Monday, April 30, 2007

Thailand Not a Threat to Pharmaceutical Industry

by David E. Williams
Health Business Blog



Todd Seavey from the American Council on Science and Health has himself worked up into a lather about Thailand’s willingness to break drug company patents to cut its spending on AIDS drugs: (Drug Patent Violations, Knock-Offs Harm Us All)

Contrary to the assertions of the Thai government and Doctors Without Borders.. violating drug companies’ patents and making knock-offs of their drugs is not in the long-term best interest of patients. Just as letting people shoplift today can drive stores out of business tomorrow — and just as price controls make customers happy for a day but produce long-term shortages — so too do patent violations gut the incentive to invest millions in researching the even better drugs of tomorrow…Economically and scientifically ignorant moves like this could shrivel or destroy the pharmaceutical industry, and that will not make the Thais or anyone else healthier in the future.


(Actually, the drug companies have a lot more to fear from today’s Supreme Court decision that will make it harder for them to patent obvious inventions for extended release formulations.)

But let’s examine Seavey’s arguments for a minute:

1. Is breaking a patent like shoplifting? Will it “drive stores out of business”?
2. Will moves like Thailand’s “shrivel or destroy the pharmaceutical industry”?

Shoplifting hurts stores because they get zero revenue for goods they paid for. It raises their cost of doing business by forcing them to pay for security measures and to raise prices to make up for their losses. I’m not sure what the “stores” are in Seavey’s analogy. In general, drug wholesalers and pharmacies are pleased to stock and sell generics, which tend to be as or more profitable than branded products. (Drug stores don’t tend to allow shoplifting of generic or brand drugs.)
Thailand isn’t going to be stealing pills from Abbott, it’s just not going to place any orders.

Thailand’s moves aren’t going to affect whether companies continue to develop new drugs and certainly won’t destroy the industry. That would only happen if the US, Europe or Japan eliminated patents. Thailand doesn’t factor into the go/no-go decision for pharmaceutical development. Sure, Thailand is freeloading –but look at the benefits they’re already deriving in the form of lower prices from the branded players.

The best hope the drug makers have to keep Thailand and other developing companies from breaking their patents is to find other pressure points besides the unpersuasive (not to mention untrue) argument that they are destroying incentives for drug development. That’s why the pharmaceutical industry pays such close attention to trade legislation.

There’s a self-correcting mechanism that makes Thailand and its ilk less of a threat to the pharmaceutical industry than it may seem. Once a country starts producing substantial intellectual property of its own it begins to be more respectful of patents. That transition is highly correlated with an increase in national wealth that makes a country able to pay for high-priced drugs in the first place.


Source: HealthBusinessBlog.com



RELATED READING:
- Thailand's Compulsory Licensing of Pharmaceuticals Under TRIPS Stirs Controversy

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Medical Firms Make Product Placement Deals with ER, Grey's Anatomy

by Sara Calabro
Med Tech Sentinel



Small medical device firms don’t spend much time worrying about advertising. When working within tight budget constraints, a 30-second spot is a luxury most emerging firms can’t afford. But product placement may be an opportunity for smaller companies to get their products in front of a consumer audience – without breaking the bank.

Washington CEO magazine today has an article about three Seattle-area firms that have landed their products on Grey’s Anatomy and ER through barter deals with television networks. Philips Medical Systems, Cardiac Science (CSCX) and SonoSite (SONO) have seen their devices appear on one or both shows and have paid nothing for the honor. “These relationships are basically win-win because these productions need the props, and this helps us to build awareness of our brand,” Philips’s North American CEO Brent Shafer tells Washington CEO. He says it would cost between $7 million and $8 million to buy the equivalent amount of air time to what Philips gets for free each year through product placement barter deals.

Sure, established companies like Philips have the manpower to negotiate these kinds of deals. But it’s something for small companies to consider. Instead of saving pennies for that 30-second spot, perhaps a nominal investment in reallocating marketing resources to focus on barter deals would be a worthwhile investment.

“The fact is,” Cardiac Science’s VP of marketing, Garry Norris, tells CEO, “when our products appear in the show, we get a lot of e-mail. Customer service gets calls from people saying, ‘I saw your product on Grey’s Anatomy and wanted to learn more about it.’”


Source: OneMedPlace.com

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Cramer's "Ultimate Defensive Portfolio" of Medical Stocks

Jon C. Ogg
24/7 Wall St.



On tonight's MAD MONEY on CNBC, Jim Cramer said he's seen enough earnings from big companies and he is fed up with the Fed sitting around while the US economy is slowing. He wants to show you stocks that are safe and ones that will make you money. This is his "Ultimate Defensive Portfolio" of 3 stocks for tonight. He is looking for companies still growing that are not growing only because of overseas growth. He is unveiling 3 medical related:

CR Bard (BCR) is one he's been behind since 2005, and he is still behind it. He thinks this is a great medical device maker that has 65% of the peripherally inserted catheters and leaders in other catheters. He also likes their biopsy technology and the angioplasty operations. They are mostly #1 or #2 in their markets. In 2005 he thought it would be a takeover target, and he thinks it is still a takeover candidate in 2007. Anyone wanting to buy this company has to do it before the Democrats get to change the merger rules. This one is also in a group that the healthcare spending won't hit.

Jim Cramer's Second defensive stock on CNBC's MAD MONEY in medical devices as a portfolio of last resort is Becton Dickinson (BDX). It is a safe traditional medical device and diagnostics company. They even invented a longer needle because of Americans getting fatter and needing longer needles. The Genome and Tripath acquisitions are going great and they are into screening for cancer. It is up 31% since he first recommended it in July, but their increased guidance will drive this stock higher. The analysts are 4 buys and holds, so he thinks that ratio of 2:1 analysts being negative will create upgrades and the company will be able to beat estimates. Cramer thinks the analysts are holding back so they can cover other names.

