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Swine Flu Index Takes Top Spot 6/4/09 

Multiple vaccine companies made news on Thursday, sending the sector higher.

Today it was announced that the National Institutes of Health will test Novavax's (NVAX) VLP technology, which according to the company is able to produce H1/N1 targeted vaccines within weeks. Novavax said that it has already produced enough of the vaccine for animal testing, which the Centers for Disease Control plan to commence. Shares are skyrocketing today by over 50% on the news.

As a whole, the Swine Flu and Bird Flu Stocks Index is up by 7.2%. It is now beating the S&P 500 by 59.2% over the last month.

Generex Biotechnology (GNBT) also made news today, announcing that it will present at the American Diabetes Association's annual meeting, held Friday through Tuesday. The company specializes in drug delivery through mouth lining in treatment of metabolic diseases. Shares are up by 30% on the day.

Hemispherx Biopharma (HEB) is up by 14% today after Japanese researchers named its drug technology the "most promising mucosal adjuvant for influenza."

Alpha Pro Tech (APT) also made an announcement today, stating that it will report record second-quarter sales. The company cited its ability to increase manufacturing to meet accelerated demand for its respirator masks amid the swine flu scare. Shares are up by 9%.

The multi-billion dollar players are mixed today. Sanofi-Aventis (SNY) is up by 4% while GlaxoSmithKline (GSK) is up fractionally. Gilead Sciences (GILD) is up by less than 1%.

Dynavax Technologies (DVAX) is giving back some of yesterday's gains. The stock is an industry laggard today, falling by more than -12%.

As of this writing the Swine Flu and Bird Flu Stocks Index is the top performing tickerspy Index over the last month, gaining 52.8%.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.

Tags: APT, DVAX, GILD, GNBT, GSK, HEB, NVAX, SNY

A 'Pandemic' Now Declared, Focus Back on Swine Flu Stocks
On Friday June 12, 2009, 12:00 pm EDT

The H1N1 virus is officially a pandemic, and vaccine stocks are responding.

Swine flu stocks are up again today, with some extending weekly gains to more than 20%. A number of companies released good news to end the week. From small-cap players to multi-billion dollar giants, shares are up big on high volume. Novartis (NYSE: NVS) announced today that it will have a swine flu vaccine ready by this fall. Shares are up by 4% on the news.

On Thursday, the World Health Organization raised its alert level on the virus to "Phase 6," indicating that it has officially become a pandemic.

As a whole the Swine Flu and Bird Flu Stocks Index is up by 2.5%. It is now beating the S&P 500 by 35.5% over the last month.

Generex Biotechnology (NASDAQ: GNBT) is leading the Index today with 10% gains. The company was granted five new patents for its drug delivery systems. The patents were awarded in Canada, Australia, New Zealand, Brazil, and Lebanon. The stock is still in negative territory this week by -3%.

Sinovac Biotech (AMEX: SVA) is adding another 3% to its industry-leading 30% weekly rally. On Monday the company announced that it had begun production of a swine flu vaccine, and noted that it could produce up to 30 million doses per year.

Vical (NASDAQ: VICL) has fallen from earlier highs, and is now trading up fractionally. Thomas Weisel initiated coverage of the company today with an Overweight rating and a $5 price target. The analyst cited Vical's proprietary technology, strategic partnerships, and licensing agreements.

GlaxoSmithKline (NYSE: GSK) and Hemispherx Biopharma (AMEX: HEB) are both ahead by more than 4% today.

Pure Bioscience (NASDAQ: PURE) and AVI Biopharma (NASDAQ: AVII) are industry laggards today, falling by -3% and -6% respectively.

As of this writing the Swine Flu and Bird Flu Stocks Index is a top-three performing tickerspy Index over the last month, gaining 39.5%.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.
http://www.tickerspy.com/index/Swine-Flu-and-Bird-Flu-Stocks?refer=2028Y3
   

A 'Pandemic' Now Declared, Focus Back on Swine Flu Stocks
On Friday June 12, 2009, 12:00 pm EDT

The H1N1 virus is officially a pandemic, and vaccine stocks are responding.

