When the SPDR TRUST (NYSE:SPY), Power Shares QQQ(Nasdaq:QQQQ), and Diamonds trust Series 1 ETF (NYSE:DIA) found a low in March 2009 the public was in despair. People believed that the next great depression was underway. Massive liquidity was put into the market by every central bank in the world. Cash literally poured into every toxic asset that was ever designed. Since that time the markets have responded by moving over 50 percent off their lows. Now what? Are we back to normal yet?

Today the markets want to know what is next from Mr. Bernanke and company (other central banks). Like the Janet Jackson song says, “what have you done for me lately”? What is next for an encore? The general problems such as the severe housing crisis still remains, the high unemployment picture has not changed, banks have cut credit lines are still not lending or making significant loans, and spending by the consumer continues to remain near extremely low levels. While the Federal government can create tax breaks and incentive programs for hurting citizens and residents to make them feel like they are getting something, however, can that really fix the problem?

Where are we now? Currently we are in the middle of a correction. If you have ever gone to a party, you know the party must come to end eventually. Well, the market is telling you that the 2009 party is over for now. Yes, someone will have another party along the way. New spending programs will come up to give the markets a lift. However, someone has to pay for these parties and with the current problems the cash is limited. Therefore, while there will be rallies along the way don’t expect 2010 to be anything like 2009.

Nicholas Santiago

Chief Market Strategist

www.InTheMoneyStocks.com

Taking a look at the chart, it is easy to see why technical analysis fans might call this a ‘lucky break’ type of investment, and there’s a number of reasons to validate that terminology. Firstly, the all important Relative Strength Index (RSI) has positioned itself in an upward trend, making a move past the climactic 49.79 level, representing that the stock has a neither overbought or oversold sentiment in the market. Next in line we have the MACD divergence which is beginning to turn and trend upward, followed by the Full Stochastics which is bouncing off the key 18.50 bottom further verifying the bullish indicators. Most importantly, we notice the volume bars marked by the green, and the red bars which represent the sell orders. As we can see, the fewer green bars outweigh the many smaller red bars, indicating a long-term bullish pattern, and further confirming that the recent decline was a simple consolidation, perhaps an indication of longs taking profits.

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Anna Gluskin, CEO of Generex Biotechnology (NASDAQ:GNBT), talks about the company’s oral treatment for diabetes along with a cancer vaccine under development. MarketWatch’s Kristen Gerencher reports from the J.P. Morgan health-care conference in San Francisco.

Highlights

• Oral-Lyn is a liquid spray which allows the patients to be treated without injections (patient friendly)
• Not inhaled version, this product is absorbed by the cheeks, thus not entering the lungs
• It is given before meals, type 1 diabetes would only require one injection versus three or four
• 21 million patients with diabetes, Generex hopes to reach 10% of the market

Oral-Lyn Product

Generex Oral-lyn™, is an insulin spray for the treatment of Type I and Type II diabetes. Generex Oral-lyn™ is a safe, simple, fast, effective, and pain-free alternative to subcutaneous injections of prandial insulin and is conveniently delivered to the membranes of the oral cavity by a simple asthma-like device with no pulmonary (lung) deposition. As a pain-free and convenient method of insulin delivery, Generex Oral-lyn™ will allow individual patients to “fine tune” and then maintain their metabolism resulting in an improved quality of life. Accordingly, Generex Oral-lyn™ provides the opportunity for the establishment of a new and more efective diabetes treatment paradigm.

Generex Partnerships

Generex is dedicated to the research, development and commercialization of drugs delivery via the buccal mucosa. Generex seeks to out-license its RapidMist™ product programs and identify in-licensing opportunities and acquisitions in the areas of diabetes, drug delivery, cancer, H5 avian influenza, HIV, generic and branded prescription drugs, 505(b)2 product candidates, and late stage development opportunities.

Here are some of the companies we have partnered with; Please click on company urls the get the details.

