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From: Western Rookie4/4/2012 2:12:31 PM
   of 72
 
Couple new Nutracueticals to watch...

Neutra Corp / NTRR:OTC... Home | Neutra Corp.


and

Asantae Holdings / JVA-V Asantae

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From: Western Rookie4/5/2012 2:38:46 PM
   of 72
 
Small-Cap Ideas with Double-Digit Growth Potential: Frederick "Rick" Wise TICKERS: ATRC, ISRG, STJ, SYK, UNIS, VOLC

Source: George S. Mack of The Life Sciences Report (4/5/12)

You can own large medtech and diversified medical supply companies for low volatility and incremental upside in a trending economy (yawn. . .), but small- and mid-cap companies offer the real double-digit growth possibilities. In this exclusive interview with The Life Sciences Report, Analyst and Managing Director Frederick "Rick" Wise of Leerink Swann shares small-cap ideas that could wake up investors' portfolios.



Companies Mentioned: AtriCure Inc. - Intuitive Surgical Inc. - St. Jude Medical Inc. - Stryker Corporation - Unilife Corporation - Volcano Corp.


The Life Sciences Report: Back in early March you attended the 2012 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting in San Diego. Were there topics or companies that the physicians were especially interested in?

Frederick Wise: Whether in a consumer setting or a medical meeting, doctors are drawn to what's new, just like consumers would be. Physicians want to see innovative technologies and understand them. There is a competitive element to it, and two of the biggest companies in the general surgery space were there: Covidien Ltd. (COV:NYSE ) and Johnson & Johnson (JNJ:NYSE) Ethicon Endo-Surgery. Both were displaying a number of new surgical products. I would say that one of the most exciting innovations right now in the medical technology space is in robotics, and for that reason there was a great deal of interest at SAGES in Intuitive Surgical Inc. (ISRG:NASDAQ), which is in the earliest stages of taking its da Vinci robot into the field of general surgery. That's a hot topic for sure.

TLSR: You follow the large-cap diversified supply and device companies. Every recession brings a shakeout that creates efficiencies in business. Have you seen this occur?

FW: That is a crucial point when thinking about this industry today. Virtually every large company I follow has, in some way, shape or form, announced formal restructurings, increases in efficiencies and headcount reduction. Many have combined business units and are looking for efficiencies in terms of manufacturing, distribution or sourcing among other factors.

TLSR: When the economy and employment recover and when patients return for the elective procedures they've been putting off, will these large companies be better positioned than they were in the past?

FW: Yes, I think the large-cap mature companies are moving past many of the obvious negatives and challenges, and are extremely well positioned to show some positive sales and operating leverage as the global economy gradually recovers. Most of these larger companies have market-leading positions in their major markets. All of them are reshaping their portfolios and focusing on more innovative, differentiated products and markets with potentially better pricing, better demand and better margins. We don't have to get back to 15% top-line growth to see leveraged bottom-line growth. Maybe we can get to a point in the recovery where incremental top-line growth of even 12% could produce very positive, very leveraged impacts on the bottom line.

TLSR: With a few exceptions you're basically in the large-cap medical device and diversified supply space. What case do you make for them?

FW: I've never been very fond of generalizing, but I think you have to start from the point that this group has underperformed the broader markets and often the rest of healthcare now for several years. Multiples are low; dividend yields have risen; free cash flow yields are actually at historically high levels. This is all understandable in the context of a maturing industry. I'm inclined to think that in a stable to improving economy, with procedures rebounding, tremendous cash flows, the improved operating leverage I mentioned, and with virtually all large-cap companies increasing dividend payouts, that these could be very attractive total return stories without a lot of risk over the next few years.

TLSR: Clearly, recurring revenue is part of the story for the mega-caps like Johnson & Johnson (J&J), Abbott Laboratories (ABT:NYSE) and even smaller large caps like Baxter International Inc. (BAX:NYSE) and Covidien. But these companies are so widely diversified in their product portfolios that growth is difficult. Also, huge market caps like $90 billion (B) are hard to double. What kind of edge can investors get?

FW: I don't know that there is an edge so to speak, but again, I don't think you have a lot of downside with the large-caps mega companies like J&J, with revenues approaching $70B, and Abbott, approaching $40B. My theme has been to focus on the relatively smaller large-cap companies. In particular, I'm thinking of St. Jude Medical Inc. (STJ:NYSE) and Stryker Corporation (SYK:NYSE) (now followed by another Leerink colleague), both of which have a relatively smaller revenue bases that should be growable, especially given their increasingly attractive portfolios—especially if the business has been run well and if their pipelines are growing and expanding. That happens to be the case with both of these companies.

TLSR: Speaking now to the mid-cap and small-cap companies in your coverage, is consolidation part of your theme?

FW: As I said, one of my themes is the low-risk, total-return concept. A second theme is buying the larger-cap companies with the best pipelines, but with a relatively small revenue basis and that are able to grow faster than the group average—like St. Jude Medical and Stryker. My last major theme is in the direction you suggest: consolidation.

TLSR: May we speak about some of your recommendations for investors? Let's talk about specific companies.

