NOVAVAX

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Novavax to lease Gaithersburg space to support flu contract.

Washington Business Journal by Bill Flook, Staff Reporter
Date: Monday, November 21, 2011, 2:52pm EST - Last Modified: Monday, November 21, 2011, 4:41pm EST

Vaccine maker Novavax Inc. .. will lease 74,000 square feet, mostly laboratory and manufacturing space, in Gaithersburg to support its massive federal flu vaccine contract, according to a source with knowledge of the expansion.

The Rockville-based company is set to take on space at 20 and 22 Firstfield Road, the source said. Both of the properties are owned by Alexandria Real Estate Equities Inc. .. (NYSE: ARE); the former is listed as the headquarters of the shrinking U.S. arm of Austrian biotech Intercell AG.

Novavax (NASDAQ: NVAX) did not return a call for comment. Scheer Partners Inc. .. , a Rockville commercial real estate firm that represents Novavax in the lease negotiations, also declined to comment.

The lease represents another big move for a biotech that was elevated to the big leagues by a lucrative seasonal and pandemic flu contract in March worth as much as $179 million, followed shortly after by the departure of CEO Rahul Singhvi and the appointment of Chairman Stanley Erck as Singhvi’s replacement. Another top executive, senior vice president of business development John Trizzino, left in September.

Novavax’s contract with the Biomedical Advanced Research Authority is split between an initial three-year, $97 million base period that pays for clinical development of its vaccine candidates, and a possible $82 million extension to support manufacturing scale-up and U.S. Food and Drug Administration approval. The initial contract also includes the development of a plan for a manufacturing facility able to produce a minimum 50 million vaccine doses within half a year of the declaration of a flu pandemic.

It’s unclear whether the new Gaithersburg space is directly related to that manufacturing plan. Singhvi said in March the company would probably need to take on additional space simply to accommodate the growth in headcount resulting from the BARDA contract. Also unclear is whether a lease for the new space has been signed yet.

Novavax’s vaccine technology is based on non-infectious virus-like particles, or VLP’s, which prompt the same immune response from the body as an actual virus.

www.bizjournals.com/washington/news/2011/11/21/novavax-to-lease-75k-sq-ft-in.html

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2011 Press Releases


•NOVAVAX to Present at 23rd Annual Piper Jaffray Health Care Conference
11/28/11
•NOVAVAX Acquires New Manufacturing and Office Facilities in Gaithersburg, MD
11/21/11
•NOVAVAX to Present at the Lazard Capital Markets 8th Annual Healthcare Conference
11/09/11
•NOVAVAX Appoints Russell “Rip” Wilson Senior Vice President of Business Development
11/07/11
•NOVAVAX Reports Third Quarter 2011 Financial Results
11/04/11
•NOVAVAX Appoints Erica S. Shane, Ph.D., Vice President, Process Development
11/03/11
•NOVAVAX to Report Third Quarter 2011 Financial Results on November 4, 2011
10/28/11
•NOVAVAX CEO Addresses U.S. Patent and Trademark Office (USPTO) on Behalf of the Biotechnology Industry Organization (BIO)
10/27/11
•NOVAVAX Announces Conference Call to Discuss Results from Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate
10/10/11
•NOVAVAX Announces Contract Award from U.S. Department of Homeland Security [/b]to Develop Foot-and-Mouth Disease Vaccine
10/05/11
•NOVAVAX Reports Positive Results from Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate
10/03/11
•NOVAVAX to Report Top-Line Results from Phase I Respiratory Syncytial Virus Vaccine Clinical Trial on October 3rd at 5th Vaccine and ISV Annual Global Conference
09/26/11
•NOVAVAX Announces Publication of Results from H5N1 Influenza Virus-Like Particle Vaccine Phase I/IIa Clinical Trial[/color]09/08/11[/b]

[diamonds]

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Dec 3, 2011 10:44:00 GMT -5 @lonewolf said:

Doth...I'm confused as to why you are posting all of this.

For the SECOND/THIRD TIME .... because I agreed to do it (for the MOD) when the MSN THREADS WERE DIABLED.

END OF STORY!

Have a lovely weekend.

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Dec 3, 2011 10:49:04 GMT -5 diamonds said:

YOU TOO!

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NVAX Bioterror & H5N1

21-Dec-11

Last night the "NBC Nightly News" TV program highlighted the debate for selectively releasing the research done on manipulating the H5N1 virus to produce a readily transmittable virus that kills 60% of humans who contract it.

A Univ of Pitt expert spoke on limiting the info to the science community for fear a bio-terrorist might copy the results.

A normal response to the news segment would be a stock market uplifting on nvax's shares because they're developing a vaccine to combat the virus, but trading is being controlled by those on the short side of the market.

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NOVAVAX Reports Progress Under Joint Venture in India with Cadila Pharmaceuticals
01/03/12

Article:
www.novavax.com/download/releases/Novavax%20-%20Cadila%20Joint%20Venture%20Progress%20Report%202012-01-03.pdf

NOVAVAX Reports Progress Under Joint Venture in India With Cadila Pharmaceuticals
2012-01-03, Source: Novavax, Inc.

Novavax, Inc. (Nasdaq:NVAX) today announced that CPL Biologics (CPLB), its joint venture in India with Cadila Pharmaceuticals Ltd., has made significant progress with its vaccine-development programs in 2011 and is preparing to initiate clinical studies of vaccine candidates to prevent influenza and rabies in 2012 and 2013, respectively. Cadila is one of the largest private pharmaceutical companies in India. CPLB was established in 2009 to combine Novavax's novel vaccine technology and Cadila's product development and manufacturing expertise to develop vaccine candidates from both companies and manufacture and market them in India. Novavax retains rights to products developed for markets outside of India.
Among the joint venture's recent achievements is the development of a rabies vaccine candidate engineered by Novavax which has shown great promise in preclinical testing. Rabies remains a significant public health hazard in India where 36 percent of the world's rabies deaths occur. According to the World Health Organization, the majority of these deaths are the result of children under the age of 15 coming in contact with infected dogs. CPLB completed positive preclinical immunogenicity studies of a rabies G-protein nanoparticle vaccine and has recently received approval from the Review Committee on Genetic Manipulation (RCGM) to begin toxicology studies of this vaccine prior to initiating human clinical trials. The RCGM is responsible for regulating preclinical and clinical testing of recombinant vaccines, diagnostics and biologics in India.

In addition, CPLB has made rapid progress with the validation of its state-of-the-art manufacturing facility in Dholka, India, which is now operational and capable of producing a significant volume of novel vaccine doses every year. This facility utilizes the single-use vaccine bioprocessing system that Novavax employs at its pilot plant in Rockville, Maryland. The facility in Dholka will be used initially to produce clinical supplies of vaccine candidates to prevent influenza and rabies and will later be used to produce commercial product as well as clinical supplies for other undisclosed new vaccine candidates to meet critical medical needs.

