Federal budget savings

In an effort to curb federal spending, departments and agencies came up with $102 million in proposed savings. The problem is that this year's budget deficit approaches $2 trillion. It does indicate our government is bloated and highly inefficient.

http://online.wsj.com/article/SB124882436513388423.html

Why the economy still stinks

Despite proclamations of green shoots, a pending recovery (and a surging stock market), I am skeptical of any economic recovery. Here are a couple articles on two common themes: bank insolvency and lack of transparency of toxic assets, and under-reporting of unemployment:

http://www.bloomberg.com/apps/news?pid=20601039&sid=a5BsXz90CMso

http://money.cnn.com/2009/07/17/news/economy/unemployment_benefits/index.htm

NVAX

NVAX, a long-term influenza play, surged again today, despite no news. An FDA vaccine committee meeting is occurring today, but I don't expect any orders or EUA to come out of it. Without any major catalysts in the near-term horizon, I decided to take some profits, after effectively doubling my money in two months. I will leave the rest on the table as NVAX VLP technology gains traction in Spain and Indian, and potentially with the rest of the world. The NVAX value proposition is a faster time to vaccine manufacturing, higher yields, and reduced manufacturing cost from disposable systems.

Other swine flu companies are consolidating after a huge run up. I anticipate another leg up as awareness of its virulence gains media attention. It's all house money at this point, so I will let the market run its course into the fall flu season.

Big news--naked short selling ban

Perhaps government agencies CAN get things right. The SEC made permanent a ban on naked short selling, a tactic used by stock market manipulators to induce a bear raid. The The SEC rule goes into effect July 31, when the temporary rule expires. The uptick rule is also being considered.

http://finance.yahoo.com/news/SEC-rule-on-naked-apf-3523034809.html?x=0&sec=topStories&pos=main&asset=&ccode=

Legislation is also being proposed to ban flash trading, a computer trading program used by Goldman Sachs to achieve unfair millisecond transparency advantages over other traders. A buy or sell order is "pinged", and if there are no fills, Goldman's fast servers can withdraw the orders instantenously, and determine Level III buy/sell order levels before others have access to them.

In any case, with naked short selling now banned, expect heavily shorted (i.e. manipulated) share prices of microcap companies to lift off next week.

Tamiflu-resistant swine flu

The US has a huge stockpile of Tamiflu and Relenza as anti-virals. Anti-virals are treatments for patients who have contracted the various flus already--they are not vaccines and hence, are not used as prophylaxis in prevention of said influenza viruses.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5816a6.htm

Read the editorial note, not just the article. Down at the bottom, you will see this:

Compared with M2 blockers, NAIs previously exhibited lower frequency of antiviral resistance during therapeutic use (16,19). However, during the 2007--08 influenza season, emergence and transmission of oseltamivir-resistant A (H1N1) viruses, with a H274Y mutation in the neuraminidase protein, was simultaneously detected in several countries in the Northern Hemisphere (4,20--22) and spread globally (7,9,23). As of April 2009, similar trends have been observed in the 2008--09 influenza season, with many countries reporting up to 100% oseltamivir resistance in A (H1N1) viruses

.

In case you were wondering, oseltamivir = Roche's Tamiflu, currently the anti-viral of choice for the nation's stock pile. It no longer works for avian or swine flus! So if you're sick from the swine flu enough to get admitted into a hospital, they will probably administer Tamiflu orally, as it is a pill. I have seen government data that up to half of admitted swine flu patients in ICU end up dead. One other possible reason for resistance (besides prevalence of Tamiflu in our sewage and water system) is oral consumption decreases and delays absorption of the compound. One of the members in this email thread used to work at Roche, perhaps he can add some color to this assessment.

The 2nd drug of choice is GlaxoSmithKline's Relenza, or zanamivir. It has maintained efficacy for treating various strains of flu, and is in the form of powder. If a patient is seriously ill enough to be intubated, that option is ruled out because Relenza can only be inhaled.

Which only leaves us with BCRX's Peramivir intravenous application as the only option. The share price has gapped up recently, despite only completion of Phase II clinical trials in the US. It is already approved for E-IND use, which basically allows individual doctors to administer it for individual patients as an emergency. But due to its efficacy, investors are waiting for Emergency Use Authorization, which allows national stockpiling, despite lack of FDA approval. This will translate to millions of doses, not just a few thousand.

