BELLEVUE, Wash.–(BUSINESS WIRE)–Aug. 29, 2005–SCOLR Pharma, Inc. (AMEX:DDD - News) announced today that it 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 hydrochloride is the active ingredient in Evista®, Eli Lilly’s immediate release tablets for osteoporosis. Evista uses a different solubilization technology. In 2004, Eli Lilly (NYSE:LLY - News) reported over $1 billion in global Evista sales. Commercially available Evista 60 milligram (mg.) 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.

Stephen J. Turner, SCOLR Pharma’s Vice President and Chief Technology Officer, said, “Although this was a small study, we are very pleased with the results. This is the first human clinical evaluation of our patented amino acid technology intended to address insoluble and poorly soluble compounds. The human data indicate that our amino acid technology can enable us to obtain equivalent plasma levels without the use of costly and complex technology. In addition, all three amino acid CDT-based raloxifene formulations had less variability in the value for maximum plasma concentration (Cmax) than Evista and the 45 mg. control. Cmax is a very important pharmacokinetic (PK) metric used for the determination of bioequivalence.”

Turner further noted, “It is estimated that up to 40% of new chemical entities are poorly soluble. Many current synthesis processes lead to active pharmaceutical ingredients (APIs) with poor solubility. We are confident that our proprietary delivery technology can cost-effectively enhance the delivery and uptake of difficult drugs.

“As previously announced, we have initiated development of CDT-based ondansetron hydrochloride formulations, three of which are being produced for use in a human pilot study later this year.” Ondansetron hydrochloride is the active ingredient in Zofran, GlaxoSmithKline’s widely used product to prevent chemotherapy and radiation-induced nausea and vomiting. In 2004, GlaxoSmithKline reported over $1.4 billion in global Zofran® sales.

“The successful application of our amino acid technology to raloxifene is an important demonstration of SCOLR Pharma’s unique ability to work with drugs that pose solubility challenges. We look forward to initiating potential partnership discussions based on our raloxifene pilot data while at the same time we work to optimize the formulation, initiate a pilot study for our CDT-ondansetron formulations, and advance additional applications of our amino acid-based CDT technology,” concluded Turner.

Daniel O. Wilds, SCOLR Pharma’s President and CEO, stated, “I believe that the completion and positive results from this pilot human study represent the attainment of a significant milestone for SCOLR Pharma. It further validates our CDT amino acid technology as a differentiated alternative to more costly and complex methods for increasing the bioavailability of orally administered drugs. New and existing drugs with solubility and uptake formulation issues represent one of the largest challenges and greatest growth opportunities for today’s pharmaceutical industry. If we continue to see clinical success in future applications of this exciting technology, we will be positioned to establish our CDT amino acid technology as a viable alternative to resolving formulation hurdles with important positive implications for our business.”

Based in Bellevue, SCOLR Pharma, Inc. is a specialty pharmaceutical company leveraging formulation expertise and its patented CDT platform to introduce distinctive and novel OTC products, prescription drugs and dietary supplements. SCOLR Pharma’s CDT drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. For more information on SCOLR Pharma, including the raloxifene pilot study results, please visit http://www.scolr.com/.

This press release contains forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including activities, events or developments that we expect, believe or anticipate will or may occur in the future. A number of factors could cause actual results to differ from those indicated in the forward-looking statements. For example, if our clinical trials are not successful or take longer to complete than we expect, we may not be able to develop and commercialize our products. Even if we complete a clinical trial of one or more potential products, the clinical trial may not provide sufficient data to the extent required by the FDA or other regulatory agency to approve the product. If we are required to conduct additional clinical trials or other testing of our products in development beyond those that we currently contemplate, we may be delayed in obtaining, or may not obtain, marketing approval for our products. Our product development costs may also increase if we experience delays in testing or approvals, which could allow our competitors to bring products to market before we do and would impair our ability to commercialize our products. Other factors include our ability to successfully develop new formulations and complete research and development, including pre-clinical and clinical studies, our ability to raise additional funds, the continuation of arrangements with our product development partners and customers, competition, government regulation and approvals, and general economic conditions. Additional assumptions, risks and uncertainties are described in detail in our registration statements, reports and other filings with the Securities and Exchange Commission. Such filings are available on our website or at www.sec.gov. Readers are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances.

Copyright ©2005 SCOLR Pharma, Inc. All Rights Reserved.

Contact: Bibicoff & Associates, Inc. Terri MacInnis, 818-379-8500 terrimac@bibicoff.com

Source: SCOLR Pharma, Inc.