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

Started by fill_the_gap, August 25, 2005, 08:44:09 AM

Previous topic - Next topic

LiveLife

Scenes like these will be the "daily ponder" for many as Avian spreads all over the world.  Migrating flocks of birds and disinfection of vehicles of affected/quarantined areas:

http://www.cnn.com/2005/HEALTH/conditions/10/22/birdflu.main/index.html
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

setravis

This has been a great pick, also a great looking running thread on this stock. ;)
I am going to take the time and applaud everyone here.

• Novavax upgraded by RBC Capital Mkts
Briefing.com (Fri 7:42am) 


The 50-day EMA crossing  over the 200-day EMA.
If a Golden Cross means anything,we have one taking place in this stock.
When a shorter moving average like the 50-day crosses above a longer one like the 200-day it is a major buy signal. In Japan this signal is called a "Golden Cross." The reverse is called a "Dead Cross" and it is a sell signal. Using moving average crossovers takes the subjective part of chart reading, as this is just pure math in determining the trend. When the 50-day crosses above the 200-day it's a signal to go long.

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
34.55%above 13-day EMA
90.52%above 50-day EMA
RS Rating: 99 

Fundamentals
Analyst Upgrade to Sector Perform

Key Data:
Market Cap (M): $111.93 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 11/09/2005
Last Analyst Rating: Sector 



I will be a buyer on Monday at the open. ;D
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

LiveLife

#197
Thank you setravis, for your support = return applaud =

As a fellow ex-service man, I believe in professional, "facts-only" postings as much as possible.

I like the phrase of fellow poster here "Fail to plan, plan to fail"  ... So true!

Well, we are planning for the Avian threat by supporting this company and letting the word out.  I have been supporting the Yahoo Message Board NVAX thread.

For the traders (short-term and long-term) AND investors, and even swing traders like me,  ;) NVAX, I believe is a solid play that may follow in the footsteps of VPHM (like the message thread is titled - how coincidental or perhaps "destined" is that?)

With the attention and coverage NVAX is receiving right now, next week looks to be very promising for NVAX, even despite the current "bearish" market conditions.

We broke through the 200 day moving average on Friday and received an analyst upgrade!  NVAX is still the week and month volume leader with the highest Institutional gain activity!  In a still "bearish" market conditions, $0.54 gain on Friday that was a consistent and gradual climb all day with continued accumulation by Institutional/money managers with no selling activity demonstrates the strength of this stock.

As a swing trader, I am constantly re-adjusting my sell target, and becoming more and more relaxed to allow the stock to gain in price.  NVAX is gradually making me a "long-term" holder from a short-term swing trader.

Good trading!
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

#198
With the attention and coverage NVAX is receiving right now, next week looks to be very promising for NVAX, even despite the current "bearish" market conditions.

We broke through the 200 day moving average on Friday and received an analyst upgrade!  NVAX is still the week and month volume leader with the highest Institutional gain activity!  In a still "bearish" market conditions, $0.54 gain on Friday that was a consistent and gradual climb all day with continued accumulation by Institutional/money manager with no selling activity demonstrating the strength of this stock.

As a swing trader, I am constantly re-adjusting my sell target, and becoming more and more relaxed to allow the stock gain in price.  NVAX is gradually making me a "long-term" holder from a short-term swing trader.

Good trading!
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

shaka88

Zacks.com Announces That Gregory Spear Highlights the Following Stocks: Novavax, Vical, and Crucell



BusinessWire
All Business Wire News

Gregory Spear and his team, from the Spear's Security Industry Analyst newsletter, offer insight on three avian flu related stocks. Learn about Novavax NVAX, Vical VICL, and Crucell CRXL. Click here for the full story exclusively on Zacks.com: http://at.zacks.com/?id=84

Highlights from the October 19 Featured Expert column by Gregory Spear include:

Commentary

The bird flu stocks are definitely experiencing a mini-mania and that creates a certain danger, especially for stocks of companies that don't have P/E ratios greater than zero. Momentum traders are notoriously fickle and momentum always operates in both directions, up and down. Thus, several of Gregory Spear and his team's new buys have limits on them.

