The Uppsala Monitoring Centre collaborates with Lincoln Technologies.

Business Editors/Health/Medical Writers/High-Tech Writers

BOSTON & UPPSALA, Sweden--(BUSINESS WIRE)--March 15, 2004

The UMC (The WHO Foundation Collaborating Centre for International Drug Monitoring) and Lincoln Technologies, Inc. today announced the availability of the WHO-ADR database / Vigibase (including over three million reports internationally) within Lincoln's Web-based WebVDME-WHO safety data mining and reporting system.

Lincoln's data mining software has been used by the pharmaceutical industry and FDA to identify unexpectedly frequent combinations of drugs and events, and to organize, identify, and interpret patterns in both the FDA AERS FOI data as well as companies' internal safety databases. Following the agreement between the UMC and Lincoln, Lincoln will now provide user-friendly web access to signal scores from the WHO data based on both Dr. William DuMouchel's MGPS Empirical Bayes algorithm, and PRR. For the first time both the FDA FOI and the WHO data are open for customers to analyze by using the MGPS Empirical Bayes algorithm.

In addition, WebVDME-WHO provides powerful interactive query and reporting tools for creating case lists and generating custom reports on cases of interest. It also offers numerous standard reports to support routine operations by safety reviewers.

The service will be available to Lincoln's clients in the 2nd quarter of this year.

Chan Russell, President of Lincoln Technologies, said "We are very excited to be able to offer our multinational clients the ability to have online access to both the FDA AERS data and the multi-national ADR resources of the Vigibase database. The WHO database is a unique resource providing an international perspective on the safety profile of thousands of drugs."

Ralph Edwards, Director of UMC, said

"Following a new agreement at the International Conference of Drug Regulatory Authorities, the WHO and UMC is pleased to be able to offer wider access to the unique resources of the WHO database. Since 1997 the UMC has provided a routine data mining service for all national drug safety authorities around the world, and it is right that a similar service should be available to industry to help with the early warning of adverse reactions on their products"

About UMC

The UMC is responsible for the collection and global analysis of adverse reaction reports, from over 70 countries in the WHO Programme. The UMC has developed many leading-edge tools and standards to support the examination of drug safety data. The WHO Drug Dictionary is the world standard for coding medicinal products used throughout the world both by national drug safety authorities and industry. It is one amongst a portfolio of major resources for all specialists in drug safety as well as an essential tool for clinical trials when it comes to coding medicinal products. The UMC website is: www.who-umc.org

About Lincoln Technologies

Lincoln Technologies is a software development and consulting company focused on data management, integration, and analysis in support of the drug development, drug safety, submission and regulatory review processes. Lincoln provides products and services for pharmaceutical sponsors, FDA and other Government health-related agencies, and other pharmaceutical industry solution providers. In addition to this safety data mining CRADA, Lincoln and FDA have also entered into a separate CRADA to develop standard data evaluation and review tools for eSubmission data.

Lincoln Technologies is headquartered in Wellesley, Massachusetts, with European offices in Belgium, and can be found on the web at www.LincolnTechnologies.com.