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Monday, May 16, 2011

Biotech and Pharma Stocks Research News; Q1 Publishing Research Report on Verisante Technology, Inc. (TSX-V: VRS) (OTC: VRSEF)

May 16, 2011 - Investorideas.com newswire, a leader in investor stock research including biotech stocks, publishes the following Q1 Publishing Research Report on Verisante Technology, Inc. ( TSX-V: VRS) (PINK SHEETS: VRSEF). Q1 Publishing is an independent investment research firm which offers research on effective investment tools to investors. (http://www.q1publishing.com/investmenttools/reports)
Investorideas.com Newswire features third party research and equity reports from multiple research firms from within the investment community.
Jump on this Rapidly Unfolding Med-Tech Innovation Now
By Andrew Mickey, Q1 Publishing
We've only had this feeling a few times before.
It's the feeling we're onto something big - real big - at a very early state.
The same feeling we had about fertilizer stocks in July 2006. The same feeling about the Nintendo Wii when it exploded in Japan and its US launch was still months away. Or when Intuitive Surgical's robotic surgery technology was just making it into hospitals.
You know the feeling you're sitting on your next five- or 10-bagger, you understand it, you know it's big, and you're just waiting for everyone else to figure it out.
Frankly, it's a rare feeling. It's even rarer in a market like this where everything seems priced for perfection.
It's rare, but it's not impossible. Right now, we've got that feeling one small and fast-growing company is about to change a lucrative medical field for the better. And do it soon.
But we're not alone here. Some of the leading medical journals and magazines see the enormous potential we've spotted.
Biotechnology Focus magazine calls this development "ingenious."
The BC Medical Journal says, "Preliminary clinical results have so far demonstrated 100% efficacy."
Darrell Rigel, a professor of dermatology at NYU's Langone Medical Center, told MIT's Technology Review journal there's "a need" for innovations like this.
Despite the medical community's excitement, it still hasn't gone mainstream…yet.
Our window of opportunity to buy into Verisante Technology (TSX-V: VRS or OTCQX: VRSEF) will not be open forever.
Right now Verisante is a small $35 million company, just on the verge of leading medical technology revolution, has shown stellar preliminary clinical results, and based on market comparables is a ten-bagger-in-waiting.
In a few months, all that will be history and Verisante will be value much higher. Let's start at the beginning.
The Next Big Med-Tech Winner
If you're like me, you've learned (the hard and often expensive way) to become highly skeptical when it comes to new technologies.
They consistently over promise and under deliver.
Well, I think Verisante has under promised and is set to over deliver.
Verisante is aquickly emerging medical technology (med-tech) company which, despite its small size, is on the verge of doing something truly revolutionary.
The technology has been in development for 10 years. Its development has been led by some of the world's leading cancer researchers. It has received funding from leading cancer research organizations including the BC Cancer Society.
And, although it's technology has the potential to change almost every field of medicine, it's initially focused on a subsector of the medical field that's overdue for innovation.
Now with a recent $5 million capital infusion to take it to final commercialization, Verisante is poised to make it very big, very soon.
10 Years of Development About to Pay Off
Verisante is has entered the final approval stages for its proprietary cancer screening device.
On the surface, Verisante's Aura device is really simple. It detects cancerous cells by an advanced laser scanning system. And it does it with an astonishing rate of accuracy.
Think of a price scanner at the grocery store. It scans a bar code and tells you the price. Verisante's Aura concern detection device scans a skin lesion and tells you if it's cancerous. (For a complete explanation of how it works, follow this link to a recent feature on Canada's BTV )
Again, it really is a simple concept. But the science behind it is much more advanced than that.
Most importantly though, the Aura has shown the potential to revolutionize cancer detection and save a lot of lives and money in the process.
Verisante has targeted melanoma, one of the most feared and costly to treat cancers, for its initial launch.
Future Market Domination
The Aura device has shown remarkable accuracy and consistency in detecting melanoma at a very early stage (more details below).
Skin cancer is one of the most common forms of cancer. More than two million Americans are diagnosed with it each year. It will affect one in five US residents. And at least 40% of Americans can expect to get non-melanoma skin cancer before they turn 65.
Melanoma specifically one of the most deadly types of cancer. If detected in the Stage I it has an 85% survival rate. In Stage IV the survival rate falls to an ominous 15%.
Melanoma and skin cancer is costly too. It costs $1.5 billion a year to treat melanoma alone.
Despite the high costs of treatment and its deadly nature, there has been little advancement in detection.
