paul collins

MannKind: No Partnership Likely for Inhalable Insulin

Navdeep S. Jaikaria, Ph.D., a Senior Biotechnology Analyst at Rodman & Renshaw, he reiterated his Market Outperform Rating on Generex and $6 price target. Some of the highlights of the report, titled, "NO IMPACT ON ORAL-LYN FROM LILLY TERMINATION OF ALKERMES INHALED INSULIN" were:

Alternative Insulin Competitors Continue to Fall and Enhance the Oral-ly Opportunity Last Friday, Alkermes Inc. (ALKS, Not Rated) announced that it received a letter from Eli Lilly (LLY, Not Rated) terminating their license agreement for the development of AIR Inhaled Insulin. This news, as well as the announcement in October 2007 by Pfizer Inc. (PFE, Not Rated) of the termination of its development of Exubera, an in-market inhalable insulin by Nektar Therapeutics Inc. (NKTR, Not Rated), have continued to place unwarranted pressure on the shares of Generex, which is in the final stages of preparation for a Phase III trial with Oral-lyn, the company's proprietary oral insulin product candidate. We believe disappointing sales with Exubera inhaled insulin made uncertain the prospects for further commercialization of Alkermes' AIR and AERx, an inhaled insulin system by Novo Nordisk A-S (NVO, Not Rated) whose Phase III development was discontinued in January 2008. We believe this news is positive for Generex as they enhance Oral-lyn's opportunity as a safe, more tolerable, non-injectable insulin for the treatment of patients with diabetes.

We Reiterate that the High Hurdles with the Inhaled Route of Insulin Delivery are Not Likely to be Observed with Buccal Cavity (Oral) Delivery of Insulin Concerns continue to grow that inhaled insulins, such as Exubera, may all be plagued by the observation of an early, non-progressive decline in lung function that does not improve over long-term use of Exubera, as well as problems associated with formulation of insulin into inhalable powder form. Further, the advancement of more convenient injectable devices, such as pens filled with pre-mixed insulin analogs, obviated the value of convenient mealtime titratable insulin delivery. We believe the significant hurdles seen with the inhalation route of delivery bode negative for inhaled insulin products, and open the door for Oral-lyn as the insulin potentially with the best non-injectable alternative route of mealtime insulin delivery.

Generex Biotech: A Breath of Fresh Insulin

Navdeep S. Jaikaria, Ph.D., a Senior Biotechnology Analyst at Rodman & Renshaw, he reiterated his Market Outperform Rating on Generex and $6 price target. Some of the highlights of the report, titled, "NO IMPACT ON ORAL-LYN FROM LILLY TERMINATION OF ALKERMES INHALED INSULIN" were:

Alternative Insulin Competitors Continue to Fall and Enhance the Oral-ly Opportunity Last Friday, Alkermes Inc. (ALKS, Not Rated) announced that it received a letter from Eli Lilly (LLY, Not Rated) terminating their license agreement for the development of AIR Inhaled Insulin. This news, as well as the announcement in October 2007 by Pfizer Inc. (PFE, Not Rated) of the termination of its development of Exubera, an in-market inhalable insulin by Nektar Therapeutics Inc. (NKTR, Not Rated), have continued to place unwarranted pressure on the shares of Generex, which is in the final stages of preparation for a Phase III trial with Oral-lyn, the company's proprietary oral insulin product candidate. We believe disappointing sales with Exubera inhaled insulin made uncertain the prospects for further commercialization of Alkermes' AIR and AERx, an inhaled insulin system by Novo Nordisk A-S (NVO, Not Rated) whose Phase III development was discontinued in January 2008. We believe this news is positive for Generex as they enhance Oral-lyn's opportunity as a safe, more tolerable, non-injectable insulin for the treatment of patients with diabetes.

We Reiterate that the High Hurdles with the Inhaled Route of Insulin Delivery are Not Likely to be Observed with Buccal Cavity (Oral) Delivery of Insulin Concerns continue to grow that inhaled insulins, such as Exubera, may all be plagued by the observation of an early, non-progressive decline in lung function that does not improve over long-term use of Exubera, as well as problems associated with formulation of insulin into inhalable powder form. Further, the advancement of more convenient injectable devices, such as pens filled with pre-mixed insulin analogs, obviated the value of convenient mealtime titratable insulin delivery. We believe the significant hurdles seen with the inhalation route of delivery bode negative for inhaled insulin products, and open the door for Oral-lyn as the insulin potentially with the best non-injectable alternative route of mealtime insulin delivery.

