FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.

The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).

Bull or Bear? Vote in Our Poll

The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.


Avanir and Exact Sciences Crash in Afterhours Trading

Exact Sciences (EXAS)  has crashed steadily since yesterday's close of 8.57.  It has slumped to the 6.90 range after yesterday announcing Positive Study News.  Unfortunately, this is just a study which will lead into a lengthy clinical trial that will cost money.  I think investors have been misled by this news and now they don't know what to do and are panicking.  Hey Stop Panicking.

Exact's stock is rated a buy and will soon return to the 9-10 range in a few months and could skyrocket to 13 with Positive Clinical Trial News.  There really is no quick buck when it comes to stock investing.  It happens, and it can happen, but more times than not, these things take time. 

On other news Avanir's Stock (AVNR) has declined sharply in afterhours saying they have not heard from the FDA and is anticipating news concerning their approval for psuedobulbar affect.  I am expecting a CRL from the FDA and no approval and this would be devastating to Avanir Shareholders.  But it could get approved.  It does have a fighting chance. 

In other news Vivus receives a CRL for Qnexa and the share price has gone up.  That one I really don't get but investors sometimes don't know what they are getting themselves into.  Sure if approved it would be monumental, but I don't see that happening anytime soon.  Vivus' shares are up 26.43% at 7.75.  Today it gained 1.62 points.  I don't see this ride ending well for investors but what do I know.  I am baffled at the stock market right now.

Wikinvest--Exact Sciences (EXAS)
Wikinvest--Avanir (AVNR)
Wikinvest--Vivus (VVUS)


Battling Deadly Diseases--13 Antibiotic Makers

Magnified 20,000X, this colorized scanning ele...Image via Wikipedia

Top Antibiotic Makers:

Trius Therapeutics--(TSRX)
Forest Labs--(FRX)
Optimer Pharmaceuticals--(OPTR)

These stocks haven't necessarily done extremely well this year, but the high cost of Clinical Trials leads to debt.  Once the clinical trials are approved and these antibiotics go on the market these should have noticeable gains.  I think these could have potential to invest in the long term futures.

Another company of note is SIGA Technologies (SIGA).  SIGA makes bioweapons vaccines for the government and recently announced a government contract for small pox treatment.  From Marketwatch:  SIGA soars on government contract
Hope In The Grim Fight Against Drug-Resistant Germs

Exact Sciences Announces Positive Results For Cancer Diagnostics Screening

DNA - Blue

Exact Sciences is experiencing a wild After-Hours Ride Today.  It has dropped significantly below 6.50 then back up to 8.57 and now back down to 6.75.  I wonder about a flash crash happening in after hours trading and how much investors are selling off their stocks.  Right now Exact is down 1.83 at 6.74 a 21% loss.  But it will be right back up tomorrow so I'm not sure what is really going on.  Massive afterhours sell-off is causing a crash.  Take a look at afterhours trading news here at Marketwatch:  EXAS

Now is not a time to sell as trading Friday could be significant gains with news of a successful Diagnostic testing for Colon Cancer screening.  But what is going on with Investment Banks right now in after hours trading is somewhat troubling.  How much is controled in after hours trading is a mystery to me, but I know it is not the average investor making these moves.  Internal trades are happening at this moment but why is the price of Exact Sciences dropping so much.  Trading was halted earlier today in anticipation of the news release.  Here is that news. 

Exact Sciences says colon cancer test successful

* Screening test detects 64 pct pre-cancers

* Detects 85 pct cancers
* Exact Sciences test detects 87 percent of tumors

* Finds 64 percent of pre-cancerous growths (Adds details on 2nd test, refiles to fix headline)


This Week's Watchlist Oct 25 2010 With the FDA

From left to right, the structures of A, B and...Image via Wikipedia
A, B and Z DNA Structures, the building blocks of Proteins and Amino Acids

Today's Theme For Pictures Today
 On tap for this week we have three FDA decisions:

ARNA - Arena received an expected CRL on Saturday for its weightloss drug Lorcaserin. (Subscribers to BioRunUp were immediately notified via SMS and email alerts) The CRL was as expected with no real surprises. It will be interesting to see how the market reacts to the FDA's requests on Monday morning. ARNA closed at $1.63 on Friday after surging nearly 22% at one point during the day. These prices are much below its run-up high of $8 in late July.  Arena Receives CRL

BIOD - Biodel is up for an FDA decision on 10/30/10, and trader consensus is clearly leaning towards a CRL from the FDA. Traders became even more jittery last week as the FDA delivered some heavy handed CRLs to AMLN/ALKS, on a drug that was widely expected to receive approval. The market seemed to react as if saying 'If AMLN/ALKS was 'in the bag' and the FDA required more trials, there is NO way that the FDA will approve Linjeta with that botch India data.' Trading at under a 100M market cap, BIOD has incredible potential on approval. However FDA uncertainty seems to have limited the run-up.