CPLB is also now pursuing early development of undisclosed new vaccine candidates to prevent other diseases. The targets of these vaccine candidates will be identified as they progress into preclinical and clinical studies.

Stanley Erck, President and CEO of Novavax, stated: "CPLB has made great progress this year with its state-of-the-art manufacturing facility and vaccine pipeline. It continues to demonstrate the power of combining our technology with world-class research, clinical development and manufacturing expertise to develop potential in-border vaccine solutions. I am particularly excited about the team's accelerated vaccine development efforts this year and the approval by the RCGM to initiate the rabies toxicology studies which is an important milestone. In addition to sharing directly in any success from CPLB's efforts to commercialize vaccine products in India, Novavax can utilize CPLB's development work on vaccine candidates like rabies to initiate similar efforts in other territories that would benefit from such a program. We see CPLB as a long-term strategic partner that expands Novavax's vaccine development capability plus adds to our global manufacturing capacity. I look forward to reporting more about their current and new vaccine programs in 2012."

Indravadan A. Modi, Chairman of Cadila Pharmaceuticals Ltd., stated: "Our joint venture with Novavax is progressing well and remains on track to begin clinical testing of two new vaccine candidates. In addition, we have continued to add talented new scientific and manufacturing staff as we prepare for the launch of our production facility and expand preclinical testing of new vaccine candidates for undisclosed targets."
About Novavax

Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: www.novavax.com.

About Cadila Pharmaceuticals Ltd.

Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the State of Gujarat. Over the last five decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in India and in over 50 countries around the world. Cadila Pharmaceuticals is an integrated healthcare solutions provider with a pharmaceutical product basket in therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunologicals. The state-of-the-art research and development (R and D) facility at Cadila Pharmaceuticals is manned by more than three hundred and fifty scientists and engineers from various disciplines including biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry and different disciplines of engineering.

The company also participates in public-private partnerships for developing preventive and curative pharmaceutical and diagnostic products. Over the last decade, Cadila Pharmaceuticals has focused on novel approaches to cancer management and is the first Indian company to get multiple investigational new drug applications (INDs) cleared by USFDA. The company has state-of-the-art manufacturing facilities conforming to the most stringent international norms at Dholka, Ankleshwar, Kadi and Hirapur in Gujarat; Samba in Jammu and Kashmir and Addis Ababa in Ethiopia. Cadila Pharmaceuticals has recently emerged on the world map with the development of Polycap - a novel and world's first drug combination for primary prevention of cardiovascular heart disease (CHD).

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Undervalued Stocks Trading At Lows That Are Being Accumulated By Insiders

January 6, 2012

The current volatility in the market has left many promising stocks trading near their lows. We mined through the over 6,000 insider transactions filed on SEC Forms 3, 4, and 5 by insiders in the month of December, and crossed them with stocks currently trading at their lows, many at valuations much cheaper than their peers, to identify the following candidates. These are stocks that while trading at their lows and down strongly in the past year, nevertheless, are seeing unusual insider buying by multiple insiders signaling perhaps that a bottom may be near (for more info on how to interpret insider trades, please refer to the end of this article):

Chimera Investment Corp. (CIM): CIM is a REIT investing in residential mortgage-backed securities (RMBS), residential mortgage loans, and real-estate related securities. It is externally managed by Fixed Income Discount Advisory Company (FIDAC), a wholly owned-subsidiary of leading mortgage REIT (mREIT) Annaly Capital Management Inc. (NLY). Insiders currently hold 2.0 million or 0.2% of outstanding shares.

CIM is down 38% in the past year, and currently trades near its all-time lows, with the most recent fall after the company announced on November 10th that it would delay the filing of its Q3 report as it has not completed an analysis of the treatment under GAAP of other-than-temporary impairments (OTTI) related to the company's investments in securities rated less than AA, non-rated non-Agency securities and other subordinate securities. However, subsequent to that, on November 14th, the company updated the status of its 10-Q filing, noting no material changes to historical financial statements and perhaps more notably a GAAP book value of $3.27, more than 25% higher than yesterday's closing price in the $2.50s.

Analysts seem to be divided on their verdict on CIM, as of the eleven analysts covering the stock, six rate it at hold, three at buy and two at underperform/sell. Also, its shares trade at 5-6 forward P/E and 0.8 P/B compared to averages of 8.4 and 0.8 for its peers in the mREIT group. Furthermore, its peer and industry leader NLY is trading at much higher 7 forward P/E and 1.0 P/B, and given that CIM besides being a peer is also run by a wholly owned subsidiary of NLY, one can argue that they should trade at comparable P/E and P/B, that would value CIM at 20%-25% above current prices.

However, while the turmoil continues, insiders have been confidently buying stock, with three insiders (all Directors) purchasing a total of 157,848 shares in December for $0.6 million, at a higher rate than usual given that insiders purchased only an additional 20,000 shares in the past three months, and they purchased a total of 0.66 million shares in the past year. Also, perhaps even more notably, the last time insiders sold CIM shares was in November of 2008.

First Niagara Financial Group (FNFG): FNFG is a holding company for first Niagara Bank that provides retail and commercial banking, and other financial services to individual, families and businesses via over 250 offices across upstate NY and PA. Insiders currently hold 3.7 million or 1.3% of outstanding shares. The stock is down 36% in the past year, and trades near almost ten-year lows. About half of the fall has been precipitated after the company's announcement on August 1st of a definitive agreement to acquire 195 Upstate New York and Connecticut branches and $15.0 billion of deposits from HSBC Bank USA, a subsidiary of U.K. based global provider of commercial and investment banking services HSBC Holdings Plc (HBC). The decline has been precipitated based on investor concerns that the transactions would not be immediately accretive, and also to account for the recent $450 million offering of its common stock that added 17% to its outstanding shares.

FNFG trades at a discount 8-9 current P/E on a TTM basis, and at 0.6 P/B, compared to averages of 13.7 and 0.7 respectively for its peers in the savings & loan group. Insiders have been quietly accumulating shares in the company, as eight insiders purchased a total of 21,000 shares for $0.5 million in December, a strong pickup in buying given that insiders bought only a total of 64,300 shares (selling 17,000 shares) in the past year. The buyers included CFO Gregory Norwood, EVP Oliver Sommer, SVP John Mineo and five other directors.

Triquint Semiconductor (TQNT): TQNT manufactures a broad range of high-performance RF, analog and mixed-signal ICs that are incorporated into a variety of communications products, including cellular phones and pagers, fiber optic telecommunications equipment, satellite communications systems, high performance data networking products and aerospace applications. Insiders currently hold 1.2 million shares or 0.8% of outstanding shares. Insiders hold 1.4 million or 0.8% of outstanding shares.

