NVAX - Sector: Healthcare --- Industry: Biotechnology & Drugs

[LiveLife]

Nice to have you back in NVAX David!

[wisebuys]

Nice job of keeping the NVAX thread alive LiveLife!  I'm still with you too.

[poorman1]

GO NVAX! HEB and SVA! (and NNVC.pk)

http://biz.yahoo.com/prnews/051017/nym261.html?.v=3

Wave Biotech Announces Strategic Alliance on Pandemic Influenza Vaccine Production Technologies
Monday October 17, 3:38 pm ET


SOMERSET, N.J., Oct. 17 /PRNewswire/ -- Wave Biotech, LLC, has announced today that the company is working with a number of worldwide pharmaceutical and biotech manufacturers that are making vaccines in the disposable Wave Bioreactor®. In its latest collaboration effort, Wave Biotech has entered into an agreement with Novavax, Inc. (Nasdaq: NVAX - News), based in Malvern, PA, and both companies will jointly collaborate on the development of a commercial scale production process for Novavax's pandemic influenza virus (avian flu) vaccine and other biological products. Wave Biotech will provide process and equipment expertise for the propriety technology based on disposable equipment for the manufacture of biologicals. The initial focus of the collaboration will be on Novavax's H5N1 avian-flu-Like Particle (VLP) vaccine. The joint collaboration will demonstrate in a production process that can express potent vaccine at high yield at the 500-liter scale.

Vijay Singh, President and founder of Wave Biotech, LLC, issued the following statement: "Wave Biotech's disposable cell culture technology is an ideal fit for the Novavax application because it provides scalable technology that can be delivered, installed, and commissioned quickly for possible worldwide use."

Non Traditional Approach May Prove Necessary in the Race Against Time

Wave Biotech first began development on their innovative technology for the bioreactor six years ago, which may prove to be a critical component in the race to develop vaccines before a flu pandemic has an opportunity to occur. The company offers a quick way to rapidly manufacture and deploy bioreactors of up to 500 liters operating volume. Using large plastic bags as cell culture vessels, the bags are inflated, filled with culture nutrients, and inoculated with the cells of choice. These bags are placed on special machines that rock in a back and forth motion, generating waves that effectively aerate and mix the contents, thus producing a highly effective environment for cell growth and productivity. The machines have been fully operational since 1999, and are currently in use at almost every pharmaceutical or biotech company worldwide. They have been licensed as part of processes to produce human therapeutics and are built to comply with all applicable FDA guidelines. Most critically, they have a proven track record with many cell lines and viruses having been used for the production of proteins, viruses, gene therapy products, and vaccines. Due to the inexpensive and simple pre-sterilized disposable culture bag, cell culture can be carried out by low-tech labor without the need for extensive plant infrastructure. The rocking machines are mass-produced and can be delivered in weeks as compared to six months or longer for traditional stirred tank bioreactors.

Dr. Singh acknowledged that current issues concerning the possibility of an influenza pandemic striking humanity in the very near future is based on several notable factors. "First of all, the influenza virus is capable of mutating rapidly so that most people would have no significant resistance and would succumb. Additionally there is a disturbing increase in the occurrence of avian flu in Asia as well as the latest evidence in some of the eastern European countries. It is clear that the great influenza epidemic of 1918 was avian origin, followed by others in 1957 and 1968," he said. "Statistically," he continued, "another appears to be due at this time." He also noted that there are now anti-viral pharmaceuticals that may be useful in treating those people infected by the influenza virus, but he cautioned that the efficacy and availability of such drugs are very limited.

"The problem with influenza vaccines is that the virus mutates rapidly and a vaccine made against one strain will likely be useless against another one," said Singh. "Making such a vaccine is very time consuming and takes eight to ten months to build up a significant stockpile of doses."

The manufacturing equipment developed by Wave Biotech can be quickly configured and deployed anywhere in the world within days. The cells only contact a single-use bag and these bags can be stockpiled for up to three years providing an option for almost instant vaccine manufacturing. The equipment has been optimized over several years to enable easy operation with minimal training required. This method would enable vaccine facilities to be rapidly established anywhere in the world to combat the disease at the local level, thus preventing its release into the general population. The disposable cell culture bags can be manufactured in large quantities in simple factories using heat seaming equipment, delivered pre-sterilized by radiation and ready for use.