Fertin Pharma
Fertin Pharma (www.fertin.com), is a world leader in the development and manufacture of medical chewing gum and is working in partnerships with a wide range of well-respected pharmaceutical companies. Fertin Pharma’s patent protected MediChew® technology is based on unique know-how with controlled release of active substances from gum bases, fully documented release testing procedures, taste modification, and development of gum bases.

Cardinal Health
Ranked No. 19 on the Fortune 500, Cardinal Health (www.cardinal.com), manufactures or packages products for nine out of the top 10 pharmaceutical companies and most leading biotechnology companies. The company manufactures or packages more than half a billion doses of pharmaceuticals every day.
Leosons General Trading Company
Leosons (www.leosons.com), a leading distributor of North American healthcare products in the region and the Company’s Marketing and Distribution partner in the Middle East, recently entered into a collaboration with Sheikh Saeed Bin Obaid Al Maktoum, a member of the Royal Family of United Arab Emirates. Recently, the two parties have established Medpro LLC with offices to be set up in the Dubai Healthcare City. Medpro is expected to market the Company’s products.

Adcock Ingram
Adcock Ingram (www.adcock.co.za), part of the Tiger Brands Group, is a leading South African pharmaceutical company with an 11.4% share of the private healthcare market. Adcock Ingram has an extensive range of prescription, generic, and over-the-counter products and also provides life saving hospital equipment and diagnostic products and services.

PharmaBrand SA

Ecuador-based Pharmabrand (www.pharmabrand.com), a distributor of pharmaceutical products, was established in June, 2000 with the acquisition of an Ecuadorian pharmaceuticals plant from Schering-Plough Corporation. Its management team, led by Dr. Cid, has extensive experience in the pharmaceutical industry. Dr. Cid holds a Doctoral Degree in Pharmacy and Chemistry from the University of Chile and a Master of Business Administration degree from Columbia University in New York. He has also undertaken graduate studies in strategic management at Harvard Business School. Dr. Cid has more than 30 years’ experience in the multinational pharmaceuticals industry, having held executive positions with Schering Plough, Pfizer and Merck. He served as General Manager & Regional Director of Latin America for Pfizer.

Shreya Life Sciences Pvt
Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in), a leading Indian-based pharmaceutical company. Shreya is the fourth largest distributor of insulin in the Indian insulin product market with a compound annual growth rate of 38% (per C MARC market research). Shreya has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments including cardiology, neuropathy, and diabetes. The company has business operations in India, Russia, the Commonwealth of Independent States, and African countries. The parties are making arrangements for the expansion of extant production facilities to meet the anticipated demand for the product in India and other jurisdictions where governmental approvals are pending.

Benta Pharma Industries
Benta Pharma Industries (www.bpi.com.lb) is a state of the art manufacturing facility dedicated to the development of new and enhanced formulations of pharmaceutical products and production of a wide range of medical devices that fulfill most physicians’ needs. Benta production facility is designed in manner that constrains human direct interaction with the drug eliminating risks of contamination and cross contamination. Benta cooperate closely with its sister company Benta Trading for distribution and marketing of its products. Benta trading founded in 1968 is well known distribution company entrusted by many multinational companies for its high degree of flexibility creativity and expertise in this field. The management and personnel of BPI has been chosen with gigantic care to develop set of services.

About Generex Biotechnology Corporation

Generex Biotechnology Corporation (NasdaqCM: GNBT) is a leader in drug delivery for metabolic diseases through the inner lining of the mouth. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth.

Generex’s flagship product, Generex Oral-lyn™, an oral insulin spray for the treatment of diabetes, is approved for sale in India, Algeria, Lebanon and Ecuador, and is in Phase III clinical trials with over 347 patients being enrolled in 74 clinical sites around the world, including sites in the United States, Canada, Bulgaria, Poland, Romania, Russia and Ukraine. Also, Generex has developed MetControl™, a proprietary Metformin medicinal chewing gum, which is currently being prepared for submission to various regulatory authorities throughout the world.