FW: I'm going to start with two companies I just initiated coverage on that I'm very excited about. These are at the opposite end of the spectrum from J&J, Abbott, Medtronic Inc. (MDT:NYSE), Boston Scientific Corp. (BSX:NYSE) and St. Jude.

First, I would like to mention AtriCure Inc. (ATRC:NASDAQ), the market leader in the surgical treatment of atrial fibrillation (AF), with roughly half of the surgical AF market.

TLSR: We're talking about atrial ablation, correct?

FW: Right, but ablation in a surgical setting. Atrial fibrillation, as you know, is a complex and very serious disease. The idea is that you burn lines in the heart tissue to stop the cascade of heart cell contractions, which is a harmful process that almost is like dominos falling, but in a chaotic fashion. With these burn lines, or lines of block, you prevent the electrical arrhythmias from running all over the heart, and if you are successful, you force them back into more regular patterns. Electrophysiologists do atrial ablation procedures as a catheter-based procedure from inside the heart. But, cardiac surgeons have a major opportunity to treat AF from outside the heart. And if you're doing coronary artery bypass graft (CABG) or valve replacement or repair procedures, with the chest open, you've got open access to treat the AF.

TLSR: What's the size of this market?

FW: In the U.S. alone, again just looking at the AF procedures done surgically, atrial ablation done with open-heart procedures could easily be a $250 million (M) market. In round numbers, there are about 350,000 (350K) CABGs done annually in the United States alone, and obviously a lot more internationally. Probably a quarter of them—or about 85K—are performed on patients who have AF, which is not surprising since older people, ages 60–80, tend to have multiple co-morbidities, multiple clinical issues. Of the 85K potential cases of AF, fewer than 20% of them are actually treated during a surgical procedure, despite the fact that it's very well documented in clinical studies that approximately 80–90% of these patients are cured if their AF is treated during surgery. Patients can even stop taking anticoagulants, which are expensive and produce complicating side effects that make it difficult for physicians to manage other co-morbidities. This is a great procedure.

TLSR: Rick, in December Atricure received FDA approval for an expanded AF indication for its Isolator Synergy Surgical Ablation system. You have written that this should drive growth, but the stock didn't react particularly favorably, or for that matter unfavorably.

FW: I'm glad you asked about that because it's important to reflect on the challenges AtriCure faces, as well as the opportunities. Historically, for a couple of reasons, the company was not able to optimally train and educate doctors about its atrial fibrillation treatment. Cardiac surgeons got excited about this approach to AF in the days before AtriCure became public in August 2005. Then the company faced a very challenging period from 2008 to 2010, when the Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) stepped up enforcement on off-label promotion of medical products and drugs for all healthcare companies. Unfortunately, AtriCure was one of the first companies to feel the ramifications of this stepped-up enforcement. They weren't doing anything terrible, and their products were approved, but approved for general approaches to cardiac ablating procedures, rather than for specific targeted procedures, and not specifically for atrial fibrillation use. And so again the FDA decided to raise the bar, not just for AtriCure, but for everybody. We've also seen this same raising of the regulatory bar in the spine/orthopedic arm of the industry, for example. For Atricure, this process understandably changed the company's approach to training and education. The very good news for the company is that this DOJ investigation was fully resolved in 2010. Having been the first in, if you will, AtriCure is also now, in a sense, the first out. Now Atricure is the only company with an AF device specifically approved and labeled for educating and training doctors in atrial ablation, etc.

Having said all that, frankly, I can understand why investors are in a "show me" mode relative to the stock. Especially since I'm in that mode, too. But I believe the company is well positioned to show me—and show the rest of the investment community—that they have a real opportunity to drive surgical AF procedure penetration. It's like baking a cake in a way. If you have got all the ingredients—flour, sugar, butter, etc.—you can turn those ingredients into something very special. Although it will take a few quarters to see it show up in revenues, I think there's an above average chance that we'll see all the ingredients coming together to bake up something very tasty at AtriCure.

TLSR: Training is a major issue. It's important to get new modalities into teaching institutions because established clinicians do not want to take up new procedures. The cardiovascular surgeon wants to graft the new vessels onto the myocardium and get out.

FW: Well said and so true. As in the evolution of all procedures and all technologies, the docs are thinking about what they know from three, five or eight years ago, about earlier generations of these AF products and earlier experiences with less-evolved products and techniques. In the case of surgical atrial ablation, my due diligence suggests that under the best circumstances it can take only an additional five minutes of operating room time to do this procedure successfully. AtriCure's challenge is to bring that message more clearly, succinctly and directly to surgeons, and to help them understand what's possible despite their existing mindsets. This is trench warfare for Atricure—doctor by doctor, hospital by hospital. You can't just put an ad on the screen at the Super Bowl to make this process happen. It’s a doc-by-doc training and education process.

TLSR: What was the other company you just initiated coverage on?

