3SOF

12 Extreme FDA Trades on New Product Decisions


Below are 12 companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.

See the BioMedReports.com FDA Calendar.

1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). 4/17/09 is date for FDA to accept the filing and rule on priority review request – if granted the PDUFA would be 8/17/09 instead of 12/17/09 for standard 10-month review.

2.) Discovery Labs (DSCO): Surfaxin (lucinactant) NDA for prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last May and submitted its complete response to the FDA in mid-October with an expected decision date of 4/17/09. The stock price dipped below a dollar after the FDA issued a six-month Class II review (as investors hoped for the shorter 60-day Class I review) for the NDA re-submission, but DSCO has rebounded sharply since that time and is up over 30% in the past few days and closed today at $1.72 per share.

3.) Northfield Labs (NFLD): PolyHeme BLA (priority review) for life-threatening red blood cell loss. The FDA accepted the Company's BLA for PolyHeme and granted a priority review in the treatment of life-threatening red blood cell loss with a PDUFA date of 4/30/09.

4.) Vanda Pharma (VNDA): The Company's iloperidone (formerly Fanapta) NDA resubmission is in response to a previous not approvable ruling by the FDA on 7/25/08. The PDUFA decision date for iloperidone as an atypical anti-psychotic treatment for schizophrenia is 5/6/09.

5.) Hemispherx Biopharma (HEB): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09.

6.) Acusphere (ACUS.PK): Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. Amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09.

7.) Arca biopharma (ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09. ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes.

8.) BioDelivery Sciences (BDSI): Onsolis (BEMA fentanyl) NDA Re-Submission for breakthrough cancer pain with an expected decision date of 6/15/09 and a $27M milestone payment if approved from partner Meda AB (MDABF.PK). Onsolis is a small/dissolving polymer delivery system with opiate painkiller fentanyl designed for quick absorption through the cheek.
BDSI submitted a Risk Evaluation and Mitigation Strategy (REMS) for Onsolis last December based on the feedback it received from a complete response ruling by the FDA in August 2008. Since the FDA has informed BDSI that all other aspects of the NDA review are complete, the prospects for Onsolis approval are excellent, with an approval decision possible by mid-June based on a Class II (six-month) review by the agency on the re-submission.

9.) Spectrum Pharma (SPPI): Zevalin sBLA (priority review) as consolidation therapy follicular B-cell non-Hodgkin's lymphoma if a first-line treatment response is achieved. Cell Therapeutics (CTIC) recently sold its 50% interest in a joint venture between the two companies to market Zevalin so SPPI owns a 100% stake in the cancer drug. A three-month delay in the PDUFA decision date to 7/2/09 was announced on 2/23/09 as SPPI submitted additional data to the FDA, which was classified as a major amendment to the sBLA filing
SPPI also has a pending sNDA for Fusilev (levoleucovorin) for Injection to expand use of the drug in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The PDUFA decision date for the sNDA is 10/8/09.

10.) Labopharm (DDSS): A decision date of 7/18/09 is looming for the Company's rapid-onset formulation of trazodone (DDS-04A) for the treatment of depression through the 505(b)(2) regulatory pathway for new formulations drugs that are already on the market.

11.) Transcept Pharma (TSPT): The decision date for Intermezzo (zolpidem sublingual lozenge) NDA for use as-needed for insomnia from middle of night awakenings is 7/30/09.

12.) Advanced Life Sciences (ADLS): ADLS has a pending NDA for cethromycin as a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia (CAP) with a decision date of 7/31/09. Also, the Anti-Infective Drugs Advisory Committee of the FDA is tentatively scheduled to meet on 6/2/09 to discuss the NDA for cethromycin.

  Breakout Stocks...Will They Trend Up Or Top Out? 

A healthy consolidation is often crucial for a stock emerging into a new trend. A consolidation occurs when a stock transitions from a trending move to a sideways trading range. These trading ranges serve a vital role in the life of the larger trend, as they allow for the exchange of hands from weak participants to stronger ones. This is healthy for a stock, as these new participants are less likely to get shaken out on typical market noise.

A sound base often takes time to develop, and quick or choppy bases often result in failed moves as there are still many participants from the prior trend anxious to take their profits. Once a stock emerges from a consolidation, the base will usually serve as a strong support or resistance level because that area is filled with other traders who missed the breakout and are anxious to avoid missing a second opportunity.

Computer Programs and Systems (Nasdaq:CPSI) is an example of a stock that has broken above a healthy consolidation. Notice how CPSI was consistently rejected by the $28.50 range on three separate attempts. Sellers were getting comfortable in this area and notice that once it was cleared, CPSI was able to climb over 20% fairly quickly. The only pullback was quickly met with buyers.


Sometimes a stock will gap out of one of these bases, surprising a large group of traders. First Solar (Nasdaq:FSLR) is a good example of what this looks like. Often this move will result in a breakaway gap, which can ignite a new trend and act as strong support moving forward. A breakaway gap is usually accompanied by a sharp increase in volume, revealing new interest and also how the participants on the other side of the trade were shocked into relinquishing their positions.


F5 Networks (Nasdaq:FFIV) is another example of a stock breaking out of a consolidation via a breakaway gap. It's interesting to note that the gap has yet to be filled after several days of trading. FFIV has been overbought for a few weeks without any considerable pullbacks, which further illustrates how the breakout often catches the other side by surprise.


Sohu.com (Nasdaq:SOHU) is a good example of how a consolidation can serve as support after a stock breaks out. SOHU was respecting the $50-$51 range as resistance while it consolidated for several months. It was able to decisively clear this area in late April, and quickly reversed back higher from the level when the stock pulled back to test it the next two sessions. While SOHU could easily pull back to test this area again, the stock should find eager buyers who missed the first run after the breakout.


Bottom Line
Most of the stocks above are overbought, which shouldn't be a surprise based on the sharp rally that has occurred in the general markets. Identifying promising trade candidates is only one step of a successful trading plan, and a trader must develop a methodology to weigh the risk and reward for each setup they take. What this type of analysis does accomplish, however, is to identify stocks that should be emerging into new trends higher. Each of these stocks is emerging from a consolidation in the direction of the prior trend and the path of least resistance favors a continuation move. A healthy consolidation provides the fuel necessary for a sustained move. Pullbacks should be met with buyers, and offer trading opportunities if the trend remains healthy. Do you think these stocks will continue to trend higher, or are they close to topping out? Let me know your opinion...     

Why We Love Wild Penny Stocks...

Penny stocks have huge potential -- that's their blessing and their curse.

The potential rewards are enormous. Just take a look at the returns from Diedrich Coffee (Nasdaq: DDRX)


Vanda Pharmaceuticals (Nasdaq: VNDA),


or Cell Therapeutics (Nasdaq: CTIC),


each of which has returned more than 500% over just the past six months! Neither traded for more than $0.65 per share six months back.

Those quick jumps look like easy gains, considering that CME Group (Nasdaq: CME)

and PotashCorp (NYSE: POT) would need to add more than $270 and $110, respectively, to their share prices to even double.

Everybody loves pennies
It's the potential of quick gains in "cheap" stocks that keeps investors coming back. We typed "penny stocks" into Google, and the search engine spat out "about 1,870,000" hits. We did the same for more time-tested terms such as "blue-chip stocks" and "dividend stocks" -- the terms folks should be searching for in a bear market like this -- and got just 232,000 and 594,000 hits, respectively.

Sure, we expected a discrepancy, but the size of the gap was startling. It became even more interesting when we broke down those hits with Google Trends. According to Trends, penny stocks are particularly alluring to investors in Tampa, Miami, and Orlando -- the locales where the term is most often searched.

We hope the folks Googling "penny stocks" down there aren't retirees trying to cope with this crazy, crazy market.