AVNR - Out of this week's watchlist stocks, AVNR seems to have the best odds of approval. Despite this, AVNR still took a hit from the AMLN/ALKS CRL. This was because that CRL was based largely because the FDA was concerned about prolongation of QT interval, a concern that was also expressed by the FDA in Avanir’s first CRL for AVP-923. Will this continue to haunt AVNR? We will soon find out.

EXAS - Its catalyst time for one of our best picks of the year. We recommended EXAS in the high $3 range and were thrilled to watch it climb to over $9. Study results are going to be presented this Friday, 10/29 at the AACR conference.  
BioPharma Investor's Decisions:
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Boehringer Gains Approval To Market Blockbuster Blood Thinner Which Works Better

Boehringer IngelheimImage via WikipediaBoehringer Beats Bayer, J&J to Market With Pradaxa

By Naomi Kresge and Catherine Larkin

(Adds executive comment from fifth paragraph, closes Bayer shares in the seventh paragraph.)

Oct. 20 (Bloomberg) -- Boehringer Ingelheim GmbH won U.S. approval to sell Pradaxa, beating drugmakers including Bayer AG and Johnson & Johnson to the market with the first rival to the half-century-old blood thinner warfarin.

The Food and Drug Administration cleared the drug for patients with an irregular heartbeat that may raise the risk of a stroke, the agency said yesterday in a statement.

Jim Cramer Makes Mistakes Too

Yoda and Jim Cramer Bobble HeadImage by Michael McDonough via FlickrJim Cramer apologizes for his mistakes.  Jim Cramer isn't always right on his calls so just take that in mind when you watch Mad Money.  But the guy is entertaining And sometimes he is right and sometimes he is wrong.  I too didn't see this decision by the FDA happening and apologize myself but I only liked Alkermes as a trade and still think it is a buy right now.  Alkermes symbol ALKS.  Eli Lilly (LLY) also posted strong 3Q earnings and was up Friday. 

4 Rules for Trading Biotech Spec Stocks

Two stocks that Cramer recommended last Thursday, Oct. 14 got crushed this week after an expected Food & Drug Administration approval never happened.

Everyone, including the “Mad Money” host, assumed regulators would bless a new diabetes medication being made by Amylin [AMLN 11.30 -0.18 (-1.57%) ] and Alkermes [ALKS 11.07 -0.03 (-0.27%) ]. But when the FDA on Tuesday requested more data rather than approving the drug, their share prices plummeted 50 percent and 30 percent, respectively.

So where did Cramer, and even the most negative of analysts, go wrong? What lessons has he learned from this week? He broke them down into four takeaways for any investors considering a little biotech speculation going forward. Watch the video 4 Rules For Trading Biotech for his full report.

Related articles


Put Calls Anyone?

A diagram of the 9 levels of Dante's Hell.Image via Wikipedia Arena Pharmaceuticals is in a tough spot as the FDA rejects their weight loss drug lorcaserin, apparently one of the safer of the 3 up for approval.

Here is the link to investors. 

This decision was expected and predicted in my past articles on the Obesity Drug Market.  We all saw it coming.  I'm sorry if you didn't.  But expect loses for Orexigen, and Vivus with their upcoming FDA decisions.   I can only see gains made with shorting the stocks.  Those that had are sitting pretty right now.  It's a gamble but sometimes these gambles pay off.  I expect more loses to mount for these companies in the near future.  Arena Pharmaceuticals, Vivus Inc., and Orexigen Therapeutics.

What they chose to do next is anyones guess.  The technology could be sold off for further research.  And the company enters bankruptcy court.  Nonetheless just passing on the news.  I'm not always right but some are easier to pick than others.  Last weeks news of Amylin, Alkermes, and Eli Lilly and Company for their diabetes medicine was a heartbreaker for those who thought it would go the other way.  But there are always more to look at.  Keep looking forward and use it as a lesson.

Arena Pharmaceuticals Enters FDA Purgatory

Welcome to FDA purgatory, Arena Pharmaceuticals. It could be a long wait.