Generex’s product pipeline includes: Generex Oral-lyn™, MetControl™ Metformin Gum, Glucose RapidSpray™, BaBOOM!™ Energy Spray, Crave-NX™ Day Diet Aid Spray, Fentanyl Spray, Morphine Spray, Breast and Prostate Cancer Vaccine and Avian Influenza Vaccine.

Generex’s wholly owned subsidiary, Antigen Express, Inc., concentrates on developing proprietary vaccine formulations that work by stimulating the immune system to either attack offending agents (i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements (i.e., self proteins and allergens). Clinical development of Antigen’s synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer in a Phase II clinical trial and patients with prostate cancer and against avian influenza in two Phase I trials. Additional development efforts includes seasonal influenza virus, H5N1, HIV, HPV, melanoma, ovarian cancer, allergy and Type I diabetes mellitus.

Disclosure: Long GNBT

TheMarketFinancial is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.

(Public, NASDAQ: GNBT)

This past year, small cap  biotech investors were witness to some of the most profitable gains ever recorded. The only way to encapsulate it would be through two simple words, “FDA Approval”. Yes, any company with high probability of approval on their blockbuster drugs saw their shares literally explode beyond technical analysis comprehension. Companies like Dendreon Corporation (NASDAQ: DNDN), Human Genome Sciences (NASDAQ: HGSI), and MannKind Corporation (NASDAQ: MNKD) went from relatively unknown bench warmers to being the MVP trades of the year, having their share prices gain multi-hundred percentages while leaving investors hungry, salivating for the next candidate. Many tried, yet only a few succeeded to truly join the winner’s circle. So, now comes the tough question, how do we find a major exchange stock, one that has the right volume to attract institutional investors, as well as the ability to generate buzz within the investment community.  After having our team spend months conducting due diligence, we strongly believe we have found it, and boy are we ever excited.

The following is a compilation of due diligence on our first company profile for the new year, Generex Biotechnology Corporation (NASDAQ: GNBT). To truly grasp the market potential of this company, one has to look at the main products, so of which already approved and marketed,while others are on the verge of being approved to be marketed in the US & Worldwide global markets. The tip of the iceberg hasn’t even been scratched on this remarkable company, hopefully this analysis will shed some light and once again garner attention while shares are still highly undervalued. Perhaps one of the best kept secrets of 2009, Generex looks to break into the spotlight during 2010 and establish itself as a highly profitable and dominant player within the biotech industry.

About Generex Biotechnology Corporation

Generex Biotechnology Corporation (NasdaqCM: GNBT) is a leader in drug delivery for metabolic diseases through the inner lining of the mouth. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth.

Generex’s flagship product, Generex Oral-lyn™, an oral insulin spray for the treatment of diabetes, is approved for sale in India, Algeria, Lebanon and Ecuador, and is in Phase III clinical trials with over 347 patients being enrolled in 74 clinical sites around the world, including sites in the United States, Canada, Bulgaria, Poland, Romania, Russia and Ukraine. Also, Generex has developed MetControl™, a proprietary Metformin medicinal chewing gum, which is currently being prepared for submission to various regulatory authorities throughout the world.

Generex’s product pipeline includes: Generex Oral-lyn™, MetControl™ Metformin Gum, Glucose RapidSpray™, BaBOOM!™ Energy Spray, Crave-NX™ Day Diet Aid Spray, Fentanyl Spray, Morphine Spray, Breast and Prostate Cancer Vaccine and Avian Influenza Vaccine.

Generex’s wholly owned subsidiary, Antigen Express, Inc., concentrates on developing proprietary vaccine formulations that work by stimulating the immune system to either attack offending agents (i.e., cancer cells, bacteria, and viruses) or to stop attacking benign elements (i.e., self proteins and allergens). Clinical development of Antigen’s synthetic peptide vaccines designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene for patients with HER-2/neu positive breast cancer in a Phase II clinical trial and patients with prostate cancer and against avian influenza in two Phase I trials. Additional development efforts includes seasonal influenza virus, H5N1, HIV, HPV, melanoma, ovarian cancer, allergy and Type I diabetes mellitus.