FW: The other small-cap company is Unilife Corporation (UNIS:NASDAQ). It's more of a hospital supply-type name, but a very special one. Unilife manufactures prefilled syringes for large pharmaceutical and biotech companies that want to take both new pipeline products, as well as products coming off patent, and package them attractively in a user-friendly, safer way—and in the process meaningfully differentiate their delivery system from others. There's also the important and essential issue of preventing accidental needle sticks for health care workers and patients alike. The company has something like 12 issued patents on their safety and delivery technologies, with a core patent covering the key feature in all of Unilife's safety syringes, revolving around the method of needle retraction within an integrated device.

TLSR: Rick, because these are off-patent drugs and because only a device as been added, can these syringes be approved through the 510(k) process?

FW: The simple answer is yes, but your premise isn't 100% correct. Some are going to be drugs coming off patent, absolutely. But some are going to be drugs in development that can go through all the clinical trials with the Unilife device. Some devices will be approved as a 510(k), some will be approved as part of a device/drug combination.

TLSR: Unilife is a small-cap company, and manufacturing prefilled syringes sounds like a capital-intensive business. I'm curious to know about the drug trials you just referenced. Are the pharma partners going to be paying Unilife for these syringes during the trials? Is the company capitalized well enough to withstand these costs?

FW: Excellent question, because the company has barely any revenue right now. Unilife does have development/customization programs, and it does get paid, but the business is capital-intensive to the extent that it had to build a facility. You have to spend money on equipment to manufacture prototype devices, and the company has done this. Will it need additional capital going forward? The simple answer is probably yes. The complex answer is that maybe it will depend on how the deals are structured and how the cash flows are structured.

TLSR: What else are you talking to investors about currently, Rick?

FW: On the smaller side we continue to like Volcano Corp. (VOLC:NASDAQ). Volcano sees itself today as a very high-level, precision guided therapy company. Volcano already is the global market leader in intravascular ultrasound (IVUS), as well as being one of two key players in the rapidly growing fractional flow reserve (FFR) measurement market. IVUS imaging is used inside the coronary artery before, during and after procedures to better understand both the anatomy and the nature of the blockages inside the artery during percutaneous coronary intervention (PCI) (stent) procedures.

Volcano has had an excellent track record since it became public in 2006. The company has steadily gained market share on a global basis and at the same time has invested heavily in the future. Right now the company has a global installed base of some 6,800 IVUS instruments alone in catheter labs around the world. And at this point, particularly with its latest generation platform, it has the opportunity to expand into other areas of imaging.

As I mentioned, right now both Volcano and St. Jude Medical are benefiting from the very rapid growth and acceptance of fractional flow reserve (FFR) technology, another important diagnostic tool for the catheter lab. It allows for very effective, very simple assessment of coronary artery blockages. Bottom line, right up front doctors get more accurate diagnoses and measurements to determine which patients should get a stent, and whether patients should be stented at all.

TLSR: Is Volcano an acquisition candidate?

FW: I definitely believe Volcano is an acquisition candidate. As a reminder, the other major player in the global IVUS market is Boston Scientific.

TLSR: Is Medtronic in this market?

FW: Medtronic does not offer either IVUS or FFR. Looking at the stent market, Abbott, Boston Scientific, and Medtronic are the three major players in the global stent market. But, of the three, only Boston has IVUS, not FFR, and again, Volcano has both an IVUS and an FFR offering, as well as a full pipeline of new additions to its precision guided therapy portfolio. So, you'd think that could be an interesting portfolio addition at some point.

TLSR: Do you also follow Boston Scientific?

FW: I think it's fair to say it is one of the most controversial large-cap stocks I follow. Boston Scientific has had a very difficult decade. The headwinds that the entire industry has been facing have been doubly or triply challenging for Boston Scientific for a host of reasons. The company very famously paid top dollar for Guidant in April 2006, just as the implantable cardioverter defibrillator (ICD) market slowed precipitously and just as the FDA was raising standards. Expenses were too high and revenues were slowing in a world that was changing dramatically, and the company suddenly found itself overleveraged. It has taken the company time to adapt to the changing environment and its changed circumstances—a process that is far along but still underway.

TLSR: You've got Boston Scientific rated Outperform. Why?

FW: Today, with an entirely new management team in place and with significant restructuring, the last of the major rating agencies has just returned the company's debt to investment grade from a junk rating. The company is generating over $1B/year free cash flow, and the business has now stabilized. It has made significant and important external investments in new and emerging markets, and in products. It very recently made an acquisition that brought with it some differentiated and potentially very exciting ICD technology. I think Boston has positioned itself for much better revenue and earnings-per-share growth over the next three to five years. Its stock has understandably been largely avoided, but over the next one to two years people are going to say, "Wow, that's better than I thought," as opposed to the opposite.

TLSR: You alluded to the recent (March) deal to acquire Cameron Health, which has developed a "leadless" ICD system. How important is a leadless system?

FW: This is a fascinating idea. Cameron has been working to develop this technology over the last decade, and Boston has been an investor from the beginning and has had an option to buy the company for a long time. There were very specific milestones, and Cameron must have met those milestones, based on the decision Boston has made to buy it.

