MOUNTAIN VIEW, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Pharsight Corporation , a leading provider of software, strategic, and regulatory services for optimizing clinical drug development, today announced that it has more than 100 customers of the IVIVC Toolkit for WinNonlin globally. The IVIVC Toolkit, released in January 2007, is an optional add-on to WinNonlin that extends its capabilities beyond pharmacokinetic, pharmacodynamic, and non-compartmental analysis to the development and application of in vitro-in vivo correlations.
“The IVIVC Toolkit enables customers to reduce the amount of expensive in vivo testing during early-stage drug development,” said Shawn O’Connor, president, CEO, and chairman of Pharsight. “In addition to top 50 pharmaceutical companies such as Servier and Pfizer, we are also seeing adoption by smaller and mid-sized companies. Many of these companies attended our July webinar titled ‘IVIVC Applications and Case Studies.’ By providing a tool for users to develop in vivo-in vitro correlations inside the WinNonlin environment, we have expanded our addressable market by creating functionality that will appeal to a new group of customers working in formulation development, line extension, and generic drug development. We believe this expanded market could also potentially drive demand for other Pharsight products, as we have seen that customers with multiple WinNonlin licenses are likely to adopt our enterprise products, including WinNonlin AutoPilot(TM) and Pharsight Knowledgebase Server(TM) (PKS(TM)), our enterprise repository for pharmacokinetic and pharmacodynamic data management.”
About IVIVC Toolkit for WinNonlin
Leveraging WinNonlin’s powerful modeling engine, the IVIVC Toolkit allows scientists to build customized models to relate a drug formulation’s dissolution characteristics to the in vivo pharmacokinetic (drug concentration) profile. A validated IVIVC can be used to help predict in vivo behavior of a formulation to assess the likelihood of success before entering it in a biostudy. With the IVIVC Wizard(TM) (provided as part of the IVIVC Toolkit) scientists can quickly explore their data and find a suitable model. The IVIVC Wizard also manages the data and workflow, allowing the project files to be shared amongst various working groups while keeping track of the status of the work. In conjunction with PKS, the IVIVC Toolkit can be used as part of a workflow compliant with CFR 21 part 11.
About Pharsight Knowledgebase Server (PKS)
PKS is a high-productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. PKS enables pharmaceutical and biotechnology companies to better manage and control preclinical and clinical PK/PD data and analyses, thus supporting higher modeling productivity as called for in the FDA’s Critical Path Initiative. Companies also use PKS to build PK/PD data management architecture that complies with the FDA’s regulation 21 CFR Part 11, which has set new standards for computer system validation and usage. PKS is directly integrated with WinNonlin Enterprise, Pharsight’s industry-leading PK/PD modeling and analysis tool, for state-of-the-art modeling and analyses, and supports direct access to any ODBC-capable data source. PKS also supports analysis with leading tools such as NONMEM(R), and SAS(R), and data import from leading clinical data management and laboratory information management systems such as Watson LIMS(TM). PKS software is designed to complement other Pharsight products, including Trial Simulator(TM) and Drug Model Explorer(R) (DMX(R)), which are used for computer-based drug-disease modeling, clinical trial simulation, and drug model visualization.
About WinNonlin AutoPilot
WinNonlin AutoPilot orchestrates PK analyses by selecting input data from a user’s local file system or PKS, and then directs WinNonlin(R) to perform analyses and produce report-quality tables, figures, and text output (e.g., in Microsoft (R) Excel, SigmaPlot(R), and Microsoft(R) Word) 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 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 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 potential benefits and demand of Pharsight software 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 August 13, 2007. 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, WinNonlin AutoPilot, Pharsight Knowledgebase Server, PKS, PKS Reporter, IVIVC Toolkit, IVIVC Wizard, Trial Simulator, Drug Model Explorer, DMX, and WinNonlin are trademarks or registered trademarks of Pharsight Corporation. NONMEM, SAS, Watson LIMS are trademarks or registered trademarks of their respective holders.
CONTACT: Investors, Jennifer Beugelmans, +1-646-201-5447, or Douglas
Sherk, +1-415-896-6820, or Media, Jennifer Saunders, +1-646-201-5431, all
of the EVC Group, for Pharsight Corporation
Web site: http://www.pharsight.com/
