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Bentley Reports Positive Results with Nasulin Intranasal Insulin,Spray at the American Diabetes Association Meeting

EXETER, N.H.--(BUSINESS WIRE)--Jun 25, 2007 - Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, today announced positive clinical results in three Company-sponsored studies of its investigational drug, Nasulin(TM), an intranasal insulin spray. The data were presented this past weekend at the American Diabetes Association 67th Scientific Sessions in Chicago.

In a placebo-controlled Phase II pharmacokinetic study in patients with type 1 diabetes, the 12 patients receiving Nasulin demonstrated more rapid onset of action than when they received either regular or fast-acting injectable insulins. In addition, blood sugar levels for two hours after eating in patients treated with Nasulin were similar to those who received both injectable insulin formulations. No adverse events were reported during this study.

Patients in the study were randomized to receive the following 4 regimens: intranasal doses of 25 IU Nasulin (approximately bioequivalent to 5 IU insulin SC), regular insulin (Humulin R(R) (5 IU)), rapid-acting insulin (Humalog(R) (5 IU)) and saline nasal spray (placebo). The primary objectives of the trial were to compare the pharmacokinetic and glucodynamic characteristics of Nasulin, as well as its bioavailability/bioequivalency, with injectable forms of insulin. Each regimen was given after an overnight insulin drip to maintain standard glucose levels. Each patient received a 450 calorie high-protein boost challenge after the study drug was administered.

Researchers also presented results from two additional Bentley-sponsored studies to determine if smoking had any effect on the absorption of Nasulin in normal male smokers and non-smokers and to determine if there were any absorption differences due to the normal nasal cycles that occur between nostrils (alternating levels of mild congestion). Nasulin was absorbed equally in a study of 18 smokers and 18 non-smokers,
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