In a startling revelation, the San Jose Mercury News revealed today that Nektar CEO Howard Robin told financial analysts that Exubera “is not strategically relevant to the future success of” the company.
Some analysts have called Exubera “a spectacular flop,” and that more than a few diabetes doctors are hesitant to prescribe the drug.

“I see it as my job to talk people out of (using) it,”  Dr. John Buse (inset, left), the president-elect of the American Diabetes Association (’ADA’) told one New Jersey newspaper.

Buse is on a mission: to convince diabetics that Exubera is not worth the inhaled insulin’s potential safety risks.

Dr Ahmed El Hakim, the Senior Manager of Pfizer’s (NYSE:PFE) Middle East Arab Group, recently defended the drug company’s lackluster worldwide Exubera inhaled insulin sales.

Downplaying the diabetes drug’s widely known poor worldwide launch, El Hakim explained to ArabianBusiness.com that “this is the price you pay as an innovator - the concept [of using inhaled insulin] has not yet been established, and while we are now establishing the concept of using this convenient therapy, sales have not been up to the expectations of many people.”

A study published in the World Health Organization’s journal, the Eastern Mediterranean Health Journal, concluded that diabetes was a growing problem in Saudi Arabia, citing the following factors:

• A high prevalence of obesity;
• A diet rich in carbohydrates (e.g., bread, dates, sugar, and potatoes);
• Lack of exercise; and
• Genetic factors

At the time the study was reported in 1998, it found that there was more than a 300% increase in Type 2 diabetics older than 30 in Central Saudi Arabia, from 6% in 1982 to more than 18.22% in 1998.  Pfizer’s El Hakim told a reporter that the country’s now approximately 25% of Saudis are diabetics.
That’s a huge potential market for the pharmaceutical company’s diabetes and cardiovascular drugs.

According to Michael Krensavage, a pharmaceutical equity analyst at Raymond James Financial, Inc. (NYSE:RJF), the launch of Exubera inhaled insulin for diabetics “has been one of the most spectular flops in the pharmaceutical industry.”

Krensavage made this analysis when interviewed about Pfizer, Inc.’s (NYSE:PFE) difficulty in launching and maintaining profitable new drugs in a highly competitive market.  “No matter how you look at it,” Krensavage concluded, Pfizer’s drug research and development efforts have yielded “a disappointing pipeline.”
Pfizer’s 8K report to shareholders disclosed Exubera’s continued market failure. “Sales of Exubera continue to be disappointing, with $4 million of worldwide revenues in the second quarter of 2007.”
Generating only $4 million in revenue on a diabetes drug for which Pfizer paid Sanofi-Aventis $1.3 billion in January 2006 is an abysmal failure, there may still be a silver-lining for diabetics.

By sticking to proven diabetes medications that do not have unknown pulmonary and related risks for diabetics that are the subject of long-term FDA-mandated drug safety studies (as a condition of the drug’s approval), endocrinologists appear likely to give their patients trusted choices for managing their care.

Even given reported the Avandia heart attack risks for Type 2 diabetics, Pfizer doesn’t seem to have convinced endocrinologists that Exubera is a better diabetes drug.

Spain’s National Health System decided to fund the cost of Exubera insulin inhalers for diabetics.

Patients will pay no more than 3€ for the Pfizer inhaled insulin, and a new report says that pharmacies in Spain now have the drug in stock.

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.”