Jim Cramer's third pick as a defensive medical industrial complex stock that he thinks can't get hurt by the economy is Baxter International (BAX), but he would only buy it if it pulls back right now. He likes this as a "best of breed" compared to a "worst of breed" stock like Boston Scientific (BSX). Hemophelia, dialysis, cancer treatments, immune disorders, and many other things. Cramer said that Boston Scientific (BSX) paid too much for Guidant and is having to spin off a good area of future operations just to pay for debt.


Source: 247WallSt.com



RELATED READING:
- Cramer Looking For the Next Dendreon
- Jim Cramer on Dendreon
- Cramer Calls Out His Next Biotech Picks
- Nastech Pharma: Cramer Thinks Biotech Zombie Worth Second Look

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Monday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor.com



Biotechnology

REXAHN PHARMACEUTICL [RXHN.OB] +20.00%
BIONOVO INC [BNVI.OB] +17.80%
BOSTON LIFE SCIENCES [BLSI] +14.84%
SEQUENOM INC [SQNM] +12.16%
CARDIUM THERAPEUTICS [CDTP.OB] +8.77%



Diagnostic Substances

EPICEPT CORPORATION [EPCT] +10.36%
SCOLR PHARMA INC [DDD] +4.07%
ICAGEN, INC. [ICGN] +3.92%
PALATIN TECH INC [PTN] +3.59%
SURMODICS INC [SRDX] +3.57%



Drug Delivery

QUIGLEY CORP THE [QGLY] +1.86%
NOVADEL PHARMA INC [NVD] +1.57%
K V PHARMA CL A [KV-A] +0.27%



Drug Manufacturers

ATHEROGENICS INC [AGIX] +8.77%
AVANIR PHARMACEUTICL [AVNR] +6.89%
PROVECTUS PHARMA [PVCT.OB] +6.71%
DUSA PHARM INC [DUSA] +5.83%
ACCESS PHARMACEUTICL [ACCP.OB] +4.60%



Drug Related Products

IMAGENETIX INC [IAGX.OB] +4.00%
ARGAN INC [AGAX.OB] +3.83%
NATROL INC [NTOL] +2.59%
MANNATECH INC [MTEX] +2.52%
XELR8 HOLDINGS, INC [BZI] +2.33%



Generic Drugs

CARACO PHARMA LABS [CPD] +0.07%



Medical Appliances & Equipment

SONIC INNOVATIONS [SNCI] +5.59%
RESTORE MEDICAL INC [REST] +5.51%
MEDICALCV INC [MCVI.OB] +5.00%
CHOLESTECH CORP [CTEC] +4.98%
GIVEN IMAGING LTD [GIVN] +4.52%



Medical Instruments & Supplies

ENPATH MED INC [NPTH] +27.58%
NEPHROS INC. [NEP] +11.33%
CRYOCOR, INC. [CRYO] +7.02%
NEUROMETRIX, INC. [NURO] +6.53%
UROPLASTY INC [UPI] +5.69%



Medical Laboratories & Research

SPHERIX INC [SPEX] +7.72%
BIO-IMAGING TECH [BITI] +3.15%
PSYCHEMEDICS NEW [PMD] +0.56%
BIO-REFERENCE LAB [BRLI] +0.30%
NATL DENTEX CP [NADX] +0.22%



- Friday's Top Biotech and Medical Stocks
- Thursday's Top Biotech and Medical Stocks

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Sunday, April 29, 2007

Omrix’s Biosurgical Products

by Brian Orelli
Baby Biotechs



Now I’m no surgeon, but I can guess that during surgery, there’s a lot of blood (actually, come to think of it, that’s part of the reason that I’m not a MD). Generally speaking, bleeding isn’t a good thing; Omrix’s (OMRI) biosurgical products and pipeline are designed to stop the bleeding (herein referred to by it’s clinical name, hemostasis).

Now how do you promote hemostasis in surgery? Well, the same way you do if you cut yourself when you’re shaving:

1. If it’s a small cut, you let the proteins in the blood form a clot (scab). Essentially fibrinogen, a protein in the blood stream, combines with another protein in the blood stream, thrombin, to form a clot. Omrix’s Evicel (marketed as Quixil outside the U.S.) is essentially purified fibrinogen. Since it’s purified from human plasma, it contains naturally occurring proteins as part of its biological active component (BAC), which help form a clot that sticks to the wound better. Omrix is also in phase 3 trials for purified thrombin, the other component of the clot, which results in a much slower hemostasis (preferred in some types of surgery).
2. If the cut is a little bigger or won’t stop on its own, you put a bandage on it. Omrix has designed a biodegradable patch that contains purified fibrinogen. The patch, which is in phase 1 clinical trials, is designed for high bleeding situations, like the emergency room, where the high flow/pressure from a wound rips a fibrinogen induced clot right off.


From my reading, it looks like they don’t have a patent on fibrinogen. Although they may have a patent on their purification process. Since they’re in a highly competitive field, they need to give the doctors a reason to buy their brand over any others. Omrix’s main advantage is that they purify fibrinogen out of human plasma while other competitors purify it out of cows, potentially causing the immune system to have to work overtime to fight off the perceived foreign infection. They’ve also packaged the fibrinogen in an easy to use form that can be stored at 4 degrees Celsius (refrigerator) for extended periods of time resulting in reduced waste of the product.

Omrix’s other competitive advantage in that they are good at purifying proteins out of human plasma. This same type of purification is used to create their passive imunotherapy product line, which I will talk about next time.


Source: BabyBiotechs.com

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Weekly Top Biotech and Medical Business Articles

by H.S. Ayoub
BioHealth Investor.com



The following articles were the most popular at BioHealth Investor for the week of April 21 - April 27.

