REDMOND, Wash.--(BUSINESS WIRE)--Feb. 12, 2003--
Extends Drug Delivery Capability and Range of Business Development
Partners for CDT(TM) Controlled Delivery Technology
SCOLR, Inc. (OTCBB:SCLL) announced today that the Company has been issued patent # 6,517,868 from the United States Patent Office for its amino acid CDT(TM) drug delivery platform for pharmaceutically active compounds.
The amino acid CDT(TM) platform is one of three SCOLR patents for modified oral dosage release systems currently in pre-commercialization development by the Company. Designed as a simpler solution to certain difficult formulation issues, the amino acid platform extends the Company's capability to include poorly soluble drugs which are difficult and costly to formulate and produce with currently available manufacturing techniques and processes.
Although this is the Company's third CDT(TM) patent, it is the first issued directly to SCOLR. The first two CDT(TM) patents were licensed exclusively by SCOLR from Temple University, Philadelphia. In collaboration with Dr. Reza Fassihi, Professor of Biopharmaceutics and Industrial Pharmacy at the Temple University School of Pharmacy, SCOLR has, over the last two years, developed prototype prescription drugs, OTC products and dietary supplements which employ the novel delivery system concepts embodied in all three CDT(TM) patents.
Taking advantage of the faster time-to-market in the dietary supplement industry, several nutraceutical products employing CDT(TM) technology were introduced in 2002. The first commercial introduction of an OTC product utilizing CDT(TM) is expected in late 2003 and CDT(TM)-based prescription drugs are planned for after 2005.
David T. Howard, President and CEO of SCOLR, said that, "The issuance of our third CDT(TM) drug delivery patent is particularly gratifying. We are no longer only a licensee of technology, but have advanced to become an innovator in drug delivery. This new CDT(TM) platform broadens the field of potential prescription drug candidates for our CDT(TM) technology to include drugs with solubility issues where developing controlled release formulations is currently both difficult and costly," continued Howard.
"This new CDT(TM) amino acid patent, in conjunction with the CDT(TM) salt patent and CDT(TM) dual polymer patent, combine to create a range of modified oral drug delivery systems which address the most challenging hurdles of oral drug delivery, including zero order kinetics, poorly soluble active ingredients and ingredients difficult to tablet. Our CDT(TM) technology has been shown to accomplish this at reasonable cost and time savings to the manufacturer," said Howard.
"We applied the art embodied in our newest patent in prototype compounds and the results of these in-vitro trials were released at the American Association of Pharmaceutical Scientists (AAPS) meeting in November 2002. The Company expects to follow up this early work with additional in-vitro experiments designed to characterize the technology fully permitting SCOLR to move forward with a partner to in-vivo biotrials in 2004, with fully developed candidates being ready for submission to the FDA in 2005, and possible commercial availability through a licensing agreement with a pharmaceutical company after 2006. It is important to note that the CDT(TM) in-vitro/in-vivo clinical (IV/IVC) results we presented in November 2002 at AAPS demonstrated very high correlation between the laboratory results and the performance of our systems in humans."
"Dr. Fassihi, the discoverer of the patented Controlled Delivery Technology(TM) platforms, also presented at AAPS the early results of our work with the amino acid patent on dimenhydrinate, ondansetron, glipizide, and other active pharmaceutical ingredients, all of which show promise of benefiting from this unique drug delivery platform," Howard stated.
"Our Intellectual Property portfolio now consists of three issued CDT(TM) patents and a fourth in development, providing SCOLR with the versatility necessary to formulate products and optimize the delivery system to both meet the individual products' therapeutic goals and to optimize the intrinsic properties. Like our first two patents, the amino acid patent supports our business model of providing extended release formulations which are faster to market, less expensive to develop, and have costs to produce that closely approximate the immediate release versions of the products we formulate; thereby providing our licensees with controlled delivery technology at affordable and competitive costs."
Howard continued, "Our technology is well suited to the niche of cost-competitive extended-release prescription drugs and is particularly well suited to generic prescription drugs, OTC's and nutraceuticals where price is critical to commercial success. This patent issuance coincides with the introduction of our CDT(TM) Glucosamine/Chondroitin product in over 2,000 retail outlets in the U.S. expected by April, with royalties expected to begin in late in Q2."
Based in Redmond, Washington, SCOLR, Inc. (formerly Nutraceutix, Inc.) is a biopharmaceutical company leveraging specialized knowledge, proprietary and patented products and technologies, such as the patented CDT(TM) Controlled Delivery Technology platform, to introduce distinctive and novel OTC products, prescription drugs and dietary supplements. SCOLR currently operates in two business segments - drug delivery and nutraceuticals. Its CDT(TM) drug delivery platform provides distinctive products with tangible benefits for the consumer and competitive commercial advantages for licensees. Established partnerships with pharmaceutical, OTC and natural products industry companies enable SCOLR to co-develop new products and to add value and protection to existing product franchises. For more information on SCOLR, please call 1.800.548.3222 or visit http://www.SCOLR.com.
Except for any historical information, the matters discussed in this press release contain forward-looking statements within the meaning of Section 37A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements involve risks and uncertainties, including activities, events or developments that the company expects, believes or anticipates 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, including the Company's ability to continue to successfully market and provide its products and services and maintain their effectiveness, the continuation of the arrangements with the Company's product development partners, the ability of the Company to meet its financial projections, and general economic conditions. Such statements are subject to a number of assumptions, risks and uncertainties. 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. The Company undertakes no obligation to publicly update or revise forward-looking statements whether as a result of new information or otherwise.