Many investors feel this action is not just pending, but imminent. Vaccine manufacturers are scrambling to meet exploding demand--and they will still fall short, as best-case scenarios call for delivery in October. Unfortunately, school starts in August/Septemer, so we will unquestionably see a soaring number of cases this fall--rendering vaccines useless. Fortunately, most cases will be mild, and won't require hospitalization. But due to the high infectious rates, and sheer numbers of cases, hospitalization and death rates will be higher than seasonal flu cases by orders or magnitude.

http://news.yahoo.com/s/ap/20090724/ap_on_he_me/us_med_swine_flu

http://www.cbsnews.com/stories/2009/07/21/earlyshow/health/main5177452.shtml

Government health officials aren't in business to create unnecessary hype--quite the contrary--they aim to act quickly and decisively while attempting to not cause undue panic. They usually fail in both. However, they are on the hook to prepare for a worst-case scenario, and they will look awfully foolish if they don't take emergency measures as part of their contingency plans. In Japan and the rest of Asia, where sensitivity and awareness to infectious disease is high due to close living quarters, their FDA equivalent health agency has already completed Phase III trials, and results for Peramivir were positive. Approval in Japan will precede US FDA approval, and they will surely order millions of doses of Peramivir.

While FDA approval for Peramivir is further down the road, they will have to act soon in order to secure enough Peramivir inventory to prepare for a worst-case scenario. Because the public will not appreciate it if they find out their own US government is forced to stand in line--behind other countries because they didn't act quickly enough to protect their citizens.

I bought BCRX in the 2's and 3's in May and June, and it's currently bumping up against $10. I'm praying for a pullback to accumulate more shares, but I'm afraid the world is waking up to the severity and depth of the swine flu. It may keep increasing, as the big boys on Wall St. become more cozy with the investment thesis. However, with market makers, you never know, and they can force one more bear raid to help the shorts cover, and to help their friends at Goldman Sachs buy in at lower prices. Wall St. analysts usually don't get it right, so when they guess wrong, they have friends who come to their rescue to drive share prices down. Instead of complaining about it, we can use it to our advantage, buying at lower prices when the opportunity presents itself. But it can easily gap up into the teens upon arrival of the EUA. Let's hope all the fear-mongering ends up being a false alarm. On the other hand, I'm not betting on it. Good luck to all longs,

Disclaimer: This is not a recommendation. Do your own due diligence.

Disclosure: Long BCRX shares.

Mortality rates from swine flu

The FDA Vaccine Advisory Committee had a meeting yesterday, and according to the latest data, 5 - 9% of confirmed H1N1 cases required hospitalization, with approximately half of them dying. That equates to a 2.5 - 4.5% lethal rate.

In Mexico, 6% of confirmed cases required hospitalization, and 46% died, which yields a 3% lethal rate, in line with US data.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM172424.pdf

According to the CDC:

Each flu season is unique, but it is estimated that, on average, approximately 5% to 20% of U.S. residents get the flu, and more than 200,000 persons are hospitalized for flu-related complications each year. About 36,000 Americans die on average per year from the complications of flu

.

Extrapolating those numbers, 15 million to 60 million Americans contract the seasonal flu every year. Of those, 1.3% to 0.3% require hospitalization. Of those hospitalized, 18% will die, on average. The lethal rate is 0.24% to 0.06%.

By contrast, with the swine flu, based on a worst-case scenario of 100 million Americans (33%) contracting the swine flu, up to 9 million will require hospitalization, of which 4.5 million will perish. That's a 125-fold increase in deaths from the swine flu this winter season.

We won't know what the actual outcome will be yet, but the consensus among world health officials is that this novel H1N1 virus is spreading faster than any other pandemic influenza in history. While not especially lethal, it is more lethal than most seasonal influenza viruses.

Why Tamiflu may not help

The season, avian and swine flu strains are developing a resistance to Roche's anti-viral Tamiflu. Here are the possible reasons why:

http://www.sciencedaily.com/releases/2007/10/071002213442.htm

GSK's Relenza has to be inhaled, so cannot be administered to intubated, critically severe cases.