Product, Trials, and Phases Matrix

The Rise of the Tides

After reaching a low of $0.45 per share during the end of November 2009, the company’s stock bounced off the support and never looked back. News has been flooding the headlines lately, causing shares of the company to recently gain some much needed momentum. With cash burn of nearly $8.2M annually, something needed to be done in order to save the company from digging itself into a deep financial hole. While it does have a respectable $26.2M cash on hand, you can rest assured liabilities, cost of clinical trials and marketing / distribution efforts would eventually catch up. Worst of all, a second dilution may have been on many investors minds, plaguing / negating any thoughts of entering a position in the company. Amidst all of this, salvation came at hand, two official company press releases in the form of 7000 stores (most speculating this pharma giant to be CVS) generating an order of $800,000 for Company’s proprietary Crave-NX(TM) 7-Day Diet Aid Spra.

Finally, a viable reocurring revenue stream which will see its balance sheet turn positive, and thus allow it to easily flow (either in Q3/Q4)  into  its much anticipated phase III breast cancer immunotherapeutic vaccine, and its long awaited NDA on its type I, type II innovative insulin treatment, where approval is almost certain due to USFDA’s Treatment Investigational New Drug program. It is important to note that 39 companies, according to a BioWorld report have attained this status, and all 39 have attained FDA approval. Both events are scheduled to come into fruition sometime mid-to-end 2010.  Additionally, in a recent PR, Generex noted that, “This latest FDA approval will permit the Company to charge for the product to recover costs.” meaning that they have the ability to obtain a small portion of sales which could potentially help generate some further revenues.

For a list of complications derived through needle based insulin intake, visit the following link.

Another overlooked factor which gives Generex’s Oral-Lyn treatment a significant advantage over the pre-existing ones is patients who are prescribed with Trypanophobia. This condition is the extreme and irrational fear of medical procedures involving injections or hypodermic needles. People who suffer from vasovagal trypanophobia fear the sight, thought, or feeling of needles or needle-like objects. The primary symptom of vasovagal trypanophobia is vasovagal syncope, or fainting due to a decrease of blood pressure.

The Cancer Immunotherapy Index has perhaps never been a hotter investment. It  has appreciated at a 100% annualized rate since its creation by Mentor Capital, July 10, 2009. In fact it has been so successful that in response to the resulting investor interest, Mentor Capital plans to initiate an actively managed Cancer Immunotherapy Index fund in January 2010. A significant majority of Mentor Capital cash proceeds that spring from its $140 million in freely tradable warrants are targeted to be invested through the fund. Some of the companies included will be: Dendreon (NASDAQ:DNDN), Oncothyreon (NASDAQ:ONTY), ImmunoCellular Theraputics (OTCBB:IMUC), Antigenics (NASDAQ:AGEN), Biovest International (BVTI.PK), Celldex Therapeutics (NASDAQ:CLDX ), Northwest Biotherapeutics (OTCBB:NWBO), CEL – SCI Corp. (AMEX:CVM) and Generex Biotechnology (NASDAQ:GNBT). This ensures that institutional investors will be made well aware of Generex in the upcoming year, after all, they have a network just like we do — you can bank on it that they will be using it to communicate the hottest companies to each other.

A Quick Backgrounder on Generex’s Ii-key Hybrid Vaccine AE37 for Breast Cancer can be found by clinking this link.

To understand Generex’s wholly owned subsidiary, Antigen Express, Inc. unique cancer technology, visit this link.  In short, the immunotherapeutic agent being developed by Antigen Express is a peptide derived from a tumor-associated protein that has been modified to enhance stimulation of CD4+ T helper cells. The target protein is encoded by the HER-2/neu oncogene, which has been found to be over-expressed in a variety of tumors, including breast, ovarian, prostate, lung, colon, stomach and pancreas.