Swine flu stocks are up again today, with some extending weekly gains to more than 20%. A number of companies released good news to end the week. From small-cap players to multi-billion dollar giants, shares are up big on high volume. Novartis (NYSE: NVS) announced today that it will have a swine flu vaccine ready by this fall. Shares are up by 4% on the news.

On Thursday, the World Health Organization raised its alert level on the virus to "Phase 6," indicating that it has officially become a pandemic.

As a whole the Swine Flu and Bird Flu Stocks Index is up by 2.5%. It is now beating the S&P 500 by 35.5% over the last month.

Generex Biotechnology (NASDAQ: GNBT) is leading the Index today with 10% gains. The company was granted five new patents for its drug delivery systems. The patents were awarded in Canada, Australia, New Zealand, Brazil, and Lebanon. The stock is still in negative territory this week by -3%.

Sinovac Biotech (AMEX: SVA) is adding another 3% to its industry-leading 30% weekly rally. On Monday the company announced that it had begun production of a swine flu vaccine, and noted that it could produce up to 30 million doses per year.

Vical (NASDAQ: VICL) has fallen from earlier highs, and is now trading up fractionally. Thomas Weisel initiated coverage of the company today with an Overweight rating and a $5 price target. The analyst cited Vical's proprietary technology, strategic partnerships, and licensing agreements.

GlaxoSmithKline (NYSE: GSK) and Hemispherx Biopharma (AMEX: HEB) are both ahead by more than 4% today.

Pure Bioscience (NASDAQ: PURE) and AVI Biopharma (NASDAQ: AVII) are industry laggards today, falling by -3% and -6% respectively.

As of this writing the Swine Flu and Bird Flu Stocks Index is a top-three performing tickerspy Index over the last month, gaining 39.5%.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.

Investors can follow the Swine Flu and Bird Flu Stocks Index and view related performance charts and metrics at tickerspy.com.
http://www.tickerspy.com/index/Swine-Flu-and-Bird-Flu-Stocks?refer=2028Y3
   

Novavax in multi-million Spanish deal on vaccines
Novavax in deal with Spain to complete development, sell genetically engineered flu vaccines
By Linda A. Johnson, AP Business Writer
On Tuesday June 30, 2009, 4:28 pm EDT

TRENTON, N.J. (AP) -- Vaccine developer Novavax Inc. has signed a deal with Spain's health ministry and a specialty drugmaker there to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country's first vaccine-making plant.

Novavax shares finished the day up 78 cents, or 31 percent, at $3.28 on the news.

Rockville, Md.-based Novavax told The Associated Press the deal, to be announced later Tuesday by the Spanish government, will bring the company development funding needed in the short term and will be worth tens of millions of dollars in future royalty and milestone payments once the vaccines are approved and marketed.

Novavax, Spain's Ministry of Health and ROVI Pharmaceuticals of Madrid are aiming to have the manufacturing plant running and win approval to sell the vaccines in the European Union in 2012. The plant is to be built in Granada, at an expected cost of about 20 million euro, or $28 million.

Novavax, a development-stage company with no marketed products, is in midstage testing in the U.S. of a vaccine against swine flu, or H1N1 flu, using the same technology to produce vaccines more quickly and cheaply than the traditional method of growing the key vaccine component in chicken eggs, a process that takes several months.

Novavax developed what's called virus-like-particle technology to make vaccines. The technology genetically engineers a particle that looks like a flu virus, but contains contains only three of its eight genetic building blocks, enough to make the shell of the virus and key proteins on its surface, Singhvi said.

"It's like a decoy of the virus, but the immune system recognizes it as if it were the flu virus" and mounts a vigorous immune response, he said. "It cannot replicate, and it cannot cause illness."

