Pfizer Ditches Inhaled Insulin Drug after Lung Cancer Cases Rise

By Anastacia Mott Austin

It was a bad week for Pfizer and its partner Nektar Therapeutics, as well as any other companies considering marketing an inhaled form of insulin.

Pfizer and Nektar announced this week that in clinical trials of the inhaled insulin drug Exubera, a higher number of those taking the drug developed lung cancer. The news effectively squashed Nektar’s hopes of finding a new partner, as Pfizer had abandoned the product late last year due to poor public reception.

Nektar also announced its plan to abandon the trials of Exubera and another form of inhaled insulin which was in early testing.

Exubera was developed as an alternative means of administering insulin for blood sugar control in diabetics. While interest was initially high in a product that held promise for avoiding needle sticks, consumer interest fell last year due to concerns about lung risk and the fact that the inhaling device was unwieldy to use.

In trials comparing two groups of over 4,000 patients (4,470 taking Exubera, 4,292 not taking the drug), six people in the Exubera group developed lung cancer, as opposed to one in the other group.

While the numbers are low, clinical health experts say the difference is still statistically significant. The researchers were careful to note that all of the lung cancer cases developed in patients who were smokers or who had previously smoked. Still, the risk remains high enough that Pfizer was compelled to make note of it on the label.

The news not only puts the kibosh on Exubera, but essentially killed several other inhaled insulin products in the works.

Suffering possibly the worst blow was Mannkind, which had been in the middle of testing its own version of inhaled insulin, Technosphere. Though other companies, such as Eli-Lilly and Novo Nordisk, had withdrawn their own similar projects last year after Pfizer ended its participation with Exubera, Mannkind had remained determined to continue plans for Technosphere.

That appears to have ended, as experts claim that now Mannkind will have virtually no chance of securing FDA approval now for Technosphere. "We view this as an absolute disaster for MannKind and do not see a believable scenario in which the FDA would approve another inhaled insulin," said marketing analyst Jon LeCroy.

Stocks for Nektar dove this week, down nearly 30% in Wednesday’s trading. Pfizer and Mannkind also took unfavorable hits.