This list can also be found on the right navigation bar of the blog during the week.



1. Short Squeezing Biotechs

2. Wal-Mart General Hospital

3. Dendreon: Countdown to FDA

4. Palomar Medical: To Dominate the Aesthetic Laser Market?

5. AlphaMD: An Investor's Lens to the Medical World



Last Week's Top Articles

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NFL Stars Back New Supplement Delivery System

by Sara Calabro
Med Tech Sentinel



HealthSport (HSPO.OB), an Amherst, NY-based company that makes an edible film strip delivery system for nutritional supplements, has raised $3 million in a private placement.

The money, part of which came from three National Football League stars turned investors — Bruce Smith and Jim Kelly, formerly of the Buffalo Bills, and Bernie Kosar, an ex-Cleveland Brown — will be used to commercialize the firm’s Enlyten SportStrips. The strips replace the electrolytes the body loses while exercising through buccal (cheek to gum) absorption. This mode of absorption differs from other electrolyte delivery predecessors because gastric absorption is bypassed and the electrolytes are directly absorbed into the body.

HealthSport says the SportStrips also help to avoid the over-hydration that can occur with excessive consumption of sports drinks.


Source: OneMedPlace.com


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Getting physicians to think seriously about radiation exposure

David E. Williams
Health Business Blog



I’ve mentioned a few times on this blog that I’m concerned about the levels of radiation patients are being exposed to as a result of medical imaging, especially CT. Radiologists and referring physicians haven’t taken the issue too seriously because:

- The scans are useful and, of course, well reimbursed
- They weren’t aware of the issue
- There’s generally no easy way to track how much radiation patients have been exposed to


I’ve reported on anecdotal evidence of radiation exposure in the past, and ways to reduce dosages by adjusting scanners. Now a study has reported overall information on exposure. The numbers are high: per capita exposure is up 6x since 1980, and it’s disproportionately due to CT.

Consciousness raising among physicians is a good first step, but patients need to keep track of their own exposure and work in conjunction with their physicians to balance risks and benefits. One thing that’s really unacceptable is having a scan repeated because a previous one is lost or inaccessible.
I’ve always thought one good use of a personal health record is to keep track of lifetime radiation exposure, even if the numbers are just estimates. (The real figures would be even better.) I haven’t seen this functionality yet, though maybe it exists somewhere.


Source: HealthBusinessBlog.com



RELATED READING:
- Three Biotech Drugs Have Potential to Treat Polonium-210 Radiation
- Hollis-Eden Anti-Radiation Government Contract Delayed Again

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New Eye Mask for Growing Blepharoplasty Market

by Sara Calabro
Med Tech Sentinel



BioElectronics Corporation (BIEL.PK), a Frederick, MD-based company that makes anti-inflammatory patches to accelerate healing after surgery, has come out with a new eye mask to hold in place its ActiPatch therapy on patients who have had eyelid surgery. The mask, made of a soft, breathable fabric, has a pocket on each side that holds a crescent shaped ActiPatch to assure proper placement over each eye. ActiPatch is a drug-free anti-inflammatory patch with an embedded battery operated microchip that delivers continuous pulsed therapy. It has been clinically proven to reduce swelling and bruising up to 50%.

Market potential for eyelid-surgery recovery devices is promising. Known as blepharoplasty, this kind of surgery is a cosmetic procedure that removes fat deposits, excess tissue, or muscle from the eyelids to improve the appearance of the eyes. More than 1.8 million surgical cosmetic procedures were performed in 2006, up 2 percent from 2005, according to the American Society of Plastic Surgeons. Blepharoplasty was the fourth-most common form of cosmetic surgery in 2006, with 233,000 procedures being performed.


Source: OneMedPlace.com



RELATED READING:
- Sights Set on Advancing Treatment for Retinal Disease
- eXegenics: An exciting new approach to macular degeneration

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Saturday, April 28, 2007

IBD Weekly Top Ranked Medical Stocks

The following list represents the top ten medical stocks ranked according to Earnings Per Share and Relative Strength by Investor's Business Daily (4/28/07)


scores out of 100 (last week's rank, change in score):

1(2) Medtox Scientific (MTOX) EPS=99 RS=99(+2)
2(1) Rochester Medical (ROCM) EPS=98 RS=99
3(3) Cynosure (CYNO) EPS=96 RS=98(+1)
4(4) Wellcare (WCG) EPS=97 RS=95
5(5) American Orient Bioeng (AOB) EPS=95(-1) RS=93(-1)
6(-) Celgene (CELG) EPS=99 RS=87
7(-) Gilead (GILD) EPS=98 RS=88
8(7) Emdeon (HLTH) EPS=99 RS=87(-1)
9(6) Arrhythmia Research (HRT) EPS=94 RS=92(-2)
10(-) LHC Group (LHCG) EPS=98 RS=87



- Apr 21; IBD Weekly Top Ranked Medical Stocks
- Apr 14; IBD Weekly Top Ranked Medical Stocks
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Friday, April 27, 2007

Dendreon: Countdown to FDA

by Jon C. Ogg
24/7 Wall St.



Dendreon's (DNDN) short interest actually grew again in April from 26.4 million shares in March to 33.9 million shares. The short interest was listed as 16.8 million shares in February. That is almost infathomable if you consider that some short sellers probably were killed and crushed after being wrong for more than a 200% loss in the short sell. So much for the rule of "Don't fight the tape."