The stock is down over 60% in the past year, and trades near its lows of the year, and at 14-15 forward P/E and 0.9 P/B, while earnings are projected to collapse from 83c in 2010 to 50c in 2011 to 35c in 2012. During the month of December, two insiders (both Directors) reported that they bought a total of 116,833 shares for $0.5 million (including shares bought during the last two trading days in November), a pickup given that insiders reported buying only an additional 35,500 shares during the remaining eleven months of the year. The pickup in insider buying as the stock forms what appears to be a technical bottom in the $4 to $5 range may be a sign of confidence in the outlook for the company.

Novavax Inc. (NVAX): NVAX is a development stage biotech company focused on the development of recombinant vaccines using its virus-like particle (VLP) platform technology, targeting pandemic and seasonal influenza, and other infectious diseases. Insiders currently hold 11.1 million or 10.0% of outstanding shares. The stock is down 45% in the past year, and it trades within striking distance of its lows for the year. While the stocks grinds to its lows, insiders bolstered their confidence in the company, as in the month of December, Chief Science Officer Gregory Glenn and Director James Young bought a total of 204,000 shares for $0.3 million. This is significant and a sign of confidence in the outlook for the company, especially given that insider buying is relatively uncommon at NVAX, where in the past three plus years insiders bought only an additional 205,000 shares.

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KNOW WHAT YOU OWN:



HOMEPAGE: Start on the left and click on the tabs....
www.novavax.com/


PARTNERS:
www.novavax.com/go.cfm?do=Page.View&pid=12
Novavax HHS-BARDA Contract

Novavax announced in March 2011 that it had 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 Novasome adjuvant);
Phase II dose-ranging trial and Phase III 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 III trial.


www.novavax.com/go.cfm?do=Page.View&pid=5
Cadila Pharmaceuticals, Ltd.
Ahmedabad, India

In 2009, Novavax formed a joint venture with Cadila Pharmaceuticals Ltd. to develop, manufacture and market vaccines, pharmaceuticals and diagnostic products in India. This joint venture, called CPL-Biologics or CPLB, is developing a number of Novavax's VLP vaccine candidates, as well as a number of Cadila's therapeutic vaccine candidates for the Indian territory. This strategic alliance allows Novavax to utilize Cadila's world-class research, clinical development, and manufacturing expertise and infrastructure to support development of current and future vaccine candidates. CPLB has constructed a state-of-the-art vaccine facility in Dholka, India that has the capability of producing potentially 60 million doses of novel vaccines every year.

Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies in India, headquartered at Ahmedabad, in the state of Gujarat. Over the last five decades, it has been developing and manufacturing pharmaceutical products and selling and distributing these in India and in over 50 countries around the world. Cadila Pharmaceuticals is an integrated healthcare solutions provider with a pharmaceutical product basket in therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunologicals. The state-of-the-art research and development facility at Cadila Pharmaceuticals is manned by more than three hundred and fifty scientists and engineers from various disciplines including biology, pharmacology, clinical research, chemistry, toxicology, phytochemistry and different disciplines of engineering.

Cadila Pharmaceuticals also participates in public-private partnerships for developing preventive and curative pharmaceutical and diagnostic products. Over the last decade Cadila Pharmaceuticals has focused on novel approaches to cancer management and is the first Indian company to get multiple investigational new drug applications (INDs) approved by U.S. Food and Drug Administration. The company has state-of-the-art manufacturing facilities conforming to the most stringent international norms at various locations in India and in Addis Ababa in Ethiopia.


www.novavax.com/go.cfm?do=Page.View&pid=9
Collaboration with General Electric Healthcare

As announced in December 2007, Novavax is partnered with GE Healthcare to co-market a pandemic solution that can quickly scale-up production of influenza VLP vaccines at high yields using fully closed, disposable, and mobile equipment. Such an integrated production approach could address issues of cost and timely supply, both relevant for preparing a global vaccine solution for a pandemic situation. A traditional egg-based inactivated influenza vaccine plant with 50 million doses/annum capacity may cost $150-200 million, take four years to build and commission. Furthermore, the only planned U.S. cell-culture facility with capacity of 100 million doses/annum of seasonal flu vaccine has been projected to cost over $1 billion. By way of comparison, a Novavax VLP vaccine plant capacity of 75 to 100 million doses could be built and commissioned for $35-40 million within 24 months. Importantly, this plant would be able to begin shipping VLP vaccine within 12 weeks ensuring a rapid response during a pandemic. And unlike other traditional vaccine plants, the Novavax facility can support other vaccines beyond pandemic. This creates even greater value and vaccine self-sufficiency for the country and its citizens.

www.novavax.com/go.cfm?do=Page.View&pid=10
LG Life Sciences, Ltd. (LGLS).
LG Group Conglomerate 104,300 177,000 LG Electronics is in the S&P Asia 50 stock index LG CNS, LG Chem, LG Dacom, LG Display, LG Electronics , LG Telecom, LG Powercom, LG Solar Energy, LG Life Sciences
ONE OF THE TOP 5 COMPANIES IN SOUTH KOREA

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Novavax, Inc. (NVAX)
-NasdaqGM

1.5299 0.0799(5.51%) 11:19AM EST - Nasdaq Real Time Price

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

NOVAVAX and the Mexican Social Security Institute Publish Results from H1N1 Influenza Vaccine Trial in Mexico

Rockville, MD (August 4, 2011)–Novavax, Inc. (Nasdaq: NVAX) and Specialties Hospital of the National Medical Center, Mexico City, today announced the publication of safety and immunogenicity results from a clinical study of Novavax’s A/H1N1 virus-like-particle (VLP) pandemic influenza vaccine candidate in the journal Vaccine. The two-stage, Phase 2, randomized, double-blind, placebo-controlled study was conducted in Mexico during the 2009 pandemic to evaluate the safety and immunogenicity of one or two doses of a monovalent recombinant A/California/04/2009-like influenza VLP vaccine in 4,563 healthy adults, 18-64 years of age.

The study data showed that hemagglutination-inhibiting (HAI) antibody responses to the vaccine fulfilled the immunogenicity criteria that are required to be considered for accelerated approval of seasonal and pandemic influenza vaccines by the US FDA Center for Biologics Evaluation and Research. These criteria were met at all dose levels after a single injection, including the lowest dose of 5 micrograms. Single administrations of the VLP vaccine induced high levels of HAI titers in subjects without pre-existing detectable immunity to the pandemic strain. Overall, the data indicated that Novavax’s H1N1 VLP vaccine was well-tolerated and immunogenic.

VLPs mimic the external structure of viruses but lack the genetic material that is responsible for viral replication and infection. Novavax’s VLP vaccines are designed to match individual viral strains using proprietary, portable, recombinant cell-culture technology.