The company is aiming to get approval to sell both pandemic flu vaccines and seasonal flu vaccines in the U.S., also by 2012.

Spanish government agencies will provide 60 million euros, or about $84.1 million, to complete late-stage testing of the vaccines and gain marketing approval in the European Union and eventually elsewhere. In addition, ROVI will make an immediate $3 million equity investment in Novavax, at a 10 percent premium to the company's $2.50 closing price on July 29, and will provide additional development funding if needed.

"This is a huge validation of our technology," Rahul Singhvi, president and chief executive of Novavax, said in an interview. "This is going to enable us to go to market," both with vaccines made by ROVI and with its own products.

ROVI will use the same technology to make its vaccines.

Virus-like-particle technology is behind Merck & Co.'s cervical cancer vaccine Gardasil. Other companies working on flu vaccines are using the technology in laboratory testing, but Novavax is the only company using the technology that has advanced to midstage testing in people for flu, Singhvi said.

ROVI, which makes and sells a version of the blood thinner heparin in about two dozen countries in Europe, Asia and South America, will have exclusive licenses to sell the vaccines in Spain and Portugal, plus nonexclusive licenses in Europe, Latin America and Africa. The company does contract manufacturing for other drugmakers, including filling syringes with various vaccines.

Novavax will retain exclusive licenses for the vaccines in North America, Asia and Australia and also would be able to sell them in other countries, except Spain and Portugal.

The planned Granada plant would be able to make more than 15 million doses of seasonal flu vaccine a year, plus surge capacity to produce many more doses in the event of another pandemic flu, said Tom Johnston, vice president of strategy at Novavax.

That's intended to supply the market in Spain, which has more than 43 million people and is the world's eighth-largest economy, with some remaining for other parts of Europe, Latin America and Africa.

Novavax stock soars on license deal...
Novavax Inc. stock has soared on news that it's negotiating a multimillion-dollar deal to license out its flu-vaccine-making technology to a Spanish pharmaceutical partner that plans to further test and produce seasonal and pandemic flu vaccines for several European countries.

The agreement is a considerable win for Novavax, which like many other area biotechs, had been hunting for larger partners to supply some much-needed cash through the downturn and take its clinical programs forward. "We continue to discuss opportunities with other pharmaceutical companies and governments to implement this compelling influenza vaccine technology around the globe," said Rahul Singhvi, Novavax president and CEO.

52wk Range: 0.52 - 3.88
Volume: 33,151,400
Avg Vol (3m): 5,036,210

Technicals
Most Actives
Stochastic - Bullish

Last Price Quote is:
-9.10%below 13-day MA
39.40%above 50-day MA
RS Rating: N/A 

Fundamentals
Key Data:
Market Cap (M): $90.07 
P/E Ratio: 10.26 
PEG Ratio: N/A 
Next Earnings: N/A
Last Analyst Rating: N/A

Companies start shipping U.S. seasonal flu vaccine
Mon Jul 27, 2009 7:24pm EDT

CHICAGO, July 27 (Reuters) - Two U.S. flu vaccine makers have started to ship seasonal flu vaccine to health providers preparing to juggle both seasonal flu and swine flu vaccination programs, they said on Monday.
Both Sanofi Pasteur, the vaccines unit of Sanofi Aventis (SASY.PA), and CSL Biotherapies, a unit of Australia's CSL Ltd (CSL.AX), said they had begun shipping seasonal flu vaccine to health providers in the United States.

Health officials face a daunting dual vaccination program during the Northern Hemisphere autumn aimed at preventing deaths and disease from both seasonal and the H1N1 swine flu.

European health officials said on Friday they have begun a fast-track process for reviewing data on pandemic flu vaccines in hopes of getting drugs to protect against the new H1N1 virus before the start of flu season in the Northern Hemisphere, likely in September.

