Pfizer Cancels Its New Diabetes Inhaled Insulin Drug, Exubera

The dreams of many insulin dependent diabetics were destroyed, as Pfizer pulled its new inhaled diabetes drug, Exubera, from the market on October 18, 2007. Pfizer, the world's largest drug company, promoted the new drug widely, but was unable to boost sales, despite a $2.8 billion investment associated with the drug. It was promoted as a painless way to administer insulin to diabetics, who were currently using injections. The shots would not be eradicated completely, but the number of shots would be reduced.

Doctors and patients were not accepting of the awkward and inconvenient Exubera inhaler. Patients found it more complicated to use than insulin injections. Prescriptions for the new drug resulted in less than 1% of the insulin market. The New York Times called the fiasco "one of the most expensive failures in the history of the pharmaceutical industry." Pfizer had predicted that the new drug would be a "blockbuster." Sales suffered due to inconvenience, safety concerns, questions about the drug's effectiveness, and high cost. Because the drug caused "marginal breathing ability problems" in clinical testing, all patients taking Exubera were required to have a lung capacity test before being prescribed the drug, and an additional lung function test 6 months later. This was a deterrent to both doctors and patients, and also caused a concern about the daily amount of insulin that would be consumed, due to fluctuating lung function. Insulin must be delivered accurately in order to avoid hypoglycemia (low blood sugar) which can lead to diabetic coma, or hyperglycemia (excessively high blood sugar) which can cause organ damage and many other complications. The inhaler was also bulky and burdensome. (Diabetic insulin needles have become much smaller over the years, resulting in less painful injections, and have always delivered a precisely measured dose of insulin.)

Because of the high costs of the drug, compared to injectable insulin, and the necessary lung function testing, insurance companies were hesitant to pay for Exubera, which did not control blood sugar any better than ordinary insulin shots. Exubera costs almost twice as much as injectable insulin.

Nektar Therapeutics, the developer of Exubera, blamed the disappointing sales on poor marketing techniques by Pfizer. They say the drug was not manufactured quickly enough, after being approved by the U. S. Food and Drug Administration. As a result, the advertising campaign was delayed as well. The initial designated sales team had little knowledge of diabetes, or the medical devices associated with it, and were consequently unable to sell doctors on the advantages of the inhaler.

Other companies, including Eli Lilly, are also working on the development of inhaled insulin drugs, but will probably be dealing with the same concerns. Pfizer does not plan on releasing a replacement for Exubera, according to The New York Times article.

According to Exubera's web site, the decision was not due to safety concerns or negative feedback, but because too few patients were taking the drug. Pfizer called the drug "safe and effective." Exubera will be available for the next 3 months, until patients and doctors can make a smooth transition to another form of blood sugar control.

Sources: http://www.nytimes.com/2007/10/19/business/19pfizer.html?_r=2&oref=slogin&oref=slogin
http://www.exubera.com/content/con_index.jsp?setShowOn=../content/con_index.jsp&setShowHighlightOn=../content/con_index.jsp
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