August 29, 2005

SCOLR Pharma has successfully completed pilot bioavailability testing in Canada of its controlled delivery technology (CDT) raloxifene tablets. The trial data demonstrates that SCOLR's patented amino acid CDT-based platform can be a viable alternative to currently utilized solubility and permeability-enhancing practices.

Raloxifene HCl is the active ingredient in Evista, Eli Lilly's immediate release tablets for osteoporosis. Evista uses a different solubilization technology. Commercially available Evista immediate-release tablets served as the external reference control for SCOLR Pharma's pilot study.

The pilot testing consisted of a 20-subject, randomized, five-way crossover, open-label, fasting trial. It compared three 45 mg formulations of the CDT-based raloxifene with two controls: Evista and an internal control. SCOLR Pharma previously reported that an animal evaluation of an amino acid-based CDT-raloxifene formulation increased the total bioavailability for raloxifene as compared with the controls, which is consistent with the results of the pilot human trial.