CLEVELAND and DUBLIN, Ireland, March 3 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , a technology company focused on global eClinical solutions for the clinical trials industry, today reported that its DATATRAK EDC(R) Version 4.0 software has been selected by a new European client, Cosmo Technologies, Ltd. for two Phase III clinical trials. Cosmo Technologies, a company of Cosmo Holding S.p.A. Group, is a leading pharmaceutical company with a focus on gastrointestinal drugs. Together, the two clinical trials will involve 230 users at 110 sites and will seek to enroll 650 patients in countries throughout Europe, North America and South America. Work on these new clinical trials begins immediately.
DATATRAK’s policy of not announcing every contract remains in effect; however, periodic updates can provide a beneficial education to investors for 2006. This announcement does carry the significance of a new customer addition in Europe with Cosmo Technologies Ltd., which was facilitated by the Company’s established Technology Transfer client, Cross, S. A. of Arzo, Switzerland.
“This is a year of important achievements for Cosmo, after the milestone reached with the filing for registration of Shire’s Mesavance(TM), the first product developed in our laboratories and out-licensed to Giuliani S.p.A. and Shire Pharmaceuticals Plc four years ago,” said Mauro Ajani, Chairman and Chief Executive Officer of Cosmo Holding S.p.A. “The agreement with DATATRAK is a consequence of our recent strategic decision to conduct the whole clinical development for the other pharmaceutical products in the pipeline.”
“We are delighted to begin this new relationship with Cosmo Technologies and we look forward to assisting them in accelerating the clinical development process for their important and innovative research programs,” stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. “These clinical trials will be performed with the long- established platform of DATATRAK EDC(R) Version 4.0, leveraging the previous Technology Transfer investment made by Cross. This client addition brings the total customer base of DATATRAK to 48 who are actively performing clinical trials, which is an all-time high.”
Cosmo is an R&D based pharmaceutical company. Its R&D covers advanced oral applications in gastro intestinal disorders with focus in IBD, new chemical entities and biotechnology. In addition, it manufactures pharmaceuticals and offers development services to other pharmaceutical companies. Cosmo is based in Lainate (Milan), Italy, where its production plant and principal laboratories are situated. These cover an overall area of approximately 10,000 square metres. Cosmo’s R&D activities are also exploited in Dublin, Ireland and are complemented by efforts in the research and development of biotechnological products in the immunological arena, with offices and laboratories in San Diego, California, USA. The company currently employs about 120 people, 50% of whom are involved in production and 40% in research and development. Visit the Cosmo web site at www.cosmospa.it.
DATATRAK International, Inc. is a worldwide technology company focused on the provision of multi-component eClinical solutions and related services for the clinical trials industry. The Company delivers a complete portfolio of software products that were created in order to accelerate clinical research data from investigative sites to clinical trial sponsors and ultimately the FDA, faster and more efficiently than conventional, manual methods. DATATRAK’s software suite can be deployed worldwide through an ASP offering or in a licensed Technology Transfer model that fully empowers its clients. The DATATRAK software suite and its earlier versions have successfully supported hundreds of international clinical trials involving thousands of clinical research sites and encompassing tens of thousands of patients in 56 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the clinical development of 14 separate drugs that have received regulatory approval from either the United States Food and Drug Administration or counterpart European bodies. DATATRAK International, Inc. has offices located in Cleveland, Ohio, Bonn, Germany, and Bryan, Texas. Its common stock is listed on the NASDAQ stock Market under the ticker symbol “DATA”. Visit the DATATRAK International, Inc. web site at www.datatrak.net.
Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. Factors that may cause actual results to differ materially from those in the forward- looking statements include the ability of the Company to absorb corporate overhead and other fixed costs in order to successfully market its software; the development and fluctuations in the market for clinical trial technology; the degree of the Company’s success in obtaining new contracts; the timing of payments from customers and the timing of clinical trial sponsor decisions to conduct new clinical trials or cancel or delay ongoing trials; governmental regulation; the early stage of the Company’s business and operations; and general economic conditions. In addition, the Company’s success depends on the outcome of various strategic initiatives it has undertaken, all of which are based on assumptions made by the Company concerning trends in the clinical research market and the health care industry.
DATATRAK International, Inc.
CONTACT: Jeffrey A. Green, Pharm.D., FCP, President and Chief ExecutiveOfficer, +1-440-443-0082 x112, or Terry C. Black, Chief Financial Officer,+1-440-443-0082 x110, both of DATATRAK International, Inc.; or NealFeagans, Investor Relations, of Feagans Consulting, Inc., +1-303-449-1184,for DATATRAK; or Giuseppe Cipriano, Chief Operating Officer of CosmoHolding S.p.A., +39 02 93 33 76 14, or giuseppe.cipriano@cosmospa.it