Hence, BCRX's Peramivir may play a leading role, as late-stage clinical trials in Japan and the US show positive results when administered intravenously.

Lebron James gets dunked on

Check out this video of LeBron James, NBA MVP, being dunked on by a college player:
http://sportsillustrated.cnn.com/2009/basketball/nba/07/22/lebron_dunk/index.html?bcnn=yes

This was a bootleg videotape by an observer at the camp.

Nike is losing its touch. Fearing damage to their icon's reputatiion, they confiscated videocamera men's tapes, blowing a great deprecating opportunity to portray Lebron as human. He does it already in funny commercials with Nike and ESPN. This is exactly why incumbents lose market share--they get defensive, put in a version of the prevent defense, and eventually lose out to a disruptive startup.

Nike is known for being an innovative, edgy, irreverent, and creative marketer--now they look like an old fogey, unable to handle a little rejection, and trying to suppress a potentially embarrassing event. They appear pathetic by attempting to cover up an otherwise meaningless occurrence.

After all, everybody gets dunked on at some point by other world class basketball players, including MJ and Kobe.

HEB

HEB shares dramatically dropped $0.92 to $2.40, giving up all the gains from the past several days. The conference call update on swine flu initiatives worldwide didn't impress investors, as they focused on the delays in FDA approval for Ampligen as a treatment for Chronic Fatigue Syndrome. Days like today are exactly why one should take partial profits on recent large gains, which we did yesterday. As this is all "house" money, I can afford to wait for further developments on either the CFS or swine flu adjuvant front.

BCRX and NVAX share prices were up modestly today after large gains in previous trading sessions, waiting in anticipation of tomorrow's FDA vaccine advisory committee meeting. Both are waiting for pending positive news on Emergency Use Authorization, which will allow them to manufacture doses for the national stockpile. NVAX's VLP technology cuts down the time to manufacture vaccines, which is becoming increasingly urgent as the pending swine flu season is expected in September when schools re-open.

BCRX's Peramivir is not a vaccine, but an anti-viral treatment that reduces the symptoms of the flu and shortens recovery time. EUA is expected for intravenous use in severe cases requiring hospitalization.

Both NVAX and BCRX are working with health officials worldwide, with especially intense clinical activity being performed in Japan and the US.

Swine flu plays resurface ahead of next FDA vaccine meeting

BioCryst Pharmaceuticals (BCRX) gapped up again 22% from yesterday's close of $6.21 to $7.58 today, up 22%, while Hemispherx Biopharmaceuticals surged almost 33% from $2.49 to $3.31. Both are up triple digits since we bought them in May (see June 4, 2009 "Swine flu revisited" blog).

BCRX's Peramivir is an effective intravenous anti-viral against seasonal flu, avian flu, and the latest swine flu (H1N1), shown to reduce flu symptoms in Phase III trials conducted by Japanese partner Shionogi. BCRX is also waiting for Emergency Use Authorization (EUA) by the FDA for severe cases requiring hospitalization. The EUA is required since Peramivir is not approved by the FDA. Peramivir has shown at least equal efficacy against the flu when compared to Roche's Tamiflu anti-viral in clinical trials.

HEB is having a conference call tomorrow to update the investment and medical communities on their clinical developments for Ampligen, a flu adjuvant. Studies have been performed worldwide for use of Ampligen as a booster alongside existing vaccines. Ampligen is also under FDA review for approval as a treatment for Chronic Fatigue Syndrome.

Novavax (NVAX) ended today's session at $3.19, up from $3.02. They also named John Trizzino Senior VP of International and Government alliances, in a sign that they are intensifying efforts with government agencies worldwide on getting approved for their vaccine-line particle (VLP) platform. With VLP, the time to manufacture a vaccine is cut in half--approximately 10-12 weeks, and yields are higher because they don't require egg-based cultures. Fixed costs are also lower due to disposable manufacturing systems.