The study’s principal investigator, Dr. Constantino López-Macías, Professor of Medical Research-Mexican Social Security Institute, stated: “The immune response demonstrated in this study suggests that VLPs can be highly immunogenic and that protective levels of virus-neutralizing immunity can be achieved even with only a 5 microgram dose of the H1N1 VLP vaccine without the use of adjuvants. This is an important advance which we hope will lead to eventual licensure of a VLP vaccine so that we may protect citizens against both seasonal and pandemic influenza viruses.”

Dr. Gregory Glenn, Chief Medical Officer of Novavax, stated: “This publication represents the first peer-reviewed publication of clinical data generated using Novavax’s influenza VLPs. We demonstrated that our H1N1 influenza VLP vaccine candidate was well-tolerated and generated robust immune responses at antigen doses at or below those
administered for egg-derived A/California/04/09 vaccines. This provides important new
information supporting our ongoing efforts to develop novel seasonal and pandemic
influenza vaccines based on recombinant technology that offers an alternative to eggs and
that has potential to be both rapid and cost-effective.”

Novavax was awarded an advanced development contract by the Biologics Advanced
Research and Development Authority (BARDA) of the Department of Health and Human
Services earlier this year. Within the next 12 months, Novavax expects to initiate further
clinical evaluations of both seasonal and H5N1 pandemic VLP vaccines under the initial
phase of the BARDA contract; a 3 year, $97 million award.

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
single-use bioprocessing system enable rapid vaccine development and production where
and when they are 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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NOTE REPLY #101 ABOVE


Mexico focuses H1N1, WHO says

Mexico is the only country in the world where the predominant influenza type A/H1N1, which has more complications, reported the World Health Organization (WHO).

According to an agency document, dated January 20, the dominant strains in the world in this flu season are type B and A/H3N2, but Mexico has a growing cases of so-called pandemic strain between the different types of flu that is transmitted between humans, is what causes the most severe symptoms and further complications.

"The type of virus most commonly detected in the Northern Hemisphere temperate zone has been A/H3N2 flu, with the exception of Mexico, where H1N1 flu pdm 09 is the predominant subtype in circulation and China, which is reporting predominance of type B influenza. "

"With the exception of Mexico, only a very small number of cases of influenza A/H1N1 have been reported pdm 09 worldwide," WHO said in its report on the updating of the influenza.

According to WHO, Mexico has now a number of localized outbreaks of the virus.

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BARDA Contract

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

BARDA requirements

Recombinant VLP influenza vaccine
Less than 12 weeks production cycle time
US based manufacturing facility
Capability to produce 50 million doses
in 6 months (surge capacity)

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 lives during a pandemic as
well as during seasonal flu outbreaks.¡¨ -- HHS Secretary Kathleen Sebelius

www.novavax.com/download/file/presentations/DTRA_Deck_John_Madsen_Novavax_07Nov11.pdf

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NOVAVAX to Present at the 14th Annual Bio CEO & Investor Conference
Rockville, MD (February 10, 2012)-/GlobeNewswire, Inc./-Novavax, Inc. (Nasdaq: NVAX) a clinical-stage vaccine company, announced today that Frederick W. Driscoll, Vice President and Chief Financial Officer of Novavax, will be presenting at the 14th Annual Bio CEO & Investor Conference in New York on Monday, February 13th at 4:00pm. A live audio-only webcast link for the presentation can be accessed via the company website at www.novavax.com under Investor Info/Events.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company’s website, www.novavax.com

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

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

•Novavax NCT00903552: 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

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

•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

•Novavax NCT01290419: A Phase I, Randomized, Placebo-Controlled, Observer-Blinded, Escalating Dose-Ranging Study to Assess the Safety, and immunogenicity of 4 different recombinant RSV-F formulations in healthy adults (18 to 49 years of age

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NOVAVAX HIGHLIGHTS 2011 and UPCOMING IN 2012


•Novavax to speak at the XIV International Symposium on Respiratory Viral Infections
•Novavax to speak at the ISBio Tech 2nd Annual Meeting
•Novavax to speak at the World Vaccine Congress
•Novavax to present at the 14th Annual Bio CEO & INVESTOR Conference November 2011
•Novavax presented at the 2011 Piper Jaffray Health Care Conference
•Novavax presented at the Lazard Capital Markets 8th Annual Healthcare Conference
•Novavax Co-Chaired at the 2011 Chemical and Biological Defense Science and Technology (CBD S&T) Conference October 2011
•Novavax spoke at the BIO International Convention in China

Novavax announced Contract Award from U.S. Department of Homeland Security to Develop Foot-and-Mouth Disease Vaccine

Novavax reported Top-Line Results from Phase I Respiratory Syncytial Virus Vaccine Clinical Trial at 5th Vaccine and ISV Annual Global Conference

•Novavax spoke at Skin Vaccination Summit September 2011

Novavax announced publication of results from H5N1 Influenza Virus-Like Particle Vaccine Phase I/IIa Clinical Trial August 2011

Novavax and the Mexican Social Security Institute Publish Results from H1N1 Influenza Vaccine Trial in Mexico

NASDAQ Stock Symbol NVAX Employees 110 Incorporated 1987 IPO 1995

Collaborations & Partnerships

HHS BARDA – contract to develop pandemic and seasonal influenza vaccine

Cadila Pharmaceuticals (CPL Biologicals) – joint venture for development and production of VLP vaccines in India

Novavax Licenses Recombinant VLP Influenza Vaccine to LG Life Sciences for South Korea and Other Countries

Recombinant cell versus traditional egg-based manufacturing

Novavax’s single-use bioprocessing system has significant advantages over the traditional egg-based method. Less space is needed; it takes one 1,000 liter stir tank
compared to one million eggs to produce one million doses
of vaccine. The use of disposables makes it efficient and
highly cost effective. Furthermore, Novavax can produce
reliable and effective influenza vaccine in about half the
time it takes for the traditional egg-based method.
Novavax stands ready to partner with governments to
quickly respond when the next influenza pandemic strikes.