MannKind: No Partnership Likely for Inhalable Insulin

If the street had listened to Dr. Bernstein, the former head of the American Diabetes Association, they would have predicted the sudden drop in Mankind's (MNKD) stock last week. Back in December, 2007, Dr. Bernstein predicted that MNKD would fail.

www.ft.com/cms/s/2/94f...

Dr. Bernstein now serves for Generex and has committed his life to developing and obtaining approval for its flagship product, Oral-Lyn. He strongly believes in the safety and efficacy of the product. And, thus I highly doubt that the product will fail. GNBT should see $5/share within the coming year (remember it was $22 just because they had a partnership with Eli Lilly). Now they are in Phase 3 in the USA, and they have regulatory approval in India, one of the largest Diabetes markets in the world. For reference, Dr. Bernstein's bio is below.

Dr. Bernstein, M.D., F.A.C.P. graduated from Dartmouth College and Tufts University School of Medicine. He is board certified in internal medicine (1966) and endocrinology and metabolism (1973). Dr. Bernstein is an associate clinical professor at the Albert Einstein College of Medicine in New York. He is an attending physician at Beth Israel Medical Center, and physician emeritus at Lenox Hill Hospital and Montefiore Medical Center, all in New York. He was formerly Director of the Beth Israel Health Care Systems Diabetes Management Program. Dr. Bernstein was president of the American Diabetes Association in 1998-99 and was for many years a member of the ADA's Board of Directors and its Executive Committee. He received the ADA's Banting Medal for Service in 1999. Dr. Bernstein presently serves on several ADA committees and on the Board of Directors of the American Diabetes Association Research Foundation.

Oral Insulin: Balancing Safety with Efficacy

If the street had listened to Dr. Bernstein, the former head of the American Diabetes Association, they would have predicted the sudden drop in Mankind's (MNKD) stock last week. Back in December, 2007, Dr. Bernstein predicted that MNKD would fail.

www.ft.com/cms/s/2/94f...

Dr. Bernstein now serves for Generex and has committed his life to developing and obtaining approval for its flagship product, Oral-Lyn. He strongly believes in the safety and efficacy of the product. And, thus I highly doubt that the product will fail. GNBT should see $5/share within the coming year (remember it was $22 just because they had a partnership with Eli Lilly). Now they are in Phase 3 in the USA, and they have regulatory approval in India, one of the largest Diabetes markets in the world. For reference, Dr. Bernstein's bio is below.

Dr. Bernstein, M.D., F.A.C.P. graduated from Dartmouth College and Tufts University School of Medicine. He is board certified in internal medicine (1966) and endocrinology and metabolism (1973). Dr. Bernstein is an associate clinical professor at the Albert Einstein College of Medicine in New York. He is an attending physician at Beth Israel Medical Center, and physician emeritus at Lenox Hill Hospital and Montefiore Medical Center, all in New York. He was formerly Director of the Beth Israel Health Care Systems Diabetes Management Program. Dr. Bernstein was president of the American Diabetes Association in 1998-99 and was for many years a member of the ADA's Board of Directors and its Executive Committee. He received the ADA's Banting Medal for Service in 1999. Dr. Bernstein presently serves on several ADA committees and on the Board of Directors of the American Diabetes Association Research Foundation.

Generex Biotech: A Breath of Fresh Insulin

If the street had listened to Dr. Bernstein, the former head of the American Diabetes Association, they would have predicted the sudden drop in Mankind's (MNKD) stock last week. Back in December, 2007, Dr. Bernstein predicted that MNKD would fail.

www.ft.com/cms/s/2/94f...

Dr. Bernstein now serves for Generex and has committed his life to developing and obtaining approval for its flagship product, Oral-Lyn. He strongly believes in the safety and efficacy of the product. And, thus I highly doubt that the product will fail. GNBT should see $5/share within the coming year (remember it was $22 just because they had a partnership with Eli Lilly). Now they are in Phase 3 in the USA, and they have regulatory approval in India, one of the largest Diabetes markets in the world. For reference, Dr. Bernstein's bio is below.

Dr. Bernstein, M.D., F.A.C.P. graduated from Dartmouth College and Tufts University School of Medicine. He is board certified in internal medicine (1966) and endocrinology and metabolism (1973). Dr. Bernstein is an associate clinical professor at the Albert Einstein College of Medicine in New York. He is an attending physician at Beth Israel Medical Center, and physician emeritus at Lenox Hill Hospital and Montefiore Medical Center, all in New York. He was formerly Director of the Beth Israel Health Care Systems Diabetes Management Program. Dr. Bernstein was president of the American Diabetes Association in 1998-99 and was for many years a member of the ADA's Board of Directors and its Executive Committee. He received the ADA's Banting Medal for Service in 1999. Dr. Bernstein presently serves on several ADA committees and on the Board of Directors of the American Diabetes Association Research Foundation.

