MDL Announces Cooperative Research and Development Agreement with United States Food and Drug Administration.

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SAN LEANDRO, Calif.--(BUSINESS WIRE)--July 10, 2003

Collaborative effort produces MDL(R) Carcinogenicity 

Module for predicting a substance's carcinogenic potential

MDL Information Systems, Inc. (MDL(R)), the leader in discovery informatics for the life sciences and a member of the Elsevier Life Sciences division, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Food and Drug Administration (USFDA), Center for Drug Evaluation and Research (CDER). Under the terms of the CRADA, MDL and the USFDA will jointly develop a series of predictive software modules that represent major toxicological endpoints of interest to the regulatory agencies and the pharmaceutical industry. These endpoints are human adverse effects, carcinogenicity (ability to cause cancer), teratogenicity (ability to cause birth defects), and mutagenicity (ability to cause changes in genetic material).

The software modules will enable scientists in the pharmaceutical and biotechnology industries to identify and eliminate compounds with high potential for toxicity, such as those likely to be carcinogens, early in the drug discovery process. The ability to make better decisions earlier will accelerate the discovery of safer drugs, while also reducing animal testing.

The software is based on the MDL(R) QSAR platform, a comprehensive predictive modeling system that enables scientists to establish reliable quantitative structure-activity and structure-property relationships, create models for in silico screening, and generate new compound libraries based on the results.

The MDL(R) Carcinogenicity Module is the first module completed, and preliminary validation studies indicate that the MDL(R) QSAR modeling process, as performed by the USFDA, produces good estimates of a substance's carcinogenic potential. The module is based on historic data generated from rodent carcinogenicity studies that are used to predict the potential carcinogenic risk to humans. The predictive model does not require rodent studies to predict the human carcinogenic effect; it calculates a prediction based on chemical structure.

"Applying MDL QSAR's robust analysis capability to the USFDA toxicology databases creates powerful predictive models for the testing of drug candidates," said Lars Barfod, executive vice president and chief business officer of Elsevier Global Life Sciences Business. "This joint initiative underscores MDL's commitment to improving the predictive performance of computational toxicology software and enhancing decision support in both the regulatory and research domains."

The principal investigators for the USFDA are Dr. Joseph F. Contrera, Dr. Edwin J. Matthews, and Dr. R. Daniel Benz of the Informatics and Computational Safety Analysis Staff in the Office of Pharmaceutical Science. The MDL investigator is Philip M. MacLaughlin, product manager with the MDL(R) Discovery Predictive Science group.

MDL will make these toxicity modules, jointly created by MDL and the USFDA, available commercially to provide users with effective tools for the identification of potentially unsafe substances early in the discovery process. The MDL Carcinogenicity Module is available in July 2003.

About MDL

Over 1,000 life science companies supercharge their discovery engines with MDL software solutions to generate fresh ideas and make breakthrough discoveries. By synchronizing and streamlining the sharing and management of vital information and knowledge, we enable scientists to work more efficiently and invent drugs faster. This saves time, money, and lives. In support of our customers and the momentous challenges they face, everything we do must be reliable, resourceful, innovative, and insightful. We are an international business headquartered in San Leandro, CA with offices worldwide.

MDL is a member of Elsevier Life Sciences division, which combines all of Elsevier's life science content products with MDL's extensive informatics, database, workflow, and decision support solutions. The unique synergy between Elsevier's scientific and biomedical information and MDL's integrated discovery informatics software enables Elsevier Life Sciences to bring unparalleled solutions to researchers, significantly advancing the efficient, cost-effective development of new medicines. Elsevier is owned by Reed Elsevier PLC (NYSE: RUK) and Reed Elsevier NV (NYSE: ENL).

For more information, visit www.mdl.com.

MDL is a registered trademark in the United States of MDL Information Systems, Inc. "Powering the Process of Invention" is a trademark of MDL Information Systems, Inc., U.S. registration pending. Elsevier is a registered trademark in the United States of Reed Elsevier US Holdings Inc., and of Reed Elsevier NV in other countries. All other company and/or product names may be trademarks or registered trademarks of their respective owners in the United States and other countries. All rights reserved.