For decades, dermatologists have relied on their eyes and patients to self-identify abnormal growth in moles and skin lesions. These crude methods successfully identify about one in three cases of melanoma.
Recently, however, the markets had high expectations that one of Verisante's competitors made a major breakthrough in melanoma detection. And investors were willing to pay top dollar merely speculating the technology worked effectively and consistently enough for regulatory approval.
Why Verisante is a True 10-Bagger
Knowing differences between the Verisante's and MELA Sciences (NASDAQ:MELA) – Verisante's closes competitor - devices reveals the true opportunity here.
MELA has been one of the most closely watched med-tech device stocks over the last year.
MELA's melanoma detection device, MelaFind, was in the final stages of regulatory approval heading into the end of 2010.
Investors were willing to risk getting in early because the upside potential was massive. If approved, MELA would be dominating a mult-billion dollar market virtually overnight.
MELA shares ran to more than $9 per share in anticipation of U.S. Food and Drug Administration (FDA) approval. At its peak, the total market value exceeded $200 million. Keep in mind, MelaFind is only aimed at melanoma and not the many other cancers Verisante's Aura has the potential to be used to detect. And it still was worth $200 million.
Then last November the FDA rejected MELA's device and its shares plummeted.
But here's the thing, MELA's device was rejected for a number of reasons that Verisante will not be affected by.
MELA was rejected because of its low degree of accuracy and large number of false positives.
In my opinion, MelaFind was basically not much more effective than what a dermatologist can determine just by looking at a suspicious mole.
The FDA requires a device to have a certain level of accuracy and consistency. MelaFind had neither.
Now MELA is going to need more studies and more capital to complete those studies. Yet it still has a market value almost three times higher than Verisante.
Key to Success: The Molecular Signature
The key difference between MELA's device and Verisante's is how they identify potentially cancerous cells.
MelaFind takes a picture of a mole or lesion. It then analyzes it against a database of images of confirmed melanoma cases. It uses a proprietary algorithm to compare shapes, sizes, and abnormalities of the lesions. This method didn't produce the accuracy or consistency required by the FDA.
Verisante's device works in a completely different way.
The Aura device analyzes what I call the "molecular signature" of the mole or lesion to determine whether it's likely cancerous or not.
The Aura uses Raman spectroscopy to detect the potential cancer at the molecular level. The studies conducted on the Aura device confirm how effective this process is.
In a six-year clinical trial conducted at the University of British Columbia's dermatology department and Vancouver General Hospital (which has 80,000 dermatoligical patients per year), the Aura device has detected melanoma with incredible accuracy and consistency.
Over a preliminary sample of 274 lesions, the Aura identified 45 melanoma occurrences. Thirty four of those occurrences identified by Aura were confirmed by a biopsy.
These preliminary results give melanoma a 100% accuracy rate and, as a testament to the reliability of the device, a 70% specificity.
These rates are critical part of the regulatory review process. The accuracy rate shows Aura works. The specificity rate shows Aura doesn't give too many "false positive" diagnoses. After all, you can't have a device that gives too many false positives. It would be worthless if it did.
This kind of accuracy and specificity is the critical difference for Verisante. And it shows how revolutionary this product is.
But it takes more than a better mousetrap to be successful. And Verisante has laid out a business model that has been exceptionally profitable for many of the leading companies in the world.
A Dermatologist's Perspective
The most impressive part of Verisante is its business model for commercializing the Aura device.
Once the Aura is approved, Verisante has planned a way to generate a profit by both selling its Aura devices and still earning an ongoing stream of revenue.
Verisante is using the "razor and blade model."
Do you think Gillette makes a lot of money selling a Mach 3 razor for $12? They do, but they make a lot more selling $4 razors month after month after month. Verisante is using the same strategy.
Let's take it from a dermatologist's perspective.
A skin doctor would be able to buy an Aura device and generate a lot of revenue from it. They would be able to charge anywhere from $100 to $500 for a cancer screening and do it for thousands of patients each year.
Many, I'm sure, would be able to pay at least $50,000 for a device that could generate between $100,000 to $1 million a year in revenue from it.
Verisante will likely be able to be able to build Aura devices for about $10,000. This will likely improve as demand increases and economies of scale are achieved, but let's take the more conservative $10,000 estimate. Verisante would be able to sell the device for between $30,000 and $60,000 to dermatologists.