That said, one of the avian flu companies Spear and his team have been watching, Novavax NVAX, experienced a volume surge late in the day on Monday suggestive of institutional accumulation. Why? In a study published in the medical journal Vaccine, researchers found that Novavax`s Virus-Like Particle, or VLP, flu vaccine protected animals that were exposed to a strain of avian flu. The VLP components are nano-sized proteins synthesized from cloned virus genes that quickly stimulate an immune reaction. Moreover, their VLP technology uses a scalable, high volume manufacturing process with short production lead times.

Vical VICL is working on a variety of vaccines using a proprietary DNA technology. Conventional vaccine development and manufacturing technologies are slow, often taking several years to refine and ramp up after the emergence of a new pathogen. Vical's DNA processes allow initial production of vaccines much more quickly, in as little as 3 months. The company has also received funding from DARPA to scale up manufacturing processes, potentially allowing production of millions of doses in a matter of weeks.

Crucell CRXL owns patents on the most efficient way to make commercial quantities of vaccines without injecting chicken eggs. The company provides vaccine technology and services to 40 partners worldwide, including most of the large players like Merck, Sanofi-Aventis and GlaxoSmithKline. Crucell reported great revenue gains and a lower loss in the most recent quarter.

Read Gregory Spear's complete commentary and take a look at other stocks by clicking: http://at.zacks.com/?id=85

About Zacks Featured Experts

Successful investing requires professional advice from knowledgeable experts who can help investors achieve their financial goals in good markets and improve their portfolios, especially in bad ones. That is why Zacks Investment Research has assembled the best investment experts in the business to offer their powerful advisory newsletters on all the major investment topics: Stocks, Mutual Funds, Bonds, Options, Futures etc.

Additional recommendations from Zacks.com Featured Experts are highlighted in the free investment newsletter, Profit from the Pros. Each issue highlights several Featured Experts in this free e-mail newsletter. Register for a free subscription to "Profit from the Pros" at: http://at.zacks.com/?id=86

About Zacks

Zacks.com is a property of Zacks Investment Research, Inc., which was formed in 1978 to compile, analyze, and distribute investment research to both institutional and individual investors. The guiding principle behind Zacks work is the belief that investment experts, such as brokerage analysts and investment newsletter writers, have superior knowledge about how to invest successfully. The goal is to unlock these pros' profitable insights for individual investors hard-pressed to find this valuable information in one source. A free subscription to "Profit from the Pros" weekly e-mail newsletter provides the best way to use these experts' insights for more profitable investing. Register now for a free subscription to the Profit from the Pros newsletter at http://at.zacks.com/?id=87

Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.

Disclaimer: Past performance does not guarantee future results. Investors should always research companies and securities before making any investments. Nothing herein should be construed as an offer or solicitation to buy or sell any security.

Contact Information: Zacks.com Alex Kolb, 312-630-9880 Ext. 149 [email protected] www.Zacks.com

http://news.moneycentral.msn.com/ticker/article.asp?Feed=BW&Date=20051021&ID=5212296&Symbol=US:NVAX

LiveLife

Check out this PDF report on Avian "An Economist View Of A Pandemic Flu":  Thanks vrossi7 for the link!

http://www.bmonesbittburns.com/economics/reports/20051011/dont_fear_fear.pdf

Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

Check out this PDF report on Avian "An Economist View Of A Pandemic Flu":  Thanks vrossi7 for the link!

http://www.bmonesbittburns.com/economics/reports/20051011/dont_fear_fear.pdf
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

#202
shaka88 thanks for the post!

