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Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
Date:11/7/2007

hird) showed a statistically significant reduction in cigarettes smoked over the full 12 months compared to placebo (p<0.022):

* Using a repeated measures model, vaccinated smokers who failed to quit

but showed a high antibody response smoked a median of only 10

cigarettes per day while in the study, compared to their own baseline

values of 20 cigarettes per day before treatment.

Safety Trends Continue - NicVAX(R) Shows No Compensatory Smoking, No Increased Withdrawal

Importantly, there was no evidence of compensatory smoking or increase in withdrawal symptoms observed in NicVAX(R) patients at any stage of the 12- month trial. NicVAX(R) continued to be well-tolerated with the placebo and NicVAX(R) dose groups showing comparable adverse event profiles at each stage of the clinical study.

"We are excited and greatly encouraged by the significant learning which has come from this first efficacy trial of NicVAX." said Dr. Leslie Hudson, Interim President and Chief Executive Officer of Nabi. "It is important to note that we have seen success in each of the critical parameters of this trial; we know the dimensions of the therapeutic antibody window which will drive continuous abstinence out to a full year, we know the relationship between the psychological and biochemical drives to quit and remain abstinent and, most importantly, we believe we now have the insight to drive a higher rate of response. We will use these encouraging final data to advance our NicVAX partnership discussions and to determine the optimal design for the next step in our clinical trial efforts for this important primary care product candidate."

About the Phase 2b Study

The Phase 2b study was a double-blind, placebo-controlled and dose-ranging study comprised of 301 patients designed to establish proof of concept and the optimal dose for the Phase 3 program. This study was designed in collaboration with the U.S. Food and Drug Administra
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SOURCE Nabi Biopharmaceuticals
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