That's a solid margin. The real money, however, comes from the continuous revenue it would receive. The "blades" part of the razor and blade model.
Each screening with the Aura device requires a new tip. The tip includes a lens and other proprietary features to prevent misdiagnosis. Verisante sells the specialized tips required for each use. The tips would likely cost dermatologists $10 each and significantly less to produce.
Verisante would be generating between $20,000 and $50,000 in gross profit per sale of each device. Then it would generate anywhere from $10,000 to $100,000 in additional revenues from the specialized tips from each device owner per year, every year.
Multiply those numbers out over a few hundred dermatologists (although there are thousands around the world) and you get some staggering numbers.
It's a massive opportunity which has the potential to make Verisante a $1 billion company as the Aura spreads across high-demand markets in Canada, Europe, and the United States.
On top of that, it's important to keep in mind that's just with melanoma. Verisante's technology has been proven to successfully identify many different types of cancers. Early trials have shown its effectiveness in identifying lung, cervical, and colon cancer.
Melanoma is just where Verisante's technology has had most of the research and testing geared towards. Once you add in potential opportunities in the other cancers, Verisante's potential is exponentially higher over the long run.
Nearing the Finish Line
Verisante seems to have it all. It's better, cheaper, and potentially very profitable. But the key with any investment in medical technology is completing the regulatory approval processes.
Verisante is aiming at completing the regularity approval process in a faster, less-costly way.
First, most of the expensive and time-consuming research is already completed. The Aura device has been in development for about 10 years. And it already has one six-year study completed.
Now Verisante is in the final stages of approval with Canadian medical authorities. Final approval is expected to be made by the end of 2011.
After that, Verisante has already started the European approval process. It expects to the "CE Mark" (the symbol of European approval) to be granted as early as the end of 2011.
If and when this is approved, Verisante has instant access to markets in the European Union, South Africa, and Australia.
Finally, with European and Canadian approval in hand, its' going to then move to the United States. It needs more studies for U.S. approval, but like many other drugs and medical devices, it's a lot more likely to get approval in the United States after Canada and Europe give the official thumbs up.
A Big Winner in the Making
Verisante Technology (TSX-V:VRS or OTCQX:VRSEF) is in position to have an exciting few months ahead as the story unfolds and even more great years beyond that.
It has all the elements of a giant med-tech success story.
It has superior, proven technology.
It has years of costly and time-consuming research behind it.
It's very near to final regulatory approval in Canada.
It has shown the potential to save a lot of lives too.
On top of all that, Verisante was recently able to attract an addition $5 million capital infusion in a market where med-tech and biotech aren't getting very much venture capital.
Perhaps most importantly, Verisante has huge growth potential. At a mere $35 market cap, the upside is tremendous. Remember, its closest competitor, MELAScience, had a market value of about $200 million just in anticipation it would be successful. And after it got rejected by the FDA, it still has a $90 million market value.
That's the kind of potential here where once the Aura is approved; Verisante is on its way to being worth $1 billion.
Head over to Verisante.com to see for yourself.
Andrew Mickey
Chief Investment Strategist, Q1 Publishing
Disclosure: The editor does not own shares and is not paid by any of the companies mentioned for distribution of this report. It is, however, an open recommendation in Q1 Publishing's President's List premium research service.
If you like ideas and research like this, the President's List is a premium investment research focused on the maximum risk-reward opportunities available anywhere in the world. You can learn more about a no-risk trial offer here. Legal Disclaimer : The information contained on this e-mail and in other Q1 Publishing communications is intended for general information purposes only. Q1 Publishing has not taken into account the specific investment objectives of any particular investor. You should always seek the counsel of a professional financial advisor before purchasing or selling stock. Directors, employees and outside contributors to Q1 Publishing may hold substantial positions in the recommended securities and may increase or decrease such positions without notice. We believe the sources of information to be reliable but Q1 Publishing does not guarantee the accuracy or completeness of the information provided on this website or in other Q1 communications, and expressly disclaims liability for any errors or omissions that may be contained in the information
More research;
To view a profile on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) as aired on BTV, click on the following link
http://www.youtube.com/verisante#p/u/2/PHugTxLXQGI