For general background, you need to first appreciate that one of the major challenges in using ICDs is that the leads create many complications. Every major company has had performance challenges with their leads. Having thin wires inside a beating heart for years can take a toll on the products. With traditional ICDs, once the leads are in place they grow into the heart tissue, and it's hard to take them out without a very invasive procedure. If you could develop a product that, for a significant number of patients, could eliminate the need for a lead, the implantation procedure would be made simpler, faster, easier and less complicated. Cameron has done that. Boston has acquired them, and I think Boston could be well ahead of the pack in this respect.

TLSR: At minimum, then, you are thinking Boston Scientific's cardiac rhythm management division could be revived?

FW: A fully approved Cameron device would be transformative to Boston's cardiac rhythm management business. The ability to talk about a unique, and potentially game-changing, technology with hospitals and physicians would enhance Boston's ability to sustain and even gain both market share and physicians' mind share. All this could be quite positive for the company's Customer Relationship Management division outlook.

TLSR: Rick, many thanks to you. I've enjoyed this.

FW: Thank you. My pleasure.

Prior to joining Leerink Swann in 2008, Frederick "Rick" Wise was a senior managing director and medical supplies and devices analyst with Bear Stearns for 22 years. For the past 13 years, he has been a member of the Institutional Investor All-America Research Team, most recently with a runner-up ranking in the 2009 poll. He was also ranked #4 in the 2006, 2007, and 2008 Greenwich Associates U.S. Equity Analysts poll. Prior to joining Bear Stearns, Wise served as an analyst at Kidder, Peabody & Co. and at Forbes, Inc. Wise received a master's degree and a bachelor's degree from the Manhattan School of Music. He is also a Chartered Financial Analyst.

Want to read more exclusive Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see a list of recent interviews with industry analysts and commentators, visit our Exclusive Interviews page.

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From: Western Rookie4/5/2012 3:09:32 PM
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With or Without "Obamacare," Healthcare Stocks Are Headed HigherSource: Don Miller, Money Morning (4/2/12)

"With the bill's fate up in the air, major players will have to devise new strategies for either outcome."




The fat lady hasn't sung yet. . .but she is warming up.

Three days of arguments before the Supreme Court have made it abundantly clear—"Obamacare" is in danger of being gutted or completely wiped off the books.

Only one thing's for sure. Investors will want to keep buying healthcare stocks—especially as 10,000 baby boomers a day turn 65 years old for the next 20 years.

But there's one segment of the healthcare sector that will be sitting in the driver's seat when it comes to delivering healthy profits and investment returns—no matter how the court rules.

Here's what you need to know. . .

Obamacare's Confusing Details

Fact is, analysts have been struggling to figure out how the Affordable Care Act (ACA) would impact various segments of the healthcare sector ever since the bill was passed.

"For most companies, the bill is neither very good nor very bad," Dan Mendelson, CEO of Avalere Health, told NPR after the bill passed in 2010. "Across each of the different segments there are pieces that will be good and pieces that will be more challenging."

That's because in addition to a slew of new taxes on pharmaceutical, hospital, and insurance businesses, Obamacare includes a dizzying array of incentives that will have a dramatic effect on industry profits.

Uncertainty surrounding the law is already rattling stocks.

Healthcare stocks have underperformed the broader market this year, up 6.4% compared to the S&P 500's 11.6% gain.

With the bill's fate up in the air, major players will have to devise new strategies for either outcome.

What Obamacare Means for Healthcare Stocks

Here's what the law might mean for major players.

Big Pharma: Big drug makers like Pfizer Inc. and Eli Lilly & Co would pay about $85 billion over 10 years to fund ACA. They also made concessions that would save the Medicare system billions of dollars a year.

In return, they were able to kill a proposal to allow cheaper prescription drugs from Canada and were granted longer patents on generic versions of biotech drugs.

On balance, they probably would come out ahead.

Insurance Companies:The picture appears positive for insurance companies. The infusion of 40 million new people into the system is seen as a gigantic shot in the arm.

But there are huge tradeoffs.

Most importantly, the insurers would no longer be able to deny people coverage based on pre-existing conditions. They also would face billions of dollars in new taxes and restrictions.

But insurers supported the plan for one simple reason—they can pass any cost increases on to their customers.

Hospitals & Doctors:Over the next 10 years, hospitals and doctors would contribute $155 billion to paying for the legislation by taking smaller payments from Medicare and other government programs.

But if the court rules that the individual mandate is constitutional, hospitals would no longer be forced to treat patients who can't pay for their services.

The Ultimate Winner in the Obamacare Debate

There's only one sector that is likely to benefit no matter what the court decides.

Managed care companies, typically known as Health Maintenance Organizations (HMO) and Preferred Provider Organizations (PPO), are already heavily involved in reducing health care costs.

They do that through a variety of techniques to reduce unnecessary health care costs by reviewing the necessity of services, controlling admissions and lengths of stay and intensive management of health care cases.

Although widely criticized for denying medical services, they are also credited with subduing medical cost inflation.

But here's the kicker: fully 90% of insured Americans are enrolled in plans with some form of managed care, according the industry's trade association.