Nektar, Mannkind Suffer from Pfizer's (Discontinued) Inhaled Insulin Effects

ATTENTION: WALL STREET WAKE UP!

Safe Oral Insulin called ORAL-LYN by Generex in PHASE3 6 Month Trial in North America Already approved in INDIA sales starting Expecting to be approved world wide PHASE3 Trails across the Globe

The street.com writes Aprill 9 2008
Meanwhile, small-cap Generex Biotechnology (GNBT - Cramer's Take - Stockpickr), which has an oral insulin product -- absorbed through the mouth and designed not to enter the lungs -- in late-stage development, saw its shares edge up 12.2% to $1.20 on more than double normal volume.

June 2007 ANALYST NOTES:

GENEREX’ ORAL-LYN OFFERS SIGNIFICANT ADVANTAGES OVER
EXISTING INSULINS Many Type II diabetic patients who would benefit from
insulin therapy are not started on insulin because of the inconvenience and
dis comfort of insulin injections. This situation has led several companies to
develop alternate technologies for insulin delivery. We believe that Generex’
Oral-lyn has advantages over other non-injectable insulin solutions. While many
of these systems deliver insulin to the lungs and bronchial tree, Oral-lyn delivers
insulin to the oral mucosa, avoiding the potential risks of chronic lung tissue
exposure to insulin. Additionally, pharmacokinetic studies have shown that Orallyn
reaches peak circulating levels in 30 minutes compared to 60 minutes with
injected insulin. This more rapid onset will offer patients a better quality of life by
providing more flexibility at meal times, and better glycemic control.
INSULIN – A FAST GROWING MARKET The diabetic patient population is large
and growing rapidly, from 21 MM patients in the US alone in 2007 to an
estimated 48 MM in 2050. This growth will not be limited to the US and EU, but
will also be in the emerging markets of India and China. Among the leading
companies, we believe that Generex’ insulin delivery technology offers great
potential to both patients and investors. Currently, the insulin market is
dominated by only three companies - Eli Lilly (LLY, Not Rated), Novo Nordisk
(NVO, Not Rated) and Sanofi Aventis (SNY, Not Rated), recording blockbuster
insulin sales of >$7 BN in 2005. By 2010 the global market for insulin is projected
to be worth around $12 BN. Given such a large number of diabetic patients , we
believe Generex has a large and rapidly expanding potential market opportunity.

INITIATING COVERAGE WITH A MARKET OUTPERFORM RATING Our
analysis therefore derives a fair value of $6 (P/E multiple of 25x our 2012 EPS
estimate of $1.62 discounted at an annual rate of 45%) for Generex shares and a
rating of Market Outperform. Our analysis indicates that Generex’ oral insulin,
Oral-lyn, could be a significant player in the non-injectable insulin market. We
believe that Oral-lyn’s product profile, combined with strong clinical data and
expected rapid growth in the global diabetic population, could result in >$600 MM
in revenues by 2013. Generex also has two other smaller products in diabetes
and an early-stage cancer vaccine pipeline.

Generex Biotechnology "market outperform"

Wednesday, January 16, 2008 9:22:33 AM ET
Rodman & Renshaw

NEW YORK, January 16 (newratings.com) - Analysts at Rodman & Renshaw reiterate their "market outperform" rating on Generex Biotechnology Corp (ticker: GNBT). The target price is set to $6.

In a research note published this morning, the analysts mention that the execution of the company?s low-risk Oral-lyn pre-commercialization activities and the preparations for the late-stage Phase III clinical trial are on track. Generex Biotechnology is a leading player in the alternative drug delivery market, the analysts add.

MannKind: No Partnership Likely for Inhalable Insulin

ATTENTION: MIKE HUCKMAN & WALL STREET WAKE UP!

Safe Oral Insulin called ORAL-LYN by Generex in PHASE3 6 Month Trial in North America Already approved in INDIA sales starting Expecting to be approved world wide PHASE3 Trails across the Globe

The street.com writes Aprill 9 2008
Meanwhile, small-cap Generex Biotechnology (GNBT - Cramer's Take - Stockpickr), which has an oral insulin product -- absorbed through the mouth and designed not to enter the lungs -- in late-stage development, saw its shares edge up 12.2% to $1.20 on more than double normal volume.

