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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, March 7, 2010

Oral-lyn Buccal Insulin- No serious adverse events in any study to date

This is an interesting time for those of us that have long followed the companies developing needleless insulin delivery options. A new report was published in Diabetes Care (February 2010 issue; vol 33: pp 240-245) which asked 502 people with diabetes who used insulin to complete an internet survey. More than half of those surveyed, 57 percent, said they had intentionally missed an insulin dose, and 20 percent said they regularly skipped insulin injections. Among the reasons for skipping insulin injections were complaints of injection pain, embarrassment by the need for insulin and thought that the injections interfered with their daily life. One in five stated they skip insulin injections often.

This study further validates the original rational the large pharmaceutical companies had in researching inhalable insulin, an effort they all subsequently abandoned due to safety and marketing related issues. A large pharma may or may not pay large fees to partner with Mannkind for Afrezza inhalable insulin, and all eyes are on the FDA as they have extended well beyond the original PDUFA date for deciding the fate of Mannkind's New Drug Submission. That will be interesting to watch and to see the FDA's action, and if they send an approval with certain label restrictions.

In my opinion, Generex Biotechnology appears to be the stand out in the quest to develop a needleless insulin delivery sytem, since they are not developing an insulin that is absorbed in the lungs. Generex has had no serious safety concerns for Oral-lyn buccal insulin, at least so far, and the final Phase III results are pivotal. For Oral-lyn, Generex is busy with the Phase III, expanding access to the Treatment IND, and hopefully with preparing new submissions for a growing number of markets. Let the safety concerns swirl around prospects for inhalable insulin while the Oral-lyn buccal insulin Treatment IND sounds like a great marketing advantage, since more and more diabetics and physicians will learn of buccal insulin as Generex works towards full approval.

Those 57 percent of diabetics that stated they sometimes skip insulin injections represent a true market of patients that may be open to a safe and effective non-invasive insulin. In my mind, Generex's buccal insulin is the best looking candidate to succeed in making insulin available to a wider spectrum of patients that would typically avoid insulin treatment. To read the report in Diabetes Care click here.

Last month, Diabetes Care (January 2010 vol. 33 no. 1 55-60) reported a new study result which makes me feel that if the FDA does give Afrezza a restrictive label, Mannkind may find themselves finding apprehension amongst the physicians that treat the diabetics currently free of pulmonary disease, since they are at increased risk for developing these pulmonary conditions. The fear, whether it is valid or not, may be that inhalable insulin could hasten the demise of the lungs leading to these pulmonary issues.

The STUDY CONCLUSIONS- "Individuals with diabetes are at increased risk of several pulmonary conditions (asthma, COPD, fibrosis, and pneumonia) but not lung cancer. This increased risk may be a consequence of declining lung function in patients with diabetes." The FDA may grant approval for Afrezza just like they had for Exubera, but to the chagrin of Mannkind the market for Afrezza may also more closely resemble what was seen for Exubera. To read this second report click here.