This stock is set to take off! Or not.
According to the Securities and Exchange Commission, the term "penny stock" generally refers to low-priced (below $5), speculative securities of very small companies. To quote the SEC: "Investors in penny stocks should be prepared for the possibility that they may lose their whole investment." (It's worth noting that the emphasis in that last sentence is in the original.)

Pay attention to the SEC's entire definition, not just the stock price. Going solely on price would wrongly categorize billion-dollar companies Office Depot (NYSE: ODP)

and Flextronics (Nasdaq: FLEX) as penny stocks.

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...Securities and Exchange Commission, the term "penny stock"
The term "penny stock" generally refers to low-priced (below $5), speculative securities of very small companies. While penny stocks generally are quoted over-the-counter, such as on the OTC Bulletin Board or in the Pink Sheets, they may also trade on securities exchanges, including foreign securities exchanges. In addition, penny stocks include the securities of certain private companies with no active trading market.

Before a broker-dealer can sell a penny stock, SEC rules require the firm to first approve the customer for the transaction and receive from the customer a written agreement to the transaction. The firm must furnish the customer a document describing the risks of investing in penny stocks. The firm must tell the customer the current market quotation, if any, for the penny stock and the compensation the firm and its broker will receive for the trade. Finally, the firm must send monthly account statements showing the market value of each penny stock held in the customer's account.

Penny stocks may trade infrequently, which means that it may be difficult to sell penny stock shares once you own them. Because it may be difficult to find quotations for certain penny stocks, they may be impossible to accurately price. Investors in penny stocks should be prepared for the possibility that they may lose their whole investment.

For more information, read the penny stock rules section of our Broker-Dealer Registration Guide. You may also want to review the penny stock rules (Securities Exchange Act Rules 3a51-1 and 15g-1 through 15g-100).

Before you consider investing in the stock of any small company, be sure to read our brochure, Microcap Stock: A Guide for Investors.


http://www.sec.gov/answers/penny.htm
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Regardless, the SEC is spot-on when it says that true penny stocks are among the surest ways to lose money in the stock market.

Well, then, why do we love penny stocks?
We love penny stocks because they're fascinating. The world of pennies is inhabited by hardworking average Joes and Janes hoping to strike it rich, as well as by pumpers and dumpers, hypesters and scammers. In pennies, the logic and reason that apply in the rest of daily life are replaced by zeal and prayer.

However, we don't love them enough to actually buy them. Yes, they have big potential, but their daily gyrations are unpredictable -- the stock price movements have next to nothing to do with the underlying company the stock represents. In fact, trading in pennies is highly illiquid, and prices are often manipulated by forces not at all related to the business.

The dangers of incredible promises
If you're buying stocks without paying attention to the businesses you're buying, then you might as well be buying a lottery ticket. Or, to use another analogy, you might as well buy up every baseball card of a benchwarmer on the Akron Aeros Class AA baseball team and hope that he someday rises up, fulfills his potential, and becomes an all-star for the big-league Cleveland Indians.

There's a better way                                                                 
Before you start saying the rest of the stock market is boring -- though you're probably not saying that any longer -- let us introduce you to some underfollowed small caps. They're nothing like penny stocks, yet they still offer some of the best returns on the market. Unlike penny stocks, promising small caps:

•File reliable financial statements
•Are transparent
•Have conference calls that individual investors can listen to
•Don't simply hype their stock in press releases

That's a starting point. There are more -- and more important -- criteria to help you find great small-cap companies.
for instance, look for a balance sheet with lots of cash and no debt, and a tenured CEO (or founder, if possible) who holds a substantial ownership stake in the business. In other words, we're looking for big returns with good old-fashioned bottom-up analysis.

Swine Flu getting worse.......

The number of swine flu cases worldwide has surpassed 20,000 after the U.S. reported over 1,000 new infections.

4 new swine flu deaths reported in U.S.
Virus expected to continue spread in Southern Hemisphere
msnbc.com news services
updated 6:15 p.m. CT, Thurs., June 4, 2009

Health officials in Wisconsin, California, Illinois and Utah reported deaths from swine flu on Thursday and said all four patients had had other health problems.

The Wisconsin death, of a Milwaukee adult, was the state's first from the H1N1 virus. City Health Commissioner Bevan Baker would not release any details except to say that the person had a common underlying health condition that he would not specify.

A 74-year-old man from Gurnee, Ill., died Tuesday, according to the Lake County Health Department. Officials said he had significant medical conditions that increased his vulnerability.

Officials in California said a 9-year-old Concord girl had been diagnosed with swine flu and had a bacterial infection before she died May 29. The patient who died in Utah also was under 18, according to Gary Edwards, executive director of the Salt Lake Valley Health Department.

Officials with the U.S. Centers for Disease Control and Prevention said Thursday that there have been 11,468 probable and confirmed swine flu cases in the U.S., including 770 hospitalizations. They've confirmed 19 deaths; the four announced Thursday are not yet included in the government's tally.

The swine flu epidemic peaked in Mexico, the center of the outbreak, in late April, and now has spread throughout the Northern Hemisphere. But it will continue to be a threat south of the equator, where countries are entering the winter months and traditional flu season, according to the CDC study, one of the most comprehensive yet on the effect of the virus on people.

South America already has had more than 600 cases, including one death in Chile, while Australia has reported more than 500.

On Thursday, Mexico had confirmed 5,717 cases, including 106 deaths, as scientists test a backlog of samples from patients.

Swine flu has hit more than 66 countries, with the United States reporting the most cases.

The CDC said children and adults under 60 are at greater risk of dying, judging from confirmed cases. One reason could be that younger people and children haven't built up immunities to seasonal flu as older people have. About one-third of U.S. adults aged 60 and older who were tested had antibodies from vaccines or exposure to other flu strains that could also keep them from contracting swine flu, the report said.

In Mexico, only 2 percent of confirmed cases have been 60 years old or older. But 42 percent of patients were under the age of 15 and 32 percent were between the ages of 15 and 29. The remaining 24 percent were aged 30-59.

term predictions for the epidemic difficult, the CDC said, but "data suggest the outbreak likely has moved beyond its peak nationally" in Mexico.

Mexico, like the United States, has struggled to keep up with laboratory testing to confirm suspected cases of the flu. The outbreak has led to a surge in testing at Mexico's National Laboratory from 30 specimens to 900 daily.

The CDC has praised Mexico for its response. Mexico ordered schools closed April 27 and then followed up with a five-day national shutdown of nonessential businesses to curb the spread of swine flu.

"I think in retrospect some people might look back and say, well, maybe that was extreme. But from the public health perspective, we would say in the face of uncertainty that's erring on the side of being safe," said Dr. Scott F. Dowell, who heads the CDC's international swine flu team.

http://www.msnbc.msn.com/id/30503740/

Selected Healthcare Sectors Buck Market Dip
the tickerspy.com Staff
On Monday June 8, 2009, 11:24 am EDT

Related:Aastrom Biosciences, Inc., Geron Corporation, Generex Biotechnology Corp.
The market started the week in the red, but there was money to be made in a handful of healthcare subsectors.

Equity markets are largely lower today as investors await the government's decision on allowing banks to return TARP funds. The selloff has put a number of sectors under a lot of pressure, some falling an aggregated -5%. The healthcare industry is bucking the trend today, showing pockets of strength in multiple subsectors.

The Swine Flu and Bird Flu Stocks Index is among the day's top performers. It is trading higher by 1%.

Hemispherx Biopharma (AMEX: HEB - News) is the top swine flu stock, adding 9% to its impressive 77% five-day rally. It is followed by Novavax (NASDAQ: NVAX - News), which is up by 3%.

Generex Biotechnology's (NASDAQ: GNBT - News) -11% drop is not enough to pull the index into negative territory.

