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MannKind Initiates U.S. Pivotal Phase 3 Study of Inhaled Technosphere(R) Insulin

Two-Year Study to Focus on Pulmonary Safety in Patients With Type 1 and Type 2 Diabetes

VALENCIA, Calif., June 29 /PRNewswire-FirstCall/ -- MannKind Corporation (Nasdaq: MNKD), focused on discovering, developing and commercializing treatments for diabetes and cancer, today announced that it has initiated patient enrollment in its pivotal phase 3 safety trial of inhaled Technosphere(R) Insulin (TI) in the United States. The open-label, randomized, prospective study will evaluate the pulmonary safety of TI in patients with type 1 and type 2 diabetes. This is the second phase 3 clinical trial of inhaled Technosphere(R) Insulin following the commencement of MannKind's initial phase 3 efficacy study in Europe in late 2004.

"Our pharmacokinetic studies have shown that Technosphere Insulin is rapidly absorbed into the bloodstream, mimicking the first phase insulin release that has been lost in all patients with diabetes. This approximation of the first phase release significantly improves glucose control without increasing the risk of hypoglycemia. Earlier this month MannKind presented data at the American Diabetes Association Scientific Sessions from a recently completed phase 2b study, showing significant reductions in HbA1c levels over a three-month period with no increase in the risk of hypoglycemia. We hope to obtain further confirmation of these findings in our phase 3 studies, moving this important new treatment for diabetes closer to commercialization," said Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation.

In addition to the initiation of the pivotal phase 3 safety trial, the Company is in the process of scaling up its manufacturing facilities in anticipation of regulatory filings and commercialization. With the current clinical package, the Company's data demonstrates that Technosphere Insulin is stable for at least 18 months under refrigerated conditions and for at least two months at room temperature, which is equivalent to or surpasses commercially available insulin products.

About Technosphere Insulin

The MannKind inhaled insulin delivery system consists of a proprietary dry powder Technosphere(R) formulation of insulin that is inhaled into the deep lung using MannKind Corporation's proprietary MedTone(R) inhaler, which utilizes single-use, disposable, plastic cartridges containing Technosphere(R) Insulin powder. The inhaler is light, easy to use, and fits in the palm of the patient's hand, which is believed to facilitate patient compliance. The Company believes that the combination of Technosphere(R) Insulin's unique performance characteristics including the rapid transfer of the insulin into the blood and the significantly higher bioavailability, along with the convenience and ease of use of the MedTone(R) inhaler, may have the potential to change the way diabetes is treated. In particular, the Technosphere(R) Insulin System may be the only product under development that produces a profile of insulin levels in the bloodstream that approximates the natural first-phase insulin release spike normally seen in healthy individuals following the beginning of a meal.

About MannKind Corporation

MannKind (Nasdaq: MNKD) focuses on the discovery, development and commercialization of therapeutic products for diseases such as diabetes and cancer. The Company is currently in phase 3 clinical trials of its lead product, the Technosphere(R) Insulin System, in the US and Europe to study its potential for the treatment of diabetes. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com.

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, 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, 2004 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.

Company Contact:
Hakan Edstrom
President and Chief Operating Officer
661-775-5360
hedstrom@mannkindcorp.com

SOURCE MannKind Corporation
06/29/2005
CONTACT: Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation, +1-661-775-5360, hedstrom@mannkindcorp.com
Web site: http://www.mannkindcorp.com



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