Healthcare Industry News:  inhaled insulin 

Biopharmaceuticals Endocrinology

 News Release - September 14, 2006

MannKind Corporation Completes Patient Enrollment for the Major Phase 3 Safety Study of Technosphere(R) Insulin in Patients With Diabetes

VALENCIA, Calif., Sept. 14 (HSMN NewsFeed) -- MannKind Corporation (Nasdaq: MNKD ) today announced the completion of patient enrollment in the pivotal long-term safety study of Technosphere® Insulin, an investigational inhaled insulin formulation delivered via the Company's proprietary inhaler to patients with diabetes mellitus. Over 1,800 subjects have been enrolled in this open-label, randomized, prospective study, which will evaluate the pulmonary safety of Technosphere® Insulin in patients with type 1 and type 2 diabetes as well as a subgroup of individuals without diabetes. This study is the first pivotal study to complete enrollment and is part of a comprehensive Phase 3 clinical program for which the additional pivotal studies, of shorter duration, are now all actively recruiting at centers in the United States, Europe and Latin America.

Dr. Peter Richardson, Chief Scientific Officer of MannKind, commented, "We are delighted to have completed enrollment in this Phase 3 study, which is a milestone toward the New Drug Application for Technosphere® Insulin. Our previous studies on Technosphere® Insulin have shown no adverse effects on lung function. We are hopeful that these results will continue for the duration of our long term trial. Clinical results to date have also shown reduced post-prandial glucose excursions and no weight gain. Collectively, these data demonstrate a potential advantage of Technosphere® Insulin over established insulin therapies."

"This successful recruitment of patients represents a major achievement for the development of Technosphere® Insulin, and demonstrates our ability to execute a comprehensive clinical program," stated Alfred Mann, Chairman of the Board and Chief Executive Officer of MannKind.

About Clinical Research

Large-scale Phase 3 clinical trials are conducted during the final phase of the development of a new therapeutic agent prior to the evaluation by regulatory authorities of its safety and efficacy.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD ) focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. Its lead investigational product candidate, the Technosphere® Insulin System, is currently in Phase 3 clinical trials in the U.S., Europe and Latin America to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to MannKind's clinical trials and product candidates that involve risks and uncertainties. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the Company's current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the progress, timing and results of clinical trials, the risk that future safety and efficacy studies may not confirm our past clinical results, intellectual property matters, difficulties or delays in seeking or obtaining regulatory approval, manufacturing the Company's lead product candidate, competition from other pharmaceutical or biotechnology companies, the Company's ability to enter into any collaborations or strategic partnerships or obtain additional financing to support the Company's operations, the Company's ability to meet milestones and other risks detailed in MannKind's filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2005 and periodic reports on Form 10-Q and Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this news release.

Source: MannKind

Issuer of this News Release is solely responsible for its content.
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