To view the Zacks Investment Research Initiation Report on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) click on the following link:
http://verisante.com/docs/verisante_zacks.pdf

To view media articles and stories on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) click on the following link:
http://verisante.com/news/media/
Investorideas.com disclaimer and disclosure � the following news is a paid news release distribution (one thousand for 2 releases) Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. www.InvestorIdeas.com/About/Disclaimer.asp
The published report by Q1 Publishing is the property of Q1 Publishing and is not the opinion of Investorideas.com. Investorideas.com is a news publisher of third party research.

Friday, May 13, 2011

Biotech/Pharma Stocks: (OTCBB: AEMD), (NYSE: MRK), (VRTX) Progress on Potential New Treatments for Hepatitis C Virus (HCV)

Point Roberts, WA - May 13 2011 - Investorideas.com. a leader in sector stock research including biotech and pharma stocks issues a sector snapshot of three companies, Aethlon Medical, Inc. (OTCBB: AEMD), Vertex Pharmaceuticals Inc. (VRTX), Merck & Company, Inc. (NYSE: MRK) and their developments and progress for the treatment of Hepatitis C Virus (HCV).
Trading Snapshot
  • Aethlon Medical, Inc. (OTCBB: AEMD) trading at $0.1030, up 0.0040 (4.04%)
  • Merck & Company, Inc. (NYSE: MRK ) trading at$37.08, down 0.12 (0.32%)
  • Vertex Pharmaceuticals Inc (VRTX ) trading at $57.30, down 0.71 (1.22%)
Aethlon Medical, Inc. (OTCBB: AEMD) recently announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
Full News: http://www.investorideas.com/CO/AEMD/news/2011/05091.asp
Vertex Pharmaceuticals Inc (VRTX ) reported in its May 3 rd update that they intend to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
Full news: http://finance.yahoo.com/news/Vertex-Reports-First-Quarter-bw-1531348977.html?x=0&.v=1
Merck & Company, Inc.(NYSE: MRK ) reported April 27 th, that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck's investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. VICTRELIS is one of a new class of medicines known as HCV protease inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The committee's recommendation will be considered by the FDA in its review of the New Drug Application for VICTRELIS. The FDA is not bound by the committee's guidance, but takes its advice into consideration when reviewing investigational medicines. The company anticipates FDA action on VICTRELIS by mid-May.
Full news: http://www.merck.com/newsroom/news-release-archive/research-and-development/2011_0427.html
Investorideas.com Newsire Structure of the IRES located in the 5'-UTR of HCV
http://en.wikipedia.org/wiki/Hepatitis_C_virus
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Contact:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech,  biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011       
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Source - Investorideas.com

Biotech Investor Trading Alert; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Trades up 9.01 % on over 5 Million Shares Volume

Point Roberts, WA, LINCOLNSHIRE, Ill - May 13, 2011 – Investorideas.com, a leader in sector stock research for independent investors, issues a trading alert for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). The stock closed trading May 12th, at $2.54, up $ 0.21 (9.01%) on over 5 Million shares and continued gains in after hours trading, up another $0.03, (1.18%).
Investorideas.com About BioSante Pharmaceuticals, Inc: BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as “will,” “potential,” “could,” “would,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc

For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
The full BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Source: Investorideas.com, BioSante, Investorideas.com
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Thursday, May 12, 2011

Biotech/Pharma Investor Spotlight - Recent Interview with Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)

Point Roberts, WA, LINCOLNSHIRE, Ill - May 12, 2011 - Investorideas.com, a leader in sector stock research for independent investors, releases the following updates for featured showcase biotech/pharma stock BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). The company's President and CEO, Mr. Stephen Simes, was recently interviewed by CEOCFOinterviews.com.
The interview and article entitled , With An Eye on Women's Sexual Health, BioSante Pharmaceuticals, Inc. is Developing their LibiGel® for the Treatment of Female Sexual Dysfunction for which there is No Approved Product in the United States, provides investors insight into the current status of LibiGel®, clinical data, market opportunities and the significance of being first to market with a product for women's sexual health.
In a quote from his Q&A with Ceocfointerviews.com, Mr. Simes explains; "BioSante is a very interesting opportunity and is a company on the leading edge of a very important unmet medical need. Female sexual dysfunction is a very critical issue and again I will repeat, thirteen years after Viagra was approved for men, women still don't have an option for their sexual health. To the extent that women want to be treated, we think a product should be available. It is all about choice for women. We are developing LibiGel, which is in late stage, Phase III clinical development with an approval on the horizon. We believe the upside for our stockholders is dramatic. We have the money in the bank to implement the plan… as well as the people to take this product through to an FDA approval…In summary, we believe BioSante is well positioned for increasing value for our stockholders.”
Full Q&A at: http://www.ceocfointerviews.com/interviews/BPAX-BioSante11.htm
More from the interview:
"From the beginning, we have had our eye on women's sexual health…We believe this represents a blockbuster opportunity.”- Stephen M. Simes, President and CEO
CEOCFO: How does LibiGel work?
Mr. Simes: LibiGel is a testosterone gel. As we age, both men's and women's testosterone levels decline. Although it is not well known, a normal pre-menopausal woman actually has more testosterone flowing in her blood than she has estrogen. As women get older, their testosterone levels go down, and with the declining testosterone levels often their sexual desire and sexual activity decline. What LibiGel aims to do is bring those testosterone levels back to where they used to be and to restore sexual desire and sexual activity.
CEOCFO : Has testosterone been tried before; in what way is LibiGel different?
Mr. Simes: As I mentioned there is no product FDA-approved for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder, so nobody has been successful at providing to the FDA the safety and efficacy data required to get approval for a product.
There are two issues of critical importance: one is the efficacy of a product, and the FDA end points are an increase in sexual desire and an increase in the number of satisfying sexual events. We are measuring those using validated instruments in two LibiGel Phase III efficacy trials.
The other critical issue is the safety of a product. We have known for many years that testosterone can increase desire and sexual activity; what has not been produced yet are the safety data that will convince the FDA that it is safe to use testosterone in women. We are working to provide these data by conducting the very large LibiGel Phase III safety study now in its fourth year. We are planning to submit our new drug application requesting approval in 2012.
Full Q&A at: http://www.ceocfointerviews.com/interviews/BPAX-BioSante11.htm
About BioSante Pharmaceuticals, Inc: BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will,” "potential,” "could,” "would,” "can,” "believe,” "intends,” "continue,” "plans,” "expects,” "anticipates,” "estimates,” "may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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Tuesday, May 10, 2011

