MannKind is absolutely committed to the continued development of its leaddevelopment product, Technosphere(R) Insulin. We use our small,patient-friendly Medtone(R) inhaler to deliver Technosphere(R) Insulin topatients with diabetes in a way that much more closely matches the pattern ofinsulin secretion seen in people without disease. MannKind believes that theresulting efficacy and safety profile is unique and clearly differentiatedfrom all existing diabetes treatments. To achieve normal glucose control, itis necessary to independently address both mealtime and fasting glucose. Webelieve Technosphere(R) Insulin is the only therapy that separately andindependently lowers prandial glucose excursions, and that it will thus offeran important benefit to many patients with this devastating disease.
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MannKind recognizes that in order to be successful in today's health caremarket a product must offer improved efficacy and safety, not just improvedconvenience. The decisions of Eli Lilly and Company as well as Pfizer and NovoNordisk to discontinue the development of their inhaled insulin productsreinforce this view. None of those products offer any advantages overinjectable rapid acting insulin analogs.
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By contrast, in clinical trials to date, Technosphere(R) Insulin has shownimportant advantages over the treatment that is presently considered to be themost effective meal-time therapy for patients -- rapid-acting insulin analogs.Specifically, Technosphere(R) Insulin has demonstrated:
Even with these advantages over existing insulin therapy, MannKindunderstands that physicians and regulatory agencies are cautious about a newroute of administration. For this reason, MannKind is conducting a veryrobust clinical trial program involving more than 5,000 patients withdiabetes, which it determined is consistent with the FDA's recently releasedguidance for the development of drugs to treat diabetes. As part of thisprogram, a 2,050-patient, two-year pulmonary safety trial will conclude laterthis year; this trial was recently recognized by the American Association ofRespiratory Care as setting new quality standards in the conduct of clinicalstudies. In the interim, all of MannKind's clinical trials are monitored byan independent data safety monitoring board that meets at regular intervals toreview safety data. To date, the data safety monitoring board has fullyendorsed continuation of the trials as planned.
MannKind has also undertaken a more comprehensive examination of thetoxicology profile of Technosphere(R) Insulin than has been reported for anyother inhaled insulin. Last year, MannKind completed a two-yearcarcinogenicity study in rats in which Technosphere(R) Insulin, and largedoses of Technosphere(R) particles alone, were well tolerated after dailyinhalations for 104 consecutive weeks. There were no indications in thesestudies that either Technosphere(R) Insulin or Technosphere(R) particles alonehad any carcinogenic potential or caused any cellular proliferation in thelungs. MannKind also recently completed a six-month carcinogenicity study intransgenic mice, finding no macroscopic indications of carcinogenicity inanimals given daily subcutaneous injections of Technosphere(R) Insulin orTechnosphere(R) particles for 26 consecutive weeks. In addition, MannKindplans to submit data from over 100 preclinical studies supporting the safetyof our product, the vast majority of which have already been completed.
The pharmacokinetic profile of Technosphere(R) Insulin sets it apart fromall other insulin products. The large surface area of the lung provides uniqueaccess to the circulatory system, but the sugar-based carriers used by otherssimply cannot convey insulin to the bloodstream any faster than that ac