Engineered Baculovirus

Current vaccine manufacturers use 1950's chicken egg technology and other methods to make the vaccine. Singh considers these methods far more primitive because "even 350 million chicken eggs would only yield 300 million doses which would take at least six months to develop." Dr. Singh added, "This technology is not likely to save a significant number of people since compounding the problem is that if, indeed, the flu is avian origin, then where are the significantly large numbers of eggs needed to make the vaccine going to originate? The Spanish Flu epidemic of 1918 is estimated to have killed between 50 and 100 million people, at a time when world population was only 1.8 billion. Today we have 6.5 billion people and the impact of a virus such as the one in 1918 would clearly prove to be even more devastating."

Singh claims it is both necessary and critical for governments worldwide to secure alternative technologies to rapidly make an engineered cell line for vaccine production.

"One approach, developed by Novavax, is to identify the gene sequences of the virus as it exists now in the Far East and rapidly clone into baculovirus," said Dr. Singh. "This engineered baculovirus can be used to infect insect cells grown in liquid culture media and rapidly express large amounts of a suitable vaccine. This approach has been tested, proven and requires simple culture media that can be made from common chemicals. This way, it is possible to clone and develop a cell expressions system against a specific influenza strain within six weeks of securing the sample. While getting a cell line that produces the desired vaccine is only part of the story, in order to make sufficient quantities of the vaccine in such a time- sensitive manner, it will be essential to grow large numbers of cells using thousands of liters of cell culture capability."

About Wave Biotech

Wave Biotech is a research-based company that develops and manufactures innovative process equipment for the pharmaceutical and biotechnology industries. The Company's focus is on developing disposable bioprocess equipment for the operation traditionally requiring stainless-steel tanks and piping. Key products, such as the Wave Bioreactor®, WaveMixer®, FlexMixer®, and Sterile Tube Fuser, feature disposable contact materials that eliminate cleaning and validation, thereby reducing costs in operations ranging from cell culture, media preparation, and buffer dissolution and thawing process intermediates to patient specific cell therapy in hospitals. These unique, patented, devices can be installed and commissioned rapidly, thereby drastically reducing the time-to-market for biological products. Wave Biotech's equipment is in use with hundreds of companies worldwide, both for R&D, as well as commercial applications.

[gmarc66]

Hey Livelife....great news for NVAX!

News out half hour before market close today.  It went crazy with the news!

Goodluck!!

October 17, 2005 - 3:38 PM EDT     

 
Wave Biotech Announces Strategic Alliance on Pandemic Influenza Vaccine Production Technologies
SOMERSET, N.J., Oct. 17 /PRNewswire/ -- Wave Biotech, LLC, has announced today that the company is working with a number of worldwide pharmaceutical and biotech manufacturers that are making vaccines in the disposable Wave Bioreactor(R). In its latest collaboration effort, Wave Biotech has entered into an agreement with Novavax, Inc. (Nasdaq: NVAX), based in Malvern, PA, and both companies will jointly collaborate on the development of a commercial scale production process for Novavax's pandemic influenza virus (avian flu) vaccine and other biological products. Wave Biotech will provide process and equipment expertise for the propriety technology based on disposable equipment for the manufacture of biologicals. The initial focus of the collaboration will be on Novavax's H5N1 avian-flu-Like Particle (VLP) vaccine. The joint collaboration will demonstrate in a production process that can express potent vaccine at high yield at the 500-liter scale.

Vijay Singh, President and founder of Wave Biotech, LLC, issued the following statement: 'Wave Biotech's disposable cell culture technology is an ideal fit for the Novavax application because it provides scalable technology that can be delivered, installed, and commissioned quickly for possible worldwide use.'