The Cancer Stocks Index is up fractionally today. Less than half of the Index's 35 equities are trading higher today, but the top performers are showing massive gains.

Keyrx Biopharmaceuticals (NASDAQ: KERX - News) is leading the way with 28% gains. Monday morning the company announced positive results from the Phase 2 study of its Zenerex drug. According to the FDA, the results were strong enough to warrant moving on to Phase 3 trials.

XOMA (NASDAQ: XOMA - News) and Peregrine Pharmaceuticals (NASDAQ: PPHM - News) are also helping the Index higher with gains of over 7%.

The Stem Cell Stocks Index is also in positive territory today, up by 0.6%. As of this writing, five of nine of the Index's stocks are trading higher.

Geron (NASDAQ: GERN - News) is the best performer today, up by 6%.

Aastrom Biosciences (NASDAQ: ASTM - News), StemCells (NASDAQ: STEM - News), and Thermogenesis (NASDAQ: KOOL - News) are all in positive territory as well.

With the exception of the Dialysis and Kidney Disease Stocks Index, Pain Management Stocks, and Diabetes Stocks, the remainder of the tickerspy healthcare Indexes are down today.

Investors can follow these and other Indexes and view related performance charts and metrics at tickerspy.com.

Fun and informative, tickerspy.com is a free investing website where you can track multiple stock portfolios and compare against 250 proprietary Indexes tracking themes from nanotech to agriculture to precious metals. Best of all, tickerspy.com lets you spy on the portfolios of nearly 3,000 Wall Street institutions and hedge funds and see graphs of their performance. Try tickerspy.com today and find out how you stack up against investing legends like Warren Buffett!

I think those who keep selling the swine flu stocks will regret their actions soon.
I'm accumulatinig more stock on the cheap!




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
     

Swine Flu Stocks - Just Wait Until Fall

I've been watching some of the Swine Flu Stocks I initially covered right when the first cases were identified with a mixture of a) disbelief in the volatility and gains on little fundamental substance contrasted with b) envy that I didn't pick the right one(s) and let 'em ride.

Novavax (NVAX): If we take Novavax as an example, I had highlighted here in this Novavax CEO interview article that while the stock had rallied coming off the breaking news, much of it seemed to be based on hype and I postulated that the large pharmas with the existing capacity and approved technologies would likely get the lionshare of the tenders for vaccines. Following my post on 4/30, shares dipped as much as 40% within weeks and unfortunately, I didn't play it right and make any money on the call. However, subsequently, shares are now up 34% vs. the S&P rally of 15% even inclusive of that dip. For a high Beta stock like this, perhaps not to be unexpected even in lieu of any Swine Flu news, but not too shabby either.

Some Other "Swine Flu Stocks" over the prior 3 month period:

AVII is up 152%
BCRX is up 157%
VICL is up 59%
DVAX is up 59%
SVA is up 79%
Each of these has a particular niche or stake in a swine flu breakout worth investigating further. Some have more diverse pipelines and approved products that don't rely so heavily on swine flu hype, and SVA is a Chinese biotech which adds an additional emerging market/preferred local China supplier tilt to the equation.

My calls that still stand:


a) Most of these "swine flu stocks" will not be able to retain their gains once the dust has settled.

b) Some will continue to run due to a large tender award here and there (if there isn't enough capacity to go around from large pharma, some of these smaller players will inevitably get some tenders)

c) Anyone making predictions on just how virulent and contagious the swine flu will become this fall doesn't know what they're talking about - anything can happen.

d) The revenues derived by the large pharmas like GSK will likely not see a meaningful impact to their bottom line (above and beyond what is already baked in to committed orders) given the relative small impact to revenues - and vaccines in general are a low margin business compared to small molecule products sold in massive scale like typical blockbusters.

Swine Flu Investing Idea

Rather than throwing money after individual stocks which are subject to massive volatility, perhaps consider some speculative cash going toward several cheap way out of the money call options on multiple stocks. If just one or two of them hit, the gains of Thousands % on the couple options that hit will more than offset the inevitable declines/losses you'll see in expired options that didn't go anywhere. I wouldn't advise LEAPS or waiting until January expiry. I think it will be quite evident by the Nov. time period both how severe the pandemic becomes and also, how effective/available the existing supplies of vaccines are. If things go well, expect options to expire worthless and your speculative play lost 100%. If things don't go so well on any of the multiple fronts, at least some of these shares could continue to see triple digit rallies, sending options returns into the 4-digit realm easily given the leverage employed and low starting share/strike prices.

Companies Involved in the Treatment of Swine Flu

Introduction
On June 11, 2009, the World Health Organization (WHO) declared the swine flu (swine influenza) outbreak as a global pandemic (worldwide outbreak of disease).

To date, 28,774 confirmed cases of swine flu have been reported in 74 countries across the world, including 13,000 confirmed cases in the U.S. The disease has caused 144 deaths throughout the world, including 27 deaths in the U.S. The origin of the swine flu outbreak can be traced to Mexico, where the virus has reportedly killed and infected 108 and 6,241 people respectively (data as of June 11, 2009).

Recently there have been sporadic cases of swine flu reported in countries throughout the world.

This report discusses the details of the disease, the estimates (by the World Health Organization) on the extent of the spreading of the disease, the companies who are currently selling products that are being used to treat this disease and companies that have new flu treatments in their pipelines, which may also be used to target swine flu disease.

Companies with Existing Treatments for Swine Flu

Gilead Sciences, Inc./Roche Holding Ltd. (GILD/RHHBY.PK) - Tamiflu (oseltamivir)
GlaxoSmithKline Plc./Biota Holdings Ltd. (GSK/BTAHY.PK) - Relenza (zanamivir)
Companies with Potential Vaccines and Treatments for Swine Flu

Biota Holdings Ltd. (BTAHY.PK) and Daiichi Sankyo - CS-8958
BioCryst Pharmaceuticals, Inc. (BCRX) - Peramivir Intravenous
Novavax Inc. (NVAX) - swine flu vaccines by using Virus-like particle (VLP) technology
MedImmune, a unit of AstraZeneca PLC (AZN) - needle-free, nasal spray swine flu vaccine by using Live Attenuated Influenza Vaccine (LAIV) technology
Novartis AG (NVS) - swine flu vaccine
Sanofi-Aventis (SNY) - swine flu vaccine
Baxter International Inc. (BAX) - swine flu vaccine
What Is Swine Flu?
Swine flu is a highly infectious, severe respiratory disease that most commonly occurs in pigs (swine). This disease is caused by the H1N1 strain of the Type A influenza virus (see explanation below).

Though swine flu frequently occurs in swine and causes high levels of illness, it has rarely been known to kill the swine. The 2009 flu outbreak is being referred to as 'Swine Flu' because the form of this virus bears the closest resemblance to the swine flu virus. The 2009 'Swine Flu' is being caused by a modified H1N1 form of the Type A influenza virus, which is infecting humans and has been shown to be fatal in some cases.

The origin of this new strain of H1N1 virus is still unknown, although most hypotheses point to the swine as being the originator of this new mutated (undergone changes in its structural composition) virus strain.

There are 3 types of influenza virus: Type A, Type B and Type C.

Type A influenza virus can cause flu in humans, animals and birds. It is the most infectious type of influenza virus, and is responsible for regular outbreaks.

Type B influenza virus infects only human beings. It causes a less severe infection than the Type A virus and does not cause outbreaks.

Type C influenza virus is able to infect only humans and animals; however, the flu in humans caused by this type of virus is very uncommon, as compared to Type A and Type B. It does not cause outbreaks.

Further explanations (i.e., why Type A can cause an outbreak while Type B and Type C cannot), descriptions, differences and unique characteristics of each of the aforementioned types of influenza virus are discussed later in the report.

