Pfizer updates Exubera label with lung cancer warning

New York Pfizer announced today that it was updating the label on its inhaled insulin joint venture drug Exubera, according to published reports. Pfizer had marketed the drug with Nektar Therapeutics before it decided to stop marketing the drug in October of last year.

The label is being changed due to increased instances of lung cancer being discovered after reviewing clinical trial data. Pfizer found six occurrences of lung cancer in the 4,740 patients treated with the drug compared with one out of 4,292 patients who were not treated with Exubera. The label states that all of the patients who developed lung cancer had previously been cigarette smokers, but that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera.

Nektar also announced that it would stop looking for a new marketing partner for the drug and would stop all spending related to its inhaled insulin program. Back in November, Pfizer paid the company $135 million to resolve all outstanding contractual issues with Exubera and Nektar’s other inhaled insulin products, which were in phase 1 clinical trials.

Included in that deal was an agreement that if Nektar found a new partner, Pfizer would agree to transfer its remaining rights and economic benefits for Exubera and the Next Generation Inhaled Insulin product. This would have included Exubera’s new drug application and investigational new drug applications, as well as all ex-U.S. regulatory filings and applications, continuation of ongoing Exubera clinical trials and certain supply chain transition activities.

Pfizer said that it would monitor closely patients still on Exubera and help them make the transition to alternative therapies.