The company has a "by May 15th" date indicated by the FDA for the approval decision of Provenge for prostate cancer, and the options activity is still substantial along with the open interest. Stock options in May expire on May 18, 2007. Here is the open interest for the MAY CALLS and PUTS:

Call Strikes and Open Interest
10.00 49,014
12.50 22,349
15.00 49,225
17.50 41,927
20.00 56,825
22.50 16,594
25.00 44,336
30.00 28,548
35.00 11,915

Put Strikes and Open Interest
2.50 58,718
5.00 38,375
7.50 70,000
10.00 73,633
12.50 82,954
15.00 77,144
17.50 38,018
20.00 24,989
22.50 6,481
25.00 4,653
30.00 2,946
40.00 19,548

Just yesterday Forbes ran a piece showing a doctor's efforts urging the FDA to delay the approval of Provenge. The funny thing is that open interest for the JUNE Put and Call options is very small. The interpretation of that would be that there is no expected delay in the review by speculators and investors. Literally only the JUne $20 Calls have an open interest with more than 1,000 contracts; all others are under 1,000 in the open interest.

If you want to go back over what was said on March 29 after the FDA Panel Backing, here is a link to that call.

Here is how the stock has been trading this week:

Day Close Volume
April 26 $15.45 20,855,900
April 25 $16.80 11,412,400
April 24 $17.07 24,417,500
April 23 $16.78 36,770,800

Shares have traded "only" 4 million shares today and are down 1.2% at $15.25 in late-morning trade. You can expect a pick-up in the interest and trading on this probably starting at the end of next week. The trading range on this one is amazing because its shares were as low as $3.57 a week or more before the FDA Panel backing, and shares traded up to $25.25 in the onslaught after the news went in their favor.

The fact that insiders took some money off the table right after the panel backing is probably not a shock. But investors who trade this stock need to keep in mind that the company does have an active shelf registration that would allow the company to sell what was up to $146.8 million in securities at the time and the company has already telegraphed that a) it would need to raise cash to further the sales and development of Provenge, and b) it would sell securities after the FDA decision. The actual shelf registration denotes that only a portion of this will be equity sales.


Source: 247WallSt.com



RELATED READING:
- Short Squeezing Biotechs
- Biotech Stocks Following FDA Extensions
- Cramer Looking For the Next Dendreon
- Out of Dendreon; Another Chance in May

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Friday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor.com



Biotechnology

IDM PHARMA INC [IDMI] +35.23%
LPATH INC [LPTN.OB] +11.11%
EXACT SCIENCES COR [EXAS] +8.30%
GENVEC INC [GNVC] +7.53%
HEMOBIOTECH INC [HMBT.OB] +5.95%



Diagnostic Substances

ICAGEN, INC. [ICGN] +19.53%
NYMOX PHARM CORP [NYMX] +14.31%
ROSETTA GENOMICS LTD [ROSG] +7.81%
QUIDEL CP [QDEL] +6.42%
PONIARD PHARMA [PARD] +4.67%



Drug Delivery

INSITE VISION INC [ISV] +12.75%
QUIGLEY CORP THE [QGLY] +3.87%
BIOVAIL CORP [BVF] +2.19%
PENWEST PHARM CO [PPCO] +1.92%
NOVADEL PHARMA INC [NVD] +0.79%



Drug Manufacturers

ARQULE INC [ARQL] +8.00%
INSPIRE PHARMACEUT [ISPH] +7.74%
DUSA PHARM INC [DUSA] +7.19%
ATHEROGENICS INC [AGIX] +6.21%
NEXMED INC [NEXM] +4.62%



Drug Related Products

XELR8 HOLDINGS, INC [BZI] +11.40%
IMAGENETIX INC [IAGX.OB] +4.17%
LABOPHARM INC. [DDSS] +3.71%
NATROL INC [NTOL] +1.31%
ZILA INC [ZILA] +1.01%



Generic Drugs

CARACO PHARMA LABS [CPD] +2.37%
HI-TECH PHARMACAL [HITK] +0.52%
PHARMACUTICAL CO [PRX] +0.45%



Medical Appliances & Equipment

ALPHA INNOTECH [APNO.OB] +10.37%
ARTHROCARE CP [ARTC] +7.53%
MICROTEK MED HLDGS [MTMD] +6.77%
QMED INC [QMED] +6.62%
AMER MED ALERT CP [AMAC] +3.28%



Medical Instruments & Supplies

ENPATH MED INC [NPTH] +9.66%
MEMRY CORPORATION [MRY] +8.42%
DIOMED HOLDINGS INC [DIO] +8.09%
AMDL, INC [ADL] +7.97%
ENDOLOGIX INC [ELGX] +6.02%



Medical Laboratories & Research

NEOGENOMICS INC [NGNM.OB] +8.11%
ERESEARCHTECHNOLOG [ERES] +5.97%
MEDTOX SCIENTFIC INC [MTOX] +3.97%
BIO-IMAGING TECH [BITI] +3.25%
OSI PHARMACEUTIC [OSIP] +0.50%



- Thursday's Top Biotech and Medical Stocks
- Wednesday's Top Biotech and Medical Stocks

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Palomar Medical: To Dominate the Aesthetic Laser Market?

by Anthony Payne
Atlas BioResearch


Palomar Medical Technologies (PMTI) released earnings today. It reported increased revenues compared to a year ago. Revenues also increased from 4Q 2006. Set this against the backdrop of disappointments from the company’s main rivals Candela (CLZR) and Cutera (CUTR), we think its performance was spectacular.

In addition, the list of competitors obtaining licenses from PMTI is growing. Recently, privately held Alma Lasers agreed to obtain a license from PMTI. Alma will pay a 9.5% royalty to Palomar for sales of its products going back to 2003 and an 8.5% royalty on sales from now through the end of 2007. That fee will drop to 7.5% for future sales, beginning next year. Companies already paying PMTI royalties include Cynosure (CYNO), Cutera (CUTR), and Iridex (IRIX) subsidiary Laserscope.

