MannKind has also undertaken a more comprehensive examination of the toxicology profile of Technosphere(R) Insulin than has been reported for any other inhaled insulin. Last year, MannKind completed a two-year carcinogenicity study in rats in which Technosphere(R) Insulin, and large doses of Technosphere(R) particles alone, were well tolerated after daily inhalations for 104 consecutive weeks. There were no indications in these studies that either Technosphere(R) Insulin or Technosphere(R) particles alone had any carcinogenic potential or caused any cellular proliferation in the lungs. MannKind also recently completed a six-month carcinogenicity study in transgenic mice, finding no macroscopic indications of carcinogenicity in animals given daily subcutaneous injections of Technosphere(R) Insulin or Technosphere(R) particles for 26 consecutive weeks. In addition, MannKind plans to submit data from over 100 preclinical studies supporting the safety of our product, the vast majority of which have already been completed.
The pharmacokinetic profile of Technosphere(R) Insulin sets it apart
from all other insulin products. The large surface area of the lung
provides unique access to the circulatory system, but the sugar-based
carriers used by others simply cannot convey insulin to the bloodstream any
faster than that achieved by a subcutaneous injection of a rapid-acting
insulin analog. In contrast, the pH-sensitive Technosphere(R) particles
dissolve upon contact with the lung surface, releasing insulin monomers
that rapidly enter the bloodstream. As described in recent publications in
the Journal of Diabetes Science and Technology, MannKind's Technosphere(R)
Insulin achieves peak insulin levels within 12-14 minutes of
administration, effectively mimicking the release o
|SOURCE MannKind Corporation|
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