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Apr 9, 2008

Updated Exubera Label Warning of Lung Cancer Cases Triggers Nektar to Quit Search for Partner

  • Data showing an increase in lung cancer cases in people using marketed inhaled insulin product, Exubera, spells more bad news for partners Pfizer and Nektar Therapeutics. Pfizer has been forced to update the label information for Exubera. Nektar, which has been looking for a commercialization partner since Pfizer washed its hands of marketing the treatment, has now decided to nix these efforts.

    Nektar’s stock plummeted by about 39% to open trading at $5.17. The firm says that it will cease all spending associated with the inhaled insulin program and will not incur any additional charges related to this event.

    Mannkind, another company with an inhaled insulin treatment in Phase III, found its value slumped by over 50% to open the day at $2.90. Leerink Swan downgraded the stock from Market Perform to Outperform based on the Exubera news. Leerink Swann reports that it doesn’t expect the company to be able to attract a partner and that there is a possibility that a clinical hold will be placed on the current late-stage study.

    Pfizer has been conducting a review of data from the Exubera development program and a postmarketing study. Over the course of the clinical trials, six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not taking Exubera developed lung cancer. Additionally, the postmarketing evaluation reports one lung cancer case for an Exubera-treated patient.

    Pfizer has updated the label to reflect this information. The new label also states that all patients who developed lung cancer had a history of cigarette smoking and that there were too few cases to determine whether the development of lung cancer is related to the use of Exubera.

    In October 2007, Pfizer said that it would stop marketing Exubera because sales were less than expected; the company had anticipated that the treatment would bring in around $2 billion in sales. 

    Since Pfizer's decision last year, Novo Nordisk and Eli Lilly also terminated their inhaled insulin development programs.



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