News traveling fast! These "alerts and reports" will be flying for days and weeks to come.

http://news.moneycentral.msn.com/ticker/article.asp?Feed=BW&Date=20051021&ID=5212296&Symbol=US:NVAX

"... one of the avian flu companies Spear and his team have been watching, Novavax NVAX, experienced a volume surge late in the day on Monday suggestive of institutional accumulation. Why? In a study published in the medical journal Vaccine, researchers found that Novavax`s Virus-Like Particle, or VLP, flu vaccine protected animals that were exposed to a strain of avian flu. The VLP components are nano-sized proteins synthesized from cloned virus genes that quickly stimulate an immune reaction. Moreover, their VLP technology uses a scalable, high volume manufacturing process with short production lead times."
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

#203
shaka88 thanks for the post!

News traveling fast! These "alerts and reports" will be flying for days and weeks to come.

http://news.moneycentral.msn.com/ticker/article.asp?Feed=BW&Date=20051021&ID=5212296&Symbol=US:NVAX

"... one of the avian flu companies Spear and his team have been watching, Novavax NVAX, experienced a volume surge late in the day on Monday suggestive of institutional accumulation. Why? In a study published in the medical journal Vaccine, researchers found that Novavax`s Virus-Like Particle, or VLP, flu vaccine protected animals that were exposed to a strain of avian flu. The VLP components are nano-sized proteins synthesized from cloned virus genes that quickly stimulate an immune reaction. Moreover, their VLP technology uses a scalable, high volume manufacturing process with short production lead times."
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

#204
Avian may be spreading more:  Thanks prudentman007 for the link!

http://www.sky.com/skynews/article/0,,30000-13452570,00.html

BIRD FLU HITS SWEDEN
Bird flu has been discovered in Sweden but scientists have yet to confirm whether it is the deadly H5N1 strain.
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

Avian may be spreading more:  Thanks prudentman007 for the link!

http://www.sky.com/skynews/article/0,,30000-13452570,00.html

BIRD FLU HITS SWEDEN
Bird flu has been discovered in Sweden but scientists have yet to confirm whether it is the deadly H5N1 strain.

Sweden's National Veterinary Institute said a duck found dead east of the capital has tested positive for avian flu. Confirmation of the exact strain is due tomorrow.

The news comes shortly after the British government called for a ban on the trade of all live birds in the EU in a bid to stem the spread of the virus.

Meanwhile, experts are carrying out tests on a parrot found to have died from Britain's first case of bird flu - but the Government and the EU insist the UK still has disease-free status.

The parrot was in quarantine when it died of the H5 strain of the virus and scientists are trying to confirm whether it was the feared H5N1 strain that is deadly to humans.

Chief Veterinary Officer Debby Reynolds said: "The confirmed case does not affect the UK's official disease free status because the disease has been identified in imported birds during quarantine."

More than 300 birds which were being held in a biosecure quarantine unit at an undisclosed location have been humanely culled.

The parrot was part of a mixed consignment of 148 birds that arrived from Suriname, South America on September 16. They were being held with 216 birds from Taiwan.

H5N1, which has infected over 100 people, killing 60 of them, recently spread into Romania, Turkey and Russia.

The H5 strain has also been confirmed in Croatia.

Dr Reynolds said the "incident showed the importance of the UK's quarantine system".

The last time a case of avian flu was confirmed in Britain was 1992.

It is a highly-infectious viral disease which affects poultry, pigeons and other birds and varies in severity, from causing no deaths to killing entire flocks in hours.

It is most easily spread through bird secretions, particularly faeces, but can also be passed via objects contaminated by an infected bird.

The UK's Chief Medical Officer Sir Liam Donaldson has warned that a flu pandemic may kill up to 50,000 people in the UK alone.

Between two and 50 million are expected to die globally if a pandemic occurs.

:: China has said it will close its borders if it discovers a single case of human-to-human transmission of bird flu.
Last Updated: 22:40 UK, Saturday October 22, 2005
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

#206
Here is a VERY interesting news article to examine.

