It’s official: Pfizer’s Exubera inhaled insulin experiment is over.

Sales of the diabetes drug were a complete failure. Some might even think of them as non-existent, considering that Pfizer paid Sanofi-Aventis $1.3 billion to acquire exclusive worldwide rights to market the insulin, yet only generated $4 million in sales for Q2 2007.  The company’s website for the drug acknowledged that “too few patients are taking Exubera.”

Pfizer CEO Jeffrey Kindler told shareholders in an October 18, 2007 company press release that, “[d]espite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted.”

It cost Pfizer a whopping $2.8 billion in pre-tax charges to stop Exubera sales, according to an SEC filing that the company made.

According to Pfizer CFO Frank D’Amelio, the drugmaker had approximately $661 million of Exubera inventory.  That’s a staggering amount of unsold insulin.

Although Pfizer’s website for Exubera emphasized that the company’s decision to stop selling the diabetes drug “was not based on any safety problems with Exubera” and that it remains “a safe and effective medicine,” that conclusion remains subject to debate among some endocrinologists and diabetics.

Here is a rather cheeky concept for an Exubera ad from blogger John S.

This concept is not likely to ever be approved by Pfizer.

Those PR people have done it again: surveyed names of the brands that many of them work on, and rate which new products have the best names.

Pfizer’s Exubera inhaled insulin took 3rd place for the most ‘consumer-friendly’ new drug name.

Top honors went to Barr Pharmaceutical’s menopause drug Enjuvia. Eli Lilly and Co.’s Reconcile anti-anxiety medication for dogs took second place..

The survey is was done by the N.Y. branding and licensing company TippingSprung.

If a new post on Cafe Pharma is really from a Pfizer, Inc. (NYSE:PFE) drug detail rep, it could spell huge problems for the drugmaker’s Exubera sales.

A June 14, 2007 post suggests that one doctor that the diabetes drug rep spoke with had a patient on Exubera experiencing a signficant decrease in lung function:

“[She] los[t] over 100 points on her pulmonary function test Peak Flow. She has shortness of breath and can’t vacuum her house without resting now. She has been through CXR, PFTs, treadmill, VQ scan, and the doc can’t find anything other than her having been on Exubera to explain her newfound shortness of breath. The doc and patient are now struggling to find what else they can do to get this shortness of breath resolved — looking at steroids and other stuff now. Plus, he was bitching because Pfizer is sending him Adverse Event Reporting forms ad nauseum!” (emphasis added).

This anectdote of Exubera respiratory problems appears to confirm the fears that many physicians and diabetics have continued to express about Exubera: namely, that the inhaled insulin will not be a great way to treat diabetes if it creates pulmonary risks for patients using the diabetes medication.

In November, 2006, this blog reported on the results of a study by Tufts researcher Dr. Lisa Ceglia that raised important questions about the drug’s long-term safety. Dr. Ceglia’s primary reluctance to prescribe Exubera was that “for the time being, the most worrisome concern is the effect inhaled insulin may have on lung function.”

On February 1, 2007, this blog reported the results of an important study which concluded that the number of diabetics who would be ineligible candidates for Exubera should double in seven years. The study’s lead author, Prof. Timothy E. Davis of Australia, was also a member of another research team that first reported finding a link between Type 2 diabetes and reduced pulmonary function in 2004. Davis has been involved in the Fremantle Diabetes Study that tracks diabetic health over extended periods of time.

This blog previoulsy reported on allegations of quality control problems with Exubera that reportedly delayed brining the insulin inhaler to market. The reports included allegations that “[Pfizer] recall[ed] the inhalers because they aren’t working right,” and that there were “[p]roblem[s] with high quality control failure in the inhaler and issues with 1 mg blisters.”

Respected money manger Bill Miller of Legg Mason (inset, left) shared his honest opinion about why he thinks Pfizer’s Exubera insulin inhaler isn’t doing so well: “it looks like a mini saxophone.”

That’s why Miller believes Mannkind Corporation’s (NASDQ:MNKD) Technosphere inhaled insulin could do much better if it passes Stage III clinical trials and then receives FDA approval:

“The MannKind product (inset, left) looks like a little asthma inhaler,” Miller said. “You pop it out, take a hit and put it back in your pocket.”

When this blog compared the size of Mannkind’s Technosphere with Pfizer’s bong-like Exubera inhaler six months ago, the difference was huge! Many believe that size really does matter when marketing pulmonary drug delivery devices.

At the American Diabetes Assocation’s Scientific Sessions starting this week, researchers will present the results of one study involving Technosphere inhaled insulin.

If Mannkind receives FDA approval for Technosphere, Pfizer would have competition for Exubera sales. Even though it currently ‘owns’ the inhaled insulin market beause it received FDA approval before anyone else, competition from another drugmaker could make things much more interesting for diabetics and their physicians.