The Type A influenza virus consists of two proteins called hemagglutinin (H protein) and neuraminidase (N protein). There are 16 types of H proteins (H1 to H16) and 9 types of N proteins (N1 to N9). Depending upon the combination of the types of H and N protein, there are various subtypes of the Type A influenza virus, like H1N1 (swine flu), H5N1 (avian flu) etc. The table below lists the various subtypes of the Type A influenza virus that have been found in humans, animals and birds.
In Humans: H1N1, H1N2, H2N2, H3N2, H5N1, H7N2, H7N3, H7N7, H9N2, H10N7
In Animals: Pigs: H1N1, H1N2, H3N2 Horses: H3N8, H7N7
In Birds: H1N1, H1N8, H2N9, H3N2, H3N8, H4N3, H4N6, H5N1, H5N9, H6N1, H6N2, H6N5, H6N8, H7N1, H7N3, H7N7, H8N4, H9N2, H9N6, H10N7, H10N8, H11N6, H11N9, H12N5, H13N6, H14N4, H15N4, H15N9
The swine flu virus (the H1N1, H1N2 and H3N2 subtypes of the Type A influenza virus) seldom infects human beings. The previously reported human cases of swine flu were confined to those who had direct contact with pigs, like people working in the swine industry. However, the current outbreak of swine flu in the human population in Mexico and the U.S is caused by an entirely new and mutated strain of the Type A influenza H1N1 virus, which has never been detected before.

It is theorized that the virus responsible for the current 'Swine Flu' outbreak is actually a mixture of the 3 types of H1N1 virus that are found in birds, pigs and humans (see table above). This new strain of the H1N1 virus does not appear to infect pigs, but is infecting only humans. The major concern is its ability to spread from one person to another. The disease started in Mexico, crossed the U.S. border and now threatens to develop into a pandemic. The World Bank estimates that a worldwide flu pandemic could cost approximately $3 trillion.

Despite being different, the virus responsible for the current outbreak shares the same name as the swine flu virus because after the initial analysis of the first few cases, this virus had shown many similar characteristics as that of the swine flu virus. Further analysis subsequently has revealed that the virus also contains some elements of the bird flu and the human flu virus.

On June 11th, 2009, the World Health Organization (WHO) raised the alert to Phase 6, declaring the swine flu as a global pandemic. This is the first influenza pandemic since 1968. The WHO is a United Nations agency that works to strengthen health activities and improve health services internationally. It has a numbered alert level scale, ranging from Phase 1 to Phase 6, which measures the spread and severity of infectious diseases like swine flu. An increase in the number of phase indicates an elevated risk of mass outbreak. The details of the phase alerts are as follows:

Phase 1: There are various flu viruses that circulate among animals. A Phase 1 alert indicates that the virus is circulating amongst animals but it does not cause any human infections.

Phase 2: Indicates that a flu virus in animals can also cause human infections and therefore is considered as a potential pandemic threat, but with low risk.

Phase 3: Indicates that the flu virus causes infection in humans, but there is no report of human-to-human transmission.

Phase 4: Indicates that the virus has a persistent ability to pass from one human being to another and is able to cause outbreaks in certain communities. It denotes a significant increase in pandemic threat.

Phase 5: Indicates that the virus easily spreads from human-to-human and has affected at least two countries in one region of the world. It gives a strong pandemic alert signal.

Phase 6: Indicates that the virus spreads from one country to another country located in different regions of the world, denoting an outbreak of pandemic.

Transmission of the Swine Flu Virus
Swine flu is a highly contagious disease and can directly transmit from an infected human to a healthy person. The human-to-human transmission of the swine flu virus occurs through air. When a swine flu infected person coughs or sneezes without covering his/her mouth and nose, the virus containing bodily fluid in the form of respiratory droplets (drops of moisture expelled from the nasal passages, mouth and throat) enter the air. When this air is inhaled by healthy individuals, the virus enters into his/her body through the respiratory tract.

Sometimes the infection spreads by touching some objects with the virus on their surface and then touching the mouth or nose. It can be noted that the virus does not spread by eating properly handled and prepared pork (pig meat), which is cooked at 160°F temperature.


Structure and Classification of the Influenza Virus
Almost all the round shaped influenza viruses consist of two parts: inner core and outer envelope

Inner core: The inner core comprises of the virus' genetic material called ribonucleic acid (RNA), which is responsible for the replication process of the virus. The RNA of the virus is found inside a protein called nucleoprotein (also called the structural protein of the virus) that helps in the viral replication process, as well as in selecting the proper host (such as a human, animal or bird cell) where the virus can attach itself and cause an infection.

Outer envelope: The outer envelope is made up of lipids (a type of fat) and proteins. In the Type A and the Type B influenza viruses, the two proteins (called surface proteins), namely H protein and N protein, are present in the lipid layer. In place of H and N surface proteins, the Type C influenza virus contains a different surface protein called glycoprotein 88 (gp88). The surface proteins help the virus to cause the infection in the host cell.

The classification of the influenza viruses into the three categories, namely Type A, Type B and Type C, is based on the type of nucleoprotein present in the inner core of the virus. The different types of influenza viruses have different nucleoproteins.

The Type A influenza virus can be classified into various subtypes, based upon the composition of the two surface proteins, H protein and N protein. As per the various combinations of the 16 types of H and 9 types of N proteins that have been identified till date, there are several subtypes of the virus, namely H1N1, H5N1 and others. All these subtypes can further be classified into different strains (the viruses belonging to the same subtype but with slight changes in the structure).

In contrast to the Type A influenza virus, the Type B and the Type C do not have subtypes, however, they also undergo small changes that results in the formation of a new strain of virus. The formation of subtypes and strains depend upon the ability of the virus to mutate. There are two specific ways by which the influenza virus mutates: Antigenic drift and Antigenic shift.

Antigenic drift – The Influenza viruses undergo small and steady changes in a part of the RNA that has the information of making the surface proteins (H protein and N protein in case of the Type A and B virus; gp88 protein in case of the Type C virus). These changes result in minor alterations in the structure of the surface proteins, resulting in the formation of new strains of the virus. This process is called antigenic drift. All types of influenza viruses (A, B and C) undergo antigenic drift.

Antigenic shift – This is a sudden and abrupt change in the virus that results in the formation of a new form of the virus. It is only the Type A influenza virus (and not B and C) that can undergo an antigenic shift. The Type A influenza virus is able to infect humans, animals as well as birds. Some animals, like pigs, catch the bird flu virus (the Type A influenza virus that normally affects birds), the human flu virus (the Type A influenza virus that normally affects humans) and the pig flu virus (the Type A influenza virus that normally affects pigs). As a result, inside a pig, all the three types of the A influenza viruses meet and can form an entirely new kind of the Type A influenza virus, which has a mixture of the surface proteins of the three original viruses.

This is what is theorized as the origin of the current swine flu outbreak. The causative Type A influenza virus is an entirely new virus and is a mixture of the three Type A influenza viruses that are found in birds, pigs and humans.

Reason Why Only the Type A Influenza Virus Causes Pandemics
Despite the fact that all the three types of influenza viruses can infect humans, it is only the Type A influenza virus that is capable of causing pandemics in the human population. Excluding the current swine flu pandemic (as declared on June 11, 2009 by WHO), the world has suffered three other flu pandemics, which are as follows:

The 1918 pandemic – This flu pandemic was the most severe one, which killed at least 675,000 people in the U.S. and 50 million people worldwide. It was caused by the H1N1 subtype of the Type A influenza virus. This virus originated in birds and mutated itself enough to acquire the ability to infect humans. The disease was first officially acknowledged in Spain in May 1918. In the early months of 1918 (the final year of World War I), a wave of flu appeared in the military camps all over U.S., France and Southern China. However, the news of the flu outbreak in these countries was censored for security reasons since these countries were involved in the war. The news of the outbreak spread around the world, only when the disease appeared in Spain, which was a neutral player in Word War I. Spain did not censor the news of the outbreak and the Spanish press documented the disease in detail.

