DATATRAK Congratulates Cosmo Pharmaceuticals on Budesonide MMX® Results
CLEVELAND, Nov. 29, 2010 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today publically congratulated its sponsor partner Cosmo Pharmaceuticals S.p.A. (SIX: COPN) who last week announced positive top-line results from their second pivotal Phase III clinical study which was conducted in the EU utilizing DATATRAK's unified eClinical product suite and services team to evaluate the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate ulcerative colitis. In late September, Cosmo Pharmaceuticals and Santarus also announced positive top-line results from the Phase III clinical study of budesonide MMX® in North America and in India.
"We are very pleased with the budesonide MMX® clinical trial results. We conducted the clinical trials in 177 sites in 19 countries. Being a small company of limited personnel resources, DATATRAK provided an efficient solution that allowed us to have a detailed overview of the progress of the trial at all times," said Mauro Ajani, CEO of Cosmo Pharmaceuticals.
"We congratulate Cosmo on their impressive results with budesonide MMX®, and we sincerely appreciate the positive comments from their team of investigators and end users about the DATATRAK experience," said Laurence P. Birch, DATATRAK's Chairman and CEO. "Cosmo has been a proponent of DATATRAK and its product suite, and we have thoroughly enjoyed our supportive relationship in completing these trials."
Over the past two years, DATATRAK and Cosmo have worked together to successfully complete these two pivotal studies. Cosmo utilized the electronic data capture, lab data import and medical coding components of the DATATRAK eClinicalTM solution. For more information on Budesonide MMX®, please visit Cosmo's Product Pipeline page.
About Cosmo Pharmaceutical S.p.A.
Cosmo is a specialty pharmaceutical company that aims to become a global leader in optimized therapies for selected gastrointestinal and topically treated skin disorders. The company's proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn's disease, and colon infections. Cosmo's first MMX® product that has reached the market is Lialda® / Mezavant® / Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited. Cosmo's proprietary MMX® technology is at the core of its product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the intestines. More information about Cosmo is available on the company's website at www.cosmopharma.com.
About DATATRAK International, Inc.
DATATRAK International is a worldwide technology and services company delivering eClinical solutions and related services for the clinical trials industry. DATATRAK built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via DATATRAK's Clinical and Consulting Services group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. The DATATRAK eClinicalTM software solution, deployed worldwide through an ASP or Enterprise Transfer offering, has successfully supported hundreds of international clinical trials involving thousands of clinical research sites and encompassing tens of thousands of patients in 67 countries. DATATRAK has offices located in Cleveland, Ohio, and Bryan, Texas. For more information, visit http://www.datatrak.net.
Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management's expectations, assumptions, estimates and current beliefs concerning the operations, future results and prospects of the Company and are subject to uncertainties and factors which are difficult to predict and, in many instances, are beyond the control of the Company, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. For a list of certain of the factors that may cause actual results to differ materially from those contemplated in these forward looking statements, please see the Company's quarterly report filed with the Pink OTC Markets on November 12, 2010 announcing its results for the three-month period ending September 30, 2010. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.
SOURCE DATATRAK International, Inc.
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