The battle with the one company still holding out, Candela, promises to heat up as they do not admit to needing a license from PMTI; Candela filed its own patent infringement suit against Palomar, and both say they won't allow the other to license their technology if they prevail. This lawsuit may be one of the only dark clouds in PMTI’s future as there is some doubt it will prevail against Candela. Candela also has enough cash to prosecute this action vigorously.

Our model still looks at a stock price of over $50 by the end of the year which is a solid increase from its current level of approximately $42. We think that there may be some moderation in increase in revenues during the year. However, 2008 should begin to see revenues from the consumer product royalties which will assist in boosting revenues in late 2008 and beyond. The stock will be adversely affected by failure in the Candela suit and if the revenues begin to drop off more than we expect. PMTI is a great company with strong technology having proven itself capable of selling into an increasingly competitive yet growing market. In addition, the market for its product is poised for further growth in an increasing affluent US and global society.


Source: AtlasBioResearch.com



RELATED READING:
- Palomar Medical Technologies Takes a Beating; Buying Opportunity

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Westaim Management to Look at ‘Strategic Alternatives’

by Sara Calabro
Med Tech Sentinel



Reeling from its weakened share price, Westaim Corporation (WED.TO), a Canadian company that makes wound care and pharmaceutical products from nanotechnology, is taking a closer look at its business strategy. In light of unimpressive stock performance — Westaim has been trading at less than $1, down from more than $5 one year ago — the company’s board has directed management to come up with some ”strategic alternatives” that’ll start delivering value to shareholders STAT. The kick in the pants likely came in the form of a Nasdaq Staff Deficiency Letter, which Westaim received on April 10. The letter advised the firm that for 30 consecutive business days, the bid price of its stock had closed below the minimum $1 per share requirement.

So far, Westaim has identified two kinks in its armor: iFire Technology and Nucryst Pharmaceuticals (NCST). The former, a subsidiary of Westaim that makes flat panel display technology, has been experiencing development delays. And Nucryst, of which Westaim owns 74.8%, reported disappointing results from a Phase II clinical trial for a treatment for atopic dermatitis.

Westaim has until October 8, 2007 to get its act together. Nasdaq gives delinquent companies 180 calendar days to get back to $1 before delisting them.


Source: OneMedPlace.com

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Thursday, April 26, 2007

Align Technology Blows Through Estimates

by H.S. Ayoub, DMD
BioHealth Investor.com


On Thursday, Align Technology (ALGN), the developer of the Invisalign clear teeth straightening system, blew past analyst estimates.

First quarter 2007 revenue numbers increased by more than 30% to $63.8 million over 1Q of 2006. The company also reported a return to profitability with a $.10 per share during the first quarter.

Analysts were expecting, or "guessing" might be a more accurate description, revenues of $58.5 million with a loss of $.01 per share.

The company also raised its 2007 forecast to earnings of $0.46-$0.55 a share on revenue of $268.4 million to $278.0 million.

Align stock skyrocketed by more than 33% by day end, as the quarterly report hit investors by surprise. The stock price ended trading at $23.60, blowing past the 52-week high of $17.95!

But is this new price level sustainable?

Taking the company's high end of its expected 2007 earnings, $0.55 per share, the current price would be 42x earning! That is taking the company's best expectations. If we assume a $0.46 per share profit level, the current price would be a hefty 51x earnings.

However, we must consider the fact that most high growth stocks tend to have lofty price to earning ratios. A range of 42 to 51 times earnings is not such an amazing number, as long as Align Technology continues its strong push for getting dentists to use Invisalign in their offices.

Now with the OrthoClear fiasco well behind them, Align Technology executives can focus not only on attracting more dentists from the U.S., but from abroad as well. According to the company's latest data about close to 25% of participating dentists were international, but only 74% submitted multiple cases. In contrast, 88% and 87% of U.S. orthodontists and general practitioners were multile submitting doctors respectively.

A small increase in the percentage of international dentists who submit multiple cases, and the continued growth in U.S. doctors, will at the very least justify the current price level. With another earnings surprise next quarter, and a further raising of the yearly forecast, Align Technology stock could very well cross the $30 a share milestone before the end of 2007.

As I mentioned previously, I like both Align Technology and Lifecore Biomedical (LCBM) as my small cap stock picks in the dental field.



Disclosure: Dr.Ayoub is a practicing general dentist in South Florida, does not own any position in Align Technology stock, and does not have any affiliation, business or otherwise, with the company.


Source: BioHealth Investor.com



RELATED READING:
- Investing In the Growing Dental Industry
- Why Does Procter & Gamble Need a Dental Laser?
- Oragenics Betting on Dental Cavity Vaccine
- Carrington Hopes Dental Market Improves Earnings

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Thursday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor.com


Biotechnology

INNOVIVE PHARMACEUTL [IVPH.OB] +12.99%
NEURALSTEM INC [NRLS.OB] +12.53%
ADVANCED LIFE SCIENC [ADLS] +9.52%
LPATH INC [LPTN.OB] +9.29%
VANDA PHARMACEUTICAL [VNDA] +7.89%



Diagnostic Substances

TRINITY BIO ADR [TRIB] +9.31%
PRESSURE BIOSCIENC [PBIO] +9.01%
SYNOVICS PHARMACEUTL [SYVC.OB] +6.67%
DIGENE CP [DIGE] +6.35%
ROSETTA GENOMICS LTD [ROSG] +6.31%



Drug Delivery

COLUMBIA LABS INC [CBRX] +13.25%
IOMED INC [IOX] +4.64%
PENWEST PHARM CO [PPCO] +4.25%
SKYEPHARMA PLC [SKYE] +2.39%
NEKTAR THERAPEUTIC [NKTR] +1.89%



