MannKind Licenses SemBioSys' Plant-Produced Insulin

MannKind Corporation (Valencia, CA) has purchased an option to license plant-produced recombinant human insulin from SemBioSys Genetics Inc. (Calgary, Canada) for use primarily in MannKind’s ultra-rapid acting insulin, Afresa.

SemBioSys' plant-produced insulin is human insulin produced from genetically enhanced safflower. More information about the plant-produced insulin can be found on the BioPharm web site.

SemBioSys has demonstrated that its plant-produced insulin is physically, structurally, and functionally indistinguishable from pharmaceutical-grade human insulin through analytical testing and preclinical sub-chronic toxicology studies in rodents and primates. SemBioSys is currently conducting a Phase 1–2 clinical trial of its plant-produced insulin. The three-arm study of up to 30 healthy volunteers is designed to demonstrate the bioequivalence of safflower-produced insulin to two commercial insulin standards. Full results are expected to be available during the first half of 2009.

The option expires on March 31, 2009. Mannkind has completed Phase 3 trials of Afresa and expects to file a new drug application for Afresa early this year.