Increase of Lung Cancer Among Patients Using Exubera

[Barb73]

Comment: There was also a warning issued by the FDA on this subject in my morning email.

http://www.latimes.com/business/la-fiw- ... 7981.story

Article:

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Pfizer Inc. reported an increase of lung cancer among patients who used its discontinued inhaled insulin Exubera, another setback for developers of needle-free diabetes treatments.

Shares of MannKind Corp., maker of a similar product that hasn't reached the market, fell 60% after Pfizer's disclosure. Nektar Therapeutics Inc., which developed Exubera with Pfizer, fell 25% after the cancer findings led it to cancel its search for a new partner.

Exubera was the first inhaled insulin, approved in January 2006, and Pfizer gave up selling the product in October because its cost and unwieldy design made it unpopular with patients. Eli Lilly & Co., Novo Nordisk and Alkermes Inc. also abandoned experimental inhaled insulin this year, all but ending the industry's investment of more than $4 billion and a dozen years.

"Concern over cancer will not be limited to Exubera solely," William Tanner, an analyst with Leerink Swann & Co. in New York, wrote in a research report today. "We no longer think there will be a major market for inhaled insulin" because of the cancer risk and because other forms of insulin have become more convenient, he said.

Pfizer said today it updated Exubera's prescribing information to include a cancer warning after a review of clinical trial data found there were six cases of lung cancer among 4,740 patients using the drug, compared with one of 4,292 who did not take the drug. All cases were in former cigarette smokers. The lung cancer cases were twice the number as when Pfizer won regulatory approval for Exubera in January 2006, though too few cases to prove a link, Pfizer said.

Pfizer said it will make the device available for an unspecified period while patients switch to other forms of insulin. There were 2,438 prescriptions written for Exubera in February, according to data research firm Wolters Kluwers.

When Pfizer scrapped Exubera last year, it returned the rights to the drug's developer, Nektar Therapeutics. In a separate statement today, Nektar, of San Carlos, Calif., said it ended negotiations with potential partners for the product.

Nektar fell $1.80, or 25%, to $5.39. MannKind, of Valencia, Calif., fell $2.35, or 60%, to $2.35.

MannKind has lost 84% of its value in the past 12 months as bigger drugmakers quit inhaled insulin. The company said last month it plans to file an application late this year for U.S. clearance of its Technosphere insulin inhaler. The product is in the third and final round of human tests needed to support marketing approval. Three analysts, including Tanner, downgraded MannKind today.

Nektar will now focus on other products, including treatments for colorectal cancer, cystic fibrosis and hospital acquired pneumonia, Chief Executive Howard Robin saidt.

Exubera labeling already warned of a possible risk to the lungs from studies that showed it decreased lung function. Pfizer expected $1 billion in annual sales when the product went on sale in January 2006. The company wrote off $2.8 billion last year to abandon the drug.

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(Los Angeles Times, Bloomberg News, April 9, 2008)

Disclaimer:

The information contained in these articles may or may not be in agreement with my own opinions. They are not posted as medical advice of any kind.