This Thursday, July 23, the FDA Vaccine and Related Biological Products Advisory Committee will meet with vendors to discuss vaccines against the H1N1 virus: http://www.fda.gov/AdvisoryCommittees/Calendar/ucm170908.htm

This meeting is a sequel to the National Biodefense Science Board (NBSB) meeting held last month (see July 20, 2009 "BCRX potential" blog). The questions held at the NBSB will hopefully be answered this Thursday during the FDA Vaccine AC meeting. Shares of all 3 aforementioned companies jumped in anticipation of positive results.

As mentioned in previous blogs, the World Health Organization (WHO) raised the pandemic alert in June to Phase 6--the highest level possible, which last occurred 41 years ago. The foregone conclusion is that the H1N1 is spreading faster than previous pandemic flus. By the time it hits the US hard in the fall, it is estimated that 1 out of 3 Americans will contract the virus. So far, the mortality rate is lower than the avian flu, but should it mutate, the result strains could increase the severity as well as the virulence.

SPPI Class 1 Response is a good sign

Spectrum Pharmaceuticals (SPPI) received a Class 1 response from the FDA today on their resubmission of data on Zevalin, SPPI's clinical non-Hodgkin's Lymphoma (NHL) drug. A Class 2 response could have meant a delay of up to 6 months for further FDA review. Instead, SPPI disclosed September 7 as the FDA decision date for approval. On July 2, the FDA requested additional data via a Complete Response Letter on SPPI's application for Zevalin's expanded use as first-line treatment for NHL. Currently, Zevalin is only approved for refractory, relapsed NHL. Zevalin is already approved in Europe for expanded labeling, so FDA approval is expected by many.

http://www.reuters.com/article/marketsNews/idINBNG17208020090720?rpc=44

SPPI also has another late-stage clinical drug coming up for FDA approval. Fusilev is already approved for osteocarcinoma, but is up for approval for treating colorectol cancer on October 8.

Two "misses"

BDSI's cancer pain drug Onsolis did gain FDA approval as expected, but the prices have declined since its approval, which is unexpected. I'm sitting on a slight loss on the shares, so will probably hold until their next pivotal event in September/October--or until the market realizes the commercialization potential of Onsolis, its unique breakthough drug delivery technology, and solid pipeline up for FDA approval.

I also contemplated taking a stab at Human Genome Sciences (HGSI) last week, waiting for today's announcement for its Lupus drug, Benylsta. Results were positive, and shares rocketed overnight over 200%, despite the market's prior skepticism. Even though we missed on it, I don't feel that bad, because I didn't perform enough due diligence to be comfortable enough to pull the trigger. The main beneficiary is the biotech sector, as these big winners will attract more retail and institutional investors. Clinical stage biotech stocks require capital to fund their development work, so the positive news gives them more options for financing.

BCRX potential

According to Health and Human Services (HHS) Dr. Robin Robinson:

http://www.reuters.com/article/healthNews/idUSTRE56669020090709

The federal government has 52 million treatment courses of Tamiflu and Relenza in its strategic national stockpile. Tamiflu, or oseltamivir, is made by Roche under license from Gilead Sciences while Relenza, or zanamivir, is made by Glaxo under license from Australia's Biota Inc.

Dr. Robin Robinson of HHS said the department is also considering buying another tranche of drugs, including zanamivir and pediatric doses of Tamiflu.

A third drug, Biocryst Inc's peramivir, is nearing final trials before approval, Robinson said. "That would be used for severely ill individuals in hospitals," he said.

Having three different drugs would help address the issue of resistance. Some cases of the new H1N1 swine flu have been resistant to Tamiflu and that drug is now generally ineffective against the seasonal version of H1N1, a distant cousin of the pandemic strain.

Also, start reading on page 74 of the following National Biodefense Science Board report during a recent emergency meeting at the HHS regarding H1N1 countermeasures. The fact that BioCryst was at the meeting is a portent:

http://www.hhs.gov/aspr/conferences/nbsb/nbsb-h1n1forum-sum-090617.pdf

Two ships arrive overnight...

