Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical Studies of Inhaled Insulin Patients
Wednesday April 9, 8:30 am ET
SAN CARLOS, Calif., April 9, 2008 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) announced today that it has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. 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 of 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."
Nektar will cease all spending associated with its inhaled insulin programs and will not incur any additional charges related to this event.
The Exubera label was updated by Pfizer to contain the following safety information warning:
"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."
surf's up......crikey