That puts them in a position to profit delivering investors solid returns for years to come—no matter how the Supreme Court weighs in. – Don Miller, Money Morning

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From: Western Rookie4/6/2012 2:03:28 PM
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Big Risk, Big Rewards in Small Cap Biotech





Mark Teper, the managing Partner at Strategic Wealth Partners says there's huge opportunity in the biotech sector."As wayne gretzky says, you need to skate to where the puck's going, not where it's been," explained Teper in a live interview on CNBC.

"Right now the biggest wave that's in front of us is the biotech sector. There's just a ton of companies out there that are really on the verge of some pretty remarkable breakthroughs when it comes to treating the likes of cancer, heart disease, Alzheimer's.

"These advancements are really going to change our lives over the course of the next several years. What names in particular?If you're looking to hit a home run, stay away from the big boys. Look at really the small cap players. Spectrum Pharmaceuticals. Seattle Genetics. These are all examples of companies that we feel have some pretty good potential as far as the smaller companies go.

Video of Tepper's informative appearance on CNBC appears below:

biomedreports.com

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From: Western Rookie4/10/2012 10:53:15 PM
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Stellar Biotechnologies Announces Exclusive Option to License Clostridium Difficile Technology


April 10, 2012 09:05 ET




Stellar Executes Agreement With University of Guelph for Vaccine Research






PORT HUENEME, CA--(Marketwire - Apr 10, 2012) - Stellar Biotechnologies, Inc. ("Stellar") (TSX VENTURE: KLH) (PINKSHEETS: SBOTF) (FRANKFURT: RBT) today announced that it has entered into an agreement with the University of Guelph (Ontario, Canada) for the exclusive option to license technology for the development of a vaccine candidate against Clostridium difficile infection ("CDI").

Clostridium difficile is a type of bacteria normally present in the intestine, but which can overgrow as a result of antibiotic use. CDI causes severe diarrhea and life-threatening intestinal conditions such as colitis. CDI is a major and growing cause of mortality and morbidity in hospitalized patients. In the United States, incidence of CDI is at a record high with 336,600 cases reported in 2009 and projected to continue to increase.

"The use of non-antibiotic-based approaches to control Clostridium difficile colonization may offer an important treatment option for CDI," said Herbert Chow, Ph.D., Stellar Vice President of Product Development. "Stellar is committed to identifying promising vaccine candidates such as for CDI or other disease targets that may be synergistic with our KLH platform."

Professor Mario A. Monteiro (University of Guelph) commented that, "It is very gratifying to our research group that Stellar is taking the lead in commercializing our C. difficile vaccine technology, and to see that our scientific discoveries may soon be available to the public and provide a significant positive impact on global health."

The cost of CDI-related treatments in the U.S. and European countries is estimated at more than $7 billion a year. The recent emergence and spread of hyper-virulent strains of Clostridium difficile further underscore the importance of developing novel approaches to preventing and treating CDI.

For more about CDI, visit:
Public Health Agency of Canada ctt.marketwire.com
Centers for Disease Control and Prevention ctt.marketwire.com

About the University of Guelph
The University of Guelph is ranked as one of Canada's top comprehensive universities because of its commitment to student learning and innovative research. University of Guelph is dedicated to cultivating the essentials for quality of life -- water, food, environment, animal and human health, community, commerce, culture and learning. It also shares a profound sense of social responsibility, an obligation to address global issues and a concern for international development.

About Stellar Biotechnologies, Inc.
Stellar Biotechnologies, Inc. (TSX VENTURE: KLH) (PINKSHEETS: SBOTF) (FRANKFURT: RBT) is the world leader in sustainable manufacture of Keyhole Limpet Hemocyanin (KLH). KLH is an important immune-stimulating protein used in wide-ranging therapeutic and diagnostic markets. Potent, yet proven safe in humans, KLH operates as both a vital component for conjugate vaccines (targeting cancer, autoimmune, and infectious diseases) as well as an antigen for measuring immune status. Stellar Biotechnologies was founded to address the growing demand for renewable, commercial-scale supplies of high-quality, GMP-grade KLH. Stellar has developed leading practices, facilities and proprietary capabilities to address this need. To receive regular updates, enter email at bottom ofhttp://ctt.marketwire.com/?release=871823&id=1464850&type=1&url=http%3a%2f%2fstellarbiotechnologies.com%2finvestors%2fnews_releases%2f

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From: Western Rookie4/11/2012 3:51:31 PM
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KLH-V really looks like it wants to bust a move.

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From: Western Rookie4/11/2012 7:13:15 PM
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Sirona Biochem to Present Scientific Poster of Inducer Program at 2012 Protein Engineering Summit (PEGS)


Sirona Biochem Corp.

TSX VENTURE : SBM
PINKSHEETS : SRBCF
FRANKFURT : ZSB




April 11, 2012 09:00 ET


VANCOUVER, BRITISH COLUMBIA--(Marketwire - April 11, 2012) - Sirona Biochem Corp. (TSX VENTURE:SBM)(PINKSHEETS:SRBCF)(FRANKFURT:ZSB), announced today its abstract application to present a scientific poster at the 2012 Protein Engineering Summit (PEGS) has been accepted. Sirona Biochem's scientific poster has been selected to be on display during the " Difficult to Express Proteins" track April 30 to May 1, 2012.