Jimmy Fallon Special on Comedy Central Tonight

Nick Burns the Computer Guy:  Jennifer Aniston on SNL  Jimmy Fallon Special---Hulu SNL

Weekend At Bernie's, Madoff Property Goes Up For Sale

Charles Ponzi (March 3, 1882–January 18, 1949)...Image via Wikipedia
Charles Ponzi, Boston Financial Analyst

The Spoils of the Madoff Scam to Be Sold at November Auction

Ruth's Emerald Ring, Bernie's Velveteen Slippers and the Desk Where He Ran His Scam on the Block

Photos of Madoff Property Up for Auction:  Life's Luxury For BLM

Time Magazine Photo Essay of Bernie Madoff's Stolen Luxury Items.   Nasdaq Chairman to Ponzi Billionaire.

Yachting With Bernie:  He owned 3 boats.  I like the 38 foot Lobster Speedster


The Economy Isn't As Bad As You Think, Money Magazine

In this month's Money Magazine.  Some good advice.  I will detail my own "What to Do With 10,000K" in my own article soon, but I think these are good ideas.  Money Magazine and SmartMoney are always on point for Financial Advice.  BioPharma Investor Approved. 

Dan Fuss and Loomis Sayles Bond and Pimco are good 401K planners.  Dan Fuss believes in Corporate Bonds and Foreign Treasuries.  Sounds good to me. 

Also mentioned in the What to do with 10k article, it discusses a Bond Ladder.  Bond Ladders layer out the maturities over the years and reinvests into other treasuries.  Not a bad idea.  That way you always have a bond maturing in the future. 

Why it's time to be bullish

Paul J. Lim, senior editorOctober 21, 2010: 5:34 AM ET

(Money Magazine) -- On paper, this seems like a hospitable environment for the bulls on Wall Street to roam. The recession that began in late 2007 has officially been declared over. Interest rates and inflation are at historic lows, and stocks are up more than 70% from their low 18 months ago.

But when you flip on CNBC or turn to your paper's business section, it's all gloom and anxiety. The talking heads are warning that the economy could be headed for a double-dip recession or maybe something worse.

Meanwhile, mutual fund managers are sitting on cash, and a recent survey of investment newsletters found that bearish advisers vastly outnumbered bulls for the first time since the market cratered in March 2009.

Individual investors have caught the pessimism bug too: At the end of August, only 21% of individual investors described themselves as being bullish, vs. about 50% who said they were bearish.

Down Biotechs, Equates to Foreign Investments

Between Alkermes (ALKS), Exact Sciencees (EXAS), and Human Genome Sciences (HGSI), I'm actually down a few points than I would like to admit.  But these things are typical with the times and I have investments in other foreign markets that actually balance out some of the loses. Don't panic.  Work it out, Breath. It's Ok. 

My 401K is where I keep the "safe" investments of Emerging Markets, Precious Metals, ETFs, and Funds in Southeast Asia and Latin America.  Those have handily gained close to 30% this year alone.  But my stock account does have ups and downs.  I am not too worried about it though.  Just relax and watch them return double digit gains in a few weeks. The market just fluctuates in this recession. I know that's not what you want to hear but its the truth.  It creates further opportunities to Buy and Sell.  You have to have some iron will and believe that it will be for the longer term.


The Short-Seller Who Got Amylin Right

An assortment of United States coins, includin...Image via WikipediaNEW YORK (TheStreet) -- Not all investors are shocked and upset about the decision by U.S. regulators to reject Amylin Pharmaceuticals' (AMLN) diabetes drug Bydureon. Short-sellers -- investors who bet that Amylin shares would fall -- are positively giddy and making money.

Amylin shares are down $10.35, or 50%, to $10.14 in Wednesday trading.

How did the shorts get Amylin right when a majority of investors believed Bydureon was going to be approved? I spoke with one Amylin short early Wednesday about his bear thesis. This hedge fund manager asked to remain anonymous because the rules of his fund forbid him to speak publicly about his investments.

"I always believed that Amylin and Eli Lilly (LLY) were taking shortcuts to get Bydureon through the FDA" and the agency was going to have problems with this approach, said this short seller.

Is the FDA going to Approve Anything These Days? As Amylin And Alkermes Tumble I Look At China Biopharma Plays

Amylin PharmaceuticalsImage via Wikipedia
Is the FDA going to approve anything this October? Right now the FDA has rejected an astounding rate of drugs for approval.  I could see the Obesity drugs not getting approved but the overall approval rate is not very good right now.  Less than 50%.  More like 1 out of 4.  I personally have moved my interests into China Pharmaceutical makers, Medical Devices, and Biotechs with high profit margins and low P/E values. 