Management Team
Stanley C. Erck, M.B.A.
President & Chief Executive Officer
Gregory Glenn, M.D.
Sr Vice President, Chief Medical Officer
Timothy Hahn, Ph.D.
Sr Vice President, Manufacturing & Process
Development
Russell P. “Rip” Wilson
Sr Vice President, Business Development
Frederick Driscoll
Vice President, Chief Financial Officer &
Treasurer
Louis Fries, III, M.D.
Vice President, Clinical Affairs
Jane Halpern, Ph.D.
Vice President, Regulatory Affairs
Merv Hamer
Vice President Manufacturing
Erica Shane, Ph.D.
Vice President, Process Development
Gale Smith, Ph.D.
Vice President, Vaccine Development
John Herrmann III, J.D.
Executive Director, Legal Affairs &
Corporate Secretary
Board of Directors
James Young, Ph.D.
Chairman
Former President R & D, MedImmune, LLC
Stanley C. Erck, M.B.A.
President and Chief Executive Officer
Novavax, Inc.
Richard Douglas, Ph.D.
Former Senior Vice President, Corporate
Development, Genzyme Corporation
Gary C. Evans
Chairman, Chief Executive Officer &
Founder GreenHunter Energy Inc., Owner &
Co-founder, Wind Hunter, LLC, Retired
Chairman, President & Chief Executive
Officer, Magnum Hunter Resources, Inc.
John O. Marsh, Jr.
Distinguished Professor of Law, George
Mason University, Former Secretary of the
Army & U.S. Congressional Representative
Michael A. McManus, Jr.
President, Chief Executive Officer &
Director, Misonix, Inc.
Rajiv I. Modi, Ph.D.
Managing Director, Cadila Pharmaceuticals

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FACT SHEET

Our Mission Novavax, Inc. (NASDAQ: NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. For more information, visit www.novavax.com.

Proprietary Technology 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 VLP-based vaccine candidates are produced more rapidly than egg-based vaccines using proprietary, portable, recombinant cell-culture technology.

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Influenza Vaccines

Novavax is in advanced development of VLP vaccines against both seasonal and pandemic influenza. Novavax produced VLP vaccine against the 2009 H1N1 pandemic “swine flu” influenza. In a clinical trial of more than 4,000 subjects in Mexico – where the pandemic was first recognized, the H1N1 VLP vaccine was well tolerated and immunogenic even at the lowest dose tested of five micrograms and after one immunization.

Transmission of the highly pathogenic avian H5N1 flu virus “bird flu” in domestic poultry and humans is continuing in many countries worldwide and remains a serious pandemic threat with the potential to evolve into new strains where cross-protection and induction of neutralizing antibodies will be essential. Novavax has shown in a human study that its H5N1 VLP vaccine was well tolerated, produced no vaccine-related serious adverse events and induced neutralizing antibodies that were cross-reactive with different avian H5N1 influenza viruses. This is the only report of an unadjuvanted vaccine inducing cross-reactive neutralizing antibodies against multiple clades of H5N1 influenza virus and demonstrates the significant potential of the VLP technology. Novavax is currently pursuing the advanced development of recombinant pandemic and seasonal influenza vaccines, under a contract with the U.S. Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority.

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The 14th Annual BioCEO & Investor Conference
New York City
February 13, 2012, 4:00 P.M.
Presenter: Frederick W. Driscoll


Webcast: click here

www.veracast.com/bio/ceoinvestor2012/main/main_launch_player.cfm

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

NOVAVAX and the Mexican Social Security Institute Publish Results from H1N1 Influenza Vaccine Trial in Mexico

Rockville, MD (August 4, 2011)–Novavax, Inc. (Nasdaq: NVAX) and Specialties Hospital of the National Medical Center, Mexico City, today announced the publication of safety and immunogenicity results from a clinical study of Novavax’s A/H1N1 virus-like-particle (VLP) pandemic influenza vaccine candidate in the journal Vaccine. The two-stage, Phase 2, randomized, double-blind, placebo-controlled study was conducted in Mexico during the 2009 pandemic to evaluate the safety and immunogenicity of one or two doses of a monovalent recombinant A/California/04/2009-like influenza VLP vaccine in 4,563 healthy adults, 18-64 years of age.

The study data showed that hemagglutination-inhibiting (HAI) antibody responses to the vaccine fulfilled the immunogenicity criteria that are required to be considered for accelerated approval of seasonal and pandemic influenza vaccines by the US FDA Center for Biologics Evaluation and Research. These criteria were met at all dose levels after a single injection, including the lowest dose of 5 micrograms. Single administrations of the VLP vaccine induced high levels of HAI titers in subjects without pre-existing detectable immunity to the pandemic strain. Overall, the data indicated that Novavax’s H1N1 VLP vaccine was well-tolerated and immunogenic
VLPs mimic the external structure of viruses but lack the genetic material that is responsible for viral replication and infection. Novavax’s VLP vaccines are designed to match individual viral strains using proprietary, portable, recombinant cell-culture technology.

The study’s principal investigator, Dr. Constantino López-Macías, Professor of Medical Research-Mexican Social Security Institute, stated: “The immune response demonstrated in this study suggests that VLPs can be highly immunogenic and that protective levels of virus-neutralizing immunity can be achieved even with only a 5 microgram dose of the H1N1 VLP vaccine without the use of adjuvants. This is an important advance which we hope will lead to eventual licensure of a VLP vaccine so that we may protect citizens against both seasonal and pandemic influenza viruses.”
Dr. Gregory Glenn, Chief Medical Officer of Novavax, stated: “This publication represents the first peer-reviewed publication of clinical data generated using Novavax’s influenza VLPs. We demonstrated that our H1N1 influenza VLP vaccine candidate was well-tolerated and generated robust immune responses at antigen doses at or below those administered for egg-derived A/California/04/09 vaccines. This provides important new information supporting our ongoing efforts to develop novel seasonal and pandemic influenza vaccines based on recombinant technology that offers an alternative to eggs and that has potential to be both rapid and cost-effective.”


Novavax was awarded an advanced development contract by the Biologics Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services earlier this year. Within the next 12 months, Novavax expects to initiate further clinical evaluations of both seasonal and H5N1 pandemic VLP vaccines under the initial phase of the BARDA contract; a 3 year, $97 million award.

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 single-use bioprocessing system enable rapid vaccine development and production where and when they are 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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Hum Vaccin Immunother. 2012 Mar 1;8(3). [Epub ahead of print]

Virus-like particle (VLP)-based vaccines for pandemic influenza: Performance of a VLP vaccine during the 2009 influenza pandemic.
López-Macías C.

Source
Medical Research Unit on Immunochemistry (UIMIQ), Specialties Hospital; National Medical Centre "Siglo XXI"; Mexican Social Security Institute (IMSS); Mexico City, Mexico.