The Eighth Annual PEGS conference, to be held April 30 to May 4, 2012 in Boston, MA, brings together an estimated 1,400 international decision makers in pharmaceutical, biotechnology, academia and public healthcare and focuses on the latest scientific innovations in protein engineering.

Sirona Biochem's scientific poster, "IPGMim™, A Potential New Inducer for Difficult to Express Proteins," will describe the use of its new inducer and how it may be effective at improving recombinant protein yields. The poster will also include results from the latest study demonstrating the effectiveness of IPGMim™ on a recalcitrant protein and comparing the compound against a widely used inducer, IPTG.

Additional studies are being conducted to further characterize IPGMim™ and prepare it for commercialization.

A copy of the poster will be made available on the company's website at www.sironabiochem.com after the conference.

About Sirona Biochem Corp.

Sirona Biochem is a biotechnology company developing diabetes therapeutics, cancer vaccine antigens, skin depigmenting and anti-aging agents for cosmetic use, and biological ingredients. The company utilizes a proprietary chemistry technique to improve pharmaceutical properties of carbohydrate-based molecules. For more information visit www.sironabiochem.com.

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From: Western Rookie4/12/2012 9:57:45 PM
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Vaccine Therapies Hold Promise for Investors: Stephen Dunn TICKERS: BMY, DNDN, GSK, IMUC, IMV, INO, MRK, SBOTF; KLH; RBT, VICL

Source: George S. Mack of The Life Sciences Report (4/12/12)

Developing vaccines to treat and/or prevent disease promises life-changing benefits for patients and unique opportunities for investors. In this interview with The Life Sciences Report, LifeTech Capital Senior Managing Director and President Stephen Dunn discusses the roadblocks encountered by some developers of immune therapies and how other companies are working around those obstacles, producing investment opportunities in the process.



Companies Mentioned: Bristol-Myers Squibb Co. - Dendreon Corp. - GlaxoSmithKline - ImmunoCellular Therapeutics Ltd. - Immunovaccine Inc. - Inovio Pharmaceuticals Inc. - Merck & Co. Inc. - Stellar Biotechnologies Inc. - Vical


The Life Sciences Report: I’d like to talk about preventive and therapeutic immunization. How large is the preventive vaccine market?

Stephen Dunn:According to the World Health Organization, over 12 million (M) people are reported to die from infectious diseases annually, with the unreported figures much higher. In addition, the number of people afflicted with nonfatal infectious diseases is likely near 1 billion (B), which also represents significant global healthcare and economic costs. While difficult to calculate precisely in dollar terms, the global vaccine market is roughly $30B or more, with the U.S. representing $20B or more. We expect this to grow significantly as there are over 300 infectious diseases and only about 15% of them have an effective prophylactic therapy.

TLSR: We know that governments have to be involved in preventive vaccines. Foundations, such as BIO Ventures for Global Health, the Bill and Melinda Gates Foundation, Wellcome Trust, etc., are also involved. Development costs may be subsidized, but margins will be thin for sure. What's the bottom line? How thin will margins be, and can prophylactic vaccines be profitable to companies and their shareholders?

SD: We expect margins on the basic routine immunizations with low incidence to be around 5%, which investors should treat more like an annuity than a growth vehicle. However, vaccines in new indications, especially those in highly contagious or fatal indications, can command significantly higher margins and represent significant investment opportunities. Examples of this are Merck & Co. Inc.'s (MRK:NYSE) Gardasil and GlaxoSmithKline's (NYSE:GSK) Cervarix, prophylactic vaccines for human papillomavirus (HPV), which causes cervical cancer. These have solid profit margins.

TLSR: Shifting to therapeutic immunization, one high-profile major development project that has come to fruition is Dendreon Corp.'s (DNDN:NASDAQ) Provenge. Uptake has been disappointing, and the company has had a very rough year. Does this bode poorly for other therapeutic vaccine developers?

SD: Dendreon's Q411 results were $77M in Provenge sales, with a 26% gross margin. While this looks like a high margin compared to prophylactic vaccines, it is not enough for a therapeutic vaccine. The patient volume is much lower, with only 250,000 (250K) prostate cancer patients who can be treated versus many millions of people receiving prophylactic vaccines. Provenge is patient-specific and must be custom manufactured, so the cost of production, requiring multiple production centers, is significant. The limitations are certainly a concern for patient-specific vaccines, but there are alternative vaccine approaches for investors.

TLSR: Will therapeutic vaccines developed in the future be less expensive than Dendreon's, which costs $93K/year to treat a patient?

SD: I think the entire therapeutic vaccine industry has taken notice of Dendreon's struggle to cover its costs of manufacturing a patient-specific therapeutic vaccine. The pricing issue is driven by the drug's modest effect on prostate cancer survival, and the fact that a number of new, competing therapeutic options are half the cost. Overall, pricing is always a function of benefit versus alternative therapies, the same as for any drug.