One of the one drugs it approves, Vivitrol for Opioid Dependence is tied up to today's FDA CRL for Amylin Pharmaceuticals and their Diabetes drug Bydureon.  Amylin is down roughly 50% while Alkermes is down 28%.  I personally see Alkermes as a huge buy right now.  They are the company with 2 FDA approvals under their belt and are actually generating a profit right now.  This is a loss for Alkermes but I think they will bounce right back.  It is oversold at this level.  I also see Lilly as a slight buy after being down close to 4% on the news.

Wikinveset--Alkermes (ALKS)
Wikinvest--Amylin Pharmaceuticals (AMLN)
Wikinvest--Eli Lilly (LLY)

Are you thinking over possible Short Interests in BioPharma stocks up for FDA approval?  Shorting these stocks is becoming more and more tempting with the overall likelihood of a FDA non-approval.  Shorting stocks however, requires borrowing money on a margin account set at a 7% interest rate.  This is a pretty high rate to overcome and can dig into future profits.  But with drug stocks going down well over 50%, it is not that bad an idea.  Warren Buffett might not approve but I think it can work with the right FDA plays.


Why the FDA Won't Approve Lorcaserin and Qnexa (Yet)

The four gas giants in the solar system, from ...Hot Air Images via WikipediaI don't see much hope for Arena Pharmaceuticals, Vivus, or Orexigen at gaining FDA approval at this time.  I see it as a bunch of hot air and will not be approved with this conservative FDA panel right now.  That's not to say a CRL is necessarily a bad thing but at what point does the funding run dry?  Shorting these stocks wouldn't be a bad idea.  Especially, Vivus and Orexigen.  At a lofty 5 and 6 points it won't take much time to take the plunge to 2.

Wikinvest--ARNA, VVUS, OREX

By Brian Orelli
More Articles

October 19, 2010
After months of speculation and a pair of Food and Drug Administration advisory panels, FDA decisions for Arena Pharmaceuticals' (Nasdaq: ARNA) lorcaserin and VIVUS' (Nasdaq: VVUS) Qnexa are finally upon us.

Arena's PDUFA date is Oct. 22, while VIVUS' date with destiny is six days later on the 28th. The Prescription Drug User Fee Act (PDUFA) sets the goal for the FDA to make a decision by then, but the FDA is free to make a decision at any point before or after that date. A decision on lorcaserin especially could be delayed since the FDA advisory panel met just last month.

What's the chance of lorcaserin and Qnexa gaining FDA approval? I'd put it somewhere between unlikely and nonexistent.

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor

Buffett's Johnson and Johnson (JNJ) Makes Up For Some Of His Mistakes

Alice Schroeder with Warren Buffett.Image via Wikipedia3 Stocks Warren Buffett Owns That You Shouldn't

By Anand Chokkavelu, CFA
More Articles
October 18, 2010

Yes, the three stocks I'm about to share are all owned by Warren Buffett -- and, more importantly, I don't think they should be owned by you.

To be clear, these aren't trivial positions hiding in the corners of his Berkshire Hathaway (NYSE: BRK-A) (NYSE: BRK-B) stock portfolio. No, together, they make up almost a quarter of it.

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor

Is this heresy?

Studies have proven that following Buffett pays off big time. Each quarter, Buffett must tell the world all his major stock moves via Form 13F filings with the SEC. A recent study showed that investors could have crushed the market by mimicking his moves exactly. Even with the handicap of buying those stocks up to three months after Buffett.

Black Monday 1987: History of Wall Street

Performance of the Dow Jones Industrial Index ...Image via WikipediaLessons learned

Commentary: On this day 23 years ago, the stock market crashed
By MarketWatch

CHAPEL HILL, N.C. (MarketWatch) — Today is a somber anniversary for anyone who is at least 45 years old.

And while anyone younger than that probably doesn’t remember what happened on Oct. 19, 1987, since they were not yet out of college, they should also study what happened on what came to be known as Black Monday. This includes most mutual fund managers, by the way.