Abstract
The influenza pandemic of 2009 demonstrated the inability of the established global capacity for egg-based vaccine production technology to provide sufficient vaccine for the population in a timely fashion. Several alternative technologies for developing influenza vaccines have been proposed, among which non-replicating virus-like particles (VLPs) represent an attractive option because of their safety and immunogenic characteristics. VLP vaccines against pandemic influenza have been developed in tobacco plant cells and in Sf9 insect cells infected with baculovirus that expresses protein genes from pandemic influenza strains. These technologies allow rapid and large-scale production of vaccines (3-12 weeks). The 2009 influenza outbreak provided an opportunity for clinical testing of a pandemic influenza VLP vaccine in the midst of the outbreak at its epicenter in Mexico. An influenza A(H1N1)2009 VLP pandemic vaccine (produced in insect cells) was tested in a phase II clinical trial involving 4,563 healthy adults. Results showed that the vaccine is safe and immunogenic despite high preexisting anti-A(H1N1)2009 antibody titers present in the population. The safety and immunogenicity profile presented by this pandemic VLP vaccine during the outbreak in Mexico suggests that VLP technology is a suitable alternative to current influenza vaccine technologies for producing pandemic and seasonal vaccines.
PMID:
22330956
[PubMed - as supplied by publisher]
www.ncbi.nlm.nih.gov/pubmed/22330956

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NOVAVAX Launches Phase II Clinical Trial of Seasonal Influenza Vaccine

ROCKVILLE, Md., March 1, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it has begun enrollment in a Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. This randomized, observer-blind, comparator-controlled study is being conducted in multiple centers in Australia under the company's contract with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) to develop recombinant vaccines for the prevention of seasonal and pandemic influenza. The trial will evaluate the immunogenicity and safety of three dose levels of Novavax's quadrivalent seasonal recombinant VLP influenza vaccine in healthy adults between the ages of 18 and 64.

Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "The start of this clinical trial is a significant milestone that reflects the progress we have made in our seasonal influenza vaccine program. We believe that most seasonal vaccines in the future will contain a second B strain and thus consist of a quadrivalent, or four-strain, composition. This trial allows us to transition from a trivalent to a quadrivalent seasonal vaccine candidate. The data will help establish the immunogenicity, safety and tolerability of our quadrivalent seasonal influenza VLP vaccine and determine the most effective and appropriate dose for later evaluation in young adults in our upcoming Phase III trial. This trial is being conducted in Australia so that we can evaluate our VLP vaccine candidate prior to the start of the influenza season in the southern hemisphere, and without waiting for the end of influenza transmission in the northern hemisphere. I commend my colleagues and our clinical investigators on their success in launching this important study."

The Phase II trial will enroll up to 500 eligible subjects who will be randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants will receive a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax vaccine or a standard dose of a licensed trivalent vaccine. Study participants will be evaluated at day 21 for hemagglutination inhibition (HAI) response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.

Novavax expects to evaluate the top-line data from this Phase II trial in the third quarter of 2012.

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NOVAVAX IN THE NEWS:

GE/Xcellerex
www.genewscenter.com/Press-Releas....gment-36d1.aspx

Collaboration with General Electric Healthcare
www.novavax.com/go.cfm?do=Page.View&pid=9

Tuesday, 15 November 2011: 1400 - 1600
Session 4: Advances in Regulatory Sciences: Flexible and Agile Biomanufacturing
Session Chairs: Dr. Richard Hedstrom, Defense Threat Reduction Agency and Dr. John Madsen, Novavax

cbdstconf2011.sainc.com/conference_agenda/TuesdayPM.aspx

www.dtra.mil/Home.aspx

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Novavax Fourth Quarter and 2011 Year-End Financial Results
Rockville, Maryland

March 9, 2012 10:00 am

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

NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results
Rockville, MD (March 09, 2012)–/GlobeNewswire/-Novavax, Inc. (Nasdaq: NVAX) today announced financial results for the fourth quarter and year ended December 31, 2011.

For the fourth quarter of 2011, Novavax reported a net loss of $3.7 million, or $0.03 per share, compared to a net loss of $6.3 million, or $0.06 per share, in the fourth quarter of 2010. For 2011, the company reported a net loss of $19.4 million, or $0.17 per share, compared to a net loss of $35.7 million, or $0.34 per share, for 2010. The decrease in the net loss in 2011 compared to 2010 was primarily due to revenue recognized under the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) agreement, as well as lower spending as a result of fewer on-going clinical trials during 2011.

At December 31, 2011, Novavax had cash, cash equivalents and short-term investments of $18.3 million compared to $31.7 million at December 31, 2010.

Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: “The past year has been transformational for our company as we landed two government contracts and one commercial partnership, and from a financial perspective reduced our net loss by almost fifty percent. We now have three promising vaccine candidates in clinical testing, funding from BARDA to take our seasonal and pandemic influenza vaccines through late-stage testing and BLA filing, a new research program in foot-and-mouth disease, advancing international collaborations in India and Asia and new U.S. manufacturing and office facilities to support our expansion and commercial plans. In addition, we have made several significant key hires to strengthen our team in pivotal functional areas of the company including clinical, regulatory, manufacturing and process development. With the caliber of people we are attracting to Novavax, I am confident that we now have the expertise, commitment and vision to execute our vaccine development programs successfully. These achievements reflect the significant progress we have made to realize the clinical and commercial potential of our virus-like particle (VLP) and recombinant nanoparticle vaccine technology platforms.”

Key highlights of 2011:

• In February 2011, we were awarded a $97 million 3-year contract from BARDA to develop and scale-up our seasonal and pandemic influenza vaccine candidates. BARDA has an option to extend our contract for an additional $82 million over a 2-year extension period. During 2011, we recognized revenue of approximately $15 million, made significant progress in product characterization and production scale-up and are progressing forward with our multi-year clinical-development program.

• We conducted a Phase I clinical trial testing our vaccine candidate against respiratory syncytial virus (RSV) in 150 healthy adults in a blinded, placebo-controlled, escalating-dose study. In October 2011, we presented interim top-line data from the trial at the 5th Vaccine and ISV Annual Global Conference. The positive results were consistent with pre-clinical studies and showed that the vaccine candidate was well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV.

• During 2011, the company made the following senior-executive appointments: Stanley C. Erck was named President and Chief Executive Officer, Louis Fries III M.D., was named Vice President, Clinical and Medical Affairs, Gregory Glenn, M.D., was named Senior Vice President and Chief Medical Officer, Timothy Hahn, Ph.D., was named Senior Vice President of Manufacturing and Process Development, Jane Halpern, Ph.D., was named Vice President Regulatory Affairs, Erica Shane, Ph.D., was named Vice President Process Development and Russell P. Wilson was named Senior Vice President, Business Development. In early 2012, the company appointed Mervyn L. Hamer as Vice President, Manufacturing and John A. Herrmann III, J.D. as Vice President, General Counsel and Secretary.

• In February 2011, we entered into a licensing agreement with LG Life Sciences (LGLS) that allows LGLS to use our VLP technology to develop and commercialize our influenza vaccines in South Korea and certain other emerging-market countries. LGLS holds an exclusive license to our influenza VLP technology in South Korea and a non-exclusive license in the other specified countries.
• In November, we announced a long-term lease arrangement to occupy 74,000 square feet of manufacturing, laboratory and office space in two facilities in Gaithersburg, MD. The main facility will become the primary commercial-scale manufacturing facility for production of the company’s vaccines after moderate modifications that are expected to be completed in 2012.