Market Potential of Crave-NX, Oral-Lyn, and Breast Cancer Immunotherapy Vaccine

World Diabetes Market

Diabetes effects approximately 170 million people worldwide and is increasing, with the WHO predicting 300 million diabetics by 2025. The US alone has 20.8 million people suffering with diabetes. This equates to approximately 6% of the population. It was the 6th most common cause of death as recorded on US death certificates.

The Global Diabetes drugs treatment market was valued of $15 billion in 2005. Oral anti-diabetics were the leading category of drugs – $8.19 billion – and showed a growth rate of 6.3% from the total global sales in 2004. The total sales for insulin products increased by 16.5% to total global sales of $6.83 billion in 2004.

The Global Diabetes Market Will Exceed $21 Billion by 2011. All figures verified using this source.
Cancer Immunotherapy Market

• The global market for immunotherapies to treat cancer was worth $19.6 billion in 2006 and will reach $23.7 billion by the end of 2007. At a compound annual growth rate (CAGR) of 9.5%, the global market will be worth more than $37.2 billion by 2012.
• Monoclonal cancer treatments have the largest share of the global market. In 2006 they were worth more than $10.4 billion and will reach more than $16.1 billion by 2012, a CAGR of 6.2%
• Cancer vaccines have the greatest potential for growth, growing at a CAGR of 35.2% to reach more than $5.4 billion by 2012. All figures verified using this source.

Some important highlights are:

• IND Treatment Status means that doctors in offices, and anywhere else can sell it. Only diff between full lavel approval is
  that they can sell in drug stores and such.
• Monthly events
• Expecting a partner sooner than expected
• New 23 year patents

Company Overview by Dr. Joseph Rubinfeld, Chief Scientific Advisor

*The following is a compilation of the three part press releaseases issued by the company

For most people when it comes to Generex, the focus is squarely on its flagship buccal insulin spray product, Generex Oral-lyn(TM), and its application in the diabetes arena. That focus is understandable as there is no doubt that, in order for the Company to achieve near-term large scale commercial success, Generex Oral-lyn(TM) must lead the way. I also believe that in addition to the other promising drug programs such as cancer vaccines and synthetic influenza vaccines, what is often overlooked when people evaluate Generex is that the success of Generex Oral-lyn(TM) may well validate Generex’s proprietary RapidMist(TM) drug delivery method and open up a myriad of lucrative opportunities for the Company.

In order to understand the magnitude of successfully delivering a protein-based molecule through an other-than-injectable delivery method, all one has to do is look at the billions of dollars that have been spent by some of the world’s largest pharmaceutical giants in failed efforts for delivering insulin through the lungs. And here is our Company, which stands on the verge of succeeding in not only accomplishing this task but, also accomplishing it without entering the pulmonary system and at a fraction of the cost of even one of the failed efforts by big pharma. Should Generex obtain FDA approval for Generex Oral-lyn(TM), it will enter the multibillion dollar market for diabetes treatment in the U.S. and it will also have the key to replicating this delivery for a broad based group of similar drug therapies for a variety of illnesses. Indeed, a complete success down the road would be the approval of the delivery system itself, enabling Generex to partner with other drug companies to extend the patent lives of their drugs through a less invasive delivery method. In each case, there would be the potential for large royalty streams on proven drugs for years to come.

Taking this one step further, if Generex were to become a large revenue generating company through the success of Generex Oral-lyn(TM), and its delivery method was also validated by use with other drug therapies, it would be then be possible for Generex to create a host of “super generic” drugs using its proprietary RapidMist(TM) drug delivery method and needing only to demonstrate bioequivalence, opening further multibillion dollar opportunities. Now of course this would be down the road a ways and a good many things would need to go in our favor for this to become a reality. However, it is not inconceivable that a multibillion dollar broad based drug company can grow out of our small and relatively unknown Company.

