FDA Utilizes The Rosetta Syllego™ System to Support Management of Genome-Wide Association Data Submitted Through VXDS Program

October 2, 2007 - Rosetta Biosoftware today announced that the U.S. Food and Drug Administration (FDA) will utilize the Rosetta Syllego™ system to meet its immediate need for a software solution to manage and analyze genotyping data used in genome-wide association (GWA) studies. Organizations are now beginning to submit genotyping data from GWA studies to the FDA through its Voluntary eXploratory Data Submission (VXDS) program. Research organizations conducting GWA studies have the potential to reveal genetic risk factors for diseases such as coronary artery disease, type 2 diabetes and other complex diseases.

The use of genomic data is increasingly becoming an integral part of drug and diagnostic development. The VXDS program provides an opportunity for sponsors to submit genomic data for review by the FDA in a non-regulatory context. VXDS submissions provide a means to ensure that reviewers at the FDA are familiar with and prepared to appropriately evaluate future genomics submissions, and for sponsors to understand the FDA regulatory process. To streamline the evaluation of submissions and to develop a common understanding of genomic data, the FDA also extended the Micro Array Quality Control (MAQC) program to establish microarray quality control tools and guidelines for genotyping data used in GWA studies.

"There are a growing number of genome-wide association study data submissions to the FDA through VXDS," said Weida Tong, Ph.D., Director, Center for Toxicoinformatics, National Center for Toxicological Research (NCTR)/FDA. "A genotyping solution,such as the Syllego system, will benefit both the industry and the FDA because it allows us to effectively manage genotyping data submissions and also carry out analyses to understand why the sponsor might have used a particular method to arrive at a specific outcome. We will also explore the possibility of integrating the Syllego system with the ArrayTrack software developed by the FDA."

The Syllego system is a genetic data management and analysis system that includes tools for data management, quality control, data analysis, and meta-analysis. The system provides a single repository for fast, easy access to public and private data sets, reference annotation, and non-clinical and clinical information.

In addition to the Rosetta Syllego system, another Rosetta Biosoftware product, the Rosetta Resolver® system for gene expression data management and analysis, is currently in place at the FDA's Center for Drug Evaluation and Research (CDER).The FDA uses the Resolver system and other gene expression tools alongside the FDA's genomic tool, ArrayTrack, to support the VXDS program. The Resolver system was also adopted by the Critical Path Institute, a non-profit research and education institution founded to help implement the FDA's Critical Path Initiative.

“We are proud to extend our relationship with the FDA, and to provide the FDA with powerful capabilities to manage and analyze genetic data," said Yelena Shevelenko, vice president and general manager of Rosetta Biosoftware. “By providing the Syllego system to the FDA for use with its VXDS initiative, the FDA can focus its attention on understanding the outcome of a GWA study. More importantly, by enabling the FDA with the technological capabilities of the Syllego system, we will move the whole research community forward to achieve the goals of personalized [translational] medicine."

Rosetta Biosoftware will present a Webinar featuring Federico Goodsaid, Ph.D., and CDER/FDA on October 10, 2007. This Webinar will discuss the FDA-initiated MAQC project focusing on genome-wide association studies. For more information or to register for this Webinar, please visit www.rosettabio.com/Webinars.

About the Rosetta Syllego System

The Rosetta Syllego system is Rosetta Biosoftware’s practical solution for genetic data management and analysis. The system is designed for biologists, statistical geneticists, and investigators responsible for generating genotyping data engaged in genetic studies, such as eQTL or genome-wide association or linkage. The system captures and stores SNP genotyping assay data and information from leading technology platforms for better planning and execution of genetic studies. QC tools verify that data are high quality to prevent loss of time in downstream analyses. Application tools enable the combining of relevant genotypic and phenotypic study data and the use of analysis methods of choice. Data management and visualization tools enable the analysis and cataloging of study data and analysis results, for incorporation into future studies. For more information on the Syllego system, please visit http://www.rosettabio.com/syllego.

About Rosetta Biosoftware

Rosetta Biosoftware is a leading provider of informatics solutions for life science research. Its comprehensive software solutions, including the Rosetta Resolver, Rosetta Syllego and Rosetta Elucidator systems, empower life scientists with advanced, scalable, and easy-to-use analysis platforms that accelerate discovery research and enable personalized medicine. Rosetta Biosoftware is a business unit of Rosetta Inpharmatics LLC, a wholly owned subsidiary of Merck & Co., Inc. (NYSE: MRK). More information about Rosetta Biosoftware is available at www.rosettabio.com.

Forward-Looking Statements

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Neither Rosetta Inpharmatics nor Merck & Co., Inc. undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect the business of Merck & Co., Inc. including, among others, the extent to which Rosetta Inpharmatics' technology platform can be used in drug discovery programs, uncertainty of market acceptance of Rosetta Inpharmatics' technologies, ability to compete against existing technologies, and those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K (if any) which are incorporated by reference. Rosetta Resolver and Elucidator are U.S. registered trademarks of Rosetta Inpharmatics LLC. Rosetta Syllego is a trademark of Rosetta Inpharmatics LLC.

Editorial Contact

For Rosetta Biosoftware: Sasha Paegle +1.206.926.1292