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

    CHICAGO, Nov. 26 /CNW/ - Open Text(TM) Corporation (NASDAQ:   OTEX, TSX:
OTC), a global leader in enterprise content management (ECM), 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
    For more information about Livelink ECM - Collaborative Submissions, go

    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

    About Open Text

    Open Text, an enterprise software company and leader in enterprise
content management, helps organizations manage and gain the true value of
their business content. Open Text brings two decades of expertise supporting
46,000 customers and millions of users in 114 countries. Working with our
customers and partners, we bring together leading Content Experts(TM) to help
organizations capture and preserve corporate memory, increase brand equity,
automate processes, mitigate risk, manage compliance and improve
competitiveness. For more information, visit

    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 (C) 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 further information:

For further information: Michele Stevenson, Open Text Corporation, (519)
888-7111 ext.2594,; Richard Maganini, Open Text
Corporation, (847) 267-9330 ext.4266,; Brian Edwards,
McKenzie Worldwide, (503) 577-4583,

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890