Drug Manufacturers

PLANET TECHS INC [PLNT.OB] +18.32%
AEOLUS PHARMACEUTICL [AOLS.OB] +10.48% $9.9 M
SOMAXON PHARMACEUTIC [SOMX] +9.84% $0
POZEN INC [POZN] +7.00% $217.7 M
PHARMION CORP [PHRM] +6.82%



Drug Related Products

N B T Y INC [NTY] +6.40%
PACIFICHEALTH LABS [PHLI.OB] +2.63%
TIENS BIOTECH GR USA [TBV] +2.39%
XELR8 HOLDINGS, INC [BZI] +1.58%
DRAXIS HEALTH INC [DRAX] +1.17%



Generic Drugs

HI-TECH PHARMACAL [HITK] +1.37%
CATALYST PHARMACEUTI [CPRX] +0.76%
MYLAN LABS INC [MYL] +0.32%



Medical Appliances & Equipment

ALIGN TECHNOLOGY I [ALGN] +33.40%
CHAD THERAPEUTICS [CTU] +9.64%
NON INVASIVE MONITORNG SYS NEW [NIMU.OB] +8.33%
CRITICARE SYS INC [CMD] +5.93%
BSD MEDICAL CORP [BSM] +5.63%



Medical Instruments & Supplies

WEST PHARMA SVCS INC [WST] +12.30%
MILESTONE SCIENTIFIC [MLSS.OB] +8.00%
NUVASIVE, INC. [NUVA] +6.42%
ROCHESTER MEDICAL [ROCM] +5.40%
OCULUS INNOVATIVE SC [OCLS] +5.00%



Medical Laboratories & Research

LABORATORY CORP NEW [LH] +8.93%
ARRAY BIOPHARMA IN [ARRY] +2.78%
NEOGENOMICS INC [NGNM.OB] +2.07%
ERESEARCHTECHNOLOG [ERES] +1.61%
MEDTOX SCIENTFIC INC [MTOX] +1.55%



- Wednesday's Top Biotech and Medical Stocks
- Tuesday's Top Biotech and Medical Stocks

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High Hopes for New Prostate-Cancer Test

by Sara Calabro
Med Tech Sentinel






Results released today from a study of a new test for prostate cancer have raised spirits in the medical community and at the private Seattle firm that discovered it.

Onconome’s blood test measures EPCA-2 (Early Prostate Cancer Antigen), a newly discovered blood protein that when elevated, appears to indicate the presence of prostate cancer. In this latest study, published in Urology, Onconome’s test correctly identified 94 percent of men with prostate cancer and 97 percent without. By way of contrast, with PSA (prostate-specific antigen) tests, the current standard detection method, 80 percent of patients with elevated PSA levels do not have prostate cancer and 15 percent of patients with normal PSA levels do. Despite this, nearly 1.7 million prostate biopsies are performed each year based primarily on results from PSA testing.

“It could allow us to help patients decide if they need a biopsy or if it’s tame or has the ability to invade outside the prostate,” Robert Getzenberg, a co-author of the study, told The Los Angeles Times.

PSA tests also fall short when it comes to dechiphering how aggressive the detected cancer is. “The study also shows that EPCA-2 levels are highest in patients with non-organ confined prostate cancer, which is important because cancer that has spread outside of the prostate is much more deadly,” Getzenberg, who’s the research director at the Brady Urological Institute at Johns Hopkins, said in a statement issued by Onconome.

In addition to the ProstaMark EPCA-2 Serum Assay, which could be approved by 2008, the firm also is developing a ProstaMark EPCA Tissue Assay that would provide even earlier detection. And Onconome believes its testing technology has applications for colon and other kinds of cancer as well.

Onconome’s most recent financing round — a Series B, for $8.5 million in private equity — closed in September 2005.


Source: OneMedPlace.com



RELATED READING:
- Cell Genesys Showing New Positive Study Data
- Will Dendreon's Cancer Vaccine Win Final FDA Approval?

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Up on the Hill - PDUFA Testimony

by Mark S. Senak
Eye On FDA



Last week, FDA posted a slew of testimony that was submitted before Congress. In reverse order, Steven Galson testified before the Senate Special Committee on Aging on "Bio-Identical Hormones: Sound Science or Bad Medicine" on April 19. The day before, Dr. Jesse Goodman testified before the Committee on Homeland Security, Subcommittee on Emerging Threats, Cybersecurity, and Science and Technology on "FDA’s Role in the Regulation of Vaccines".

On the 17th of April, Theresa M. Mullin, Ph.D., Assistant Commissioner for Planning offered testimony before the House Subcommittee on Health, Committee on Energy and Commerce on the Prescription Drug User Fee Act. Time and space do not permit an in-depth look at all three, though it is commendable that the agency posted these in a timely fashion. Given the expediency of the issue, perhaps it is best to look at the last one involving PDUFA.

The testimony included the usual litany of past PDUFA achievements and then looked at four specific areas for PDUFA IV funding:

Ensuring Sound Financial Footing - No surprises here - resources have not kept up with costs. The current system does not allow for payroll cost increases, only pay increases - so things like healthcare coverage, retirement benefits, etc, aren't covered. The new system would cover total payroll costs.

Enhancing Process for Pre-Market Review - This looks at two areas and in particular seeks to add additional initiatives to help expedite drug development by adding staff.

Modernizing and Transforming Post-Market Drug Safety System - This is something it seems everyone wants, it is just a matter of how. They say they are going to evaluate risk management interventions here, but not which ones. Are they going to finally see if Black Box Warnings actually have any impact? The details are a little vague here - with references to hiring additional outside research and adding staff and to identify best practices and to improve IT systems. Nothing too radical here.