This is DNA vaccine by PowerMed (UK) vs. Cell Culture vaccine by NVAX (US) as to which will get to market faster in the coming year and the future.

I have highlighted the key phrases and sentences with bold colors.

Here's my take:

But there aren't enough of them [Tamiflu] to go around, and they may not work all that well, anyway.  - Tamiflu is manufactured from the Star Anise plant from China.  90% of annual harvest goes to Roche to produce Tamiflu, anti-viral "treatment" drug that must be administered within 48 hours of infection to have maximum effectiveness.  Recent studies are showing growing resistance by the H5N1 virus to Tamiflu, that's why the bold red phrase "may not work all that well."


So his company and others are working on speedier, more modern alternatives. One promising route is growing the virus in vats of cells.

and others, and promises to cut months off production times.  - Novavax (NVAX)  is one of "other" companies using cell culturing process to produce the vaccine in 2 months!


vaccines constructed from DNA. Trials, set for next year, are needed to prove that such vaccines can actually protect people from flu.  -  DNA based vaccine trials, being worked by PowerMed,  is not set until NEXT YEAR.  Novavax is hinting their cell-culture vaccine based on the European strain of H5N1 ready around early 2006 (only several months from now).  What would happen if Novavax markets the cell-culture vaccine while PowerMed is still running the DNA vaccine trials (which has no gurantee that it will work at all)?  Even DNA based vaccine turns out to be effective, whoever goes to market FIRST will get the orders.


once the technology is proven, his company could make enough vaccine for all Americans in a kitchen-size factory in just six weeks.  -  Key phrase here is "once the technology is proven."  Until then, Cell culture vaccine appears to have the lead in development and market delivery time frame.  However, as the article says, if the DNA technology is proven and production cost/time is verified, I will be first in line to buy up the stocks of these companies.  (with the money made from NVAX gains)   ;)


U.S. Health & Human Services Department (HHS) has awarded $100 million to Sanofi to make a vaccine against avian flu using eggs and $97 million to develop cell-culture production facilities. HHS is about to hand out another award, but it has told PowderMed it has been dropped from consideration. Too unproven.  -  The problem with US and world governments right now is that they need a "definite" response to the Avian threat right now.  For UK and European Union, the Avian virus is there already.  For US, it is matter of time (days/weeks).  They must support solutions that are ready for market.  That's probably why DNA based vaccine was "dropped" from contract award considerations.



Cell-culture vaccines aren't proven, either, retorts Beadle
  -  Yes they are not, that's why Novavax and others are working very hard to "prove" the effectiveness of the cell culture vaccine as we speak.  Like I said earlier, time is the best judge and we'll know in time who can produce the effective vaccine first and take to market.

Here's the link and copy of article:

http://yahoo.businessweek.com/magazine/content/05_43/b3956057.htm

OCTOBER 24, 2005
NEWS: ANALYSIS & COMMENTARY

New Vaccines For A Pandemic
Using DNA, vast amounts could be made quickly. But will the drugs work?

If Dr. John Beadle, chief medical officer at British biotech startup PowderMed Ltd., is right, the U.S. and the rest of the world are making a big mistake. Sometime in the coming years a deadly strain of influenza will strike. If the bird flu that has already killed more than 60 people in Asia and is spreading to Europe mutates into a something that can jump from person to person, the result could be a global pandemic: millions of people dead. Fearing the worst, public health authorities worldwide are vying to stockpile anti-viral drugs. But there aren't enough of them to go around, and they may not work all that well, anyway.

What's needed is the ability to quickly make vast amounts of a vaccine. That's why President George W. Bush met with CEOs of the six major vaccine makers on Oct. 7 to try to prod them into boosting their capacity. But health experts agree that more production alone isn't the answer. Today's 1950s-era manufacturing method requires growing flu viruses in millions of chicken eggs, and it takes nine months or more to make a batch. Says Beadle: "The pandemic will have come and gone before we have the vaccine. That is what shocks me."

