Pfizer submitted its application to Health Canada, the Canadian government’s drug regulatory agency, in April of 2006, but still hasn’t received drug approval for the company’s inhaled insulin to be sold there.
That disclosure was made by Pfizer, Inc. (NYSE:PFE) in the company’s 2006 Financial Report.

This blog has been tracking Exubera approval in various countries around the world, including Canada.

Other countries in the far-flung corners of the world that have approved Exubera include Dubai and the United Arab Emirates.

We noted last summer the apparent condundrum in having Canadian pharmacies market Exubera online to American diabetics across the border when Health Canada “drug regulators haven’t even approved the new inhaled insulin.”

University of Western Ontario professor and medical researcher, Dr. Jesse Zhu, is one beneficiary of an $83.7 million Canadian government fund for the the appointment of 98 Canada Research chairs across the countr.. He was reappointed as the Canada Research Chair in Powder Technology Application at UWO.

Zhu says that he and his research associates are working on an insulin inhaler that is “more efficient and accurate” than the Pfizer, Inc.’s (NYSE:PFE) Exubera technology and pulmonary drug delivery device. Zhu’s device is expected to be palm-sized. His model delivers “more accurate doses and does not contain lactose,” a substance the lungs can’t absorb but which is used as an additive in the Pfizer model to help divide the microscopic insulin particles into doses.

Despite interest by readers of this blog in whether inhaled insulin is available in Canada, it appears that Pfizer, Inc. (NYSE:PFE) still hasn’t obtained approval to market the diabetes drug in the country.

This blog noted last summer the apparent condundrum in having Canadian pharmacies market Exubera to American diabetics across the border when Health Canada “drug regulators haven’t even approved the new inhaled insulin.”

That’s still the case today. Even though Pfizer is allowed to use Exubera in NIH-approved clinical studies in the U.S., roughly have of Canada’s provinces (Ontario, Quebec, Manitoba, Newfoundland and Labrador), and Mexico. (See, NIH Clinical Trial: Demonstrate Exubera Works As Well As Avandia When Added to Sulfonylurea+ Metformin When Controlling Glucose, Clinical Trial No. NCT00150410)

Imagine selling a drug in a country whose government regulatory agency hasn’t even approved its usage. In the U.S. that’s a risky proposition for pharmacists and snake-oil sales people. The U.S. Food & Drug Administration and Federal Trade Commission can do more than just slap your wrists: they might slap you with court injunction shutting down your business or prohibiting you from selling unapproved products.

So imagine living in the U.S. and being able to buy Pfizer Inc.’s Exubera from a pharmacy outside of America, located in a country whose drug regulators haven’t even approved the new inhaled insulin. Pretty weird, huh? Guess where you can get it:

That’s right: O, Canada! Even though Pfizer has remained tight-lipped about whether it submitted an Exubera drug approval application to Health Canada, and the country hasn’t yet approved it’s safety and availability for the public, one pharmacy in Winnipeg, Manitoba is selling the inhaled insulin, and publishing prices for the drug.

CanadaDrugs.com is already selling Exubera insulin foil blisters packets and inhalers to folks with prescriptions for the diabetes drug, even though it hasn’t been approved there. That’s a real conundrum, eh? Health Canada restricts drug advertising and sales:

Regulatory Requirements for Advertising

Only drugs that Health Canada authorizes for sale in Canada may be advertised. Specific requirements exist for advertisements of prescription drugs to consumers.

The Canadian mail-order pharmacy must be after the U.S. market for the inhaled insulin, especially since Pfizer already pushed back Exubera’s U.S. launch from July 2006 to September 2006.

CanadaDrugs.com is charging the following U.S. prices for Exubera:

• Exubera 1 mg - $ 72.18 USD (90 blisters @ $0.80 each)
• Exubera 3 mg - $178.43 USD (90 blisters @ $1.98 each)
• Exubera Inhaler Kit - $150.93 per kit
  (Each Exubera Kit includes 1 Exubera Inhaler, 1 Replacement Chamber, 1mg x 180 tablets, 3mg x 90 tablets, and 2 Exubera Release units)

Not surprisingly, the pharmacy notes that “All prescription products REQUIRE A VALID PRESCRIPTION be mailed, faxed or emailed to CanadaDrugs.com to complete your order.

How the heck can the diabetes drug be available for sale to U.S. folks by mail-order when the Canadian government hasn’t even yet approved the insulin insulin’s safety via its regulatory channels?

A corporate business consultancy, Frost & Sullivan, issued a new report detailing advancements in insulin delivery (“Diabetes Drug Delivery Methods-Market and Technologies”).

Because of this blog’s ongoing research and reporting on Pfizer’s Exubera inhaled insulin’s known and potential safety risks, we hope to review the new report in its entirety soon to examine the following conclusions by Frost & Sullivan:

• Concerns about long-term safety and efficacy of inhaled insulin exist affect the market for new diabetes drugs.
• Incidents of pulmonary fibrosis during clinical trials and the existence of side effects for diabetics are affecting inhaled insulin’s use by diabetics.
• Inhaled insulin costs may be three to five times higher than comparable injectable insulin.

Regular readers of this blog know that all of these issues have been reported on here over the last seven (7) months. We continue to research, analyze, and report on known and suspected inhaled insulin risks that diabetics and physicians have been dealing with in the U.S. and Europe, may be assessed by Canada’s drug regulatory agency.