The insulin will mainly be used in MannKind’s ultrarapid-acting product, with an NDA filing expected in early 2009.

MannKind purchased an option to license SemBioSys Genetics’ plant-produced recombinant human insulin, which ends on March 31, 2009. SemBioSys will receive $2.5 million, which includes the purchase of 2,400,000 SemBioSys units upon closing at $0.83 per unit.

The option agreement states that Mannkind will primarily use this plant-produced insulin for Afresa™, its ultrarapid-acting insulin, which recently completed Phase III studies. The company expects to finalize an NDA for Afresa to submit to the FDA in early 2009.

This pH-sensitive therapy dissolves upon contact with the lung surface, releasing insulin monomers that enter the bloodstream. It achieves peak insulin levels within 12–14 minutes of administration, thus mimicking the release of meal-time insulin observed in healthy individuals, MannKind points out.

SemBioSys’ plant-produced insulin is human insulin produced from genetically enhanced safflower. The firm reports that it is physically, structurally, and functionally indistinguishable from pharmaceutical-grade human insulin as demonstrated in its analytical tests and preclinical subchronic toxicology studies in rodents and primates.

SemBioSys is currently conducting a Phase I/II 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 unit purchase is expected to close on January 5, 2009. Each unit issued by SemBioSys will consist of one common share of SemBioSys and 1/10th of one common share purchase warrant of SemBioSys. Each whole warrant will entitle MannKind to purchase one additional common share of SemBioSys at an exercise price of C$6.00, or almost $5, for a period of 36 months from the effective date of the option.

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