MOUNTAIN VIEW, Calif., July 31, 2008 (PRIME NEWSWIRE) -- Pharsight Corporation (Nasdaq:PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that a global biotechnology company has purchased WinNonlin AutoPilot(tm) to use in conjunction with its licenses of WinNonlin and Pharsight Knowledgebase Server(tm) (PKS(tm)). The customer is the seventh company to adopt WinNonlin AutoPilot.
WinNonlin AutoPilot is configurable software that pre-clinical and clinical research scientists can use to automate common or repetitive tasks during clinical pharmacokinetic (PK) analysis, thus saving time in the generation of report-ready tables, charts, listings, and graphs. Using WinNonlin AutoPilot, companies can increase their productivity while improving the quality and consistency of analyses and reports. The customer already benefits from the use of PKS to store study data and results in a single, secure, accessible repository for PK/PD data. Adding WinNonlin AutoPilot moves the firm toward Pharsight's best practices paradigm for integrated PK/PD analysis, data management and reporting.
"The purpose of AutoPilot is to increase efficiency in the generation of standardized tables, figures, and listings for regulatory analysis and reporting, while improving scientific productivity by reducing non-research related activities such as data acquisition and report formatting," said Shawn O'Connor, chairman, CEO, and president of Pharsight.
About WinNonlin AutoPilot
AutoPilot orchestrates PK analyses by selecting input data from a user's local file system or Pharsight Knowledgebase Server ("PKS"), and then directs WinNonlin to perform analyses and produce report quality tables, figures, and text output (e.g., in Microsoft(r) Excel(tm), SigmaPlot(r), and Microsoft Word(tm)) for regulatory submissions and interim reports. Formatted PK analyses outputs must reflect the requirements and SOPs of each research organization, and WinNonlin AutoPilot provides a user interface that allows extensive configuration of formatting and business rules to enable clear communication of standards and immediate use across the organization. PK analyses that can be automated include noncompartmental analysis for different study designs and inferential statistics (e.g., bioequivalence testing), as well as comparisons between analytes, dose routes or other conditions. Used in conjunction with PKS and PKS Reporter(tm), WinNonlin AutoPilot provides standardized, regulatory compliant, secure and automatic generation of routine analyses and reports. Used independently of PKS and PKS Reporter, WinNonlin AutoPilot can provide significant return on investment through productivity gains and quality improvements in PK analysis and reporting.
About PKS
The Pharsight Knowledgebase Server (PKS) is a high-productivity, regulatory-compliant enterprise data management system. PKS is now installed in 22 major pharmaceutical and biotechnology companies and also at FDA in connection with an extensive Pharsight-FDA Cooperative Research and Development Agreement. PKS enables pharmaceutical and biopharmaceutical companies to better manage and control preclinical and clinical kinetic and dynamic data and analyses. Companies use PKS to build pharmacokinetic and pharmacodynamic (PK/PD) data management architecture compliant with FDA regulation 21 CFR Part 11, which has set new standards for computer system validation and usage. The PKS software is designed to complement Pharsight's modeling and simulation technology for computer-based drug-disease modeling and clinical trial simulation. PKS supports analysis in leading tools such as WinNonlin, NONMEM(r), and SAS(r) as well as connectivity to LIMS such as Watson LIMS.
About Pharsight Corporation
Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. The company's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products.
Pharsight's approach enhances the fundamental element of drug development success: strong decision-making. By adopting the Pharsight approach, customers acquire a new decision-making process with the potential to systematically improve every level and phase of their business and scientific processes. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight is available at http://www.pharsight.com.
Forward Looking Statements
The statements in this press release related to the performance of Pharsight products are forward looking statements. Forward-looking statements are inherently speculative, and actual results may differ materially from Pharsight's expectations due to a variety of factors, including: changes in FDA regulations may affect the demand for the product; and customers may not perceive the benefits of the product to be the same as Pharsight believes them to be. Other risk factors relating to Pharsight are disclosed in the company's most recent Form 10-Q filed with the Securities and Exchange Commission on June 30, 2008. All forward-looking statements are based on information available to the company on the date hereof, and the company assumes no obligation to update such statements.
Registered Trademarks and Trademarks
Pharsight, Pharsight Knowledgebase Server, PKS, WinNonlin, WinNonlin AutoPilot, and IVIVC Toolkit for WinNonlin are trademarks or registered trademarks of Pharsight Corporation. NONMEM, Word, Excel, Watson, and SAS are trademarks or registered trademarks of their respective holders.