June 2007 ANALYST NOTES:

GENEREX’ ORAL-LYN OFFERS SIGNIFICANT ADVANTAGES OVER
EXISTING INSULINS Many Type II diabetic patients who would benefit from
insulin therapy are not started on insulin because of the inconvenience and
dis comfort of insulin injections. This situation has led several companies to
develop alternate technologies for insulin delivery. We believe that Generex’
Oral-lyn has advantages over other non-injectable insulin solutions. While many
of these systems deliver insulin to the lungs and bronchial tree, Oral-lyn delivers
insulin to the oral mucosa, avoiding the potential risks of chronic lung tissue
exposure to insulin. Additionally, pharmacokinetic studies have shown that Orallyn
reaches peak circulating levels in 30 minutes compared to 60 minutes with
injected insulin. This more rapid onset will offer patients a better quality of life by
providing more flexibility at meal times, and better glycemic control.
INSULIN – A FAST GROWING MARKET The diabetic patient population is large
and growing rapidly, from 21 MM patients in the US alone in 2007 to an
estimated 48 MM in 2050. This growth will not be limited to the US and EU, but
will also be in the emerging markets of India and China. Among the leading
companies, we believe that Generex’ insulin delivery technology offers great
potential to both patients and investors. Currently, the insulin market is
dominated by only three companies - Eli Lilly (LLY, Not Rated), Novo Nordisk
(NVO, Not Rated) and Sanofi Aventis (SNY, Not Rated), recording blockbuster
insulin sales of >$7 BN in 2005. By 2010 the global market for insulin is projected
to be worth around $12 BN. Given such a large number of diabetic patients , we
believe Generex has a large and rapidly expanding potential market opportunity.

INITIATING COVERAGE WITH A MARKET OUTPERFORM RATING Our
analysis therefore derives a fair value of $6 (P/E multiple of 25x our 2012 EPS
estimate of $1.62 discounted at an annual rate of 45%) for Generex shares and a
rating of Market Outperform. Our analysis indicates that Generex’ oral insulin,
Oral-lyn, could be a significant player in the non-injectable insulin market. We
believe that Oral-lyn’s product profile, combined with strong clinical data and
expected rapid growth in the global diabetic population, could result in >$600 MM
in revenues by 2013. Generex also has two other smaller products in diabetes
and an early-stage cancer vaccine pipeline.

Generex Biotechnology "market outperform"

Wednesday, January 16, 2008 9:22:33 AM ET
Rodman & Renshaw

NEW YORK, January 16 (newratings.com) - Analysts at Rodman & Renshaw reiterate their "market outperform" rating on Generex Biotechnology Corp (ticker: GNBT). The target price is set to $6.

In a research note published this morning, the analysts mention that the execution of the company?s low-risk Oral-lyn pre-commercialization activities and the preparations for the late-stage Phase III clinical trial are on track. Generex Biotechnology is a leading player in the alternative drug delivery market, the analysts add.

Generex Biotechnology: Oral-lyn Buccal Insulin Takes Center Stage

Great article very informative some other facts



Analyst has $6 Target stock is $1.25

Generex Biotechnology "market outperform"
01/16/08 - Rodman & Renshaw
NEW YORK, January 16 (newratings.com) - Analysts at Rodman & Renshaw reiterate their "market outperform" rating on Generex Biotechnology Corp (GNBT). The target price is set to $6.

In a research note published this morning, the analysts mention that the execution of the company’s low-risk Oral-lyn pre-commercialization activities and the preparations for the late-stage Phase III clinical trial are on track. Generex Biotechnology is a leading player in the alternative drug delivery market, the analysts add.



www.newratings.com/en/...


Flaherty Special Situation #2
Volume 1 Issue 2
April 2008
~~~~~~~~~~~~~~~~~~~~~~...

in this issue
Bob Flaherty Rides Again! Generex Biotechnology Corporation (NASDAQ:GNBT) is his next winner.

What exciting special situation have we found for you this issue? Take a look at Generex Biotechnology, whose stock was recently $1.04 versus a 12 month high of $2.14 and an all time high of over $22. Rodman and Renshaw forecasts a 12 month stock price of $6 and after that we think further gains are possible. GNBT is successful pioneering to introduce global needle-free delivery of insulin where many famous giants and lots of others have failed. You may even know of a person who is a diabetic who could improve the quality of their life if instead of using needles all the time they could switch to Generex Biotechnology's oral insulin spray after it is approved in the U.S. as it already is in Eucador and India.Think of how many of the 194 million diabetics in the world who would benefit if they coulld change the way that they take in insulin.

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