Biotech and Pharma Stock Alert; Aethlon Medical (OTCBB: AEMD) Reports FDA Meeting Request for Hemopurifier® Investigational Device Exemption (IDE)

SAN DIEGO � May 10, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD) reports it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system.
Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
"Since submitting our IDE, we have expanded our collection of human safety data, which has also provided insight that our Hemopurifier® can have a substantial effect in reducing viral load in HCV-infected patients even in the absence of antiviral drugs," stated Jim Joyce, Chairman and CEO of Aethlon Medical. "These results combined with the emergence of a remarkable clinical validation for therapeutic filtration in HCV care provide a compelling basis for an FDA meeting to discuss and advance a potential clinical strategy to treat HCV-infected individuals in the United States."
The meeting with the FDA will provide a collaborative opportunity for Aethlon management to interact directly with Agency officials and to obtain guidance and input on advancing both its HCV and Medical Countermeasure indications in the U.S. Aethlon anticipates a meeting with FDA officials will likely occur in mid-summer.
The Company believes a significant and enduring opportunity exists for the Hemopurifier® as an adjunct to improve the benefit of current, forthcoming and future iterations of standard-of-care drug therapy (SOC) by accelerating viral load depletion in the first few days of HCV-SOC. The clinical validation for therapeutic filtration of HCV has been established by the VRAD system developed and marketed by Asahi Kasei Kuraray Medical in Japan. The early administration of VRAD in combination with HCV-SOC achieved 71.4% sustained virologic response rates (SVR) in HCV patients who previously failed HCV-SOC. These results were achieved through a once daily administration of VRAD for three consecutive days at the outset of SOC therapy. The average viral load reduction during each treatment period, which averaged 3 1/4 hours in duration, was 26.1%. In comparison, the Aethlon Hemopurifier® has demonstrated average viral load reductions of 64% during similar treatment timeframes in the absence of any drug therapy benefit. Aethlon is now actively advancing an adjunct study to demonstrate the ability of the Hemopurifier® to accelerate early viral load depletion in patients who initiate HCV-SOC. The study is being conducted at the Medanta Medicity Institute in Delhi, India.
The Hemopurifier® is also uniquely suited to treat HCV-infected End-stage renal disease (ESRD) patients, whose condition limits their ability to be treated with HCV-SOC. The incidence of HCV infection in ESRD patients is approximately 100-1000 times higher than that in the general population. Recent studies have clearly shown that HCV-infected ESRD patients on maintenance dialysis are at increased risk of liver-related mortality. A significant proportion develops chronic hepatitis, cirrhosis, and even hepatocellular carcinoma. Overall, chronic HCV patients on hemodialysis bear an increased risk of liver-related morbidity and mortality, either during dialysis or after renal transplantation. Interferon (IFN) therapy is modestly effective for the treatment of HCV infection in ESRD patients but is not recommended after renal transplantation due to the risk of acute graft rejection. Ribavirin is considered contraindicated for the treatment of ESRD patients with chronic hepatitis C because of the risk of life-threatening hemolytic anemia. A major advantage in treating HCV-infected ESRD patients with the Hemopurifier® is that the device adds no drug toxicity or interaction concerns and can be included in series with a patient's dialysis cartridge, thus adding no treatment burden beyond the patient's pre-established dialysis treatment schedule.
Aethlon further disclosed that it will begin discussions with the FDA on the regulatory requirements to obtain an Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats that emerge naturally or are released by man as an agent of bioterrorism. The Project BioShield Act of 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security. The EUA authority allows the FDA Commissioner to strengthen the public health protections against biological, chemical, radiological and nuclear agents that may be used to attack the American people or the U.S. armed forces. The FDA Commissioner may allow medical countermeasures to be used in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved and available alternatives.
Aethlon believes the Hemopurifier®, which is the sole antiviral strategy to address drug and vaccine resistant viral pathogens, is well positioned to meet the U.S. government's urgent need for innovative new medical countermeasures that can be deployed during national health emergencies.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
  1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
  2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
  3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
  4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011

Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Reports First Quarter Financial Results and Recent Developments

