MannKind Addresses Pfizer's Announcement Regardi... ( VALENCIA Calif. April 10 /- MannK...)

MannKind Addresses Pfizer's Announcement Regarding Exubera

Date:4/10/2008

VALENCIA, Calif., April 10 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD) released the following statement in response to the announcement by Pfizer Inc. that over the course of Exubera's clinical trial program, 6 of the 4,740 patients treated with Exubera developed lung cancer, although Pfizer concluded that there were too few cases to determine whether this observation was related to Exubera. According to Pfizer's "Dear Doctor" letter, Exubera remains a safe and effective medication. It is important to note that each of the patients affected had a history of cigarette smoking, a known, major risk factor for lung cancer. Although the sugar-based Exubera formulation did have a small but statistically significant impact on pulmonary function, we are not aware of any specific carcinogenicity studies of Exubera to evaluate the potential of cancer risk.

In contrast, the safety profile of Technosphere(R) Insulin has been examined in an extensive pre-clinical program, including a two-year carcinogenicity study in rats, in which we observed that Technosphere(R) Insulin and Technosphere(R) particles alone were well tolerated after daily inhalations for 104 consecutive weeks. There were no indications that our product or the carrier material alone had carcinogenic potential or caused cellular proliferation in the lungs. We also recently completed a six-month carcinogenicity study in transgenic mice that are prone to cancer. We found no macroscopic indications of carcinogenicity in animals treated with Technosphere(R) Insulin or Technosphere(R) particles for 26 consecutive weeks. The analysis of the histology data is in progress and will be completed later this quarter.

Our Technosphere(R) Insulin clinical program is de
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MannKind Addresses Pfizer's Announcement Regardi...( VALENCIA Calif. April 10 /- MannK...),Health