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor


Peregrine Pharmaceuticals Announces Positive Phase II Clinical Trials For Brain Cancer

Gliobastoma (astrocytoma) WHO grade IV - MRI s...Image via Wikipedia Wikinvest--Peregrine Pharmaceuticals  PPHM

Google Finance--Peregrine  PPHM
Peregrine Pharmaceutical Pipeline

Press Release From November 9, 2004--Peregrine's commitment to treat Brain Cancer Patients:

Peregrine Pharmaceuticals and New Approaches to Brain Tumor Therapy (NABTT) Consortium Enter Collaboration to Treat Brain Cancer Patients

Today's news seems positive.  More Clinical Trials are necessary but this could be pushed through due to their orphan drug status.  Here is a news article designating Peregrine as receiving Orphan Drug Designation for Cotara in 2002.  That is a long time but this is highly special needs cancer therapy that could be helpful if it gains FDA approval after Phase III clinical trials.  It will possibly take another year or two but these will be pushed through accordingly.  They use targeted Monoclonal Antibodies to kill the cancer tumors from the inside of the tumor without hurting surrounding cells.  That is the theory.  Hopefully it works and is approved for those at risk with Brain Tumors. 
Peregrine Pharmaceuticals (Symbol:  PPHM)  Reports Promising Interim Survival Data From Phase II Cotara(R) Brain Cancer Study

October 18, 2010
Single Medical Center Reports Interim Median Overall Survival of 86 Weeks in Patients With Glioblastoma Multiforme (GBM) Treated at First Relapse; Data Presented at 2010 Congress of Neurological Surgeons Annual Meeting


Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today reported interim data from an ongoing Phase II clinical trial of its novel brain cancer therapy Cotara(R). Interim median overall survival was 86 weeks for a cohort of 14 patients with glioblastoma multiforme (GBM) treated at first relapse with a single infusion of Cotara. Cotara is a targeted monoclonal antibody linked to a radioisotope that is administered directly into the tumor, destroying the tumor from the inside out, with minimal exposure to healthy tissue.


Exact Sciences Anticipating Oct. 29th Results

Graham Cancer Center Expansion 11Image by Christiana Care via Flickr Exact Sciences has been on fire lately.  I do think that the stock will dilute in the next few weeks but I could be wrong.  They will need to recoup some of their capital from their clinical trials debt that they have accrued.  Exact Sciences is a very explosive stock that could really go higher than expected.  Who Knows?  I really like the options for Exact Sciences growth in 2011 and beyond.  In 3 Months Exact has gone from  3.46 to 8.88, a gain of 158.89%.    I expect it to drop down a bit and would suggest any future purchase of shares to come down a bit with a Limit Order.  Buy Exact at  some form discount at these very hyped up increased levels.  But they might not come down and you should buy some at the current Market Price. 

Wikinvest---Exact Sciences (EXAS)

Google Finance--Exact Sciences (EXAS)

Biotech Stock Mailbag: Exact Sciences

BOSTON (TheStreet) -- Did you catch Jim Cramer's excellent Mad Money segment Wednesday on Exact Sciences(EXAS_)?

If not, a question from Paul P. on the colon cancer diagnostic stock kicks off this week's Biotech Stock Mailbag: "Have you followed and/or have any thoughts on Exact Sciences? I've been following it and am hearing that it may be overhyped. Your thoughts would be appreciated."

Biogen and Elan Team Up to Fight Multiple Sclerosis with Tysabri

Biogen IdecImage via Wikipedia

Wikinvest--Biogen Idec (BIIB)

Wikinvest--Elan (ELN)

Progressive Multifocal Leukoencephalopathy (PML)--severe brain infection problem associated with Tysabri that had resulted in a few deaths, Anti-JC Virus Assay was a Key Compenent in Tysabri Clinical Trials 

This is good news for the MS community as patients will now have some assurance that their experimental medicine will not cause PML because of a new Anti-JC Virus Test.

Tysabri problems in the past:  Another Tysabri Brain Infection Reported: 8th PML Infection Since Re-Launch

Data Further Supporting Anti-JC Virus Antibody Assay Presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

Posted on: Saturday, October 16, 2010 - 

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. The detection of anti-JCV antibodies may provide a means to segment, or stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI® (natalizumab) and assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but serious, brain infection. These data have been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden.

Biotech Bulls: Inhibitex Fighting Shingles

virusVirusInhibitex:  Phase II Clinical Trial for Shingles

Wikinvest--Inhibitex, Inc.  INHX

Check out Wikinvest

Inhibitex, Inc. (NASDAQ: INHX) increased 10% on Friday after announcing completed enrollment in their Phase II clinical trial of FV-100 for shingles. With top-line data expected later this quarter, expect buying pressure to increase in the short term.

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Key US Q3 Earnings Announcements

logo Johnson and JohnsonJNJ 3Q Earnings The pace of big name earnings announcements peaks next week with leaders in most sectors present. If markets can avoid a bout of profit taking from fears about US banking and housing, other major announcements could be significant for fueling or dousing the ongoing rally. Here’s a list of highlights from next week’s earnings calendar.

