Whippany, NJ USA (August 30, 2005) - Image Solutions, Inc., (ISI) a global technology company and leader in providing software solutions and services for electronic regulatory submissions and clinical trials management, announced today that their client Infinity Pharmaceuticals, Inc. of Cambridge, Massachusetts, has completed it’s first submission to the FDA of an eIND (electronic Investigational New Drug). Infinity electronically filed their lead product candidate IPI-504 (a targeted cancer therapy currently in Phase I clinical trials for the treatment of multiple myeloma) in eCTD (electronic Common Technical Document) format with the assistance of ISI’s service division ISIOneSource. ISIOneSource leverages ISI’s flagship eSubmission software eCTDXPress® to assist clients in filing regulatory submissions, streamline workflow and increase speed to market.

With the FDA’s continued promotion of electronic submissions, and a growing acceptance of the eCTD submission format, partnerships like the ISI/Infinity relationship are becoming more common for pharmaceutical and biotech organizations that moving toward electronic submissions. Infinity has implemented eCTDXPress® internally to continue supporting their IPI-504 development program as it advances through human clinical trials, as well as future applications to the FDA and other regulatory agencies. Infinity has also contracted with ISI to provide regulatory operations consulting to support their on-going efforts.

eCTDXPress® is intended for pharmaceutical and biotechnology staff who require an intuitive, streamlined system for the creation of eCTDs. eCTDXPress® can easily integrate with existing electronic document management systems (EDMS), or can function as a stand-alone eCTD solution. Either configuration affords users an ability to move from the current paper CTD (Common Technical Document) or eNDA (electronic New Drug Application) to the latest electronic Common Technical Document (eCTD) standard with security and ease.

eCTDXPress® is comprised of two integral components, eCTDXPress Manager and eCTDXPress® Compiler. eCTDXPress Manager provides a central repository for all eCTDs and allows organizations to import, view, and collaborate on the review and internal approval of any eCTD. It also allows users to display multiple documents simultaneously, share comments, manage broken hyperlinks and validate eCTDs before sending them to an agency. eCTDXPress® Compiler allows publishers to easily create the original eCTD application and maintain lifecycle updates. Compiler also contains many robust features like an XML backbone wizard, web-based link management, automatic MD5 checksum generation, eCTD cloning, study-tagging file management, all of which dramatically simplify compiling a submission built according to Document Type Definition (DTD) and agency specifications.

eCTDXPress® deploys easily, can be scaled to meet the needs of any size organization, and requires minimal training. By eliminating many of the manual tasks required to build an eCTD, eCTDXPress® streamlines the preparation effort within organizations, and dramatically accelerates eCTD distribution, review, validation and acceptance of submission formats by regulatory agencies worldwide and expedites eventual marketing approval. The web-based component of eCTDXPress® facilitates global eCTD submissions, and allows organizations to focus on drug development content rather than on eCTD structure.