For example, Bristol-Myers Squibb Co.'s (BMY:NYSE) Yervoy, for melanoma, is an immunotherapy that inhibits CTLA-4, augmenting T-cell activation and proliferation. Because there are very few options for these melanoma patients, the pricing of Yervoy at $30K per dose, or $120K for four cycles, is not out of line. In addition, this is an "off-the-shelf" therapeutic, meaning it does not require custom manufacturing for each patient, and the gross margins are significantly higher.

TLSR: Is Provenge the classic first-generation prototype, leading the way while those that follow benefit by being able to produce a product that is cheaper and better?

SD: Provenge is a classic first-generation example of a patient-specific vaccine, and illustrates the high manufacturing costs of that approach. One company addressing the manufacturing issue is ImmunoCellular Therapeutics Ltd. (IMUC:OTCBB), which is developing a patient-specific cancer therapeutic vaccine called ICT-107. The difference is that it can manufacture around 20 doses at once for the patient, versus Dendreon, which can only produce a single patient-specific dose at a time. This should result in significantly better economics.

Another vaccine approach is being used by Immunovaccine Inc. (IMV:TSX.V). This company combines seven antigens found in breast, ovarian and prostate cancers in a sustained-release formulation, rather than manufacturing patient-specific vaccines.

Other manufacturing processes, such as those used in DNA vaccines, can design and produce "off-the-shelf" vaccines faster. These represent third-generation technologies. While no therapeutic DNA vaccine has yet been approved, both Vical (VICL:NASDAQ) and Inovio Pharmaceuticals Inc. (INO:NYSE.A) currently have therapeutic DNA vaccines in various cancer clinical trials.

TLSR: How much can an adjuvant be worth to companies engaged in immune system modification—either therapeutic or preventive?

SD:Competing immunotherapies tend to converge on the same antigens in a specific indication, so the differentiator may lie with the adjuvant. Some research has shown that adjuvants may even be more important than the antigen, resulting in them being called "immunology's dirty little secret." In fact, some suggest that Dendreon's Provenge results may not have been a result of the prostate antigen but rather the adjuvant, because it used a placebo control arm. An interesting pure-play in this space is Stellar Biotechnologies Inc. (SBOTF:OTCPK; KLH:TSX.V; RBT:Fkft), which is the world leader in keyhole limpet hemocyanin (KLH) production for use as an adjuvant and protein carrier. KLH is currently being used as either an adjuvant or protein carrier in over 20 active human clinical trials in various indications. One might think of Stellar as an "arms-merchant" to immunotherapy developers.

TLSR: Thanks for your time, Stephen.

SD: My pleasure.

LifeTech Capital Senior Managing Director and President Stephen Dunn was previously the managing director of Life Sciences Research at Jesup & Lamont, as well as director of research for Dawson James Securities and director of Life Sciences at Cabot Adams venture capital group. He has held management positions in business development, finance and operations having worked in over 25 countries in North America, Europe and the Far East with biomedical companies including Beckman Coulter, Coulter, Cordis (Johnson & Johnson), Telectronics (St. Jude Medical) as well as several smaller companies. With over 25 years within the global biomedical industry, Dunn has negotiated numerous intellectual property licenses, product development agreements, venture funding, mergers and aquisitons and joint ventures. Dunn is a five-star biotechnology analyst on StarMine and has appeared in both the financial and scientific media such asThe Wall Street Journal, Newsweek, Forbes, Nature Biotechnology, The Scientist, CNN, Nightly Business Report, BioWorld and many other media outlets. He is also a frequent speaker and panel member for many financial, medical and venture capital events.

Want to read more exclusive Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see a list of recent interviews with industry analysts and commentators, visit our Exclusive Interviews page.

DISCLOSURE:
1) George Mack conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) Stephen Dunn: I personally and/or my family own shares of the following companies mentioned in this interview: None. I personally and/or my family am paid by the following companies mentioned in this interview: None. Stellar Biotechnologies is currently an advisory client of LifeTech Capital.
3) The following companies mentioned in the interview are sponsors of The Life Sciences Report: Stellar Biotechnologies Inc.; ImmunoCellular Therapeutics Ltd. Merck & Co. Inc. is not affiliated with Streetwise Reports. Streetwise Reports does not accept stock in exchange for services.

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From: Western Rookie4/12/2012 9:58:40 PM
   of 72
 
Weight Loss Stocks Race to End the Obesity Epidemic Source: Diane Alter, Money Morning (4/10/12)

"The economic burden of obesity is estimated to be 10% of total health care costs, with projections continuing to grow as the obesity epidemic spreads. For investors, that means weight loss stocks are poised to gain."




Obesity is considered the most serious health issue in the developed world. Along with growing waistlines also comes ballooning costs.

Across urbanized nations, the economic burden of obesity is estimated to be 10% of total health care costs, with projections continuing to grow as the obesity epidemic spreads.

For investors, that means weight loss stocks are poised to gain.

Here's why.

When it comes to obesity the statistics are staggering.

Currently 35.7% of U.S. adults, or more than one third, is obese. According to the Centers for Disease Control (CDC), that's a giant increase over just ten years ago.

In 2000, not a single U.S. state had an obesity rate of 30% or more. Today, 12 states have crossed that obesity threshold.

The costs attributed to obesity are estimated at $147 billion and rising.