Reviewing DTC Advertising - This one interested me most because of the situation I've raised many times here regarding DDMAC - they are getting more money and doing less with it - at least as expressed in the issuance of Warning Letters. The interesting twist here is that rather than use regular PDUFA fees for this, they would be charging only those companies who want DDMAC to review their DTC ads prior to airing. So a company that asks for a review, pays for it. I suppose that would be insurance against a Warning Letter, but the agency hasn't been issuing many Warning Letters, so what is the incentive for companies to pay this fee?


Have a good day all.


Source: EyeOnFDA.com



RELATED READING:
- Who's in Favor of Safer Drugs?
- What a Ban on DTC Means for Public Relations
- Leaving PDUFA Alone
- PDUFA Dollars Up, Warning Letters Down

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Wednesday, April 25, 2007

NutriSystem's Impressive Quarter

by Jon C. Ogg
24/7 Wall St.



NutriSystem Inc. (NTRI-NASDAQ) posted earnings with $1.04 EPS on revenues of$238.36 million; analysts expected EPS of $0.91 and revenues of $212.7 million.

GUIDANCE: Next quarter revenues $190 to $200 million and EPS between $0.82 and $0.86...compared to estimates of $170.5M revenues and $0.70 EPS. It expects full year 2007 revenues of $790 to $805 million and $3.34 and $3.46 per share....compared to estimates of $734M revenues and $3.05 EPS. Impressive.

Michael Hagan, Chairman/President/CEO: "The solid growth of our core women's market and continued strength of the men's market allowed us to achieve record earnings. In addition, an integral part of our first quarter has been the ongoing expansion of our pool of ex-customers and their desire to return to NutriSystem for weight management services. The operating margin expansion we saw in the first quarter was partially due to the growth in revenue from ex-customers."

Direct channel revenues reached $217,859,000 in the first quarter of 2007, a 64% increase over the same period in 2006. The Company added approximately 358,000 Direct channel new customers, a 52% increase from approximately 235,000 new customers in the first quarter of 2006. It also spent $76 million in Q1 to repurchase 1.7 million shares of common stock.

Well, no matter how you cut it this was an impressive turnout in numbers. The stock had already been rocked well off its highs pretty hard and short selling had increased: March's 13.4 million short interest grew to a total amount of more than 14.38 million shares in April.

The 52-week trading range is $40.82 to $76.33. Shares closed up 2.5% at $58.24 after-hours, and shares are up more than 10% at $64.75 in after-hours. You don't have to like Dan Marino and crew and you don't even have to like women that can get back into a size 2, but these numbers are hard not to like.


Source: 247WallSt.com


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CryoCor Raises $5.45 Million in Private Placement

by Sara Calabro
Med Tech Sentinel



San Diego-basedCryoCor (CRYO) has raised $5.45 million in a private placement with a group of accredited investors. The company sold 1,052,423 shares of common stock priced at a closing bid price of $5.14 per share.

CryoCor’s signature product, the Cryoablation System, treats cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The product has been on the market in Europe since 2002 for the treatment of atrial fibrillation and atrial flutter, the two most common and difficult-to-treat arrhythmias. The company is pursuing similar availability in the U.S. Earlier this month, CryoCor got word that FDA’s advisory panel will meet in June or July to review a pre-market application for using the Cryoablation System to treat atrial flutter; a trial is underway for the atrial fibrillation indication.


Source: OneMedPlace.com



RELATED READING:
- Inovio Biomedical: Tumor Ablation Technology Tempting to Big Pharmas

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Wednesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor.com


Biotechnology

XENOPORT [XNPT] +44.01%
BIODELIVERY SCI INTL [BDSI] +30.39%
EXACT SCIENCES COR [EXAS] +14.06%
INNOVIVE PHARMACEUTL [IVPH.OB] +10.00%
CV THERAPEUTICS I [CVTX] +9.13%



Diagnostic Substances

SYNOVICS PHARMACEUTL [SYVC.OB] +7.14%
PONIARD PHARMA [PARD] +6.92%
SURMODICS INC [SRDX] +6.71%
PRESSURE BIOSCIENC [PBIO] +5.33%
LEXICON GENETICS I [LEXG] +3.60%



Drug Delivery

PENWEST PHARM CO [PPCO] +4.54%
BIOPROGRESS PLC [BPRG] +1.92%
ALKERMES INC [ALKS] +1.25%
ELAN CP PLC ADR [ELN] +1.13%
NEKTAR THERAPEUTIC [NKTR] +0.87%



Drug Manufacturers

SEPRACOR INC [SEPR] +9.67%
SOMAXON PHARMACEUTIC [SOMX] +7.84%
PROTALEX INC [PRTX.OB] +6.25%
UNIGENE LABS INC [UGNE.OB] +5.09%
SHIRE PLC ADS [SHPGY] +5.01%



Drug Related Products

PACIFICHEALTH LABS [PHLI.OB] +6.74%
CURATECH INDUSTRIES [CUTC.OB] +6.47%
IMAGENETIX INC [IAGX.OB] +4.35%
LABOPHARM INC. [DDSS] +3.56%
MANNATECH INC [MTEX] +3.03%



Generic Drugs

PHARMACUTICAL CO [PRX] +1.59%
BARR PHARMA INC [BRL] +1.33%
HI-TECH PHARMACAL [HITK] +1.08%
WATSON PHARMACEUTCLS [WPI] +0.83%
CARACO PHARMA LABS [CPD] +0.36%



Medical Appliances & Equipment

SPECTRASCIENCE NEW [SCIE.OB] +16.00%
FONAR CORP NEW [FONRD] +12.55%
MEDICALCV INC [MCVI.OB] +8.00%
CONSORTIUM SVC MGT [CTUM.OB] +6.54%
AMER MED ALERT CP [AMAC] +6.38%



Medical Instruments & Supplies

ADVANCED MED OPTICS [EYE] +8.75%
UROPLASTY INC [UPI] +8.63%
INOVIO BIOMED CORP [INO] +4.84%
BOVIE MEDICAL CORP [BVX] +4.70%
ROCHESTER MEDICAL [ROCM] +4.64%



Medical Laboratories & Research

MEDTOX SCIENTFIC INC [MTOX] +6.83%
ARRAY BIOPHARMA IN [ARRY] +5.34%
ERESEARCHTECHNOLOG [ERES] +2.93%
SPHERIX INC [SPEX] +1.82%
PHARM PROD DEV [PPDI] +1.11%



- Tuesday's Top Biotech and Medical Stocks
- Monday's Top Biotech and Medical Stocks

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Iapyx Introduces Catheter Stabilization Devices

by Sara Calabro
Med Tech Sentinel



Iapyx Medical, a San Diego firm that makes single-use medical devices, today introduced two products for reducing the risk of common hospital-acquired infections.