The 1957 pandemic - This flu pandemic was moderately severe compared to the 1918 pandemic and it took 70,000 lives in the U.S. and killed 1 million to 2 million people worldwide. This was caused by the H2N2 subtype of the Type A influenza virus, which originated in birds, then eventually mutated and infected humans. This flu originated in China.

The 1968 pandemic – This flu pandemic was the least severe one amongst all three, causing at least 34,000 deaths in the U.S. and 700,000 deaths all over the world. It was caused by the H3N2 subtype of the Type A influenza virus, which also had a bird origin. This disease began in Hong Kong.

As opposed to Type B and Type C, the Type A influenza virus can cause a pandemic because it affects humans, pigs as well as birds. So along with undergoing a frequent and continuous antigenic drift, it has an ample chance of undergoing an antigenic shift, with different strains of the virus combining inside a host. An antigenic drift of the Type A influenza viruses is much easier to control than an antigenic shift.

An antigenic drift produces new strains of the subtypes of the Type A influenza virus. The human population has already been exposed to flu caused by these subtypes of the Type A influenza virus.

Thus, the entire genetic information of the virus is known, and has been used to develop preventive flu vaccines. The newly formed strain would be a result of an antigenic drift and just a slightly changed version of the subtype of the Type A influenza virus. Thus, the infections from these new strains can be controlled by using the already available preventive flu vaccines.

The only drawback is that the person needs to be vaccinated every year because as the virus undergoes an antigenic drift, a new strain is formed replacing the older strains against which the people had been previously vaccinated.

As a result, the immune system cannot recognize this new strain and an infection from this strain can occur in the body. This is why people often get infected with flu even though they have been vaccinated. It's because a new strain has developed and is attacking the body.

To overcome this problem, the government keeps a constant watch on the possible strains of the viruses that might cause an infection in the next flu season (November to March) and notifies the vaccine manufacturers about these strains so that the manufacturers can include the specified strains in the vaccines that are to be produced for the next flu season.

An antigenic shift results in the formation of an entirely new Type A influenza virus, which has never attacked the human population before. Therefore, the complete genetic information about this virus is unknown and there is no preventive vaccine available against this newly formed virus. Since human beings are exposed to this virus for the first time, their immune system does not have the mechanism to resist the virus.

In addition, the new Type A influenza virus formed after an antigenic shift generally is highly contagious for humans because it becomes airborne and thus, can spread from person to person by just a cough or a sneeze. This significantly increases the chances of the disease turning into a pandemic. Thus, an antigenic shift of the influenza virus is significantly more dangerous and problematic than an antigenic drift.

Even though the Type B influenza virus, shares a very similar structure (in respect to the surface proteins) to the Type A, it is less dangerous and causes milder illnesses, as compared to the Type A influenza virus. This is due to the fact that the Type B virus exclusively infects humans, so there is no chance for it to undergo an antigenic shift.

Thus, the Type B influenza virus can only undergo an antigenic drift, which occurs slowly in this virus and can be treated with minor modifications to the existing vaccines.

The Type C influenza virus infects animals but rarely infects human beings. The surface protein composition of this virus is entirely different from the Type A and the Type B. It contains only one surface protein, the gp88 protein, as compared to the two (H protein and N protein) proteins in the two other types of influenza viruses. The gp88 protein is much more stable than the H and N proteins and rarely undergoes any variation. There has been no report of any antigenic shift in this virus and even though it undergoes antigenic drift, it does so at a very slow rate.

The lack of possibilities of an antigenic shift in the Type B and C influenza viruses makes it practically impossible for them to cause a pandemic.

How Does the Swine Flu Virus Work?
In order to cause a viral infection, the virus must first enter a human cell. For doing so, the virus must locate a site (known as a receptor), which it can bind to and attach itself. In case of swine flu, a sugar molecule called sialic acid, which is present in the mucous membrane, acts as the receptor for the virus. (The mucous membrane is a group of cells that covers and lubricates the various passages and cavities exposed to air, including the mouth, nose and inner portion of the eyelids).

Thus, the Type A influenza virus causing swine flu enters the human body through the mucous membranes of the mouth, eyes or nose.

The swine flu virus consists of two proteins called hemagglutinin (H protein) and neuraminidase (N protein) on its surface. The H protein of the virus attaches itself with sialic acid in the mucus membrane. This binding of H protein with sialic acid permits the entry of the virus into the human cell.

Once inside the human cell, the virus releases its genetic material, called ribonucleic acid (RNA), which starts the production of new copies of the swine flu virus inside the body.

The virus reprograms the human cell to make viral proteins. By using the viral proteins synthesized inside the human cell, the swine flu virus multiplies rapidly and new copies of the virus are produced. Thus, the infected cell essentially becomes a virus-producing factory.

These newly synthesized swine flu viruses leave the infected human cell with the help of N protein and go on to infect the adjacent healthy cells.

The Current Effective Treatments for Swine Flu
Based on the U.S. government's declaration on April 26, 2009, that swine flu is a public-health emergency, on April 27, 2009, the U.S. Food and Drug Administration (FDA) recommended the off-label use of the existing flu drugs, Tamiflu (oseltamivir) by Gilead Sciences, Inc./Roche Holding Ltd. (GILD/RHHBY) and Relenza (zanamivir) by GlaxoSmithKline Plc./Biota Holdings Ltd. (GSK/BTAHY.PK) for the treatment and/or the prevention of an infection with the swine flu virus.

The U.S. government has released 25% (12.5 million dosages) of these drugs from the National Stockpile as a response to the swine flu outbreak.

Tamiflu: A pill, is approved as a treatment and a prevention of flu for individuals, who are over the age of 1, while Relenza, an inhaled drug, is approved for the treatment of flu for individuals who are over 7 years old and for the prevention of flu in individuals who are over 5 years old.
Off-label use: A physician's practice of prescribing a drug or medical device for indications beyond those approved by the FDA. For example – the drugs can be used beyond their approved age groups like Relenza can be given as a treatment for children under the age of 7, even though that is not included in its FDA approved label.
National stockpile: The U.S. government piles few million antiviral drugs as part of public health preparedness for a pandemic. This is called National Stockpile. At present, the U.S. government has 50 million anti-viral treatments in its National Stockpile.
Both Tamiflu and Relenza seem to be effective in improving the symptoms of swine flu. Additionally, the use of these drugs also helps to stop the spreading of the swine flu virus. However, these drugs are most effective when taken at an early stage (within 48 hours of the start of flu-like-symptoms).

Disadvantages of the Current Effective Treatments
Both Tamiflu and Relenza cannot be used as preventive therapies for the entire population. Unlike a flu vaccine, these drugs do not provide long-term protection and can be used as a preventive therapy only in short-term situations for people who are at increased risk of complications from swine flu.

Additionally, these drugs should be administered within a stipulated time period (within 48 hours of the start of flu-like-symptoms). This is important because the late initiation of treatment can reduce the efficacy of the drugs.

Moreover, there are dangers of the individual's development of resistance against these drugs, whereby these drugs will not be effective anymore.

No Vaccine Against Swine Flu
Currently, there are no vaccines available in the market, which can specifically give protection against swine flu. The currently approved flu vaccines like Afluria (made by CSL Limited), Fluarix (made by GlaxoSmithKline Biologicals, a subsidiary of GSK), FluLaval (made by ID Biomedical Corporation, a subsidiary of GSK), FluMist (made by MedImmune Vaccines Inc., a subsidiary of AstraZeneca Plc./AZN), Fluvirin (made by Novartis Vaccines and Diagnostics Limited, a subsidiary of Novartis AG/NVS) and Fluzone (made by Sanofi Pasteur Inc., a subsidiary of Sanofi-Aventis/SNY), will not be effective in preventing swine flu because these vaccines have been developed using the genetic information and details of the existing seasonal flu viruses.

