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MannKind (MNKD) Issues Statement On Pfizer's Exubera News

April 10, 2008 9:11 AM EDT
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 designed to provide data on safety and efficacy in a broad group of patients with diabetes. We have not observed a higher incidence of lung cancer in Technosphere(R) Insulin patients than that expected in the general population. Our independent Data Safety Monitoring Board (DSMB) regularly reviews all potential safety issues with our clinical trials and has consistently recommended that the trials continue without changes. Given Pfizer's announcement, the DSMB met again yesterday and found that on the basis of the current information our trials could continue.

Ensuring patient safety is always our primary concern. To date with our product, we have seen no adverse effects on the measures of pulmonary function that have been reported to occur with Exubera. We are working closely with the DSMB and regulatory agencies in order to understand the implications of the Exubera data.

Additionally, given the current market sentiment, we have decided to suspend partnership discussions. At this time, we believe that we will be unable to achieve an appropriate valuation for Technosphere Insulin until Phase 3 data are available that confirm our belief in the safety and efficacy of Technosphere Insulin.

NOTE: MannKind sank 60% yesterday on the news.

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