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NASTECH ANNOUNCES POSITIVE DATA ON INSULIN NASAL SPRAY

December 8, 2006

Nastech Pharmaceutical has announced results from a placebo-controlled, dose-escalation, crossover, Phase I study comparing its proprietary insulin nasal spray formulation with NovoLog insulin aspart injection and Exubera inhalation powder in healthy subjects.

Twelve subjects participated in the study and were given one treatment of a nasal placebo, three doses of an intranasal formulation of regular human insulin, one treatment of rapid-acting insulin aspart injection and one treatment of insulin human inhalation powder. Plasma insulin and glucose levels were measured 12 times in six hours, and pharmacokinetic parameters, including Tmax, Cmax and AUClast, were determined.

With respect to time to maximum plasma level for insulin or Tmax, the three nasal doses had Tmax values of 16 to 19 minutes and were the fastest compared to the rapid-acting insulin aspart and inhaled insulin. With respect to plasma insulin levels, rapid-acting insulin aspart injection had the highest concentration, followed by the three nasal formulations, with inhaled insulin having the lowest. With respect to the extent of absorption, rapid- acting insulin aspart injection had the greatest total exposure or AUClast, with the highest dose of three nasal formulations next, followed by the inhaled insulin and then the lowest doses of two nasal spray formulations.

The pharmacokinetic-pharmacodynamic relationship demonstrated a high correlation between either Cmax or AUClast and the maximum glucose response. One subject was dropped from the study due to hypoglycemia after receiving insulin aspart injection; otherwise, there were no side effects, including clinically significant hypoglycemia.