Seasoned biotech investors know that cash is essential to prevent dilution. As per NVAX’s 10-k released March 28, 2011. “Based on our cash, cash equivalents and short-term investment balances as of December 31, 2010, anticipated revenue under the HHS BARDA contract awarded in February 2011, anticipated proceeds from the sales of our common stock under our At the Market Sales Agreement and our current business operations, we believe we will have adequate capital resources available to operate at planned levels for at least the next twelve months.” There are only approximately 14 million shares left that the company can issue in the “At the Market Sales Agreement” and therefore, dilution is minimal. Note, in my valuation below, I assume a larger share increase through 2014 (approximately 27 million shares). There are a few key factors behind this assumption:

1) The HHS BARDA Contract offers Cost Plus payments, some of which include fixed costs. So the incremental costs of additional research have a minimal impact on margins.

2) The variable cost of vaccine manufacture is truly minimal at approximately 15%. This leaves fixed costs, most of which have been incurred in the ramp up of Novavax’s facilities or will be incurred by licensing partners.

Valuation

Novavax has positioned itself to be a major player in several markets:

1) RSV- The company is on track with its respiratory syncytial virus vaccine which targets a $1 billion market opportunity.

2) Pandemic Viruses- Earlier this month, the company presented excellent immunogenicity data from Novavax’ H1N1 vaccine clinical trial conducted in Mexico. Such pandemics represent multi-billion dollar opportunities as was demonstrated by Swine Flu and Avian Flu outbreaks

3) Influenza- Novavax is positioned to emerge as a major influenza vaccine player. Based on the expanding recommendation of vaccination to new age groups, the growing worldwide population to be vaccinated, and the need of an improved influenza vaccine for the elderly, global market projections of seasonal influenza are estimated to increase from $2.8 billion in 2007 to $6.5 billion by 2013. (click here)

Novavax has many potential applications of its technology and pipeline, and the first two applications given above are large. But to be conservative in the valuation estimate, let’s consider only the Influenza application. It should be noted that I expect submission of the BLA for the Seasonal Flu Vaccine next year and Licensing of the Seasonal Flu VLP by 2013.

If we assume that Novavax licenses its Seasonal Flu VLP vaccine and that its partners capture 10% of the projected $6.5 billion market. Also, to be conservative, let's assume we completely ignore upfront licensing payments and assume a royalty of 18% payable to Novavax:

$6.5 billion x 0.10 x 0.18 = $117 million annual royalties

Now, if we also assume that the BARDA grant is extended for 2014 and 2015. Additional Annual revenues would be $41 million per year, for a total of $117 million from royalties + $41 million from BARDA = $158 million total.

Then, given that the licensing strategy will impose relatively low additional fixed and variable costs, let’s assume that operating expenses increase to $42 million per year. Pre-tax income would be approximately $116 million and net income would be approximately $81 million.

As stated above under the cash burn section, let’s assume the company will issue 26% more additional shares taking the shares outstanding from 105 million to 132 million. We derive an EPS of approximately $0.62 per share in 2014 ($81 million / 132 million shares). Discounting annually at 20% and assuming the stock will trade at 30x2014 EPS, fair value for the influenza application alone could be estimated to be $10.70 per share. Clearly, the stock is very undervalued and I expect to see the stock price triple by the end of this year and quadruple by the end of 2012.

[dothedd]

A Novavax VLP
Vaccine Candidate:
Pandemic Influenza Vaccine
The History of Influenza Pandemics:
• Three major influenza pandemics
occurred over the last century, claiming
over 52 million lives
• The 1918 Spanish Flu Pandemic was the
most devastating
– Claimed over 40 million lives
worldwide
– Notorious for causing the deadliest
month in US history
•October 1918 - 195,000 US deaths
• 851 deaths in New York City in a
single day
• Experts agree that the next influenza
pandemic is imminent; however, current
technology cannot predict the timing or
causative strain

NOTE: Influenza Pandemics of Previous Century
Will one of these emerging strains cause the next pandemic?
CONTINUED:

www.novavax.com/download/File/pandemic_for_web.pdf

Clinical Trials:

Novavax NCT01072799: This is a phase II trial to assess the safety and immunogenicity of an A (H1N1) 2009 Influenza virus-like particle (VLP) Vaccine

clinicaltrials.gov/ct2/show/NCT01072799?term=novavax&rank=5

Novavax NCT01014806: This is a phase IIa trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like-particle (VLP) vaccine (recombinant) in older adults


clinicaltrials.gov/ct2/show/NCT01014806?term=01014806&rank=1

Novavax NCT00903552: This is a phase IIa randomized, double blind, placebo controlled trial to evaluate the safety and immunogenicity of a trivalent seasonal influenza virus-like particle (VLP) vaccine (recombinant) in healthy adults
clinicaltrials.gov/ct2/show/NCT00903552?term=novavax&rank=1

Novavax NCT00519389: A Phase I/IIa Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of an H5N1 Virus-Like Particle (VLP) Influenza Vaccine (Recombinant)

clinicaltrials.gov/show/NCT00519389


Novavax NCT00754455: A Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults

clinicaltrials.gov/ct2/show/NCT00754455