LINCOLNSHIRE, Ill. - May 10, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today reported on its financial results for the first quarter, cash balance as of March 31, 2011 and recent developments.
First Quarter 2011 Financial Results
BioSante's cash balance as of March 31, 2011 was approximately $51.3 million, compared to a cash balance of approximately $38.2 million on December 31, 2010.
BioSante incurred a net loss of approximately $17.3 million or $(0.20) per share for the quarter ended March 31, 2011, compared to a net loss of $10.5 million or $(0.19) per share for the same period in 2010. This expected increase in net loss was due primarily to the conduct of the three ongoing LibiGel® (testosterone gel) Phase III clinical studies to support submission of a new drug application (NDA) for U.S. Food and Drug Administration (FDA) approval.
Recent BioSante Developments
  • LibiGel® Phase III Efficacy Trials Enrollment Completed: BioSante completed enrollment of subjects in its two pivotal Phase III LibiGel (testosterone gel) efficacy trials in the first quarter. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
  • LibiGel Phase III Safety Study Continues: For the fifth time, unblinded safety data were reviewed by the independent Data Monitoring Committee (DMC) of the LibiGel Cardiovascular and Breast Cancer Safety Study. As per DMC recommendation, the LibiGel safety study continues, with no modifications.
  • Bio-T-Gel™ New Drug Application (NDA) Filed by BioSante Licensee, Teva Pharmaceuticals: An NDA for Bio-T-Gel (testosterone gel) for the treatment of male hypogonadism, was accepted for filing by the FDA following submission by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
  • Pancreas Cancer Vaccine Positive Clinical Results and Melanoma Orphan Drug Designation: BioSante reported positive Phase II clinical results for its Pancreas Cancer Vaccine. The vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. BioSante also received Orphan Drug designation from the FDA's Office of Orphan Products Development for its Melanoma Cancer Vaccine.
  • Closed $25.1 million Registered Direct Financing: BioSante closed a registered direct offering in March 2011, bringing its March 31, 2011 cash balance to approximately $51.3 million. BioSante's management believes this cash balance will be sufficient to finance operations and LibiGel clinical development well into 2012, without the need for additional funds.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com

Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).

Monday, May 9, 2011

Biotech Stock News Alert; Q1 Publishing Research Featuring Verisante Technology, Inc. (TSX-V: VRS) (OTC: VRSEF)

May 9, 2011 - Investorideas.com newswire; The following biotech stock report is issued by Q1 Publishing Research covering Verisante Technology, Inc. (TSX-V: VRS) (PINK SHEETS: VRSEF).
Investorideas.com Newswire features third party research and equity reports from multiple research firms in the industry.
To view a profile on the Company as aired on BTV, click on the following link
http://www.youtube.com/verisante#p/u/2/PHugTxLXQGI

To view the Zacks Investment Research Initiation Report, click on the following link:
http://verisante.com/docs/verisante_zacks.pdf

