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Exubera Runs Into More Woes - Wall St Jnl
  Wall St Jnl
April 10, 2008; Page D2
The once-promising concept of inhaled insulin is now all but dead.
Pfizer Inc. said Wednesday that during clinical trials six diabetics taking its inhaled insulin, Exubera, developed lung cancer, compared with one case of the malignancy among patients not using Exubera.
The New York drug maker already had announced in October that it would take a $2.8 billion charge to stop marketing the medicine, citing lackluster demand. Executives originally estimated that this novel alternative to injecting insulin could be a $2-billion-a-year business.
Exubera has remained available while doctors transitioned patients to new therapies and Pfizer's partner, Nektar Therapeutics of San Carlos, Calif., sought a new marketing partner. About 1,200 patients were in transition and 2,800 remained in clinical trials. Nektar now has decided to shelve its plans to find a new partner, and Pfizer is ceasing shipments of the inhaler and will stop manufacturing it.
Other companies that invested in inhaled insulin have dropped out one by one, after Exubera's disappointing sales showed that diabetics were reluctant to use cumbersome devices in place of sleek needles. Eli Lilly & Co. abandoned a partnership with Alkermes Inc. last month. Another company, MannKind Corp., is continuing to develop its inhaled insulin, but the cancer news sent its stock down Wednesday 60%, or $3.50, to $2.35, in 4 p.m. Nasdaq Stock Market composite trading.
All the patients who developed lung cancer had a history of smoking, and Pfizer said the numbers are too small to determine whether there is a causal link between the disease and the medicine.
The cancer concern is likely to seriously limit inhaled insulin's prospects, and could cast a pall over future efforts to use inhalers for other medicines. "You say the word 'cancer' and it's enough to scare the specialists, so it's going to be an uphill battle for anyone remaining," said Aileen Salares, a Leerink Swann biotechnology analyst. Jami Rubin, a Morgan Stanley drug-industry analyst, declared inhaled insulin dead.
MannKind remains committed to inhaled insulin, saying its version poses less danger because it passes more quickly through the lungs and has shown no lung-cancer link. The Valencia, Calif., company is studying the implications of the Exubera situation and is in contact with its data-safety monitors and the Food and Drug Administration. "We need time to look at what the Pfizer announcement really means," said Richard Anderson, MannKind's chief financial officer.
Pfizer knew about three of the six clinical-trial cases when it made its case for Exubera's approval before an FDA advisory board in September 2005. It also knew about the lone case in the studies' control group, and presented that data to the FDA. The 3-to-1 ratio wasn't unusual, said Neville Jackson, the Exubera development-team leader at Pfizer. "None of us was concerned," he said.
The FDA didn't note the cancer cases in the product label when it approved Exubera in early 2006, because they weren't statistically meaningful and reflected a common problem in smokers, said agency spokeswoman Susan Cruzan. The FDA recently requested that Pfizer update the product's label because the reports were increasing and crossed a "threshold," Ms. Cruzan said, "where even though it's not statistically significant, people should have that information."
Dr. Jackson said Pfizer learned about the additional cases in late November or early December of last year , and its decision in October to abandon the product had nothing to do with safety.
Concerns about inhaled insulin's effects on lung function have been well known and stalled the approval of Exubera for years. But the cancer link surprised doctors and analysts. Some doctors had speculated that putting a protein such as insulin into the lungs could cause abnormal cells to grow, said Jay Skyler, associate director of the University of Miami's Diabetes Research Institute, who has consulted for all the major companies involved in inhaled insulin research. But, he said, "Most of us discounted it. I never thought cancer was a serious risk."
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