Non Traditional Approach May Prove Necessary in the Race Against Time

Wave Biotech first began development on their innovative technology for the bioreactor six years ago, which may prove to be a critical component in the race to develop vaccines before a flu pandemic has an opportunity to occur. The company offers a quick way to rapidly manufacture and deploy bioreactors of up to 500 liters operating volume. Using large plastic bags as cell culture vessels, the bags are inflated, filled with culture nutrients, and inoculated with the cells of choice. These bags are placed on special machines that rock in a back and forth motion, generating waves that effectively aerate and mix the contents, thus producing a highly effective environment for cell growth and productivity. The machines have been fully operational since 1999, and are currently in use at almost every pharmaceutical or biotech company worldwide. They have been licensed as part of processes to produce human therapeutics and are built to comply with all applicable FDA guidelines. Most critically, they have a proven track record with many cell lines and viruses having been used for the production of proteins, viruses, gene therapy products, and vaccines. Due to the inexpensive and simple pre-sterilized disposable culture bag, cell culture can be carried out by low-tech labor without the need for extensive plant infrastructure. The rocking machines are mass-produced and can be delivered in weeks as compared to six months or longer for traditional stirred tank bioreactors.

Dr. Singh acknowledged that current issues concerning the possibility of an influenza pandemic striking humanity in the very near future is based on several notable factors. 'First of all, the influenza virus is capable of mutating rapidly so that most people would have no significant resistance and would succumb. Additionally there is a disturbing increase in the occurrence of avian flu in Asia as well as the latest evidence in some of the eastern European countries. It is clear that the great influenza epidemic of 1918 was avian origin, followed by others in 1957 and 1968,' he said. 'Statistically,' he continued, 'another appears to be due at this time.' He also noted that there are now anti-viral pharmaceuticals that may be useful in treating those people infected by the influenza virus, but he cautioned that the efficacy and availability of such drugs are very limited.

'The problem with influenza vaccines is that the virus mutates rapidly and a vaccine made against one strain will likely be useless against another one,' said Singh. 'Making such a vaccine is very time consuming and takes eight to ten months to build up a significant stockpile of doses.'

The manufacturing equipment developed by Wave Biotech can be quickly configured and deployed anywhere in the world within days. The cells only contact a single-use bag and these bags can be stockpiled for up to three years providing an option for almost instant vaccine manufacturing. The equipment has been optimized over several years to enable easy operation with minimal training required. This method would enable vaccine facilities to be rapidly established anywhere in the world to combat the disease at the local level, thus preventing its release into the general population. The disposable cell culture bags can be manufactured in large quantities in simple factories using heat seaming equipment, delivered pre-sterilized by radiation and ready for use.

Engineered Baculovirus

Current vaccine manufacturers use 1950's chicken egg technology and other methods to make the vaccine. Singh considers these methods far more primitive because 'even 350 million chicken eggs would only yield 300 million doses which would take at least six months to develop.' Dr. Singh added, 'This technology is not likely to save a significant number of people since compounding the problem is that if, indeed, the flu is avian origin, then where are the significantly large numbers of eggs needed to make the vaccine going to originate? The Spanish Flu epidemic of 1918 is estimated to have killed between 50 and 100 million people, at a time when world population was only 1.8 billion. Today we have 6.5 billion people and the impact of a virus such as the one in 1918 would clearly prove to be even more devastating.'

Singh claims it is both necessary and critical for governments worldwide to secure alternative technologies to rapidly make an engineered cell line for vaccine production.

'One approach, developed by Novavax, is to identify the gene sequences of the virus as it exists now in the Far East and rapidly clone into baculovirus,' said Dr. Singh. 'This engineered baculovirus can be used to infect insect cells grown in liquid culture media and rapidly express large amounts of a suitable vaccine. This approach has been tested, proven and requires simple culture media that can be made from common chemicals. This way, it is possible to clone and develop a cell expressions system against a specific influenza strain within six weeks of securing the sample. While getting a cell line that produces the desired vaccine is only part of the story, in order to make sufficient quantities of the vaccine in such a time- sensitive manner, it will be essential to grow large numbers of cells using thousands of liters of cell culture capability.'