Swine flu is caused by an entirely new virus that people have not been exposed to before. Mostly healthy adults are at risk of suffering from the serious complications of swine flu. The entire genetic information of swine flu is yet to be made available, hence, any effective vaccine development will at least take 4 - 6 months.

Upcoming Drugs for Flu: Potential Treatments of Swine Flu
CS-8958by Biota Holdings Ltd. (BTAHY.PK) and Daiichi Sankyo
Status: Phase III trial.

In March 2009, BTAHY.PK reported the completion of the enrollment process of the Phase III trial of CS-8958.

Mode of Administration: Inhaled

Mechanism of Action:

The flu virus attacks the human cells, multiplies and ultimately releases itself from the infected cells and infects new ones.

A protein, called viral neuraminidase, present on the surface of the virus enables the virus to get released from the infected cells.

CS-8958is a drug that inhibits the functioning of viral neuraminidase, thereby inhibiting the release of the virus from the infected cells.

Advantages of CS-8958:

In contrast to existing drugs like Tamiflu, which needs twice-daily oral administration for 5 days, and Relenza, which require twice-daily inhalation for 5 days, CS-8958 needs to be inhaled only once.

Peramivir Intravenous by BioCryst Pharmaceuticals, Inc. (BCRX)
Status: Phase II trial

In October 2008, the company reported positive data from the Phase II trial of Peramivir Intravenous.

Mode of Administration: Intravenous (injected in the vein) injection.

Mechanism of Action:

Peramivir Intravenous inhibits the functioning of viral neuraminidase, thereby inhibiting the release of the virus from the infected cells.

Advantages of Peramivir Intravenous:

Existing drugs like Tamiflu (which requires oral administration) and Relenza (which is inhaled) are difficult to be administered in unconscious flu patients. In contrast, Peramivir Intravenous is injected, hence, can be easily administered in unconscious patients.

Companies with Drugs that Potentially Target the Swine Flu Outbreak
The pharmaceutical and biotechnology companies that play an active role in the flu treatment and prevention market are expected to experience a substantial increase in the sales of their drugs if the outbreak of swine flu continues and the demand for the antiviral drugs, vaccines and other preventive measures increases drastically.

Roche Holding Ltd. (RHHBY.PK): It is a large-cap pharmaceutical company that focuses on the development and marketing of a wide range of pharmaceutical and diagnostic products. The company develops and markets Tamiflu, which is a drug approved for the treatment and the prevention of flu in individuals who are over 1 year old. Gilead Sciences, Inc. (GILD) co-develops Tamiflu and receives a 20% royalty on the net sales of the drug. RHHBY reported sales of approximately $349 million for the three months ended on March 31, 2009, for Tamiflu. RHHBY has increased the production of Tamiflu as the FDA has authorized the off-label use of Tamiflu for the treatment of swine flu.

GlaxoSmithKline Plc. (GSK): A large-cap pharmaceutical company, which is focused on the discovery, development and marketing of a variety of pharmaceutical and consumer health-related products. GSK in collaboration with Biota Holdings Ltd. (BTAHY.PK) develops and markets Relenza, which is approved as the treatment of flu for individuals who are over 7 years of age and as the prevention of flu in people, who are over 5 years old. GSK reported sales of approximately $462 million for the three months ended on March 31, 2009 for the drug. The FDA has authorized the emergency off-label use of Relenza for the treatment of swine flu, resulting in an escalated production of Relenza.

Biota Holdings Ltd. (BTAHY.PK): A pharmaceutical company that focuses on the development of drugs and vaccines for the treatment and the prevention of infections. In collaboration with Daiichi Sankyo of Japan, the company is developing a dry powder inhaled drug CS-8958 for the treatment of flu. The drug has been found to possess long-acting properties against the influenza virus and is also expected to work against swine flu virus.

BioCryst Pharmaceuticals Inc. (BCRX): A biotechnology company focused on the development of drugs for cancer, viral infections and immune system diseases. The company is developing Peramivir Intravenous, an antiviral drug for the treatment of flu.

Novavax Inc. (NVAX): The company focuses on developing vaccines for infectious diseases, using its proprietary technology platform known as virus-like particle (VLP) technology. This vaccine technology is one of the fastest methods for creating a vaccine, which is expected to successfully target the unmet market need for swine flu vaccine.

Virus-like particle (VLP) technology: By using this technology, a virus like particle (VLP) is made, which is structurally similar to the targeted virus (the live, disease-causing virus, against which a vaccine is being made) but does not contain the particular genetic information of the virus that is necessary for the viral replication process. When the VLP is injected into the body, it enters the human cells, just like a natural live virus. Since the VLPs look like the live virus, the immune system recognizes them as foreign, becomes activated and starts acting against them. Once the immune system gets exposed to and activated against a dummy virus (the VLP) it is able to recognize the virus if there's ever any future contact and mounts a strong attack against it at that time. Since, the VLPs resemble the live disease-causing virus, the immune system (which has been already exposed to the VLP) easily recognizes them as foreign and launches a powerful attack, when the actual live virus attacks the body.

Since, the VLP does not contain any genetic information necessary for the viral replication process, the dummy virus cannot replicate itself in the body so it does not pose any threat of infection to the person being vaccinated.

MedImmune, a unit of AstraZeneca PLC (AZN): MedImmune, wholly owned by AZN is focused on infection, cancer, respiratory diseases, inflammation, cardiovascular and gastrointestinal disease. The company is developing a needle-free, nasal spray swine flu vaccine by using its Live Attenuated Influenza Vaccine (LAIV) technology.

Live Attenuated Influenza Vaccine (LAIV) technology: By using this technology, a needle-free, nasal spray flu vaccine is made. This vaccine delivers live flu virus strains that are weakened so as not being able to cause the disease but prompt the recipient's body to produce an immune response against the virus.

Novartis AG (NVS): A multinational pharmaceutical company is developing swine flu vaccine. On June 12, 2009, NVS announced that it has produced the first batch of its swine flu vaccine, which will now be forwarded for pre-clinical testing and is also being considered for use in human clinical trials.

Sanofi-Aventis (SNY): A pharmaceutical company that focuses on enhancing the life of humans by providing medicines, vaccines and integrated health care solutions for cardiovascular, metabolic diseases, oncology, central nervous system disorders (the brain and the spinal cord disorders) and vaccines. Its vaccine unit has begun the development of swine flu vaccine.

Baxter International Inc. (BAX): This is a pharmaceutical company focused on the development and marketing of products for immune disorders, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. The company makes both seasonal and pandemic vaccines and has shown considerable interest in the development of a vaccine for swine flu.

3M Company (MMM): A diversified technology company with a wide portfolio of products and services (including health care products) to serve customers. The health care segment focuses on providing medical and surgical supplies, skin health and infection preventive products and dental products. The company makes protective face masks (marketed as N95 respirators), which are currently being used by people to prevent swine flu. This mask can effectively filter the virus from the air and prevent people from contracting the disease.

