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Generex Biotechnology, and their wholly owned subsidiary Antigen Express, are developing promising new drugs to treat diabetes, as well as synthetic peptide vaccines targeting HER2/neu cancer and pandemic flu. The flagship product for Generex is Oral-lyn buccal insulin. Antigen Express' leading vaccine is the AE37 HER2/neu synthetic peptide vaccine to prevent breast cancer recurrence. I am not qualified to offer investment or medical advice, and make no claims that I am an expert in these areas. I am a layman and a shareholder in this company. The left side of Pipeline Review holds blogs regarding Generex and Antigen Express, while the right side offers items of due diligence mixed with my analysis which may be of interest to others seeking to learn about Generex's pipeline. If the left side only shows the latest blog, click on the word home to view them all.

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Sunday, June 8, 2008

American Diabetes Association's 68th Scientific Sessions: A New Look at Insulin Therapy

The American Diabetes Association's 68th Scientific Sessions kicked off in San Francisco on June 6th and ends June 10th. Large pharma dominates the exhibition and use the venue to present their latest study results in an effort to orientate health care professionals on the products they may be prescribing as well as the investment community on the potential value hidden in their pipelines. It was at last year's ADA event, held in Chicago, where all attention centered on GlaxoSmithKline's (GSK) Type 2 oral pill Avandia. First-quarter sales of Avandia declined 56 percent after it was linked to an increased risk of heart attacks while revenue from insulin is climbing fast.

A novel theme has emerged at this year's event emphasizing the merits of insulin therapy in Type 2 patients in the wake of this tumultuous year for oral pills. Two of the largest pharmaceutical companies have brought data to support initiating insulin treatment earlier which is in contrast to previous medical practice. If this trend continues, the future benefactors may not only include the current leaders of injectable insulin such as Novo Nordisk (NVO), Eli Lilly (LLY) and Sanofi-Aventis (SNY), but also Generex Biotechnology (GNBT) and their Oral-lyn Buccal spray. Oral-lyn is a liquid based spray where the insulin delivery occurs in the inner cheek wall with no deposition into the lungs, and is still standing strong after the collapse of Pfizer's (PFE) Inhalable Exubera led to the discontinuation of the inhalable efforts of Eli Lilly, Novo Nordisk and have placed considerable doubt on the future success of Mannkind's (MNKD) Inhalable Technosphere Insulin.

Novo Nordisk A/S, the world's largest insulin manufacturer, kicked off this year's event by releasing results of a study involving early insulin therapy in Type 2 diabetics. The controlled study, partially funded by Novo, involved 382 people from 2004 to 2006 who were newly diagnosed with Type 2 diabetes. Patients randomly received either insulin shots throughout the day, infusions of insulin via a pump, or diabetes pills to bring down their blood sugar levels. The results show that the Type 2 patients who received insulin achieved better glucose controlling results than those who took traditional oral pills. Twice as many patients who received insulin reached their target blood glucose levels in a shorter amount of time than the group who took pills. Nomura Code analyst Paul Diggle believes the new research is likely to increase the $10.2 billion annual worldwide insulin market by more than 10 percent. "We're already seeing an impact of earlier use of insulin,'' Diggle said June 4 in an interview in London. "Early use is one of the things that has people interested in Novo Nordisk.''

Sanofi-Aventis was also presenting data at this year's ADA event to try and boost it's share of the $23 billion global diabetes market with help from increased sales of Lantus, the drugmaker's fastest-growing product. Sanofi has presented study results showing that it's Lantus insulin controlled blood sugar levels for patients in the early stages of diabetes better than traditional oral methods. The company finds that more doctors are starting prescribe insulin during diabetes's early stages to slow the disease's progress and lessen the risks it poses to the heart and kidneys. "Early insulinization is definitely one of the big opportunities we're looking at,'' said Alexandre Moreau, head of Sanofi's diabetes unit, in an interview in Paris. "We have a continuous flow of evidence that we can treat earlier and better. The proportion of patients today who are treated with insulin is around 27 percent. When you see the number of patients who are uncontrolled, it's quite a simple calculation to make if we can grab that percentage of people.''

Generex Biotechnology was also at this week's ADA event and presented convincing results of a 372 day Phase II study comparing Basal and Pre-Prandial Injection vs. Basal Injection and Generex Oral-lyn in Type-1 Diabetics. The investigators of the study written conclusion reads that "A regimen consisting of basal BID s.c. NPH and prandial orally-absorbed regular insulin (Generex Oral-lyn™) attained lower pre-meal glucose, HbA1c and Fru concentrations, than a regimen using basal and pre-prandial insulin analogue injections in Type-1 DM during a 372-day period." Generex also announced at the event that patient dosing has begun in their worldwide Phase III trial for Oral-lyn. Oral-lyn is a room tempeture stable liquid based formulation and a small handheld metered spray that has been proven to administer doses that measure exactly 1 unit. With its very fast onset and offset of action, Oral-lyn possesses less risk of hypoglycemia when compared to standard injections.

Generex Oral-lyn is especially enticing when considering this new trend towards earlier insulin treatment and recalling another study that was presented at last year's event. That study found that of 100 people with Type 2 diabetes, 33 would be unwilling to take insulin even if doctors recommended it. The researchers, led by Mary Larkin of Massachusetts General Hospital in Boston, found that 60 percent of that group is afraid of needles. Another fear for a Type 2 regarding initiating insulin therapy is the fear they may overshoot their insulin dose and risk suffering a hypoglycemic episode. DWS Investment fund manager Noushin Irani, who helps manage $773 million in Frankfurt, was quoted by Bloomberg last month as stating "Patients don't want to use an injection and they especially don't want to use insulin, because of the complexity in controlling blood glucose and also because it makes them feel they really are sick."

Since Oral-lyn is a 1 U handheld spray, overshooting the dose is not likely and this provides the diabetic with a "fine tune" dosing approach. Since the device is small and familar looking, it will not attract attention during use in public and may eliminate the perception that initiating insulin makes them "feel sick". The end result, as shown by studies at this year's ADA event, clearly show that the earlier insulin treatment will make them "feel better" and improve upon their health. The Novo Nordisk and Sanofi-Aventis studies are surely meant to bring attention and sales to their insulin products, but may aid Generex Oral-lyn the most.