Pfizer Exits Exubera and Takes $2.8-Billion Charge

New York (Oct. 18)-Pfizer decided to stop investing in “Exubera” (inhaled insulin), a product that had been considered a potential blockbuster drug. After it made the decision to halt its participation with the product, Pfizer reported a pretax charge of $2.8 billion for the third quarter.

“Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians,” said Jeff Kindler, chairman and CEO of Pfizer, in a company release. “We have therefore concluded that further investment in this product is unwarranted.”

The Exubera pretax charges of $2.8 billion relate primarily to the write-off of assets associated with the product and the accrual of other exit costs. The exit costs include $1.1 billion of intangible assets, $661 million of inventory, $454 million of fixed assets, and $584 million of other exit costs.

Pfizer says it will work with physicians during the next three months to transition Exubera patients to other treatment options. Despite the problems with the product, Pfizer says it will continue to evaluate inhalation technologies. “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,” said Kindler.

Nick Karachalias, cardiovascular lead analyst with Datamonitor (London) points to several problems with the product, including a cumbersome delivery device and potential clinical concerns about the risk of long-term lung damage and carcinogenicity. These factors seemed to outweigh the proposed convenience advantage and potential increase in patient compliance.

“The fact that Exubera was in essence a repackaged form of insulin, only offering a suggested convenience advantage rather than it being a truly novel treatment, made it unappealing to healthcare providers, who viewed the unmet medical need for inhaled insulin as nonexistent and thus either refused to recommend it (UK and Germany) or offered reimbursement at a higher tier than most injected insulin (US),” said Karachalias in a Datamonitor release.

Exubera was approved in 2006 to treat Type I and Type II diabetes. In 2006, Pfizer paid Sanofi-Aventis (Paris) $1.4 billion for the rights to Exubera and insulin production plants in Germany. Exubera was developed by Nektar Therapeutics (San Carlos, CA), which said it was evaluating its options with the product.

“Nektar has been very disappointed in Pfizer’s performance in marketing Exubera,” said Howard W. Robin, president and CEO of Nektar Therapeutics, in a company release. “Pfizer has publicly acknowledged its organizational difficulties and resulting poor performance in launching Exubera …. We are evaluating all of our options with respect to Pfizer’s Exubera announcement to protect the interests of Nektar. We continue to believe Exubera is an important advancement for diabetic patients.”

Implications for other antidiabetes drugs

The withdrawal of Exubera will force developers of second-generation inhaled insulins, such as Novo Nordisk (Bagsvaerd, Denmark), Eli Lilly (Indianapolis, IN), and MannKind (Valencia, CA), to assess the viability of their products, said Karachalias. “It has now become clear that true convenience in the form of a discrete portable device is required in order to win over patients, and a true therapeutic advantage compared to traditionally administered insulin needs to be proven to secure reimbursement,” he said in a company release.

The future of inhaled insulin will also be influenced by the acceptance of new classes of antidiabetic drugs. The new classes include GLP-1 agonists such as “Byetta” (exenatide) by Amylin Pharmaceuticals (San Diego) and dipeptidyl peptidase IV inhibitors such as “Januvia” (sitagliptin) by Merck & Co. (Whitehouse Station, NJ), said Karachalias.

See our poll on the future of inhalation delivery here.