So his company and others are working on speedier, more modern alternatives. One promising route is growing the virus in vats of cells. Chiron Corp. (CHIR ) is in late-stage trials with a vaccine made from such cell-grown viruses. The method is also being developed by leading flu-vaccine maker Sanofi Pasteur Inc. (SNY ) and others, and promises to cut months off production times.

"A MODEL FOR BIODEFENSE"
Beadle has a more radical solution -- vaccines constructed from DNA. Trials, set for next year, are needed to prove that such vaccines can actually protect people from flu.  But if the approach works, it would be a major advance. "DNA has some real advantages for a pandemic vaccine," notes University of Rochester professor Dr. John Jay Treanor, who tests flu vaccines. "There is no need to handle live viruses, and there are no complicated purification steps." Instead, the vaccine is largely comprised of a few genes from the virus. Once in the body, the genes tell cells to make viral proteins, which stimulate an immune response.

Such a vaccine is "trivial" to manufacture, says Erik A. Henchal, former commander of the U.S. Army Medical Research Institute of Infectious Diseases. Different genes could be swapped in, enabling rapid production not only of vaccines against new flu strains, but also against other threats. "I'm interested in encouraging this going to trial for flu because I see it as a model for biodefense," says Henchal. Beadle figures that once the technology is proven, his company could make enough vaccine for all Americans in a kitchen-size factory in just six weeks.

Given the promise of DNA vaccines, others, such as Chiron and Merck & Co. (MRK ), have tried to make them. Typically, however, experimental versions have failed to generate a sufficient immune response. PowderMed's data look far better, researchers say. One reason is the delivery method. Tiny gold particles are coated with vaccine and shot into the skin at supersonic speeds. "They know what they are doing," says Treanor.

It sounds simple, though major hurdles remain. The next step is proving DNA vaccines work against regular flu -- and that takes money. So far, the U.S. Health & Human Services Department (HHS) has awarded $100 million to Sanofi to make a vaccine against avian flu using eggs and $97 million to develop cell-culture production facilities. HHS is about to hand out another award, but it has told PowderMed it has been dropped from consideration. Too unproven.

Cell-culture vaccines aren't proven, either, retorts Beadle
: "Even if there were only a 5% chance that DNA vaccines offer the answer, wouldn't you want to put significant resources behind it to find out?" Others agree -- and Congress is making noises about intervening. "We need to learn that we can't keep doing business as usual," says Dr. Gary J. Nabel, director of the Vaccine Research Center at the National Institutes of Health. "We should have been working on these new technologies, like DNA vaccines, 10 years ago." Maybe the threat of a global pandemic will correct that mistake.
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

LiveLife

#207
Here is a VERY interesting news article to examine.

This is DNA vaccine by PowerMed (UK) vs. Cell Culture vaccine by NVAX (US) as to which will get to market faster in the coming year and the future.

I have highlighted the key phrases and sentences with bold colors.

Here's my take:

But there aren't enough of them [Tamiflu] to go around, and they may not work all that well, anyway.  - Tamiflu is manufactured from the Star Anise plant from China.  90% of annual harvest goes to Roche to produce Tamiflu, anti-viral "treatment" drug that must be administered within 48 hours of infection to have maximum effectiveness.  Recent studies are showing growing resistance by the H5N1 virus to Tamiflu, that's why the bold red phrase "may not work all that well."


