SCOLR Pharma, Inc. Issued Second Patent for Platform Used to Formulate Challenging Drugs; Broadens Application of CDT Drug Delivery Platform As Alternative Technology
SCOLR Pharma, Inc. (Amex:DDD) announced today that it has been issued a second patent (# 6,936,275 B2) from the United States Patent Office for its amino acid CDT(R) drug delivery platform which can be used for difficult to formulate drugs.
SCOLR Pharma’s amino acid-based technology is one of four components of its CDT drug delivery platform for formulating tablets and capsules. The amino acid technology is designed to solve drug formulation problems by controlling release independent of the drug’s solubility characteristics. SCOLR Pharma believes the additional patent extends its capability to improve the solubility of drugs in a cost-efficient manner.
SCOLR Pharma recently announced the successful completion of a pilot bioavailability study of CDT-based raloxifene formulations in the first human application of its amino acid technology. This study demonstrated that SCOLR Pharma’s CDT platform can be a viable alternative to currently utilized complex and expensive solubility and permeability-enhancing practices. SCOLR Pharma has also announced that it expects to begin clinical testing later this year of three formulations of its CDT(R) ondansetron as the second human application of its amino acid technology.
Daniel O. Wilds, SCOLR Pharma’s President and Chief Executive Officer, said, “The issuance of this second patent for our CDT amino acid technology is very timely and further broadens the potential application of our platform to drugs with difficult formulation issues. We believe it strengthens our proprietary position as we further employ our amino acid technology as the basis for building a differentiated portfolio of potential CDT-based products.”
Wilds further noted, “A recent ‘Generic Engineering News’ article cited that an FDA survey between 1995 and 2001 reported that only 9% of the 99 new small molecule drugs introduced were both highly soluble and permeable, and thus appropriate for conventional oral delivery. In addition, other sources estimate that up to 40% of new chemical entities are poorly soluble.
“We believe this second patent strengthens the strategic position of our CDT(R) amino acid technology to provide a viable and proprietary solution to one of the most important formulation challenges facing today’s pharmaceutical industry.”
Raloxifene hydrochloride is the active ingredient in Evista(R), Eli Lilly and Company’s immediate release tablets for osteoporosis. Evista(R) uses a different solubilization technology. In 2004, Eli Lilly and Company (NYSE:LLY) reported over $1 billion in global Evista sales. Ondansetron hydrochloride is the active ingredient in Zofran(R), GalxoSmithKline’s widely used product to prevent chemotherapy and radiation-induced nausea and vomiting. In 2004, GlaxoSmithKline reported over $1.4 billion in global Zofran(R) sales.
Based in Bellevue, Washington, 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, please call 425-373-0171 or 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, the issuance of a patent is not conclusive as to its validity or as to the enforceable scope of the claims of the patent. Our issued patents may be challenged or invalidated or may be circumvented by our competitors. As a result, these patents may not provide us proprietary protection or a commercial advantage. Furthermore, we cannot be certain that any of our future processes or products will be patentable, or that our processes or products will not infringe upon the patents of third parties. In addition, 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, or 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. 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.
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