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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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Friday, August 15, 2008

Four Drug Companies Vying for Diabetes Patients

The American Association of Diabetes Educators (AADE) released results last week at their high profile 35th Annual Meeting from an innovative new survey entitled the “Injection Impact Report”.

The report highlights the level of communication between patients and healthcare providers relating to insulin injections and also spotlights how those injections can impact patients’ daily lives and treatment adherence. Conducted online between June 12 and July 7 2008, the report surveyed 502 people with diabetes who inject insulin using either a syringe or a pen and also queried over 300 healthcare professionals who treat them. The report has gained the attention of the diabetic community, although the results were expected by many that are familiar with the burden associated with daily injections of insulin.

The findings detail that 33% of the surveyed patients with have experienced "dread" in relation to insulin injections, 14 percent surveyed feel that insulin injections have a negative impact on their life, more than 29 percent of the surveyed feel that injecting insulin is the hardest aspect of their diabetes care. Of those patients surveyed, 52% reported not discussing their concerns about the emotional and physical aspects of insulin treatment with their health care providers, yet 47% said they would be more adherent to their insulin regimen if they knew how to ease the pain and discomfort associated with injections.

Within the survey, a mere 12% of the 301 health care providers reported that their patients have addressed their "quality of life" concerns regarding insulin treatment. Seventy-one percent said they were aware of the impact of insulin injections on their patient's quality of life, but a minority of 40% reported addressing these issues with patients. This lack of communication jeopardizes effective diabetes management.

"When developing the survey, we had two goals in mind," said Amparo Gonzalez, RN, BSN, CDE, president of the AADE. "The first was to encourage patients to take a more proactive role in communicating with their healthcare team about their concerns regarding insulin injections. The second was to dispel the myth that healthcare providers were unaware of or were unwilling to address the quality of life issues surrounding insulin injections. If we can improve the quality of life for 33% of people with diabetes who are insulin dependent, then we can be one step closer to lessening the impact of the disease on our patient's lives," Gonzalez said in a press release.

The AADE report may also serve as a barometer for measuring potential strong demand amongst the 33% of diabetics experiencing dread in relation to insulin injections for the novel needle-less insulin delivery methods that are in the final stages of testing, while underscoring the apparent soft support for the injectable insulin analogues of large pharmaceutical companies such as Novo (NVO) Nordisk and Eli (LLY) Lilly. Insulin analogues act similarly to human insulin, but provide a more rapid window of action coupled with effective glycemic control. The large pharma firms are in the midst of a successful marketing campaign resulting in the conversion of prescriptions away from regular human insulin towards their more expensive, and profitable, insulin analogues.

However, many diabetics are uncomfortable in accepting the safety profile of analogues. Respected diabetic bloggers, such as Allie Beatty, report on these concerns and are aware that these large pharmaceutical companies reap greater profits by switching their prescriptions away from standard human insulin towards their new more expensive synthetic laboratory inventions. My LONG choice within the biotech sector is aided by the AADE report and recently began presenting an interesting study countering the superiority claims associated with insulin analogues.

Recent research from Generex (GNBT) Biotechnology, a company focused on advanced insulin delivery and vaccine research, dispel both the advantages of insulin analogues and eliminate the fears associated with the needles and pens used in insulin injection. Investigators from the company have been presenting their data at diabetes conferences that is co-authored by researchers from the Institute for Endocrinology IEMYR, Quito, Ecuador, and the University of Florida, Gainsville.

The year-long study examined 26 subjects with type 1 diabetes, which is normally treated with basal injected injection once or twice a day to provide baseline glycemic control, and additional insulin injections before meals. The control study group received insulin glargine (an insulin analogue) once a day as their basal dose, and a faster-acting insulin analogue before meals. The treatment group received a non-analogue long-acting insulin twice a day as their basal insulin; before meals the they took Oral-lyn, a liquid formulation of regular human insulin, developed by Generex, that is absorbed through the lining of the mouth.

Study results illustrate a rapid onset of action and superior glycemic control vs. the anlogues. Oral-lyn uses a formulation that allows insulin to pass through the “buccal” mucosa – the soft tissues lining the inside of the mouth – and into the bloodstream rapidly and safely, without injection. Unlike inhaled insulin products such as Exubera, which Pfizer (PFE) has removed from the market due to disappointing sales stemming from safety concerns of using the sensitive lungs as a delivery route for a growth agent (insulin), the combination of Oral-lyn insulin and Generex's RapidMist delivery technology allows patients to deliver a precise 1 unit dose as needed, with no deposit of insulin into the lungs and no needles.

"When Oral-lyn is absorbed through the buccal mucosa its rapid entry into the blood stream mimics and improves upon the rapid acting analogues.” commented Dr. Jaime Guevara, a study author and clinician that has conducted studies for Generex’s Oral-lyn. “Claims that analogues provide superior convenience do have some merit when these agents are compared with insulin injected before meals. However, when compared with Oral-lyn, which is not injected, even those arguments fail to make the case for drugs that cost three times as much as standard insulin."

Generex's share price has been in decline as many investors shun microcap biotechs during the current market conditions and look for safer havens to protect their holdings. However, the company has recently enrolled over 150 patients in their worldwide Phase III trial for Oral-lyn and have recorded positive developments for their vaccine subsidiary "Antigen Express". With recent financing completed and the launch of sales expected of Oral-lyn to begin in India in the next couple of months, this may be a unique opportunity for biotech investors that seek emerging companies that are well positioned for future gains.

Buying while surrounded by bears demands caution, but many biotech investors often find this the preferred environment in which to begin their hunt.

The AADE Injection Impact Report was conducted online by Harris Interactive and can be viewed by visiting here.