Financial Data
(Data as on May 4, 2009, the initial report date)

Roche Holding Ltd. (RHHBY.PK)

Stock Price as on May 4, 2009: $31.86

Market Cap as on May 4, 2009: $109,917.00

52 weeks Range: $26.01 - $93.41

Revenue FY08 ($MM): $39,772.40

EPS FY08: +$2.23

Cash Per Share: $5.26

R&D FY08 ($MM): $7,711.80


Gilead Sciences, Inc. (GILD)

Stock Price as on May 4, 2009: $44.90

Market Cap as on May 4, 2009: $40,865.29

52 weeks Range: $35.60 - $57.63

Revenue FY08 ($MM): $5,335.75

EPS FY08: +$2.10

Cash Per Share: $3.83

R&D FY08 ($MM): $721.76


GlaxoSmithKline Plc. (GSK)

Stock Price as on May 4, 2009: $30.95

Market Cap as on May 4, 2009: $80,160.50

52 weeks Range: $27.15 - $49.48

Revenue FY08 ($MM): $36,450.20

EPS FY08: +$2.64

Cash Per Share: $4.02

R&D FY08 ($MM): $5,247.80


Biota Holdings Ltd. (BTAHY.PK)

Stock Price as on May 4, 2009: $2.50

Market Cap as on May 4, 2009: N/A

52 weeks Range: $0.60 - $4.95

Revenue FY08 ($MM): N/A

EPS FY08: N/A

Cash Per Share: N/A

R&D FY08 ($MM): N/A


BioCryst Pharmaceuticals Inc. (BCRX)

Stock Price as on May 4, 2009: $3.08

Market Cap as on May 4, 2009: $118.06

52 weeks Range: $0.85 - $4.89

Revenue FY08 ($MM): $56.56

EPS FY08: -$0.65

Cash Per Share: $1.62

R&D FY08 ($MM): $73.32


Novavax Inc. (NVAX)

Stock Price as on May 4, 2009: $1.68

Market Cap as on May 4, 2009: $115.68

52 weeks Range: $0.52 - $3.88

Revenue FY08 ($MM): $1.06

EPS FY08: -$0.53

Cash Per Share: $0.50

R&D FY08 ($MM): $24.33


Sanofi-Aventis (SNY)

Stock Price as on May 4, 2009: $29.27

Market Cap as on May 4, 2009: $79,907.10

52 weeks Range: $23.95 - $39.68

Revenue FY08 ($MM): $38,233.00

EPS FY08: +$1.95

Cash Per Share: N/A


R&D FY08 ($MM): $6,069.90


Baxter International Inc. (BAX)

Stock Price as on May 4, 2009: $50.08

Market Cap as on May 4, 2009: $30,299.40

52 weeks Range: $46.63 - $71.53

Revenue FY08 ($MM): $12,348.00

EPS FY08: +$3.16

Cash Per Share: $2.74

R&D FY08 ($MM): $868.00


3M Company (MMM)

Stock Price as on May 4, 2009: $58.48

Market Cap as on May 4, 2009: $40,607.34

52 weeks Range: $40.87 - $79.89

Revenue FY08 ($MM): $25,269.00

EPS FY08: $4.89

Cash Per Share: $2.70

R&D FY08 ($MM): $1,404.00


AstraZeneca Plc. (AZN)

Stock Price as on May 4, 2009: $35.99

Market Cap as on May 4, 2009: $52,185.50

52 weeks Range: $29.96 - $49.85

Revenue FY08 ($MM): $31,601.00

EPS FY08: +$4.20

Cash Per Share: $3.10

R&D FY08 ($MM): $5,013.00


Novartis AG (NVS)

Stock Price as on May 4, 2009: $38.58

Market Cap as on May 4, 2009: $87,190.80

52 weeks Range: $33.34 - $61.30

Revenue FY08 ($MM): $42,584.00

EPS FY08: +$3.59

Cash Per Share: $3.43

R&D FY08 ($MM): $7,217.00

Swine Flu vs. Seasonal Flu
Seasonal Flu
Description in Short: Outbreak of flu that follows a predictable seasonal pattern and occurs almost every year, usually from November to March.

Symptoms: Fever, headache, tiredness, dry cough, sore throat, runny nose and muscle pain.

Market Size: U.S.: Approximately $2 billion annually

Patient Population: U.S.: Approximately 226,000 cases annually

Individuals at Risk: Old, very young and those individuals with chronic illnesses

Number of Deaths:

Worldwide: 250,000 – 500,000 people annually
U.S.: Approximately 36,000 people annually
Availability of Preventive Vaccines:

Six approved flu vaccines - Afluria (made by CSL Limited), Fluarix (made by GlaxoSmithKline Biologicals, a subsidiary of GSK), FluLaval (made by ID Biomedical Corporation, a subsidiary of GSK), FluMist (made by MedImmune Vaccines Inc., a subsidiary of AZN), Fluvirin (made by Novartis Vaccines and Diagnostics Limited, a subsidiary of NVS) and Fluzone (made by Sanofi Pasteur Inc., a subsidiary of SNY)

Available Treatments:

Tamiflu by GILD/RHHBY and Relenza by GSK/BTAHY.PK
Swine Flu
Description in Short: Sudden outbreak of a new type of flu, which has never occurred before

Symptoms: High fever (103-105°F), cough, sore throat, runny nose, nasal congestion, body aches, headache, chills, lack of appetite and fatigue, nausea, vomiting, diarrhea and dehydration

Market Size:

Estimated** U.S.: Approximately $120 billion

Patient Population:

Current:

Worldwide: 28,774 confirmed cases
U.S.: 13,000 confirmed cases
Estimated**

Worldwide: Approximately 1.5 billion cases
U.S.: Approximately 90 million
Individuals at Risk: Everyone, including young and healthy individuals who are not suffering from any kind of chronic illnesses

Number of Deaths:

Current*

Worldwide: 144 deaths
U.S.: 27 deaths
Estimated**

Worldwide: Approximately 70 million
U.S.: Approximately 2 million
Availability of Preventive Vaccines: None

Available Treatments: Tamiflu by GILD/RHHBY and Relenza by GSK/BTAHY.PK are being used off-label but no treatment that is specifically intended or indicated for the disease.

*Data as of June 11, 2009

** An estimate by the World Health Organization (WHO).

Effects on the Economy Due to Swine Flu
The swine flu outbreak poses a potential threat to the global economy. The world economy is currently suffering from the worst financial crisis in decades. If there is a widespread outbreak of swine flu pandemic, it is expected to cost approximately $3 trillion (an estimate by the World Bank), triggering a new threat to the already crippled economy.

The travel and tourism and airlines industries may undergo a major hit due to the outbreak of swine flu. All U.S. citizens have been asked to avoid nonessential travel to Mexico. The European Union has urged its citizens to avoid visiting affected parts of the U.S. and Mexico. Thailand, Australia, Japan and Singapore are certain countries that are screening travelers from North America for the disease. Hong Kong, Russia and Taiwan will quarantine visitors with flu-like symptoms.

The food industry has also been affected by the outbreak of the disease. The U.S. is a major exporter of pork. Many countries such as China and Russia, which are major importers of pork and pork products, have banned imports from the U.S.

Swine Flu vs. Bird Flu
Among the recent outbreaks of flu across the world, avian (bird) flu is a notable one and has been caused by the Type A influenza virus. Birds have been reported to be attacked by various subtypes of the Type A influenza virus including H1N1, H1N8, H2N9, H3N2, H3N8, H4N3, H4N6, H5N1, H5N9, H6N1, H6N2, H6N5, H6N8, H7N1, H7N3, H7N7, H8N4, H9N2, H9N6, H10N7, H10N8, H11N6, H11N9, H12N5, H13N6, H14N4, H15N4 and H15N9. However, all these subtypes are not responsible for causing severe infection in birds. Out of all these viruses, the H5N1 subtype of the Type A influenza virus is the most infective type, which caused serious avian flu and killed millions of poultry globally. An outbreak of avian flu was first reported in Asia in mid-2003.

There have been reports (predominantly in Asia), of the H5N1 virus spreading from birds to humans, primarily in people working closely with birds. Since 2003, there have been approximately 421 human cases of avian flu worldwide, which have resulted in 257 deaths. In the U.S, while the H5N1 virus caused outbreaks amongst poultry in 2003 and 2004, there was only one human infection reported in 2003. The symptoms of avian flu include fever, cough, sore throat, muscle aches, eye infections, pneumonia and respiratory problems.