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•Monday: IBM (IBM), Apple (AAPL), Citigroup (C), Halliburton (HAL)

•Tuesday: Bank of America (BAC), Goldman Sachs (GS), Johnson& Johnson (JNJ), Coca-Cola (KO), Yahoo (YHOO)


What is MRSA? Methicillin-resistant Staph Aureus Infection

Staphylococcus AureusMethicillin-resistant Staphylococcus aureus (MRSA) infection

Written by Dr Alan Johnson, clinical scientist

What is MRSA?

Staphylococcus aureus is a species of bacterium commonly found on the skin and/or in the noses of healthy people. Although it is usually harmless at these sites, it may occasionally get into the body (eg through breaks in the skin such as abrasions, cuts, wounds, surgical incisions or indwelling catheters) and cause infections. These infections may be mild (eg pimples or boils) or serious (eg infection of the bloodstream, bones or joints).

MRSA stands for methicillin-resistant Staphylococcus aureus, which is a type of Staphylococcus aureus that is resistant to the antibacterial activity of methicillin and other related antibiotics of the penicillin class.

Outbreak: NDM-1 and MRSA are Deadly Emerging Superbugs

Methicillin-resistant Staphylococcus aureus (M...MSRA Image by judy_breck via Flickr

Outbreak was one of my favorite movies.  I read books like The Hot Zone in school and knew I was going to study Microbiology and become a microbiologist.  Viruses were my favorites.  I now focus more on business, but right now a relatively common Staph Aureus, is gaining notoriety by being anti-biotic resistant.  Being a microbiologist, I know there are deadly germs hanging around in hospitals in the US today.  Outbreaks have hit several states and an epidemic of MRSA is fast approaching in the next few years.  Anti-biotic resistant bacteria is a very deadly condition where many young people die from these infections. 

Currently, research has not fully grasped the medicines to fully combat these Superbugs.  FDA hurdles are preventing new research into the matter.  Additionally, there is decreased funding in Research and Development at major pharmaceutical companies during this economic downturn we have been experiencing. 

Globalization causes these bugs to spread all around the globe in a matter of hours.  Anyone can get infected, not know they are carrying the bacteria for a few days, get on an airplane, and arrive to your city, and spread the disease to every hospital in a matter of weeks.  More stories to come on Superbug Anti-Biotic Companies in Phase III clinical trials.

Outbreak (film)Outbreak Movie Image via Wikipedia

Eight Deadly Superbugs Lurking in Hospitals

TheStreet Equity Top Picks: Biotechnology

Stock MarketWall Street BiotechnologyTheStreet's Top Rated Stocks

Equity Top: Biotechnology Stocks  10/14/10

Follow Biopharma Investor for more Top Picks:  http://feeds.feedburner.com/biopharmainvestor

Wikinvest Symbol--Biotech Company and Corporate Website-- Rating


Blockbuster FDA Decisions In The Next Few Months--FDA Calendar Predictions

FDA's Upcoming Blockbuster Drug Decisions for Q4 2010

October 11, 2010

Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter.  This is just an initial walkthrough of all the upcoming decisions.  Lets see how well I do.  I am doing pretty well from October's FDA calendar. 

The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.

In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.

The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.

I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010.  This is just an estimated guess off the top of my head.  Some are toss-ups.  The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval.  Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.

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FDA Calendar Predictions

Skystar Biopharma Is On Top BioPharma List With Return On Equity, Additionally So Was Talecris Biotherapeutics

Animation of the structure of a section of DNA...Genentech---DNAFrom the China Analyst.  I really like The China Analyst Website.  It always provides up to date and accurate reports and top ten lists of top performers week in and week out.  China Analyst has Talecris as No. 3 as stocks that have provided Return On Equity.  It is a pretty good indication of how profitable a company is and how well the business is working.  Basically a good return on equity means their stock will more than likely be going up.  I also look for Undervalued Companies with a High ROE and a Low P/E. 

A Low Price/Earnings means that the company is undervalued.  I high P/E means that a company is overvalued.  Overvalued companies tend to have a bubble affect and when that bubble bursts it can be a loss on investments.  Therefore a low P/E is a good investment, if the company is profitable. 

In this case I chose Skystar Biopharmaceuticals as my investment of today.  Skystar is symbol (SKBI).  Skystar is the maker of Animal Vaccinations in China.  Skystar is highly profitable and has the GMP facilities to make enough vaccines. 