I chose to be the Chief Scientific Advisor to Generex because of the vast potential I see for the technologies and science possessed by this Company. People have called me “The Grandfather of the Industry” or “The Sage of Biotech” but in the end, I am just a researcher and an entrepreneur at heart. I see Generex as an opportunity for me to stay on the biotechnology rollercoaster which I love and ride it to a multibillion dollar success as everyone at the Company works diligently to have a positive impact on the lives of people with diabetes, cancers, influenzas or the many other diseases we may address down the road.

A Brief Roadmap on Generex

*All statements are assuptions based on SEC reports, recent news and interviews
1. Moving from R&D to market penetration with their OTC drugs.

2. Enjoying sales of OTC products to offset their operational expenses monthly.

3. Using revenues from sales of its OTC to expand Oralyn globally.

4. Given that Oralyn is globally and approved in US and Canada, expect that they will expend all energy to develop Breast Cancer, Prostate Cancer, Cervical, and Flu drugs to market.

5.Overseas markets are awaiting Oralyn, approvals from FDA .If approved, will expand to Europe, Middle East, Canada, and manyother parts of the globe simultaneously.

6.Reducing expenses, creating a market Globally for all its products.

7.Reducing float and outstanding shares (OS) , by repurchasing shares in company.

8. No more dilution of shares, may seek partnerships and receive royalties. Buyout has not been named as an option.

Why Investors are Bullish on Generex

• N.I.C.E UK update expected by end of January, 2010
• A/E 37 is expected to be a multi-blockbuster likely
• Oralyn close to finish line on first (and perhaps only) Phase III completion in USA
• IND Treatment Status for Oral-Lyn (no drug granted special access by the FDA has been denied approval)
• Special access in Canada for Oral-Lyn
• Oralyn India already approved
• Oralyn South Korea already approved
• Oralyn Lebanon already approved
• Insulin Supply Deal with Sanofi Aventis

Generex Biotechnology Corporation ( GNBT) Short Interest

Growing short interest for this type of high potential company only makes it easier for the price to increase substantially when a squeeze takes place.

Technical Analysis

There are a number of key bullish indicators when trying to identify a long-term uptrend. The first being, a general rising support level, with healthy consolidation along the way. Secondly, having high volume “buy” days which exceed the volume of the more often “sell” days. The next is a steady RSI which stays above the 50 marker more often than below. Money Flow Index (MFLI) should also display that more money pressure is being placed by buyers through purchasing the stock, rather than selling it for liquid cash. All of these factors are present with Generex, now lets take a closer look:

Notice that the MACD divergence is beginning to turn positive, signalling the start of a bullish trend. The Money Flow Index indicates that the stock is neither engaged in over-selling or over-buying, but is rather set in the 50s, and trending upward which makes it prime and ready for an exchange to the buyers side of the market. We are currently sitting at a major support level at $0.68, next resistance should be upper $0.7s to low $0.8, with a breakout to $1.00 should these be broken. The company recently finalized its financing giving stock warrants (as per the latest 10-Q) at $0.76, $0.79 and $1.00 pps levels, so expect these to be small resistances, though not major, as they only represent 3x to 4x daily average volume. Looking at the recent trend, the buys (green bars) days have had higher volume than the selling (red bars) days, representing a long-term bullish signal, as the stock continues to climb, consolidates, and continues upward. This pattern is seen from the 0.1 level all the way to the current 0.61 level, as the green buying days have always had higher volume than the smaller red selling days. During last week, a doji was formed which represents indecision by the market. The recent news offset this indecision, trending it for a bullish run-up. Expect another test of the $0.80s in the coming days / weeks.

Disclosure: Long GNBT

By reading TheMarketFinacial company profiles you agree to the disclaimer, and thereby will not hold the staff and authors accountable for any transactions or decisions you make. It is up to you to do your own due diligence.

TheMarketFinancial is not paid, compensated or in any way incentivized to report news and developments about publicly traded companies, unless otherwise stated.