So his company and others are working on speedier, more modern alternatives. One promising route is growing the virus in vats of cells.

and others, and promises to cut months off production times.  - Novavax (NVAX)  is one of "other" companies using cell culturing process to produce the vaccine in 2 months!


vaccines constructed from DNA. Trials, set for next year, are needed to prove that such vaccines can actually protect people from flu.  -  DNA based vaccine trials, being worked by PowerMed,  is not set until NEXT YEAR.  Novavax is hinting their cell-culture vaccine based on the European strain of H5N1 ready around early 2006 (only several months from now).  What would happen if Novavax markets the cell-culture vaccine while PowerMed is still running the DNA vaccine trials (which has no gurantee that it will work at all)?  Even DNA based vaccine turns out to be effective, whoever goes to market FIRST will get the orders.


once the technology is proven, his company could make enough vaccine for all Americans in a kitchen-size factory in just six weeks.  -  Key phrase here is "once the technology is proven."  Until then, Cell culture vaccine appears to have the lead in development and market delivery time frame.  However, as the article says, if the DNA technology is proven and production cost/time is verified, I will be first in line to buy up the stocks of these companies.  (with the money made from NVAX gains)   ;)


U.S. Health & Human Services Department (HHS) has awarded $100 million to Sanofi to make a vaccine against avian flu using eggs and $97 million to develop cell-culture production facilities. HHS is about to hand out another award, but it has told PowderMed it has been dropped from consideration. Too unproven.  -  The problem with US and world governments right now is that they need a "certain" response to the Avian threat right now.  For UK and European Union, the Avian virus is there already.  For US, it is matter of time (days/weeks).  They must support solutions that are ready for market.  That's probably why DNA based vaccine was "dropped" from contract award considerations.



Cell-culture vaccines aren't proven, either, retorts Beadle
  -  Yes they are not, that's why Novavax and others are working very hard to "prove" the effectiveness of the cell culture vaccine as we speak.  Like I said earlier, time is the best judge and we'll know in time who can produce the effective vaccine first and take to market.

Here's the link and copy of article:

http://yahoo.businessweek.com/magazine/content/05_43/b3956057.htm

OCTOBER 24, 2005
NEWS: ANALYSIS & COMMENTARY

New Vaccines For A Pandemic
Using DNA, vast amounts could be made quickly. But will the drugs work?

If Dr. John Beadle, chief medical officer at British biotech startup PowderMed Ltd., is right, the U.S. and the rest of the world are making a big mistake. Sometime in the coming years a deadly strain of influenza will strike. If the bird flu that has already killed more than 60 people in Asia and is spreading to Europe mutates into a something that can jump from person to person, the result could be a global pandemic: millions of people dead. Fearing the worst, public health authorities worldwide are vying to stockpile anti-viral drugs. But there aren't enough of them to go around, and they may not work all that well, anyway.

What's needed is the ability to quickly make vast amounts of a vaccine. That's why President George W. Bush met with CEOs of the six major vaccine makers on Oct. 7 to try to prod them into boosting their capacity. But health experts agree that more production alone isn't the answer. Today's 1950s-era manufacturing method requires growing flu viruses in millions of chicken eggs, and it takes nine months or more to make a batch. Says Beadle: "The pandemic will have come and gone before we have the vaccine. That is what shocks me."

So his company and others are working on speedier, more modern alternatives. One promising route is growing the virus in vats of cells. Chiron Corp. (CHIR ) is in late-stage trials with a vaccine made from such cell-grown viruses. The method is also being developed by leading flu-vaccine maker Sanofi Pasteur Inc. (SNY ) and others, and promises to cut months off production times.

"A MODEL FOR BIODEFENSE"
Beadle has a more radical solution -- vaccines constructed from DNA. Trials, set for next year, are needed to prove that such vaccines can actually protect people from flu.  But if the approach works, it would be a major advance. "DNA has some real advantages for a pandemic vaccine," notes University of Rochester professor Dr. John Jay Treanor, who tests flu vaccines. "There is no need to handle live viruses, and there are no complicated purification steps." Instead, the vaccine is largely comprised of a few genes from the virus. Once in the body, the genes tell cells to make viral proteins, which stimulate an immune response.