Remember America's Chicken Egg Fiasco a couple of months ago from an Iowa Chicken Factory.  Skystar makes Chicken Vaccines and is rapidly growing.  Take the time to look at Skystar's Financial Records and see how well the company is doing.  Again that is Skystar Biopharmaceuticals SKBI   They are a Chinese Company trading on the Nasdaq.
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More can be found at their website:  Skystar Bio-Pharm

Here is an article from Seeking Alpha which highlights Skystar's Business Model from 2007.  The stock has been performing well since then. 

Skystar Bio Pharma: Leading Contender in Rapidly Growing Chinese Biopharma Market

Top 10 Biotech Stocks with Highest Return on Equity: IMMU, CRME, TLCR, GILD, GTXI, PSDV, SKBI, DNA, CPHI, SCLN (Oct 12, 2010)

Talecris Gains FDA approval for Gamunex-C

Research Triangle Park headquarters.Image via Talecris

Being a former employee of Talecris I am familiar with the IGIV Gammunex program.  This is good news for Talecris (TLCR) as it gains Patent Protection approval for providing viral free blood products to those with ImmunoDeficiency.  Those with Immuno Deficiency desperately need Talecris' Life Saving BioPharmaceuticals to its patients.  It is a very rewarding job to know that the product you are making is actually saving lives. 

Would You Actually Take This Medication If You Had To?  That is an important question for a company to ask it's employees.  Some places you might not actually do so.  That is how bad some companies can get.  Talecris is not one of them.  They have sophisticated GMP sterile fill lines that have extensive quality controls of their product.  I should know, I tested the samples day in and day out.  It was a clean, sterile facility designed with Sterilty in mind.

Gamunex is a production is a Bayer Biological Designed facility and Talecris is venture capitalized  after being acquired from Bayer. 


Talecris does have some of long term debt but that will be reduced after this announcement.
They are a takeover target with this approval in my mind.  They did not merge with their Australian counterpart a year ago due to fears of monopolizing the drug market

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See more news releases in: Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, New Products & Services, FDA Approval

Talecris Biotherapeutics Receives FDA Approval for Gamunex®-C

New Subcutaneous Administration Provides another Mode of Delivery For Patients with Primary Immunodeficiency


Talecris Biotherapeutics (Nasdaq: TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex®-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).


Sometimes The Best Things In Life Are Free

I just wanted to invite everyone to share in the success of BioPharma Investor's Biotechnology and Pharmaceutical Stock Blog.  Follow Biopharma Investor for the most up to date FDA and Clinical Trial news in the industry.  Subscribe to my feed at:  http://feeds.feedburner.com/biopharmainvestor. 

I recently noticed that BioRunUp.com went from a free site to a pay site.  Currently BioRunUp.com is charging subscriptions for $299 a year or $99 a month.  BioRunUp is a nice website that is affiliated with MikeHavRx.com.  A subscription to MikeHavRx.com is $300 a year or $50 a month.  Although I too would like to set up my own BioPharma site and have subscriber content, BioPharma Investor Blog will always be free.  I respect the other two sites and think their content is a fair value, but why not just follow my blog instead.  Hey you can't beat free stuff.  You may say you get what you pay for, but I am just as knowledgeable and creditworthy as the other sites.  I simply offer my content for free. 

Although I cannot give you the exact same advice as the other two sites, I am charging absolutely nothing.  I have worked in the industry and have experience in FDA decisions and Clinical Trials.  Like Facebook's Mark Zuckerberg, I see the value in the website and want to keep the content easily accessible for everyone.  I apply the same BioRunUp principles and  I provide up to the minute news on the Biotech and Pharmaceutical Stock Investments.  BioPharma Investor recently won an award for Best Biotech Blog and I would ask you to follow me and subscribe to my feedsDonate a coffee or two to paypal if you have the chance.  It's safe and secure.

I apply due dilegence to stock investing and provide news on FDA outcomes and Clinical Trial Data  That does not mean I am always right but no one is 100% perfect on their trades.  I provide a unique philosophy on investing and I also have learned about shorting stocks on negative FDA outcomes.  Although this is risky, I see it as an important play where Clinical Trials are costing biotechs and pharmaceuticals millions of dollars, only to be rejected by the FDA.  But most of the time I stick to sound investments and quality clinical trials with the highest level of success.

I will do my best to provide premium content for my readers and will maintain this blog as a free site.   Although I am highly successful at making trades I can't make any promises.  This is a high risk, high reward market.  Anything and everything can happen.  I only will provide you with all the information I have on the latest trends in Biotech and Pharmaceuticals.  I try to stay away from the dreaded Pump and Dumps and if I see that it is in fact a pump and dump, I will probably be shorting the stock instead of investing in it for the long run. 

Thanks for all your support.