The European Medicines Agency said it is reviewing data from manufacturers as they become available, a step that could speed approval. Shares of several smaller vaccines makers rose sharply on Monday, with Vical Inc (VICL.O), Novavax Inc (NVAX.O) and BioCryst Pharmaceuticals Inc (BCRX.O) touching new highs.

Sanofi said the early shipment of its Fluzone vaccine -- for infants 6 months and older through adults -- was meant to assist public health workers in immunization planning.

The U.S. Centers for Disease Control and Prevention broadened its recommendations for seasonal flu vaccine -- saying last week that all children over the age of 6 months should get one, in part to lower the overall burden of respiratory disease when autumn and winter comes.

Sanofi said it expects to supply more than 50 million doses of Fluzone vaccine to the United States for the 2009-2010 season.

CSL said it is on track to deliver all 8 million doses of its seasonal flu vaccine before the end of September. The company said in a statement it is also moving quickly to develop a vaccine to address the H1N1 pandemic.

The company started clinical trials of its pandemic vaccine in humans on July 22.

At least 50 governments have placed orders or are negotiating with drug companies to secure supplies of H1N1 vaccines.

Drugmakers Roche (ROG.VX), Gilead Sciences (GILD.O) and GlaxoSmithKline (GSK.L) have benefited from a worldwide rush to secure supplies of their antiviral drugs to fight the fast-spreading swine flu. Other vaccine makers working on H1N1 shots include Novartis (NOVN.VX), Baxter International (BAX.N), AstraZeneca's (AZN.L) MedImmune arm, and Solvay (SOLB.BR).

Each year, seasonal influenza alone is involved in between 250,000 and 500,000 deaths globally, the WHO estimates.

I think NVAX will continue to see its products purchased worldwide.
Short sighted traders ran down...rebound...

52wk Range: 0.52 - 3.88
Volume: 22,163,523
Avg Vol (3m): 6,218,490

Technicals
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Percentage Gainer

Last Price Quote is:
39.52%above 13-day MA
65.66%above 50-day MA
RS Rating: 99 

Fundamentals
Earnings Expected on Aug 7

Key Data:
Market Cap (M): $302.81 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/07/2009
Last Analyst Rating: Mkt Outperform

Stocks Hitting High Notes...
When a stock hits a fresh high, it can mean that it's on its way to greatness -- or that it has run its course. Even with the risk of the latter, searching for these outperformers can reveal companies that are doing something right, much to their investors' delight.

Not too late!
I don't think your too late....fasten your seat-belt! We'll see what you think when it doubles again!!

52wk Range: 0.52 - 5.23
Volume: 27,022,192
Avg Vol (3m): 5,826,260

Technicals
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Percentage Gainer

Last Price Quote is:
41.65%above 13-day MA
77.05%above 50-day MA
RS Rating: 98 

Fundamentals
Earnings Expected on Aug 7

Key Data:
Market Cap (M): $302.81 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 08/07/2009
Last Analyst Rating: Mkt Outperform

updated chart scene...

updated chart look...

NOVAVAX Elects James F. Young to Its Board of Directors


ROCKVILLE, Md., April 7, 2010 /PRNewswire via COMTEX/ -- Novavax, Inc. (NVAX, Trade ) announced today that it has appointed James F. Young, Ph.D., to its Board of Directors. Dr. Young will be an independent Board Member effective immediately.

Dr. Young has over 30 years of experience in the fields of molecular genetics, microbiology, immunology and pharmaceutical development. He was previously President of Research and Development, including responsibility for regulatory affairs, at MedImmune where he was instrumental in the development of FluMist(R) and Synagis(R). In 2005, Dr. Young was awarded the Albert B. Sabin Humanitarian Award. Prior to MedImmune, Dr. Young was influential in building the department of molecular genetics at Smith Kline & French Laboratories (now part of GlaxoSmithKline) and culminated as director, department of molecular genetics.

