Citing Lack of Acceptance, Pfizer Pulls Plug on Inhaled Insulin

NEW YORK, Oct. 18 -- Pfizer has decided to end the marketing of Exubera, its inhaled insulin for type 1 diabetes, phasing it out over the next three months.
Jeff Kindler, chairman and chief executive officer of Pfizer, said "we made an important decision regarding Exubera, a product for which we initially had high expectations. Despite 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."
Kindler said the company would work with physicians to "transition Exubera patients to other treatment options in the next three months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines."
The announcement came in the company's third quarter report, which revealed third quarter revenues of $12 billion, a 2% decline from the third quarter of 2007.
The company's third quarter net income was $761 a decrease of 77% form the same period last year, "primarily reflecting pre-tax charges of $2.8 billion related to the decision to exit Exubera," the company said.
The inhaled insulin was approved less than two years ago, but that approval followed a long and rocky development process.
Although clinical trials had demonstrated Exubera to have efficacy similar to that of short-acting insulins, but without the needle stick, a host of concerns had cropped up, including worries about pulmonary toxicities, and questions about Exubera's ability to achieve a reduction in glycosylated hemoglobin (HbA1c) levels to below 7%, the accepted gold standard.
Over the years, the developmental challenge had been to reduce insulin to particles of just the right size to be inhaled by the lung and then absorbed into the bloodstream. Too small, and the particles would be exhaled. Too large, and the particles would be filtered out.
In its approval statement, the FDA noted that the safety and efficacy of Exubera have been studied in approximately 2,500 adult patients with type 1 and type 2 diabetes.