Such a vaccine is "trivial" to manufacture, says Erik A. Henchal, former commander of the U.S. Army Medical Research Institute of Infectious Diseases. Different genes could be swapped in, enabling rapid production not only of vaccines against new flu strains, but also against other threats. "I'm interested in encouraging this going to trial for flu because I see it as a model for biodefense," says Henchal. Beadle figures that once the technology is proven, his company could make enough vaccine for all Americans in a kitchen-size factory in just six weeks.

Given the promise of DNA vaccines, others, such as Chiron and Merck & Co. (MRK ), have tried to make them. Typically, however, experimental versions have failed to generate a sufficient immune response. PowderMed's data look far better, researchers say. One reason is the delivery method. Tiny gold particles are coated with vaccine and shot into the skin at supersonic speeds. "They know what they are doing," says Treanor.

It sounds simple, though major hurdles remain. The next step is proving DNA vaccines work against regular flu -- and that takes money. So far, the U.S. Health & Human Services Department (HHS) has awarded $100 million to Sanofi to make a vaccine against avian flu using eggs and $97 million to develop cell-culture production facilities. HHS is about to hand out another award, but it has told PowderMed it has been dropped from consideration. Too unproven.

Cell-culture vaccines aren't proven, either, retorts Beadle
: "Even if there were only a 5% chance that DNA vaccines offer the answer, wouldn't you want to put significant resources behind it to find out?" Others agree -- and Congress is making noises about intervening. "We need to learn that we can't keep doing business as usual," says Dr. Gary J. Nabel, director of the Vaccine Research Center at the National Institutes of Health. "We should have been working on these new technologies, like DNA vaccines, 10 years ago." Maybe the threat of a global pandemic will correct that mistake.
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.

clearcoated

#208
another very interesting article about PowderMed, Novavax and Protein Sciences:

http://www.coxwashington.com/reporters/content/reporters/stories/BC_FLU_CELLS04_COX.html

Pandemic Threat Spurs New Vaccine Science

By JEFF NESMITH
Cox News Service
Sunday, September 04, 2005

WASHINGTON — Nearly three decades after she was plucked from a plant leaf, a single female caterpillar may help save the world from a pandemic of "bird flu."

At least that's the hope of a small pharmaceutical manufacturer in Connecticut.

Cells extracted from the ovaries of the caterpillar and multiplied trillions of times over the years are being used to grow substances which the company, Protein Sciences Inc., claims will stimulate human immunity to the dreaded H5N1 influenza virus.

The company is one of several firms that are waiting for the government to decide which will receive contracts aimed at underwriting new technologies for immunizing people against influenza.

The companies' proposals are being reviewed by officials at the Department of Health and Human Services (HHS), which has said it expects to award contracts next month.

Finding new ways to immunize large numbers of Americans quickly has taken on new urgency as the H5N1 flu strain continues to spread among chickens and other birds in much of Asia and eastern Russia.

Although 112 people are confirmed to have contracted the virus and 57 have died, health officials say the victims seem to have gotten the disease from contact with infected birds and not from other humans.

But if the virus develops the ability to spread from human to human, health officials fear it could grow into a pandemic reminiscent of the killer flu of 1918-1919.

In that event, HHS estimates, as many as 600 million doses of the vaccine in two separate waves of vaccinations would be needed to protect every American.

That's equal to the entire capacity of all the influenza vaccine makers in the world, health officials say, and is many times the capacity of U.S.-based manufacturers.

Moreover, the current method of making flu vaccine is cumbersome.

The flu virus is injected into fertile hen eggs, where it infects the embryos. After several months of growth, the virus is harvested, killed and purified. The dead virus will not cause flu in humans but stimulates immunity to the disease.

The manufacturing process ordinarily requires six months after health officials identify the virus strain they think will cause either a pandemic or an annual flu epidemic.