The current swine flu outbreak is anticipated to be much more severe than avian flu because in the case of avian flu, the human-to-human transmission was very rare, whereas in case of swine flu, the virus has the ability to spread from one person to another, posing a high risk of a pandemic.

Swine Flu vs. Mad Cow Disease
Mad cow disease is an infectious, fatal disease in cattle that affects the brain of the animals. The causative agent of this disease is an abnormal protein called prion that destroys the brain tissues of the animals, making sponge like holes in parts of the brain, ultimately causing their death. The disease was first reported in the United Kingdom (UK) in 1986, which was followed by many European countries. Canada reported its first incident of mad cow disease in May 2003, followed by another incident in Washington in the U.S. in December 2003.

Humans get infected if they eat the diseased tissues of the infected cattle and develop the human form of the disease called Creutzfeldt-Jakob disease (CJD). The first case of CJD was identified in the UK in 1996. This disease is rare in human beings and approximately 200 people are known to die from CJD annually in the U.S. The symptoms include depression, anxiety, memory lapses, social withdrawal, lack of sleep, visual disturbances, fatigue and bizarre behavior.

CJD is not caused by any virus or bacteria. It is caused by an infectious protein and does not appear to get transmitted from person to person. Additionally, CJD is not contagious.

What Are the Steps to Prevent Swine Flu?
Frequent hand washing – Frequent washing of hands with soap and water is a highly recommended measure to combat swine flu because the swine flu virus can be contracted by touching objects contaminated by the virus. Since, it's unknown about how long the swine flu virus can survive on surrounding objects, it's highly recommended to have frequent hand washes.

Masks – Wearing a mask that is capable of protecting against infections can help prevent swine flu because it prevents the virus from entering the body via the respiratory tract.

Cover the mouth and nose during coughs and sneezes – Cover the mouth and nose by a tissue while coughing and sneezing and avoid touching the mouth and nose with one's hands because the swine flu virus is transmittable through the respiratory droplets of an infected person. This is important because an individual carrying the swine flu virus can be contagious for several days before showing any symptoms of the infection. The tissue, once used should be thrown away in the garbage immediately.

Stay at home – In case a person feels sick with flu-like symptoms, he/she should stay at home and not go to work, school and any social gathering. If the condition worsens, then he/she should contact a healthcare provider or a hospital emergency room. In this way, the infection can be prevented from spreading to others.

Avoid close contact as much as possible with people who are sick – Healthy individuals should avoid coming close to infected ones, which is a method of preventing the spread of the infection.

Conclusion

The current outbreak of the swine flu virus has reached a serious pandemic threat because it is a mutated form of a virus for which there are no specific preventive or curative treatments till date.

To make matters worse, the disease is highly contagious and can be spread from person to person via the airborne method. Current treatments for the disease include off-label use of some existing seasonal flu drugs but there are companies that are in the process of developing a treatment that is specifically indicated and targeted towards swine flu.

Until a definitive treatment is developed for this disease, the only solution is prevention and control.

Some of Today's Gainers...

The Bottom Line...
The markets are once again making it difficult for traders as they mixed some very important technical failures with a strong close this week that hints at an attempt to bottom out. The possibility of a bounce from this level is very real, especially in light of the markets being oversold on a few indicators. However, the path of least resistance is lower now, with the indexes in a near term pattern of lower lows and lower highs. Traders will need to closely monitor how the indexes deal with last weeks highs if tested in the coming week. In the grand scheme of things, the general indexes remain in a much larger trading range established over the past year. All the indexes are trading closer to the bottom of this range, and coupled with the recent price action, it is making for a vulnerable environment. Traders should continue to trade cautiously until a clearer direction emerges.

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NGBF is currently priced close to its 52 week low, , leading us to believe that it is EXTREMELY OVERSOLD and ready to make a huge price reversal making it a BUY at its present levels. Only a few months ago NGBF was more than double where it is today. It can easily return to these levels. In fact...
Leading Technical Indicators Show that NGBF is Extremely Oversold and Unappreciated
The 3 most commonly followed technical indicators used by the savviest and most profitable investors are Moving Average Convergence Divergence (MACD), the Relative Strength Index (RSI) and Stochastic Oscillators.

As you can see on the chart below, all three of these indicators point to NGBF being OVERSOLD right now, which means that any positive news or event could cause a HUGE Breakout!!!

ODP - 52wk Low
http://www.chartmoney.com/stockquotes.php?ticker=odp
Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services.

Technicals
Record Price Low

Today's Market Focus.......

•   December 10-year T-notes this morning are trading down -2.5 ticks. Dec 10-year T-note prices yesterday tumbled the entire session and closed down -26.5 ticks at 124-244. Bearish factors included (1) reduced concerns about the global economy after China's manufacturing activity accelerated more than expected in August and Australia's economy expanded in Q2 at its fastest pace in 3 years, (2) the unexpected increase in the Aug ISM manufacturing index (+0.8 to 56.3 versus expectations of -2.7 to 52., (3) the unexpected increase in the prices paid sub-index of the Aug ISM manufacturing index (+4.0 to 61.5 versus expectations of -2.2 to 55.3), and (4) reduced safe-haven demand for Treasuries after the stock market rallied sharply. Bullish factors included (1) the unexpected decline in jobs in the Aug ADP employment change (-10,000 versus expectations of +15,000), and (2) the larger-than-expected decline in Jul US construction spending which fell for the third straigh t month and the downward revision to Jun construction spending (Jul -1.0% versus expectations of -0.5% and Jun revised down to -0.8% from +0.1%).

•   The dollar index this morning is slightly weaker with the dollar/yen -0.24 yen and the euro/dollar +0.22 cents. The dollar index yesterday slipped to a 1-1/2 week low and finished moderately lower. Bearish factors included (1) reduced safe-haven demand for the dollar after the stock market rallied sharply, (2) comments from Chinese Premier Jiabao that boosted the euro when he said China and western countries should work together to enhance the world's confidence in the euro and the European Union economy, and (3) the action by Bank of America Merrill Lynch to hike its year-end forecast for the yen to 81 to the dollar from a previous forecast of 90, citing expectations the Fed will increase monetary easing to preserve the US economic recovery. Bullish factors included (1) the unexpected decline in Jul German retail sales which fell for a second month and is negative for the euro, and (2) increased safe-haven demand for the dollar after the Aug ADP employment change une xpectedly declined, which fuels concern about Friday's Aug nonfarm payroll report.

•   October crude oil prices this morning are trading down -32 cents a barrel and October gasoline is -0.20 of a cent per gallon. Oct crude oil prices yesterday moved higher and closed up +$1.99 a barrel. Oct gasoline closed higher by +3.17 cents per gallon. Bullish factors included (1) the fall in the dollar index to a 1-1/2 week low, (2) the acceleration in manufacturing in the US and China, the world's biggest energy-consuming countries, by more than expected last month, (3) the rally in the S&P 500 to a 1-week high, which bolsters confidence in the economic outlook and energy demand, (4) the larger-than-expected increase in weekly crude oil inventories (+3.42 million bbl versus expectations of +1.3 million bbl), (5) the unexpected decline in weekly distillate supplies (-739,000 bbl versus expectations of +1.0 million bbl), and (6) an increase in demand after total US fuel demand rose +0.4% to 19.6 million barrels a day in the past 4 weeks ending Aug 27. Bearish f actors included (1) the unexpected decline in July German retail sales for a second month, (2) the larger-than-expected decline in the Aug UK manufacturing PMI to its lowest level in 9 months, and (3) the larger-than-expected decline in Jul US construction spending which fell for the third straight month.

New highs on IBD Top 100.......

New highs on IBD Top 100.......