The Stable-Line Arterial catheter stabilization device is designed to prevent inadvertent movement and dislodgment of arterial lines. Suture securement, the traditional means of arterial line securement, increases patients’ risks of developing catheter-related bloodstream infections, which pose a significant mortality risk. Suture securement also puts healthcare workers at risk for needlestick injuries, which expose them to such diseases as Hepatitis B and C, and HIV. Iapyx’s device works without invasive sutures or conventional strips of tape. It grips the extension set to immobilize the catheter while permitting visual inspection and monitoring of the insertion site.

The Stable-Line Foley device addresses the infection risks, complications and discomfort associated with indwelling Foley (urinary) catheters. To secure Foley catheters, most clinicians use tape and leg-straps, an ineffective method that’s also inadequate against urethral irritation, meatal erosion and accidental dislodgement. Iapyx’s Stable-Line Foley minimizes these complications by securing the catheter and reducing inadvertent movement. The device, designed with a releasable and rotating dead-bolt style locking mechanism, allows for patient movement while maintaining skin integrity.

Iapyx Medical rebranded itself (from Medical Device Group) at the end of 2006. The new name is after Iapyx, a wound healer and battlefield surgeon in Greek mythology who is one of the first people credited with identifying and treating the problem of surgical site infections. Soon after the rebranding, the company secured $9 million in funding from Tavistock Life Sciences.


Source: OneMedPlace.com

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Purdue Pharma Tries to Salvage 30-Month Stay in OxyContin Case Against Mallinckrodt

by Aaron F. Barkoff
Orange Book Blog



Purdue Pharma has been fighting in court for nearly a decade to protect OxyContin--a blockbuster painkiller and by far Purdue's best-selling drug product--from generic competition. Purdue settled its patent litigation with Endo (ENDP) and Teva (TEVA) last year, and with Impax a few weeks ago. Recently, Purdue filed complaints against Mallinckrodt and KV Pharma. Purdue's case against Mallinckrodt is particularly interesting, since it raises some new questions about 30-month stays.

In 2005, Mallinckrodt filed an ANDA for generic OxyContin (oxycodone HCl controlled-release) Tablets with paragraph IV certifications to Purdue's U.S. Patent Nos. 5,508,042; 5,549,912; and 5,656,295. Purdue received notice of Mallickrodt's ANDA filing on October 4, 2005. According to Purdue, however, various orders and injunctions in other OxyContin litigation "prevented Purdue from filing suit against Mallinckrodt at that time." Purdue waited until November 9, 2006 before it sued Mallinckrodt for patent infringement.

In December, Purdue filed a Motion for Order of 30-Month Stay in the district court, asserting "that the 45-day period related to Mallinckrodt's notice of its ANDA filing was equitably tolled until October 17, 2006, and, therefore, that the filing of the complaint on November 9, 2006, within the 45-day period, triggered a 30-month stay of FDA approval of Mallinckrodt's ANDA under the Hatch-Waxman Act." At the same time, Purdue filed a Petition for Stay of Action with the FDA, asking FDA to stay any approval of Mallinckrodt's ANDA until the district court has ruled on its motion.

Purdue acknowledges that a patent owner or NDA holder is allowed only 45 days after receipt of a paragraph IV notice letter to file a patent infringement suit if it wishes to obtain a 30-month stay. However, Purdue argues that a January 5, 2004 district court finding of unenforceability in the litigation against Endo, various collateral estoppel orders in related cases against other ANDA applicants, and a June 7, 2005 Federal Circuit opinion affirming the district court's unenforceability opinion, prevented Purdue from filing suit against any other ANDA applicants.

On February 1, 2006, the Federal Circuit withdrew its June 7, 2005 opinion and remanded the case to the district court for further proceedings on inequitable conduct. Since the February 1, 2006 Federal Circuit opinion, Purdue settled with Endo, Teva, and Impax, and filed proposed stipulated orders vacating the collateral estoppel orders in those cases. Purdue argues that it was blocked from filing suit against Mallinckrodt until October 17, 2006, when it filed the last remaining proposed stipulated order.

In its Opposition to Purdue's Motion for Order of 30-Month Stay, Mallinckrodt argues first that the statute is "plain and unambiguous": a 30-month stay is available only if suit is filed within 45 days of receiving notice of a paragraph IV certification; the statute simply does not grant a court authority to order a 30-month stay otherwise. Second, Mallinckrodt argues that the Doctrine of Equitable Tolling does not apply to the 45-day period because the period is not a statute of limitation; and even if the doctrine did apply, "Purdue's repeated failures to take action to protect its interests would bar Purdue from the benefit of the doctrine."

The parties have requested an oral hearing on Purdue's motion for a 30-month stay, although it appears that the court has not yet scheduled a hearing. In the meantime, Purdue might file a motion for preliminary injunction. Judge Sidney H. Stein in the Southern District of New York is presiding over the case.


Source: OrangeBookBlog.com

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