Open Text Announces Completion by Jazz Pharmaceuticals, Inc. of FDA Electronic Pilot Submission Using Livelink ECM -- Collaborative Submissions
Comprehensive Compliance Solution Meets Industry s Electronic Common Technical Document (eCTD) Requirements, Streamlines Processes and Reduces Delays
Chicago, IL - 2007-11-26 - Open Text Corporation (NASDAQ: OTEX, TSX: OTC), the largest independent provider of Enterprise Content Management (ECM) software and solutions, today announced that Jazz Pharmaceuticals, Inc. has successfully completed its pilot submission to the U.S. Food and Drug Administration (FDA) using Open Text s Livelink ECM -- Collaborative Submissions. This initial step is required to ensure that an electronic submission in the eCTD (Electronic Common Technical Document) format can be prepared according to published guidelines and successfully received by the FDA prior to the January 1, 2008 deadline.
Livelink ECM -- Collaborative Submissions is designed to manage and support the assembly, review, approval and release of large document sets (submissions) made to government regulatory agencies around the world that are responsible for drugs, biologics and related products. The comprehensive Livelink ECM Collaborative Submissions solution manages documents through their lifecycles and reduces time-to-market by enabling companies to prepare and make submissions in the industry s standard eCTD format.
Developed by the International Conference on Harmonization (ICH), the eCTD was designed to be a common format for company-to-regulatory agency transfer of information and is acceptable across the United States, Japan, the European Union and Canada. However, since the eCTD is still an evolving standard, with a number of different interpretations and region-specific guidelines, the FDA established the pilot submission process to certify the technology platform used for eCTD submissions.
Like many pharmaceutical companies today, Jazz Pharmaceuticals, Inc. has embraced the eCTD format as a way to improve its regulatory processes. Using Livelink ECM -- Collaborative Submissions, Jazz Pharmaceuticals prepared and sent to the FDA a very sophisticated pilot submission that was composed of more than 500 documents, including SAS-format statistical information, supplied in native form; the FDA s required Study Tagging File (STF); and the FDA s Structured Product Labeling (SPL). In addition, the company provided several hundred PDF links between the submitted documents.
The pilot submission was thoroughly verified by the FDA and passed with no issues.
We selected Open Text s Collaborative Submissions for our eCTD submissions because we wanted a tightly integrated solution to our Livelink ECM document management system, said Lynn Ferguson Lewis, Project Manager, Information Technology, at Jazz Pharmaceuticals. We are very pleased that our pilot submission was confirmed by the FDA.
Being able to submit documents according to the FDA s rules is obviously a business-critical issue for any pharmaceutical company, said John Wilkerson, Executive Vice President of Global Sales, Services and Support at Open Text. The team at Jazz Pharmaceuticals planned ahead and has deployed a solution that has worked well for a successful pilot submission that met regulatory guidelines. The success at Jazz Pharmaceuticals validates the work we ve done in the life sciences industry, with customers and partners, to create solutions that are addressing the latest compliance requirements from the FDA and other regulatory agencies around the globe.
Livelink ECM Collaborative Submissions offers life sciences companies a single, end-to-end system to help manage eCTD-compliant submissions to the FDA, the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulators worldwide. The solution combines documents, forms and records management software, content publishing tools and the ability to automate a wide range of processes, from ad hoc to tightly sequenced workflows. Integrated tools such as check-in/check-out, version history, event auditing, signing controls, alternate renditions and compound documents make it easy to manage documents, their constituent documents and related components to ensure accuracy.
For more information about Livelink ECM Collaborative Submissions, go to: http://www.opentext.com/2/sol-industry/sol-ind-pharma/sol-ind-pharma-collaborative-submissions.htm
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. Based in Palo Alto, California, the company is committed to working closely with patients, patient advocacy groups and healthcare professionals. For further information, please visit www.JazzPharmaceuticals.com.
About Open Text
Open Text is the world's largest independent provider of Enterprise Content Management software. The company's solutions manage information for all types of business, compliance and industry requirements in the world's largest companies, government agencies and professional service firms. Open Text supports approximately 46,000 customers and millions of users in 114 countries and 12 languages. For more information about Open Text, visit www.opentext.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
This news release may contain forward-looking statements relating to the success of any of the Company s strategic initiatives, the Company s growth and profitability prospects, the benefits of the Company s products to be realized by customers, the Company s position in the market and future opportunities therein, the deployment of Livelink and our other products by customers, and future performance of Open Text Corporation. Forward-looking statements may also include, without limitation, any statement relating to future events, conditions or circumstances. Forward-looking statements in this release are not promises or guarantees and are subject to certain risks and uncertainties, and actual results may differ materially. The risks and uncertainties that may affect forward-looking statements include, among others, the failure to develop new products, risks involved in fluctuations in currency exchange rates, delays in purchasing decisions of customers, the completion and integration of acquisitions, the possibility of technical, logistical or planning issues in connection with deployments, the continuous commitment of the Company's customers, demand for the Company's products and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Form 10-K for the year ended June 30, 2006. You should not place undue reliance upon any such forward-looking statements, which are based on management's beliefs and opinions at the time the statements are made, and the Company does not undertake any obligations to update forward-looking statements should circumstances or management's beliefs or opinions change.
Copyright © 2007 by Open Text Corporation. LIVELINK ECM and OPEN TEXT are trademarks or registered trademarks of Open Text Corporation in the United States of America, Canada, the European Union and/or other countries. This list of trademarks is not exhaustive. Other trademarks, registered trademarks, product names, company names, brands and service names mentioned herein are property of Open Text Corporation or other respective owners.
For more information, please contact
Michele Stevenson
Open Text Corporation
+1-519-888-7111 ext.2594
mstevens@opentext.com
Richard Maganini
Open Text Corporation
+1-847-267-9330 ext.4266
rmaganin@opentext.com
Brian Edwards
McKenzie Worldwide
+1-503-577-4583
briane@mckenzieworldwide.com