Four Drug Companies Vying for Diabetes Patients

Includes: GNBT, LLY, NVO, SNY
by: Rich Steffens

The American Association of Diabetes Educators [AADE] released results last week at its 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 who 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 patients' 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 Nordisk (NYSE:NVO), Eli Lilly (NYSE:LLY) and Sanofi Aventis (NYSE:SNY). Insulin analogues act similarly to human insulin insulin, but provide a more rapid window of action coupled with effective glycemic control.

These large pharma firms are in the midst of a successful marketing campaign, resulting in the conversion of prescriptions away from regular human insulin towards 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 prescriptions towards their new synthetic laboratory versions of insulin.

My struggling and speculative 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 these analogues. Recent research from Generex Biotechnology (OTCPK:GNBT), a company focused on advanced insulin delivery and vaccine research, dispels both the advantages of insulin analogues and eliminates 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 Oral-lyn study examined 26 subjects with type-1 diabetes. Members of 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. Members of the treatment group received a non-analogue long-acting insulin twice a day as their basal insulin; before meals 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 consistently and clearly illustrate the rapid onset of action and superb glycemic control of Oral-lyn as compared to the analogues.

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 (NYSE:PFE) has removed from the market due to disappointing sales stemming from safety concerns regarding the use of the sensitive lungs as a delivery route, there in no insulin depsoition into the lungs. The combination of Oral-lyn insulin and Generex's RapidMist delivery technology allows patients to deliver a precise 1-unit dose as needed, all with no dreaded 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 current market conditions and look for safer havens to protect their holdings. However, the company has recently enrolled over 150 patients in the pivotal worldwide Phase III trial for Oral-lyn and have recorded positive developments for their vaccine wholly owned subsidiary "Antigen Express". With Generex's recent financing completed and the launch of sales expected for Oral-lyn to begin in India (home to 1/3rd of the world's diabetics) in the next couple of months, this may be a unique opportunity for biotech investors that seek emerging companies that are well positioned for both near and future gains.

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

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

Disclosure: Long GNBT.