Nektar terminates negotiations for Inhaled Insulin after adverse reports

As a latest setback to the already faltering industry efforts to develop inhalable insulin, Nektar Therapeutics said it has ceased all negotiations with potential partners for its inhaled insulin programmes as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. Nektar would also cease all spending associated with its inhaled insulin programmes and would not incur any additional charges related to this event.

An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group, according to a Pfizer report. All new incidences of lung cancer were in patients that are former smokers.

"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 CEO, Nektar. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin. We have made great progress expanding our research efforts and have built a deep pipeline of novel partnered and proprietary drugs in various stages of development."

The Exubera label was updated by Pfizer to include the new warnings. In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking, according to a press release issued by Nektar.