The inhaled insulin field got blitzed again today after Nektar Therapeutics and Pfizer reported an increased number of lung cancer cases among patients taking the therapy during clinical trials. Nektar swiftly dumped its effort to find a new marketing partner--Pfizer had already announced its plans to pull out--and saw its stock plunge 30 percent. Even harder hit was Mannkind, which is developing its own inhaled insulin. Its stock went into free fall, losing 60 percent of its value as investors applied some dour logic from Nektar's failure to the whole area of drug development. Looking over trial data, researchers noted that six of 4,740 patients taking Exubera developed lung cancer compared to one in the control arm. Those figures were too small to reach a statistically valid conclusion whether the drug caused the cancer, and all patients were known smokers and therefore already in a high risk category. A warning on the cancer risk will be put on Exubera labels.
The cancer warning creates yet another black eye for the prospects of inhaled insulin. Once upon a time inhaled insulin was seen as a likely garden of blockbuster therapies. But that has turned around fast, as major drug developers wash their hands of pacts and go on to other programs. Exubera was once thought to be worth more than $2 billion a year, but sales have fallen far, far short of that mark.
"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials. We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies. Physicians should seek alternate treatment options to maintain patients' glycemic control," said Joe Feczko, MD, Pfizer's chief medical officer.
- see Nektar's release
- read the report in the Wall Street Journal
Related Articles:
Pfizer gives Nektar $135M for Exubera settlement
Pfizer kills off Exubera, hunts for deals
Exubera becoming a big disappointment for Pfizer
UK: Exubera not worth the price.
MannKind bets the farm on inhaled insulin