• CPL Biologics (CPLB), our joint venture in India with Cadila Pharmaceuticals Ltd., is developing a promising new rabies vaccine developed by Novavax for which it is now conducting toxicology studies prior to initiating human clinical trials. CPLB has also completed validation testing of its new manufacturing facility to produce clinical and commercial supplies of influenza and rabies vaccine candidates and has made excellent early-stage progress with the development of other new vaccine candidates.

• In October, Novavax was awarded a $1.3 million contract with the U.S. Department of Homeland Security to develop a VLP vaccine countermeasure to protect the United States from foot-and-mouth disease (FMD), a highly contagious viral disease of livestock and a potential threat to U.S. agriculture. The company will use these funds over the next two and a half years to develop a VLP that, unlike current FMD vaccines, would not require the use of infectious FMD virus to be manufactured.

• We continued to present our clinical findings at medical and scientific conferences throughout the year, including the 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials at which we presented the final positive results of our H1N1 VLP seasonal influenza study in Mexico. We also published results from this study in the journal Vaccine and the results from our Phase I/IIa pandemic H5N1 influenza study in Journal of Virology.

Anticipated events in 2012:

• In March 2012, we initiated a Phase II trial under our BARDA contract to select the optimal dose of our quadrivalent seasonal influenza VLP vaccine candidate. We also expect to initiate a dose-confirmatory Phase II trial later this year.
• We expect to launch two Phase I trials of our H5N1 VLP influenza vaccine candidate utilizing multiple adjuvants under our BARDA contract.
• We expect to initiate two dose-ranging Phase I/II trials of our RSV vaccine candidate in the elderly and in women of child-bearing age.

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Stanley C. Erck, President and CEO

NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results

Excerpts from the Fourth Quarter and 2011 Year-End Financial Results CONFERENCE CALL:

Stan Erck began the Conference Call discussing vaccine progress, the restructuring of the company and work force that included the following:

The signing of the 179 Million Barda contract that will fund our Seasonal and Pandemic Flu programs for the next several years and more recently the superb data from the RSV vaccine trail announced

October 2011:

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 90,000 to 147,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

Although these announcements were obviously important, and what was equally important, that gets much, much, less visibility was the complete restructuring of the entire company with the addition of a new management team at all levels within the company and the internal focus over the last year building robust commercialize-able manufacturing processes and quality systems. In parallel, we have built regulatory and clinical teams with experience in late stage clinical development and regulatory filings for Phase I thru product licensing.

These accomplishments will service as the base on which we carry our products development efforts forward. I believe that we entered 2012 in our strongest position ever to realize the clinical and commercial potential for the vaccine technology in the pipeline.
From a business development perspective, last year we landed two US Government contracts: The 179 million-dollar Barda advanced development contract to develop seasonal and pandemic influenza vaccines. The strategic importance in winning this award cannot be overstated since it now provides us the financial underwriting to take our seasonal and pandemic influenza vaccines through late stage testing and VLA.

We were also awarded a multi-year contract with the Department of Homeland Security to develop a VLP vaccine countermeasures to protect the United States from Foot and Mouth Disease.

On a commercial level, we launched a new collaboration with LG LifeSciences of South Korea to apply VLP technology to markets in Korea and specified development countries. And we continue to build our joint venture in India with Cadila Pharmaceuticals as evidenced by the announcement of the pre-clinical progress of our new Rabies vaccine.

On a clinical and regulatory perspective, we presented our clinical findings at multiple metropolitan scientific conferences throughout the year including the 7th WHO Meeting on Pandemic Influenza vaccines in clinical trials at which we presented the final positive results of H1N1 VLP vaccine study in Mexico.

We also published results from the study in General Vaccine of the results from the Phase I – II which is a H5N1 Pandemic Influenza study in General Virology.

In the first half of 2011 we conducted a Phase I clinical trial with a 3rd vaccine candidate targeted against respiratory syncytial virus (RSV), and showed excellent results in our blinded, placebo-controlled, escalating-dose study in 150 healthy adults from 18 to 49 years of age.

We presented interim top-line data in October at the 5th Vaccine and ISV Annual Global Conference and reported that the results were consistent with pre-clinical studies and showed that the vaccine was well tolerated and had no systemic side effects. As importantly, the vaccine candidate was highly immunogenic and produced functional antibodies that neutralized RSV. The antibody response to the RSV F-protein was significantly increased compared to the placebo in all groups and increased by 19 fold in the highest-dose group at day 60.

Needless to say we are very excited about these results and the potential of this vaccine candidate as a prophylactic solution for RSV in both pediatric and elderly populations.

Let me remind you that RSV is the leading cause of lower respiratory type infections in infants and young children, as well as, the elderly. In infants, RSV is the leading cause of hospitalizations in the US. On a global basis, the disease burden is estimated at 64 million cases, and a 160 thousand deaths every year... the need for a vaccine is greater than ever. There are no vaccines approved today to prevent RSV and current treatments are often inadequate, cumbersome and expensive. This is a very important program for Novavax and addresses a critical public health need globally.

On the personnel and infrastructure perspective, we have made great progress. I would like to spend a couple of minutes focusing on the details of this because we spent over a year of recruiting a first-class team.

While every department within the company is key to our success, I’d like to focus on a few areas that are of particular importance when developing new vaccines. So let’s start with manufacturing; overseeing manufacturing process development engineering facility is Dr. Tim Hahn. Tim brings tremendous experience from MedImmune where he was involved with their FluMist vaccine and Synagis antibody programs preceded by 15 years at Merk in various rolls of increased responsibilities and manufacturing. Tim has been involved with both commercial products and clinical development.
Working with Tim are Dr. Erica Shane. VP of process development, Merv Hamer, VP of manufacturing.

Erica ran process development at MedImmune for 17 years, and is an expert of the in’s and out’s of early to late stage product development.

Merv, also has a long career in managing manufacturing and of operations of various companies Alza, PATH, Iomai, and Intercell.
Process development and manufacturing work hand in hand with quality insurance and in order for us to submit a package for submission to regulatory agencies such as the FDA.

CONTINUED:

Novavax Fourth Quarter and 2011 Year-End Financial Results
Rockville, Maryland
March 9, 2012 10:00 am
Replay dial-in: 1-855-859-2056 (domestic) or 1-404-537-3406 (international),
Conference ID: 55983197

The Webcast continued on the link below:
www.novavax.com/go.cfm?do=Page.View&pid=36

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NVAX

www.stockconsultant.com/consultnow/basicplus.cgi?symbol=nvax

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NVAX could breakout or DOUBLE! Our analysts team have completed in depth research on NVAX and spotted various important indicators, which could help NVAX Traders and Shareholders. To receive the FREE report on NVAX, SIGN UP to the HoleinOneStocks.net newsletter by entering your email above. Follow the Instructions on the following page and You will receive a FREE Report, Trend Analysis, and email alerts.

