Top Line Clinical Results Expected in November 2008
BOTHELL, Wash., Oct. 9 /PRNewswire-FirstCall/ -- SCOLR Pharma, Inc. announced
PRINCETON, N.J., Oct. 9 /PRNewswire/ -- Zargis Medical Corp., a spin-off from Siemens Corporate Research, a division of Siemens AG , and a majority-owned subsidiary of Speedus Corp. , today announced that it was awarded six additional contracts from the U.S. Army totaling $270,000. Included in these awards is $170,000 of orders for nine upgraded versions of the telemedicine pilot-systems which Zargis delivered to the Army earlier this year. Based on the Army's successful evaluation of the initial prototypes in a large military hospital, they have decided to expand the scope of the project and purchase these additional units.
The upgraded systems provide improved data collection quality and are designed to record, synchronize and analyze heart sounds, lung sounds, ECG signals and, in some cases, blood oxygen saturation levels from patients being cared for by remote military treatment facilities located throughout the Pacific Rim. The systems will be fully integrated with an existing Army telehealth platform.
"We're very pleased by the success of the prototype telemedicine systems delivered to the Army earlier this year," stated Zargis CEO John Kallassy. "The demand for medical systems designed to remotely project the expertise of cardiologists and other medical specialists is growing very rapidly -- within both military and civilian environments worldwide -- and it is for this reason that Zargis has identified the field of telemedicine as a key focus area for commercialization of our products."
About Zargis Medical Corp.
Zargis Medical Corp. develops advanced diagnostic decision support products and services for primary care physicians, pediatricians, cardiologists and other healthcare professionals. Zargis was formed in 2001 when Siemens Corporate Research, a division of Siemens AG , and Speedus Corp. co-invested to develop and market an advanced acoustic technology designed to detect heart abnormalities identified through analysis of heart sounds.
For additional information about Zargis or Speedus Corp., contact Peter Hodge at 888.773.3669 (ext. 23) or phodge@zargis.com, or visit the following Web sites: www.zargis.com and www.speedus.com.
Statements contained herein that are not historical facts, including but not limited to statements about the Company's product, corporate identity and focus, may be forward-looking statements that are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those expressed in any forward-looking statements made by the Company, including, but not limited to, the continuing development of the Company's sales, marketing and support efforts.
CONTACT: Peter Hodge, 888-773-3669 (ext. 23), phodge@zargis.com
Web site: http://www.speedus.com/
http://www.zargis.com/
The Company enrolled and treated approximately 240 patients at a single center in the United States. The randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg ER in dental pain following molar extraction. It is anticipated that the data from this trial will be used to support a submission to the U.S. Food and Drug Administration (FDA) for product approval in the United States. If approved, the Company believes its ibuprofen product would be the first and only OTC 12-hour, extended-release ibuprofen product on the market in the United States. Additional information about the clinical trial can be found at www.clinicaltrials.gov. As previously reported, the Company will also be required to complete a label comprehension and consumer use study for product approval prior to submission.
Daniel O. Wilds, the Company's Chief Executive Officer, commented, "We are very pleased with the efficiency in which over 300 potential subjects were recruited and screened to enable the successful and timely dosing of our targeted study population. The attainment of this clinical study milestone is an important measure of our success in advancing this exciting project and we look forward to announcing study results later this year."
Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. Total global OTC sales of the analgesic market in which the 12-hour ibuprofen product will compete are estimated at more than $8 billion, according to IMS Review Plus data. The Company estimates the annual U.S. sales of immediate-release OTC ibuprofen products exceeds $1 billion.
About SCOLR Pharma:
Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma's corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. 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, including without limitation statements related to the timing and success of clinical trials and regulatory applications. 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, including 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. 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 and we may not obtain regulatory approval for our products, which would materially impair our ability to generate revenue. 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. You 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.
CONTACT: Kevin McGrath of Cameron Associates, +1-212-245-4577,
Kevin@cameronassoc.com, for SCOLR Pharma, Inc.
Web site: http://www.scolr.com/
