Generex Biotech's Oral-lyn Granted Special Access Authorization by Health Canada

Generex Biotechnology (GNBT) quietly released an 8K SEC filing on May 1st. In this "Current Report" they note:

Generex Biotechnology Corporation (the "Company") has received Special Access Programme authorization from the Therapeutic Products Directorate of Health Canada for a patient-specific, physician-supervised treatment of Type-1 Diabetes Mellitus with Generex Oral-lyn™, the Company's proprietary oral insulin spray product. Health Canada's Special Access Programme [SAP] provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.

The filing states that a Type 1 patient will be allowed access to Oral-lyn. Her Doctor will record her therapuetic response to Oral-lyn and alert the Director. Investors in Generex hope that positve results may lead to an expansion of the program.

With this development, Generex Oral-lyn is continuing with its positive momentum at a time the inhalable sector is in decline due the discontinuation of development of inhalable insulin devices by Eli Lilly (LLY) and Novo Nordisk (NVO) and the lung fuction decline and more recent lung cancer concerns raised by Pfizer (PFE) and Nektar's (NKTR) Exubera. These hightened pulmonary safety concerns have brought strong doubt on the efforts of Mannkind (MNKD) in developing it's own inhalable insulin device. Only Generex's Oral-lyn is a fine mist liquid spray where all absobtion takes place in the inner lining of the buccal cavity with no deposition into the lungs.

What this Special Access Programme [SAP] Authorization from Health Canada illustrates is that current treatment for this Type 1 patient have either failed, were unsuitable, or are unavailable. It is interesting to note that this SAP prgram is allowing the patients Doctor to prescribe Oral-lyn to fill an unspecified and unmet need. This SAP is evidence that current standard insulin injectables, pens or pumps have failed to help this patient. Through this special program, the patients doctor specifically turned to Generex Oral-lyn and Health Canada approved the treatment.

In one SEC filing, we may find evidence not only of Oral-lyn's superiority vs inhalable insulin, but potentially of it's superiority vs current approved treatment options for a specific Type 1 subgroup. This is encouraging news for Generex and their shareholders, as the microcap biotech continues with recruitment in North America for Oral-lyn's worldwide Phase III trial.

Disclosure: Long

Comments

[Slade]

This is certainly encouraging to hear as a shareholder! This could play out to be a major aid in preparing the market for Oral-lyn. Several countries have already approved Oral-lyn for public use. Oral-lyn is currently in the process of FDA approval in the United States. If tests go well and it is approved, Oral-lyn could become a common household name to people with Diabetes!

[razormdthe2nd]

HAW!...yet another try at a pump from an anonymous investor!...evidently GNBT managed to convince a GP to presribe oralyn for ONE -- strong emphasis on "ONE" -- patient...and SAP authorization does NOT mean other therapies "either failed, were unsuitable, or are unavailable"!!...... that was its original purpose it is used to obtain pretty much not currently authorized -- e.g. silicone BREAST IMPLANTS:

www.cmaj.ca/cgi/conten...

...nothing changes the FACT that the bioavailability of insulin via oralyn is only about 5-7%...in other words, the same quantity of insulin via oralyn per DAY would last 16 - 20 DAYS if given via injection...moreover, the patients would STILL require injections since oralyn is short acting and virtually ALL patients require some form of long acting insulin...and if they're afraid of needles there are needle-free injection systems available -- e.g. medi-jector...GNBT claims to have been selling oralyn in Ecuador for over a year and a half now but have yet to report a single PENNY of revenues there!...GNBT is NOTHING but a bad Canadian joke that is run by a former real estate agent.

[Lanster30]

Hi razormdthe2nd and thanks for your comments. Yes, this is an expensive and, as of yet, unproven new technology. The numbers aren't encouraging. However, I am curuious to know your take on other new products in the pipeline for Generex. Is this company viable in anyway or just another Mark Cuban short sell type deal? What about Avian flu? Enlighten us.

[razormdthe2nd]

...for "Lanster" -- GNBT's pipeline?...you must be joking...one week they're working on a SARS vaccine...the next week it's a prostate cancer vaccine...then they start up RNAi program...whatever is in the headlines on Monday will be in their "pipeline" by Friday...years ago used to claim they were working on a fentanyl and a morphine spray -- they're both still listed on their website as being in phase I but they never mention any progress with either one anymore...their "pipeline" probably serves no other purpose than of duping naieve investors into buying their stock...in 2005 they had about 35 million shares outstanding; in 2007 that had risen to ONE HUNDRED AND TEN MILLION SHARES!...and per the accountants on the annual report:

"These matters raise substantial doubt about its ability to continue as a going concern."

...you figure it out!

[Lanster30]

Hey Razor...

Well, thanks for the feed back. GNBT is up over a dollar again today, with a 52 week high of $2.14. I wonder if it could run up again, even temporarily, for a nice pop. It seems to move up and down a fair amount on any new that makes the major wires.

[bsharvy]

What's your source for these claims:
"...nothing changes the FACT that the bioavailability of insulin via oralyn is only about 5-7%...in other words, the same quantity of insulin via oralyn per DAY would last 16 - 20 DAYS if given via injection...moreover, the patients would STILL require injections since oralyn is short acting and virtually ALL patients require some form of long acting insulin...and if they're afraid of needles there are needle-free injection systems available -- e.g. medi-jector"

[razormd]

...to "bsharvy"...... "source" for my "claims"?...... GNBT's own published data and a calculator...they aren't claims, just simple scientific facts.