URGENT NVAX Updates Delivered to Your Inbox!

NVAX has been showing unusual moves recently. Novavax, Inc. (NGM:NVAX) is +0.10 - +7.75% from the previous close of $1.29. It traded between $1.3598 - 1.42 with total traded volume of 1851542 shares. Technical Indicators suggest that NVAX volitility could be caused by Market Manipulation MOST Traders dont know about...

holeinonestocks.net/landing7/index.php?code=NVAX

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Mar 10, 2012 11:36:48 GMT -5 dothedd said:

NOVAVAX IN THE NEWS:

GE/Xcellerex
www.genewscenter.com/Press-Releas....gment-36d1.aspx

Collaboration with General Electric Healthcare
www.novavax.com/go.cfm?do=Page.View&pid=9

Tuesday, 15 November 2011: 1400 - 1600
Session 4: Advances in Regulatory Sciences: Flexible and Agile Biomanufacturing
Session Chairs: Dr. Richard Hedstrom, Defense Threat Reduction Agency and Dr. John Madsen, Novavax

cbdstconf2011.sainc.com/conference_agenda/TuesdayPM.aspx

www.dtra.mil/Home.aspx

GE Healthcare Acquires Xcellerex

By: Zacks Equity Research

March 13, 2012 |Comments: 0

Recommended this article (0)

GE


GE Healthcare, a unit of General Electric Company (GE) has signed an agreement to acquire Xcellerex, Inc., a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry. Through this acquisition, GE intends to expand its Healthcare offering of products and services for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines.

The financial terms of the deal were not disclosed; however the deal is expected to close by the second quarter of 2012, subject to regulatory approvals.

Xcellerex is a leading developer and producer of turn-key bio-manufacturing systems and production-scale bioreactors based around single-use components. These products provide major advantages such as faster installation, lower capital investment, reduced risk of cross-contamination and huge flexibility unlike the traditional manufacturing technologies.

Xcellerex has a modular technology that can be well integrated with GE Healthcare's cell culture products. Also being of a modular nature they will go down well with customers because of easier installation. This in turn will speed up deployment, thus showing quickly on GE Healthcare's top line.

For fiscal 2011, GE’s Healthcare segment reported revenue growth of 7% and operating profit growth of 2% year over. Revenue growth for the year was primarily driven by increased volume from higher equipment sales and services and the effects of the weaker U.S. dollar. Geographically, the revenue growth was strongest in the emerging markets, followed by the U.S. and other international markets.

GE Healthcare (comprising 12.3% of the total revenue in fiscal 2011) is one of the world’s leading providers of essential healthcare technologies to developed, developing and emerging countries. Its Medical diagnostics and life sciences segment develops and manufactures diagnostic imaging agents used in medical scanning procedures, drug discovery, biopharmaceutical manufacturing and purification and tools for protein and cellular analysis for pharmaceutical and academic research.

General Electric currently holds a Zacks #3 Rank, which implies a short term Hold’ rating.

Read the full analyst report on GE

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XCELLEREX and NOVAVAX New White Paper release 3 12 12

News Release

New White Paper: How a Flexible Bioprocessing Platform Meets the Changing Needs of Biomanufacturing
MARLBOROUGH, MASSACHUSETTS, USA — March 12, 2012 — A new white paper detailing how a flexible bioprocessing platform meets the changing needs of biomanufacturing is now available for download from Xcellerex, Inc., at www.xcellerex.com/flexpaper.

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These include the rise of small-market pharmaceuticals, increased titers and process productivity, the emergence of biosimilars, the evolution of healthcare reform, greater competition and tighter capital markets.

As manufacturing and facilities managers confront these challenges — and are still tasked with meeting today’s capacity needs — many are turning to a new flexible factory platform that will accelerate their implementation of biomanufacturing capacity while lowering risk, reducing time to market and reducing capital costs.
A new white paper, “The Flexible Factory Concept: A Flexible Bioprocessing Platform to Meet the Changing Needs of Biomanufacturing,” examines the approach which enables the deployment of new production capabilities in 9 to 18 months (versus 3 to 5 years for today’s technology) at a total cost of less than 50% to 80% of conventional plants.

The white paper defines the “Flexible Factory Concept” as a modular biomanufacturing platform that leverages single-use technology, controlled environment modules and advanced process automation. The paper outlines the strategic advantages and benefits of the flexible factory concept for biomanufacturers, including unequaled gains in speed to market, economics, risk mitigation, and flexibility.

Download the white paper, “The Flexible Factory Concept: A Flexible Bioprocessing Platform to Meet the Changing Needs of Biomanufacturing,” from www.xcellerex.com/flexpaper.
About Xcellerex, Inc.

Xcellerex, Inc. (http://www.xcellerex.com) is commercializing turnkey biomanufacturing solutions that transform the speed and economics of producing therapeutic proteins, including biosimilars and vaccines. The company’s FlexFactory® is a complete modular and portable production train based on single-use technologies, advanced process automation, and compact clean room architecture.

DEFINING THE FUTURE OF BIOMANUFACTURING
FlexFactory allows deployment of GMP manufacturing capacity more rapidly and at greatly reduced costs compared with traditional facilities. Through its BridgeSourcing™ services, Xcellerex manufactures a partner’s biomolecules while the partner prepares for commissioning of its own new FlexFactory. When the partner’s facility is ready, Xcellerex deploys its TransPlant™ process to install, validate and train partner personnel in their own FlexFactory. This parallel-path model both accelerates time to clinical and commercial manufacturing and allows partners to manage the development and market risks associated with adding manufacturing capacity.
Xcellerex also leverages its proprietary single-use technologies through the sale of XDR bioreactors, XDM Quad Mixers, and related single-use assemblies. To date, more than 20 therapeutic proteins and vaccines have been manufactured for clinical trials using Xcellerex technology.

Based in Marlborough, Massachusetts, Xcellerex is backed by an experienced management team and top-tier venture investors including Kleiner Perkins Caufield & Byers, VantagePoint Venture Partners and SCG Capital.

Bioprocessing Platform to Meet the Changing Needs of Biomanufacturing,” from www.xcellerex.com/flexpaper.

About Xcellerex, Inc.
Xcellerex, Inc.
www.xcellerex.com/pdf/pr_120312_how-a-flexible-bioprocessing-platform-meets-the-changing-needs-of-biomanufacturing.pdf

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The 24th Annual ROTH Conference
Laguna Niguel, CA
March 14, 2012, 10:30 A.M. PDT
Presenter: Stanley C. Erck

www.wsw.com/webcast/roth26/nvax/