BDSI's cancer drug pain-killer finally gained approval yesterday, after an almost year-long delay regarding labeling issues against misuse and abuse. With a novel drug delivery system, along with a strong pipeline, and a low float of shares, this investment in BioDelivery Sciences is a winner.

http://www.reuters.com/article/marketsNews/idINN1643063420090716?rpc=44

BCRX shares shot up overnight, after partner Shionogi announced positive results in Peramivir Phase III trials in Japan and Korea. Peramivir is an anti-viral which competes against existing stockpiles of Roche's Tamiflu and GSK's Relenza. Due to mutation, viral strains are starting to show resistance to Tamiflu and possibly Relenza. Hence, the race to develop a new anti-viral.

We've known of this partnership for a while and the stock has more than tripled since we bought in May, but the shares should soar higher if and when the US assigns Emergency Use Authorization for stockpiling against a pandemic flu.

http://finance.yahoo.com/news/BioCryst-Pharmaceuticals-prnews-4103594572.html?x=0&.v=1

Critical Thinking

One of my favorite courses in college was a Critical Thinking course, as it applies in my analysis work to this day. Not only did we apply Boolean algebra, which I was already well-versed as a digital electrical and computer engineering major, but we also used subject criteria like credibility of information sources. So let's apply it here:

http://moneynews.newsmax.com/streettalk/dollar/2009/07/08/233378.html

The title of the article is: Currency Expert: Dollar not in Jeopardy

The article discloses said currency expert is Michael Woolfolk, senior currency strategist at Bank of New York Mellon. After further reading, we realize he actually acknowledges the reasons why the reserve currency status of the USDollar is in question among the BRIC countries.

Worry has arisen in financial markets that the United States will let the dollar slide to pay off its exploding debt.

“That’s certainly one of the risks, if you’re from China, Russia, the others that hold very large U.S. reserves,” Woolfolk said.

“They’re concerned about the risk of inflation in the future, … that we might take a benign neglect toward the strong dollar policy.”

But he took these countries, known as the BRIC, to task for their own currency policies.

“They now view their reserves as national wealth,” he said. “The traditional role of reserve currencies has been to support their own currencies in times of crisis.”

The BRIC nations “are concerned about what currencies to hold (reserves) in,” Woolfolk said. “They should be concerned about how they spend this money.”

While he gives reasons for the opposing view, we have to realize the source of his condescending tone, as if he is lecturing foreign sovereign holders of US Treasury debt. Bank of New York Mellon also happens to be one of the largest US government bond dealers. Robust US Treasury bond auctions are beneficial to BONY, and they have close ties to Tim Geithner, who was President of the Federal Reserve Bank of New York before being appointed as US Treasury Secretary. We all know how he was roundly ridiculed by the Chinese when he insisted the US Dollar and Treasury Bonds were "safe" assets.

Despite the title of this article, if I'm a holder of the dollar or US Treasury bonds, I'd head for the exits.

Historic shift away from the US Dollar

The US Dollar has enjoyed an uninterrupted run as the world's reserve currency since 1945.

According to the Congressional Research Reports for the People, The Dollar's Future as the World's Reserve Currency: The Challenge of the Euro, July 10, 2007:

There are significant advantages for the United States in having the dominant reserve currency. These advantages include reduced exchange rate risk and lower borrowing costs.

Another benefit is that the Federal Reserve Bank, the US central bank, can print currency when it believes it needs to, normally with impunity--because of its status as the world's reserve currency. However, the rest of the world is becoming increasingly concerned due to the Fed's profligate printing of dollars. China, Russia, and India have threatened to trade without using the dollar as a medium of eschange. Today, those threats became a reality.

This is a historic event, but lightly-covered by the media. It's the beginning of the end for the US Dollar as the dominant currency. It signals a shift away from the dollar, as the world's economic balance of power has shifted to the Far East. This will have far-reaching implications of US dominance as an economic power, its sovereignty, national security, status as a military power, and the standard of living of its citizens.

http://www.bloomberg.com/apps/news?pid=20601087&sid=a.VjgFi0enXQ

Is the FDA really corrupt?

