SAN CARLOS, Calif.—Pfizer Inc. said Wednesday it is warning patients using its inhaled insulin product Exubera about the risk of lung cancer, leading Nektar Therapeutics to terminate its inhaled insulin programs.
Nektar had been Pfizer's partner on Exubera from 1995 until Pfizer discontinued the drug in October 2007 after lackluster sales. Some patients continue to take the drug, however, including some enrolled in extended transition programs or clinical trials.
On Wednesday, Pfizer said it updated the U.S. product labeling for Exubera Inhalation Powder to include a warning about lung cancer cases observed in patients who used the inhaled insulin treatment.
Over the course of Exubera's clinical trial program, 6 of the 4,740 patients treated with Exubera developed lung cancer, compared with 1 of the 4,292 patients not treated with the drug.
There was also a post-marketing report of lung cancer in one Exubera-treated patient.
The label notes that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the cancer is related to use of Exubera.
Pfizer said the data was reviewed by the company and the Food and Drug Administration.
Nektar said it will stop all spending associated with its inhaled insulin programs and will not incur any additional charges related to the action.
"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said Howard W. Robin, president and chief executive of Nektar, in a statement. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin."