BioPharma Investor

Disclosure:  Before investing in any stock you should contact your financial advisor.  BioPharma investor is for informational purposes only.  I am not a securities broker and this website is for informational purposes only.  The reader bears responsibility for his/her own investment research and decisions, should seek the advice of a qualified securities professional before making any investment, and investigate and fully understand any and all risks before investing.
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Alkermes Gains FDA Approval For Vivitrol, Anticipating Oct 22 Approval with Amylin Pharmaceuticals

Image representing Wikinvest as depicted in Cr...Image via CrunchBase

Again another winning prediction from my FDA calendar for October.  Expect large gains for Alkermes tomorrow.  I wouldn't sell the stock as they have another approval up on Oct. 22nd in conjunction with Amylin and Eli Lilly for Bydureon, a weekly injectible diabetes medication.  I expect a FDA approval for that one too.  But you never know with the FDA.  Amylin already has approvals for daily injections but has modified the technology for weekly injections, so again I anticipate its approval as well.  Good news for Alkermes.

Try Wikinvest here--http://www.wikinvest.com/
Wikinvest---Alkermes (ALKS)
Wikinvest--Amylin Pharmaceuticals (AMLN)

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor
 Alkermes addiction drug wins wider U.S. approval

Tue Oct 12, 2010 7:26pm EDT

* Vivitrol already used in U.S. for alcoholics
* Approval may help turn around money-losing drug
* Shares up nearly 69 percent in 2010
* Shares up another 4.2 percent after hours

Big Pharma Earnings Preview: US Drug Makers May Report Lower 3Q Profits

Stocks Mentioned in this article: 
Johnson and Johnson (JNJ)
Eli Lilly and Co.  (LLY)
Merck  (MRK)
Pfizer  (PFE)

EARNINGS PREVIEW: US Drug Makers May Report Lower 3Q Profit


TAKING THE PULSE: Analysts expect most major U.S. drug makers to post third- quarter earnings slightly lower than those a year earlier, as sales of several big-name drugs have declined recently after some consumers cut back on health- care costs. Health-care reform and European national health programs imposing price cuts on drugs also offer added pressure for companies. Results in recent quarters have been skewed by big acquisitions, either boosting companies' revenue or sagging their bottom lines because of charges. Several of the industry bigwigs have also been subject to downbeat credit-ratings news because of recent problems with supply and pipeline issues, as well as upcoming patent expiry.


Big Gains For Pain Therapy Stocks Today: KG, PTIE, WPI, ENDP

King Pharmaceuticals

So Pfizer is increasing their portfolio with King Pharmaceuticals, a maker of veterinary meds and pain therapies.  In addition to this news, another company came into the spotlight for pain management therapies.  This company is Pain Therapeutics (PTIE).  Pain Therapeutics is in clinical trials now in collaboration with King Pharmaceuticals so look for Pfizer to kick in some clinical trial expertise with Pain Therapeutics (PTIE).  Additional companies involved in pain therapies is Endo Pharmaceuticals.  I highly suggest buying Endo as a buy right now.  Since June 2010 Endo's stock has risen form 20.22 to its current trading at 34.99.  I suggest a limit order to buy at some discount.  Another Pain therapies stock is Watson Pharmaceuticals, a generic drug maker. 

My opinion on this is that Pain Therapeutics could be slightly overvalued on the hyped news, and although it may seem attractive to buy right now, I suggest waiting for the pullback as it will be years before these clinical trials are actually approved by the FDA.  Also, I am a little cautious placing a buy on Pfizer right now as they will be losing patents on Lipitor next year and other brand name drugs will become available as generics.  I might actually place Pfizer's stock right now on hold or sell, as earnings could be lower than expected.  Just because everyone is doing it does not make it a buy in my opinion. I actually do not necessarily see King Pharmaceuticals as such a hot buy with only 4.85% profit margin and 18M in profits on 380M in revenue.  But given that layoff will presume who knows. 

Stick to your guns and remain a cautious investor and good things will come.  I apply Warren Buffett's principles to the BioPharma Stock World and like purchasing stocks at a discount.  You should be searching for the next Pfizer and not chasing after something that is overly hyped.  Just my opinion.

Stocks mentioned in this article

King Pharmaceuticals --(KG)
Endo Pharmaceuticals --(ENDP)
Pain Therapeutics --(PTIE)  Up 18.56% today on the news
Watson Pharmaceuticals--(WPI)


Disappointing Day For Alexza Pharmaceuticals

Image representing TheStreet as depicted in Cr...Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia

FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?

The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.