About Wave Biotech

Wave Biotech is a research-based company that develops and manufactures innovative process equipment for the pharmaceutical and biotechnology industries. The Company's focus is on developing disposable bioprocess equipment for the operation traditionally requiring stainless-steel tanks and piping. Key products, such as the Wave Bioreactor(R), WaveMixer(R), FlexMixer(R), and Sterile Tube Fuser, feature disposable contact materials that eliminate cleaning and validation, thereby reducing costs in operations ranging from cell culture, media preparation, and buffer dissolution and thawing process intermediates to patient specific cell therapy in hospitals. These unique, patented, devices can be installed and commissioned rapidly, thereby drastically reducing the time-to-market for biological products. Wave Biotech's equipment is in use with hundreds of companies worldwide, both for R&D, as well as commercial applications.

SOURCE Wave Biotech, LLC

[fous]

What a great day to be invested in the bird flu plays!

-fousc

[David Randolph]

NVAX's behavior today was curious. On the 13th of September we've had this news:

Novavax Announces Strategic Alliance on Pandemic Influenza Vaccine Production Technologies

The effect of this news was minimal at that time, check it on the chart:



Today, at exactly 3:35 pm, this news hit the wires:

Wave Biotech Announces Strategic Alliance on Pandemic Influenza Vaccine Production Technologies

And the market reaction was:



Why?

Possibly because now it was the other part of the partnership issuing the press release, which adds credibility to the news. Press Releases have more credibility when they are issued by both parts on a deal than just by one part (a lesson or trick to be learned).

But I think what caused the late day rally was that Wave Biotech was much more objective and clear on its words than Novavax. The way people say or write things, the way the information is perceived by investors sometimes is more important than the information itself.

Look at this:

«Wave Biotech, LLC, has announced today that the company is working with a number of worldwide pharmaceutical and biotech manufacturers that are making vaccines in the disposable Wave Bioreactor(R). In its latest collaboration effort, Wave Biotech has entered into an agreement with Novavax, Inc. (NVAX), based in Malvern, PA, and both companies will jointly collaborate on the development of a commercial scale production process for Novavax's pandemic influenza virus (avian flu) vaccine and other biological products. Wave Biotech will provide process and equipment expertise for the propriety technology based on disposable equipment for the manufacture of biologicals. The initial focus of the collaboration will be on Novavax's H5N1 avian-flu-Like Particle (VLP) vaccine. The joint collaboration will demonstrate in a production process that can express potent vaccine at high yield at the 500-liter scale.»

Speculators read «mass production», «worldwide sales» and the stock shot up through the roof. We also got news that Tamiflu isn't working in several Bird Flu cases, specially on a man to man case that happened in Vietnam. As we know the virus changes when he goes man to man and the change probably killed the effectiveness of Tamiflu. The search for new vaccines and alternatives has just began and if any of these companies puts their products for sale they will sell everything they can produce in a blink of an eye.

I'm sad I'm making money with such a worrisome disease, but that's the way the market goes ... I was a dumb when I sold some Bird Flu plays last week, I'm glad I bought back NVAX and I will continue holding it for the foreseeable future.

[LiveLife]

Julia, fousc, David thanks for the support. 

What a day for NVAX! = High Five to all the NVAX holders =

There was a reason for last week's accumulation by the money managers.

There was more accumulation activity today (chart from Lycos I-watch):

[[D] Investor]

More NVAX discussion, follow up, and technical analysis: http://www.d2cents.com

NVAX fan and holder since $2.28.

Cheers to all longs! This should be an interesting ride up. My [2] cents. - [D]

[LiveLife]

David and all you traders of NVAX, thanks for the support.   

What a day for NVAX! = High Five to all the NVAX holders! =

There was a reason for last week's accumulation by the money managers.

There was more accumulation activity today (chart from Lycos I-watch):

[AussieTrader]

NVAX unlike SVA (which is in blue sky zone) does have technical resistance ahead, the 200ema on my weekly chart is $4.20, so this wil be a key zone. Recent volume however is so high relative to history that that resistance might not be as hard to deal with as you might otherwise expect. Once momentum and a story get a hold of a stock it can make resistance somewhat futile On daily chart NVAX has run away from its averages, but interestingly NVAX has only just reached RSI of 70+.

[LiveLife]

NVAX unlike SVA (which is in blue sky zone) does have technical resistance ahead, the 200ema on my weekly chart is $4.20, so this wil be a key zone. Recent volume however is so high relative to history that that resistance might not be as hard to deal with as you might otherwise expect. Once momentum and a story get a hold of a stock it can make resistance somewhat futile On daily chart NVAX has run away from its averages, but interestingly NVAX has only just reached RSI of 70+.

