Pharsight Announces Release of Enterprise Editions of WinNonlin and WinNonMix With Integrated Data Access.

MOUNTAIN VIEW, Calif.--(BW HealthWire)--Nov. 18, 1999--

Pharsight Corporation, the leading company focused on applying science and information technology to optimize and accelerate clinical drug development, today announced the release of the Enterprise Editions of Pharsight WinNonlin(R) and WinNonMix(TM). These new software products add easy-to-use connectivity between a broad range of drug development databases and the most widely used commercial drug modeling and pharmacokinetic/pharmacodynamic analysis tools.

Pharmaceutical scientists who perform analyses of drug kinetics, effects, and metabolism often need to work with data from a number of sources, including clinical data management systems, laboratory information management systems, and specialized pharmacokinetic databases. Prior to the release of the Enterprise Editions, scientists often had to wait for information technology or data management groups to provide data extracts, slowing analysis and reporting, and impeding exploratory modeling and analysis of interim data. Using the data import and export facilities in the Enterprise Editions, scientists can directly access data sources, reducing the cycle time required to produce analyses needed for regulatory submission and decision-making during the drug development process.

"The Enterprise Editions of WinNonlin and WinNonMix bring direct data access to the scientist's desktop, helping our customers improve productivity and reduce cycle time in completing pharmacokinetic and pharmacodynamic analysis of clinical trial data. Because we are providing both a standard data query tool and specific Custom Query Builders for commercial data sources such as LIMS, our customers will be able to directly access the data they need without having to write and debug macros or hand-build queries in SQL," said Dan Weiner, Ph.D., vice president and general manager, Scientific Products at Pharsight Corporation.

"The need to extend the capability of Watson to communicate with commercial PK/PD (pharmacokinetic/pharmacodynamic) data analysis products has arisen frequently", said Gary L. Rathsmill, president and CEO of Pharmaceutical Software Systems, Inc. "While performing Watson demonstrations and installations for many pharmaceutical companies and contract research organizations worldwide, Pharsight's WinNonlin product has been repeatedly highlighted as the most popular and flexible PK/PD tool for bi-directional data communication purposes. This collaboration ensures our mutual clients the associated business advantages of a powerful integrated solution."

"Customers have repeatedly asked us for a gateway to Pharsight's industry leading WinNonlin and WinNonMix applications. The release of `The Enterprise Editions of WinNonlin and WinNonMix' is a powerful addition to the pharmaceutical scientist's tools for improving drug development. This collaboration with Pharsight allows us to substantially better serve our customers", said James J. Conklin, M.D., president and CEO of Integraware Inc.

Key Features

Key features of the Enterprise Editions of WinNonlin and WinNonMix include:

-- Easy to use Import Wizard -- build a query to import data into a workbook from any database by simply selecting tables, fields, and filters from lists of choices, or quickly load and run a predefined or standardized query.

-- Automatic Link to Data Sources -- automatically refresh the data in an existing workbook by re-executing the query used to originally create the data file. The details of the query are saved within each imported data set, providing additional audit information.

-- Custom Query Builder Wizards -- directly import PK/PD data from supported data management systems, including major commercial LIMS products, using an interactive interface or by loading a saved query.

-- Export to Databases -- save data sets and derived data directly to tables in a data management system, using either an interactive interface or use a predefined export definition file, ensuring secure storage for data sets and analysis results.

A software development kit is also included in the Enterprise Editions, allowing customer IT/IS staff to customize the exiting Custom Query Builders or create additional Custom Query Builder wizards to provide easy access to other PK data sources. Pharsight will also be offering a consulting service to create or customize specialized Custom Query Builders based on customer specifications.

Supported Data Sources

The Enterprise Editions of WinNonlin and WinNonMix support access to data stored in Oracle databases, SAS software data sets version 6.12, the Watson DMLIMS version 6.0 from Pharmaceutical Software Sciences, Inc., and the Integraware Drug Development Suite version 1.0, from Integraware Inc. Required ODBC drivers and database connectivity software are not included with the Enterprise Editions and should be obtained from the database vendor. Additional row-level data sources may be accessed via any ODBC driver compatible with the latest version of Microsoft's Open Database Connectivity (ODBC) API.

Price and Availability

Pharsight's WinNonlin Enterprise Edition version 3.1 will be available in December; WinNonMix Enterprise Edition version 1.1 is scheduled for release in January 2000. Licenses for WinNonlin Enterprise Edition are priced at $4,000 per machine or and $6,000 for concurrent access over a company's network. Licenses for WinNonMix Enterprise Edition are priced at $7,500 per machine or $11,250 for concurrent access over a company's network. There is an annual renewal license fee equivalent to 25% of the license price.

About Integraware Inc.

Integraware is a full-service provider of e-R&D pharmaceutical software solutions. Now in its eighth year of operation, the company has been a key player in the integration of three generations of systems technologies for the pharmaceutical industry. Integraware develops GxP compliant, protocol-driven, study-based software designed to provide support for sample and laboratory management, and to integrate and accelerate bioanalysis, metabolism, pharmacokinetics and clinical activities. While implementing systems for leading drug development and pharmaceutical research companies, Integraware has acquired a skilled team of specialists in both the IT and health care professions. The team has an intimate understanding of both the business issues and challenges facing pharmaceutical researchers in today's competitive global market. Integraware Inc. is headquartered in St. Laurent (Montreal), PQ, Canada with other locations in Philadelphia and Amsterdam. Information about Integraware Inc. is available on the Worldwide Web at http://www.integraware.com.

About Pharmaceutical Software Systems, Inc.

Since 1989, Pharmaceutical Software Systems, Inc. has provided protocol-driven, GLP-Compliant, LIMS software designed to meet the unique needs of a DMPK / Bioanalytical Laboratory environment. Watson fully supports and facilitates the drug development process during Pharmacokinetic and Drug Metabolism / Bioanalytical Studies. Watson manages the entire drug study cycle from study design, assay design, sample handling, shipment tracking and analytical run planning, while also controlling instrument interfaces and regression of standards, analytical performance reports, GLP evaluation, basic PK calculations, sample results in both table and graph formats, and the creation of flexible user defined reports. Information about Pharmaceutical Software Systems, Inc. is available on the Worldwide Web at http://www.psswatson.com.

About Pharsight Corporation

Pharsight Corporation is the leading developer and marketer of software products and consulting services that help to significantly reduce the complexity, cost and duration of the clinical development process. The company's proprietary technology and world-class consulting expertise enable pharmaceutical and biotechnology companies to make more confident decisions in dealing with complex issues of drug development and product portfolio management. Thus Pharsight helps companies derive greater shareholder value by enabling them to make more informed and objective decisions that lead to more successful and predictable trial outcomes. Pharsight's integrated suite of computer-assisted clinical trial design, modeling, forecasting and simulation products are standards in the industry, and are used by the top pharmaceutical companies and many of the leading biotechnology companies. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight Corporation is available on the Worldwide Web at http://www.pharsight.com.

Note: Pharsight and WinNonlin are registered trademarks of Pharsight Corporation. All other trademarks mentioned herein are property of their respective owners.