Image Solutions, Inc. | Press Releases

EPIX Pharmaceuticals, Inc. and Image Solutions, Inc. Complete First eIND Submission in eCTD Format to CDER at the FDA

Whippany, NJ (September 9, 2004) – EPIX Pharmaceuticals, Inc. (NASDAQ: EPIX) based in Cambridge, MA, selected Image Solutions, Inc. (ISI) of Whippany, NJ to provide ISI OneSource services to help them compile the first eIND (electronic Investigational New Drug) submission in eCTD format to CDER at the FDA. EPIX and ISI worked closely with the Division of Medical and Radiopharmaceutical Drug Products to reach this milestone. The submission of this IND marks the continued trend toward the acceptance of ePublishing for regulatory documents.

EPIX Pharmaceuticals, Inc. (EPIX) enlisted ISI because of their unique ability to provide rapid-turnaround outsourcing services for preparing electronic submissions to the FDA. ISI demonstrated proficiency in compiling eCTDs and has strong relationships with US, European and Japanese regulatory agencies.

ISI’s service arm, ISI OneSource was uniquely qualified to accommodate EPIX’s requirements for the IND in eCTD format. ISI’s staff provided the necessary regulatory operations expertise and services to compile the submission, on-time and with the highest quality standards in only five weeks! According to Debra Feldman, Senior Regulatory Affairs Associate at EPIX, "ISI demonstrated exceptional expertise in regulatory operations and were very accommodating in advising us how to build our eSubmission."

ISI initially converted 3,451of EPIX’s source documents to 194 PDF files. ISI OneSource also completed the XML backbone, and rapidly compiled the submission using ISI’s flagship application eCTDXPress. Because eCTDXPress is a web-based application, ISI was able to reduce EPIX's quality control timeframes by allowing authors to utilize Microsoft’s Internet Explorer to review and comment on the submission simultaneously from remote locations. ISI OneSource™ helped EPIX and the FDA become familiar with navigation throughout the eCTD submission by conducting training sessions with reviewers. When EPIX asked for a paper submission in addition to the electronic version, ISI utilized their new publishing tool, ISIPublisher to deliver a 16-volume paper submission.

EPIX discovers and develops innovative pharmaceuticals for imaging that are designed to transform the diagnosis, treatment and monitoring of disease. The Company uses its proprietary Target Visualization Technology™ to create imaging pharmaceuticals targeted at the molecular level, enabling physicians to use Magnetic Resonance Imaging (MRI) to obtain detailed information about specific disease processes. The Company’s lead product, MS-325, is the first imaging pharmaceutical specifically designed for Magnetic Resonance Angiography. A New Drug Application (NDA) for MS-325 was accepted for filing by the FDA in February 2004. Schering AG, Germany (NYSE: SHR, FSE: SCH), the market leader in MRI contrast agents, is the worldwide sales, marketing and development partner for MS-325. Schering AG submitted MS-325 for marketing approval in the European Union and that application was accepted for filing in June 2004. EPIX is also collaborating with Schering AG in the development of its second drug candidate, EP-2104R, for imaging blood clots using MRI, and in a research partnership to discover novel compounds for MRI. To receive the latest EPIX news and other corporate developments, please visit the new EPIX website at www.EPIXpharma.com.

About Image Solutions, Inc.

Founded in 1992, Image Solutions, Inc (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and since has delivered thousands of submissions. The company has a 49 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress, and 4 of the top 10 pharma now have ISIPublisher.

ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organisations. For more information, visit the company website at: www.imagesolutions.com.