Spectrum Pharmaceuticals received the dreaded Complete Response Letter from the FDA Friday, requesting more data from their FIT study. This essentially delays the approval for Zevalin for first-line therapy up to 6 months. Zevalin is already FDA-approved for treatment for Non-Hodgkin's Lymphoma, but this pending approval was for extension to first-line therapy. Currently in the US, Zevalin is only approved for consolidation therapy after remission induction. But in Europe and many other countries, Zevalin has already been approved for first-line therapy also. Hence, the FDA is dragging their feet again, as more patients die due to lack of alternative and supplemental options for treatment of NHL. Are they purely incompetent, or our darker forces at work, namely other chemotherapy companies who stand to lose market share if Zevalin is approved for indication extension? You decide:

According to viva.vita International, April 28, 2008:

The decision by the European Commission to grant extended marketing authorization to Zevalin® is based on data from the pivotal Phase III First-Line Indolent Trial (FIT). It showed that Zevalin®, when used as first-line consolidation therapy, significantly prolonged the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001). The data were presented for the first time at the 49th Annual Meeting of the American Society of Hematology (ASH) in December 2007.

“It is particularly impressive that with one single infusion of Zevalin®, we have achieved prolongation of median progression-free survival by two years, with a favorable toxicity profile,” said Professor Anton Hagenbeek, Academic Medical Centre, Amsterdam, the Netherlands, lead investigator of the FIT trial. “The results also show that radioimmunotherapy is a very effective single agent in the treatment of follicular lymphoma.”

The FDA does not require additional studies, additional data, or data analysis. They only require data from the European FIT trials--data that already enabled EMEA approval. That's it. The FDA essentially agrees Zevalin's adverse effects are tolerable, and Zevalin has progression-free survival benefits. It destroys tumor cells--and saves lives. Yet, approval is delayed again.

This is exactly what is wrong with our government--federal agencies and czars. Incompetence and/or corruption. Hope and change. Astounding.

SPPI news leak?

According to blogger Justin Hall, FDA approval for Spectrum Pharmaceutical's Zevalin arrived Friday, and the news has leaked. A conference call announcing the event will be scheduled Monday in pre-market trading.

http://seekingalpha.com/author/justin-m-hall/instablog

I established a position in SPPI shares a couple weeks ago in anticipation of a PDUFA date on July 2. It looks like it may have come in time. We should see some fireworks in SPPI shares Monday. I'm crossing my fingers.

Jack Welch

The former General Electric CEO in a Bloomberg TV interview: "We are going to have increased taxes--and everyone will be taxed." He included companies, individuals, families.

Have a good July 4th weekend everyone.

Biotechs and the FDA

In a letter I wrote to a friend and fellow investor:

Dick,

I like your synopsis on the disconnect between pivotal event-driven biotech stocks and the overall market (which is driven by consumer demand to the tune of 70% of our economy).

One thing I would add on the 20% success rate of FDA approval--I believe that is for drugs that enter into clinical trials--all 3 phases. I believe once a drug reaches Phase III clinical stage, the probability of approval is between 50-80%, depending on who you talk to. So if we stick with Phase III drugs, our chances of approval greatly increase, because at that stage, they are toying with dosages, and hopefully, most of the safety and efficacy issues are already ironed out.

We know the cycles for biotechs are sometimes greater than 10 years. In semiconductors, product cycle times are in the months, so investing in Phase III biotechs is necessary for the impatient (which we all are). It's been said that scientists have to discover 360 molecule compounds for every approved drug, due to the high failure rate. This ratio takes into account research and development, multiple phases of clinical trials, new drug or biologic application, FDA approval and commercial launch. Each step carries potential attrition risk.

There's another reason why I like ARNA--their patent portfolio is strong so that if other pharma companies want to target a particular malady relating to the central nervous system, metabolic systems, cardiovascular, and inflammatory diseases, chances are they will need to license one of ARNA's compounds. Dr. Behan has found a way to selectively target G Protein-Coupled Receptor's (GPCR) for their desired effect. The selectivity is what makes ARNA so valuable, as it doesn't stimulate other receptors, and therefore adverse side effects are minimized. This sounds trivial, but it's the difference between a few billion dollars in annual revenue and $21 billion of lawsuit claims that Wyeth had to pay out, due to cardiac valvulopathy from the failed phen-fen 12 years ago. It's also why I think ARNA will win out over VVUS and OREX, even if their offerings are approved also.

I really want multiple partnership deals, and not an outright buyout from a big pharma. The pps will soar if ARNA remains independent.

Greg