To view media articles and stories on the Company, click on the following link:
http://verisante.com/news/media/
Jump on this Rapidly Unfolding Med-Tech Innovation Now
By Andrew Mickey, Q1 Publishing
We've only had this feeling a few times before.
It's the feeling we're onto something big - real big - at a very early state.
The same feeling we had about fertilizer stocks in July 2006. The same feeling about the Nintendo Wii when it exploded in Japan and its US launch was still months away. Or when Intuitive Surgical's robotic surgery technology was just making it into hospitals.
You know the feeling you're sitting on your next five- or 10-bagger, you understand it, you know it's big, and you're just waiting for everyone else to figure it out.
Frankly, it's a rare feeling. It's even rarer in a market like this where everything seems priced for perfection.
It's rare, but it's not impossible. Right now, we've got that feeling one small and fast-growing company is about to change a lucrative medical field for the better. And do it soon.
But we're not alone here. Some of the leading medical journals and magazines see the enormous potential we've spotted.
Biotechnology Focus magazine calls this development "ingenious."
The BC Medical Journal says, "Preliminary clinical results have so far demonstrated 100% efficacy."
Darrell Rigel, a professor of dermatology at NYU's Langone Medical Center, told MIT's Technology Review journal there's "a need" for innovations like this.
Despite the medical community's excitement, it still hasn't gone mainstream…yet.
Our window of opportunity to buy into Verisante Technology (TSX-V: VRS or OTCQX: VRSEF) will not be open forever.
Right now Verisante is a small $35 million company, just on the verge of leading medical technology revolution, has shown stellar preliminary clinical results, and based on market comparables is a ten-bagger-in-waiting.
In a few months, all that will be history and Verisante will be value much higher. Let's start at the beginning.
The Next Big Med-Tech Winner
If you're like me, you've learned (the hard and often expensive way) to become highly skeptical when it comes to new technologies.
They consistently over promise and under deliver.
Well, I think Verisante has under promised and is set to over deliver.
Verisante is aquickly emerging medical technology (med-tech) company which, despite its small size, is on the verge of doing something truly revolutionary.
The technology has been in development for 10 years. Its development has been led by some of the world's leading cancer researchers. It has received funding from leading cancer research organizations including the BC Cancer Society.
And, although it's technology has the potential to change almost every field of medicine, it's initially focused on a subsector of the medical field that's overdue for innovation.
Now with a recent $5 million capital infusion to take it to final commercialization, Verisante is poised to make it very big, very soon.
10 Years of Development About to Pay Off
Verisante is has entered the final approval stages for its proprietary cancer screening device.
On the surface, Verisante's Aura device is really simple. It detects cancerous cells by an advanced laser scanning system. And it does it with an astonishing rate of accuracy.
Think of a price scanner at the grocery store. It scans a bar code and tells you the price. Verisante's Aura concern detection device scans a skin lesion and tells you if it's cancerous. (For a complete explanation of how it works, follow this link to a recent feature on Canada's BTV)
Again, it really is a simple concept. But the science behind it is much more advanced than that.
Most importantly though, the Aura has shown the potential to revolutionize cancer detection and save a lot of lives and money in the process.
Verisante has targeted melanoma, one of the most feared and costly to treat cancers, for its initial launch.
Future Market Domination
The Aura device has shown remarkable accuracy and consistency in detecting melanoma at a very early stage (more details below).
Skin cancer is one of the most common forms of cancer. More than two million Americans are diagnosed with it each year. It will affect one in five US residents. And at least 40% of Americans can expect to get non-melanoma skin cancer before they turn 65.
Melanoma specifically one of the most deadly types of cancer. If detected in the Stage I it has an 85% survival rate. In Stage IV the survival rate falls to an ominous 15%.
Melanoma and skin cancer is costly too. It costs $1.5 billion a year to treat melanoma alone.
Despite the high costs of treatment and its deadly nature, there has been little advancement in detection.
For decades, dermatologists have relied on their eyes and patients to self-identify abnormal growth in moles and skin lesions. These crude methods successfully identify about one in three cases of melanoma.
Recently, however, the markets had high expectations that one of Verisante's competitors made a major breakthrough in melanoma detection. And investors were willing to pay top dollar merely speculating the technology worked effectively and consistently enough for regulatory approval.
Why Verisante is a True 10-Bagger
Knowing differences between the Verisante's and MELA Sciences (NASDAQ:MELA) - Verisante's closes competitor - devices reveals the true opportunity here.
MELA has been one of the most closely watched med-tech device stocks over the last year.
MELA's melanoma detection device, MelaFind, was in the final stages of regulatory approval heading into the end of 2010.
Investors were willing to risk getting in early because the upside potential was massive. If approved, MELA would be dominating a mult-billion dollar market virtually overnight.
MELA shares ran to more than $9 per share in anticipation of U.S. Food and Drug Administration (FDA) approval. At its peak, the total market value exceeded $200 million. Keep in mind, MelaFind is only aimed at melanoma and not the many other cancers Verisante's Aura has the potential to be used to detect. And it still was worth $200 million.
Then last November the FDA rejected MELA's device and its shares plummeted.
But here's the thing, MELA's device was rejected for a number of reasons that Verisante will not be affected by.
MELA was rejected because of its low degree of accuracy and large number of false positives.
In my opinion, MelaFind was basically not much more effective than what a dermatologist can determine just by looking at a suspicious mole.
The FDA requires a device to have a certain level of accuracy and consistency. MelaFind had neither.
Now MELA is going to need more studies and more capital to complete those studies. Yet it still has a market value almost three times higher than Verisante.
Key to Success: The Molecular Signature
The key difference between MELA's device and Verisante's is how they identify potentially cancerous cells.
MelaFind takes a picture of a mole or lesion. It then analyzes it against a database of images of confirmed melanoma cases. It uses a proprietary algorithm to compare shapes, sizes, and abnormalities of the lesions. This method didn't produce the accuracy or consistency required by the FDA.
