Healthcare Industry News: Integrated BioPharma
News Release - March 6, 2006
MannKind Initiates Two U.S. Pivotal Phase 3 Studies of Inhaled Technosphere(R) InsulinVALENCIA, Calif., March 6 (HSMN NewsFeed) -- MannKind Corporation (Nasdaq: MNKD ), an Integrated BioPharmaceutical company focused on discovering, developing and commercializing treatments for diabetes and cancer, today announced that it has initiated patient enrollment in two pivotal 12-month Phase 3 clinical trials of Technosphere Insulin (TI) in patients with Type 1 and Type 2 Diabetes. The main objective of these studies is to evaluate the efficacy of TI by assessing changes both in HbA1c levels as well as in blood glucose levels after a standardized meal.
The first of these new trials, Study 009, is a 12-month Phase 3 efficacy study in 500 Type 1 patients. In this study, TI will be compared to subcutaneous injections of a rapid acting insulin analog; patients in both arms of this study will also receive a basal insulin regimen.
The second of these trials, Study 102, was the subject of a special protocol assessment by the FDA in the fall of 2005. This trial will compare TI plus basal insulin to subcutaneous injections of premixed insulin (including a rapid-acting insulin analog) over a 12-month period in 500 Type 2 diabetes patients.
"We are confident that these two new studies will further confirm the safety and efficacy that we have seen to date. Our prior studies have shown improved glycemic control in a dose-dependent manner as measured by decreases in HbA1c levels, and by significant reductions in glucose excursions following a meal. We intend to share results from two additional completed studies: Study 101 (a 3-month Phase 3 study in patients with Type 1 diabetes) and Study 014 (a six-month Phase 3 study in patients with Type 2 diabetes) in the coming months," said Peter Richardson, Chief Scientific Officer of MannKind Corporation.
Alfred Mann, Chairman and Chief Executive Officer, added: "With these latest trial initiations, we have begun all but one of our pivotal trials for US approval of Technosphere Insulin. The last remaining major trial, Study 103, is scheduled to begin sometime this summer. We also plan to initiate a number of additional studies intended to further show the advantages of Technosphere Insulin over other treatment regimens."
The Company will discuss the initiation of these new pivotal studies in further detail during its presentation at the Cowen & Co. 26th Annual Health Care Conference. Interested parties can access a link to the replay of the presentation in the Investor Relations section of the Company's website at www.mannkindcorp.com. The replay will be available for 14 days.
About Technosphere Insulin
The MannKind inhaled insulin delivery system consists of a proprietary dry powder TechnosphereŽ formulation of insulin that is inhaled into the deep lung using MannKind Corporation's proprietary MedToneŽ inhaler, which utilizes single-use, disposable, plastic cartridges containing TechnosphereŽ Insulin powder. The inhaler is light, easy to use, and fits in the palm of the patient's hand, which is believed will facilitate patient compliance. The Company believes that the combination of TechnosphereŽ 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 MedToneŽ inhaler, may have the potential to change the way diabetes is treated. In particular, the TechnosphereŽ Insulin System may be the only product under development that produces a profile of insulin levels in the bloodstream that approximates the natural rapid, early insulin release normally seen in healthy individuals following the beginning of a meal.
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 TechnosphereŽ Insulin System, is currently in phase 3 clinical trials in the U.S. and Europe to study its safety and efficacy in the treatment of diabetes. For more information on MannKind Corporation and its technology, visit www.mannkindcorp.com.
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