I am on holding pattern right now, resetting new sell targets (I modified my sell target three times today!).

This is still very "bearish" market and we all need to be very careful.  One hiccup and there maybe sell off all across the board again like last week.

With Avian virus news coverage 24/7, the Avian plays are enjoying the spotlight right now, and also the Avian support plays like makers of N95 masks and filters.

I wonder what would have happened to this sector if not for the Avian news coverage.

Anyway, back to trading!  I'll be watching NVAX activity very closely tomorrow.

Be careful everyone tomorrow!

Good trading!

[LiveLife]

Duplicate post from Premium NVAX board:

NVAX unlike SVA (which is in blue sky zone) does have technical resistance ahead, the 200ema on my weekly chart is $4.20, so this wil be a key zone. Recent volume however is so high relative to history that resistance might not be as hard to deal with as you might otherwise expect. Once momentum and a story get a hold of a stock it can make resistance somewhat futile On daily chart NVAX has run away from its averages, but interestingly NVAX has only just reached RSI of 70+.

I am on holding pattern right now, resetting new sell targets (I modified my sell target three times today!).

This is still very "bearish" market and we all need to be very careful.  One hiccup and there maybe sell off all across the board again like last week.

With Avian virus news coverage 24/7, the Avian plays are enjoying the spotlight right now, and also the Avian support plays like makers of N95 masks and filters.

I wonder what would have happened to this sector if not for the Avian news coverage.

Anyway, back to trading!  I'll be watching NVAX activity very closely tomorrow.

Be careful everyone tomorrow!

Good trading!

[LiveLife]

BTW, poorman1, I like your GoNVAX.gif!   

[LiveLife]

More continuing news coverage on Avian bird flu (this posted 11 minutes ago for EU on Yahoo).  Ongoing worldwide media coverage will only push the Avian plays and support plays further up today:

http://news.yahoo.com/s/ap/20051018/ap_on_he_me/bird_flu_eu

EU Nations: Bird Flu a 'Global Threat'

[LiveLife]

More continuing news coverage on Avian bird flu (this posted 11 minutes ago for EU on Yahoo).  Ongoing worldwide media coverage will only push the Avian plays and support plays further up today:

http://news.yahoo.com/s/ap/20051018/ap_on_he_me/bird_flu_eu

EU Nations: Bird Flu a 'Global Threat'

By ROBERT WIELAARD, Associated Press Writer 11 minutes ago

LUXEMBOURG -
European Union foreign ministers on Tuesday declared the spread of bird flu from Asia into Europe a global threat requiring broad international cooperation to contain.
ADVERTISEMENT

They also called on the EU Executive Commission to accelerate steps to draft stronger rules against the virus, which in recent days has been discovered in Greece, Romania and Turkey, leading to bans on poultry from those countries.

The deadly H5N1 bird flu strain has swept poultry populations in large swaths of Asia since 2003, jumping to humans and killing at least 61 people — more than 40 of them in Vietnam — and resulting in the deaths of tens of millions of birds.

Its spread westward by migrating wild fowl has intensified fears the virus may mutate into one that can be easily transmitted among humans — a development experts fear could provoke a global epidemic that puts millions of lives at risk.

The foreign ministers were to issue a statement saying they recognize bird flu poses a serious, global health threat if it shifts from birds to human beings and one "that requires a coordinated international reaction."

The EU stepped up biosecurity measures and installed early detection systems along the migratory paths of birds to prevent contamination of domestic flocks.

But there are concerns that European nations lack stockpiles of vaccines and anti-virals to cope with a major outbreak.

The
World Health Organization recommends governments keep enough anti-viral drugs and regular human flu vaccines to inoculate at least 25 percent of their populations.

European officials say the 25 nations in the EU, as well as Iceland, Norway and Liechtenstein, have only 10 million doses for an area with 500 million people. That's just 1 percent of the population.

Stockpiling vaccines is difficult as flu viruses can mutate quickly.

There is no human vaccine for the current strain of bird flu but scientists believe the Tamiflu drug may help humans fend off the virus.