Verisante's device works in a completely different way.
The Aura device analyzes what I call the "molecular signature" of the mole or lesion to determine whether it's likely cancerous or not.
The Aura uses Raman spectroscopy to detect the potential cancer at the molecular level. The studies conducted on the Aura device confirm how effective this process is.
In a six-year clinical trial conducted at the University of British Columbia's dermatology department and Vancouver General Hospital (which has 80,000 dermatoligical patients per year), the Aura device has detected melanoma with incredible accuracy and consistency.
Over a preliminary sample of 274 lesions, the Aura identified 45 melanoma occurrences. Thirty four of those occurrences identified by Aura were confirmed by a biopsy.
These preliminary results give melanoma a 100% accuracy rate and, as a testament to the reliability of the device, a 70% specificity.
These rates are critical part of the regulatory review process. The accuracy rate shows Aura works. The specificity rate shows Aura doesn't give too many "false positive" diagnoses. After all, you can't have a device that gives too many false positives. It would be worthless if it did.
This kind of accuracy and specificity is the critical difference for Verisante. And it shows how revolutionary this product is.
But it takes more than a better mousetrap to be successful. And Verisante has laid out a business model that has been exceptionally profitable for many of the leading companies in the world.
A Dermatologist's Perspective
The most impressive part of Verisante is its business model for commercializing the Aura device.
Once the Aura is approved, Verisante has planned a way to generate a profit by both selling its Aura devices and still earning an ongoing stream of revenue.
Verisante is using the "razor and blade model."
Do you think Gillette makes a lot of money selling a Mach 3 razor for $12? They do, but they make a lot more selling $4 razors month after month after month. Verisante is using the same strategy.
Let's take it from a dermatologist's perspective.
A skin doctor would be able to buy an Aura device and generate a lot of revenue from it. They would be able to charge anywhere from $100 to $500 for a cancer screening and do it for thousands of patients each year.
Many, I'm sure, would be able to pay at least $50,000 for a device that could generate between $100,000 to $1 million a year in revenue from it.
Verisante will likely be able to be able to build Aura devices for about $10,000. This will likely improve as demand increases and economies of scale are achieved, but let's take the more conservative $10,000 estimate. Verisante would be able to sell the device for between $30,000 and $60,000 to dermatologists.
That's a solid margin. The real money, however, comes from the continuous revenue it would receive. The "blades" part of the razor and blade model.
Each screening with the Aura device requires a new tip. The tip includes a lens and other proprietary features to prevent misdiagnosis. Verisante sells the specialized tips required for each use. The tips would likely cost dermatologists $10 each and significantly less to produce.
Verisante would be generating between $20,000 and $50,000 in gross profit per sale of each device. Then it would generate anywhere from $10,000 to $100,000 in additional revenues from the specialized tips from each device owner per year, every year.
Multiply those numbers out over a few hundred dermatologists (although there are thousands around the world) and you get some staggering numbers.
It's a massive opportunity which has the potential to make Verisante a $1 billion company as the Aura spreads across high-demand markets in Canada, Europe, and the United States.
On top of that, it's important to keep in mind that's just with melanoma. Verisante's technology has been proven to successfully identify many different types of cancers. Early trials have shown its effectiveness in identifying lung, cervical, and colon cancer.
Melanoma is just where Verisante's technology has had most of the research and testing geared towards. Once you add in potential opportunities in the other cancers, Verisante's potential is exponentially higher over the long run.
Nearing the Finish Line
Verisante seems to have it all. It's better, cheaper, and potentially very profitable. But the key with any investment in medical technology is completing the regulatory approval processes.
Verisante is aiming at completing the regularity approval process in a faster, less-costly way.
First, most of the expensive and time-consuming research is already completed. The Aura device has been in development for about 10 years. And it already has one six-year study completed.
Now Verisante is in the final stages of approval with Canadian medical authorities. Final approval is expected to be made by the end of 2011.
After that, Verisante has already started the European approval process. It expects to the "CE Mark" (the symbol of European approval) to be granted as early as the end of 2011.
If and when this is approved, Verisante has instant access to markets in the European Union, South Africa, and Australia.
Finally, with European and Canadian approval in hand, its' going to then move to the United States. It needs more studies for U.S. approval, but like many other drugs and medical devices, it's a lot more likely to get approval in the United States after Canada and Europe give the official thumbs up.
A Big Winner in the Making
Verisante Technology (TSX-V:VRS or OTCQX:VRSEF) is in position to have an exciting few months ahead as the story unfolds and even more great years beyond that.
It has all the elements of a giant med-tech success story.
It has superior, proven technology.
It has years of costly and time-consuming research behind it.
It's very near to final regulatory approval in Canada.
It has shown the potential to save a lot of lives too.
On top of all that, Verisante was recently able to attract an addition $5 million capital infusion in a market where med-tech and biotech aren't getting very much venture capital.
Perhaps most importantly, Verisante has huge growth potential. At a mere $35 market cap, the upside is tremendous. Remember, its closest competitor, MELAScience, had a market value of about $200 million just in anticipation it would be successful. And after it got rejected by the FDA, it still has a $90 million market value.
That's the kind of potential here where once the Aura is approved; Verisante is on its way to being worth $1 billion.
Head over to Verisante.com to see for yourself.
Andrew Mickey
Chief Investment Strategist, Q1 Publishing
Disclosure: The editor does not own shares and is not paid by any of the companies mentioned for distribution of this report. It is, however, an open recommendation in Q1 Publishing's President's List premium research service.
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