"We are very pleased to welcome such an accomplished and distinguished member of the biotech industry to Novavax's Board of Directors," said Stan Erck, Executive Chairman of Novavax Board of Directors. "His extensive experience and knowledge in the vaccine arena will be a tremendous advantage to Novavax as the company moves forward to advance our pipeline products."

Prior to GlaxoSmithKline, Dr. Young was on the faculty of the department of microbiology at Mount Sinai School of Medicine in New York, NY. Dr. Young received his doctorate in microbiology and immunology from Baylor College of Medicine in Houston, Texas and Bachelor of Science degrees in biology and general science from Villanova University.

About Novavax

Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com .

Forward Looking Statement

Statements herein relating to future performance, conditions or strategies and other matters, including expectations regarding the development of the Company's vaccines are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the Company's ability to progress its product candidates in preclinical or clinical trials; clinical trial results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; the rate and progress of manufacturing scale-up; and the Company's ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov . These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.

SOURCE Novavax, Inc.

Encouraging Results from Novavax


Zacks Equity Research, On Tuesday March 30, 2010, 10:40 am EDT


Recently, Novavax (NasdaqGM: NVAX - News) announced final results from a phase II trial of its trivalent seasonal influenza Virus-like particle (VLP) vaccine in adults 18-49 years of age. Initial results from the trial were reported in 2009.

The initial analysis carried out on 190 people (aged 18 to 49 years) showed strong immune system responses against three flu strains (H3N2, H1N1 and B) without any major adverse events.

The complete study was conducted on 232 people out of whom 49 were on placebo while 19 received another trivalent influenza vaccine Fluzone at 15 mcg/dose. Novavax's VLP vaccine was administered in two dosages of 15 mcg (83 candidates) and 60 mcg (81). It has been observed that the VLP vaccine induced a robust hemagglutination inhibition (HAI) antibody response against all the three strains.

Novavax is conducting another head to head trial of its VLP vaccine with Fluzone in adults above 60 years of age. Results of this trial are awaited.

The company also came out with positive results from the first stage of a two stage study evaluating the safety and effectiveness of its VLP vaccine against the H1N1 virus. This study is being conducted in collaboration with Avimex Laboratories of Mexico and GE Healthcare. If final results are encouraging enough, Novavax is looking at registering the vaccine in Mexico.

At the time of announcing fourth quarter results, Novavax said that it has identified a vaccine candidate for the prevention of respiratory syncytial virus (RSV). The company plans to complete preparations for its Investigational New Drug (IND) filing for the vaccine in 2010.


Zacks Investment Research

updated chart look...

ROCKVILLE, Md., Feb. 9, 2011 /PRNewswire via COMTEX/ -- Novavax, Inc. (NVAX) a clinical-stage vaccine company, announced today that Dr. Gregory Glenn, Chief Medical Officer of Novavax, will be presenting safety and immunogenicity data from its pivotal 2009 A/H1N1 virus-like particle (VLP) pandemic influenza vaccine clinical trial in Mexico, at the invitation-only 7th WHO Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials. The meeting is being held February 17-18, 2011 at the WHO headquarters in Geneva, Switzerland where Dr. Glenn will be part of a session entitled: "Pandemic and Potentially Pandemic Vaccines Developed Using New Technologies." Dr. Glenn's presentation is entitled: "Rapid Response during the 2009 (H1N1) Pandemic in Mexico with an Influenza VLP Vaccine." The presentation will be available at www.novavax.com under the Investors/Events tab after the event.

About Novavax

Novavax, Inc. (NVAX), a clinical-stage biopharmaceutical company, employs it's 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 unique disposable system enables rapid vaccine development and production where and when it's needed, worldwide. For more information about Novavax, please visit www.novavax.com .

SOURCE Novavax, Inc.

Pre-Market Mover...

Novavax, Inc.(NasdaqGM: NVAX )
Pre-Market Real-Time: 3.40  0.80 (30.77%) 8:35AM EST

Volume @ 553,000