Weight Loss Stocks

It is no wonder pharmaceutical companies are racing to fill the void and close the growing gap in treating this mounting epidemic.

Two leaders early in the game include Arena Pharmaceuticals Inc. and Vivus Inc. A third California-based company, Orexigen Therapeutics Inc., is also vying for Food and Drug Administration approval. All three hope to bring to the market the first weight loss treatment in some 13 years.

But getting a nod from the government regulatory agency is not easy.

On March 29th, an FDA panel voted 17–6 to recommend that companies developing weight-loss therapies should conduct clinical trials to assess heart danger or review pre-approval human trial data on heart attacks and strokes.

The panel's aim is to help the agency update guidelines for bringing obesity treatments to market, according to an FDA spokesperson.

Despite the recommendation, Vivus and Arena are unlikely to be affected. According to FDA spokeswoman Erica Jefferson, "It's unlikely that the discussions over the past couple days will impact any existing applications."

The FDA is expected to rule on Vivus's drug Onexa by April 17. Meanwhile, Arena's treatment, lorcaserin, goes before the advisory panel May 10. The agency is expected to make a decision on lorcaserin by June 27.

Of the three, Orexigen is currently trailing for FDA approval.

In September, Orexigen agreed to conduct a two-year study of heart risks for its drug Contrave. The company has partnered with Takeda Pharmaceuticals of Osaka, Japan.

Weight Loss Stocks Work to Stem the Tide

Even still it has been a long road for all three of these weight loss stocks.

The FDA had previously rejected weight loss drugs from all of them, asking for more data on the safety risks.

The last obesity drug to gain FDA approval was Roche's Xencal in 1999. It was pulled from pharmacies 15 years ago when the fen-phen appetite-suppression drug was linked to heart valve abnormalities.

With FDA approval looming, investors' appetite for all three companies has been on the rise.

Vivus, which could get the first regulatory nod, also is involved in the development of drugs to treat sleep apnea, diabetes and men's sexual health. Its shares are up 134% year-to-date. The stock soared in late February after the FDA backed its weight loss drug Qnexa.

Arena also develops drugs for cardiovascular, central nervous system, inflammatory and metabolic diseases. Up 71% since January, Arena could be considered the most risky of the trio. Rumours have swirled that the company might abandon lorcaserin due to worries over cancer found in trial rats. It was the reason the FDA rejected lorcaserin in 2010.

Orexigen has been one of the best-performing biotech companies of 2012. OREX is up a whopping 138.5% since the start of the year.

However, Orexigen remains down 72% over the last five years. In early 2011, the stock sank when the FDA expressed concerns over its anti-obesity candidate. The company is burning through cash and will likely run dry by 2014.

It is too early to tell if the heft of weight loss stocks can fatten your portfolio.

But the potential for Vivus, Arena and Orexigen are huge given the giant worldwide obesity problem.

Developing a new drug that is effective and safe is a challenge, but now might be a good time to take a close look at these biotech companies.

In the battle against obesity, weight loss stocks could be an investor's gain. - Diane Alter, Money Morning


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From: Western Rookie4/12/2012 10:02:44 PM
   of 72
 
Fatty acids fight cancer spread

Tiny agents found in omega-3 could potentially be used to block the path of primary cancer tumors, preventing the advance to secondary stage cancers according to pharmacy researchers at the University of Sydney.

Investigators in the Faculty of Pharmacy’s Pharmacogenomics and Drug Development Group are using breast cancer tissue cells to gauge the blocking capacity of the omega-3 agents called epoxides on cancer cell movement.

Dr Michael Murray, Professor of Pharmogenetics at the University, says a major life-threatening consequence of malignant breast tumours is metastasis where the disease has spread to distant sites (or tissues) and at present there are no treatments.

He led his team to the discovery of the anti-metastatic actions of epoxides which are produced within the body from omega-3 polyunsaturated fatty acids. The ground-breaking work has led Murray and his Drug Development Group deeper into the molecular structure of the omega-3 agents.

Professor Murray says:

“These agents are a bit like frontline soldiers blocking the assault of an invading army and now we want to advance our research which was published late last year and apply it to breast cancer cells.”

“We know that epidemiological studies have reported that dietary intake of omega-3 polyunsaturated fatty acids including eicosapentaenoic and docosahexaenoic acids, decrease the risk of certain cancers. And many of us are including sources of omega-3 such as tuna and salmon in our diet as a precaution.”

“The major objective of our new project is to speed the development of anti-metastatic agents based on Omega-3 epoxides and trial their effectiveness in vivo on breast cancer tissue.”

“Longer term we are aiming to develop a completely new class of anti-metastatic drugs designed to inhibit the spread of primary cancers,” Murray says.

Although not all experts agree, women who eat foods rich in omega-3 fatty acids over many years may be less likely to develop breast cancer. More research is needed to understand the effect that omega-3 fatty acids may have on the prevention of breast cancer says Murray.

Research has also shown that omega-3 fatty acids reduce inflammation and may help lower risk of chronic diseases such as heart disease and arthritis.

Source: www.sydney.edu.au

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