And if a pandemic develops because of the H5N1 virus, there is an additional delay. Since the germ is lethal to chickens, HHS estimates it may take from one to two months to adapt it to a form that won't kill the chick embryos outright but will still produce immunity in humans.

The proposal to subsidize new technologies is one of several efforts by HHS to get the U.S. vaccine industry moving into technologies that do not use eggs.

To qualify for one of the contracts, a company must show that it has plans to build a manufacturing plant in the United States and that it will seek a license from the Food and Drug Administration for a vaccine license.

It is not known how many companies are competing for the government contracts or when HHS expects to announce a decision. Agency officials did not respond last week to questions about the contract proposals.

Daniel Adams, president of Protein Sciences, says his company can rapidly produce vaccine for H5N1 flu if a pandemic develops.

"In fact, we've already done it," he said.

He said that in 1997, shortly after the H5N1 strain was first identified in Hong Kong, the company got a call from the Centers for Disease Control and Prevention in Atlanta, "saying that this bird flu was rolling around Hong Kong."

"They said they wanted at least 1,500 doses of vaccine to protect health workers and researchers, and in eight weeks we gave them 1,700 doses," he said.

The company's system employs a bit of genetic trickery against a virus that normally infects caterpillars, with devastating effect.

"It turns them into green goo," Adams said.

Protein Sciences says it has removed the gene for the protein that emulsifies caterpillars. When a new influenza strain is identified, Adams said, the company sticks the gene for an influenza protein called hemagglutinin into the caterpillar virus. Hemagglutinin is the "H" of H5N1 or any other strain of influenza.

In a stainless steel tank, the virus grows in cells that have been regenerated time and again since 1977, when they were originally removed from a female caterpillar.

Instead of making the substance that normally kills caterpillars, it produces huge quantities of hemagglutinin, which Adams says stimulates flu immunity in humans.

The company has completed several phases of human trials and has a meeting with Food and Drug Administration officials next month to discuss a new drug license for the vaccine.

Two 1,600-gallon fermentation tanks would produce enough vaccine to immunize everyone in the country, Adams said.

Another company, Novavax Inc., of Malvern, Pa., uses a similar system with caterpillar cells to create a biologically inactive "virus-like particle" that has both hemagglutinin and neuraminidase, the "N" part of H5N1, attached to it.

Novavax president Rahul Singhvi said he believes presenting both proteins to the human immune system will cause a more robust, faster immune response.

However, Novavax is not as far along in developing its flu vaccine and did not bid for one of the HHS contracts.

A British company, PowderMed Ltd., recently announced that it will soon begin human trials on a system that uses a "gene gun" to shoot the gene for hemagglutinin directly into the skin of people being immunized.

The cells, rather than chicken eggs or caterpillar cells, then produce the hemagglutinin to set the immune system in motion, said Dr. John Beadle, chief medical officer of PowderMed, a spin-off from Chiron Corp. Beadle said the company has bid on one of the HHS development contracts.

The "gene gun" that fires the DNA is a disposable, helium-filled device slightly larger than the customary vaccination needle, he said. It shoots the DNA into cells at about the speed of sound, he said.

To give the DNA enough momentum to penetrate skin cells, the company attaches it to a microscopic "nugget" of gold.

Such a small quantity is needed that PowderMed says it could vaccinate everyone in America twice with slightly more than a quart of vaccine, which it says it could produce by growing the DNA in bacteria in a few weeks.

LiveLife

#209
clearcoated!  Nice to have you onboard and thanks for the post!

Thanks for your "clarifications" and I made the necessary corrections on my previous post.

Yes, it is important to keep in mind which "past" news articles address the "bird vaccine" and which current and new articles address the "human vaccine"

Looks like Protein Sciences Inc. is another company I need to monitor.  It is not a publicly traded company yet, so I'll look out for possible "buy out" or IPO activity:

Here's the company link:

http://www.proteinsciences.com/
Give a man a fish, you feed him for a day - Teach a man to fish, you feed him for life.