MOUNTAIN VIEW, Calif., May 22 /PRNewswire-FirstCall/ -- Pharsight Corporation , a leading provider of software and strategic services for optimizing clinical drug development, today announced that a leading human therapeutics company in the biotechnology industry has become a customer for the Pharsight(R) Knowledgebase Server(TM) (PKS(TM)). The total number of PKS agreements with leading pharmaceutical and biotechnology companies is now 17. The new customer will also upgrade its existing licenses of WinNonlin(R), Pharsight's tool for non-compartmental analysis of pharmacokinetic and pharmacodynamic (PK/PD) data. The customer will use PKS as a central repository for PK/PD data and will access PKS from R&D sites worldwide.
"We believe PKS adoption continues to be driven by the FDA's call for more modeling and simulation in the Critical Path Initiative, the rising costs of drug development, and the need for regulatory-compliant PK/PD data management," said Shawn O'Connor, president, chief executive officer, and chairman of Pharsight. "Pharsight will continue to work with major pharmaceutical and biotechnology companies to realize the benefits of compliant, productive PK/PD data management supporting more and better PK/PD modeling."
About 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. The PKS software is designed to complement Pharsight's modeling and simulation products, including Trial Simulator(TM) and Drug Model Explorer(TM) (DMX(R)), which are used for computer-based drug-disease modeling clinical trial simulation, and drug model visualization. PKS also supports analysis in leading tools such as WinNonlin(R), NONMEM(R), and SAS(R), and data import from leading clinical data management and laboratory information management systems such as Watson LIMS(TM).
About WinNonlin
WinNonlin is the industry standard for pharmacokinetic, pharmacodynamic, and noncompartmental analysis. In addition to its extensive library of built-in PK, PD and PK/PD models, WinNonlin supports custom, user-defined models to address any kind of data.
WinNonlin provides a complete solution with data management, statistical, modeling, and visualization tools in one package. Its worksheet interface facilitates data handling and transformations. Its descriptive statistics and linear mixed effects modeling engines provide flexible pre- and post-modeling analyses. The bioequivalence wizard supports FDA standards for average, individual and population bioequivalence assessment. Additional tools enable exploration of a drug's properties through non-parametric superposition, semicompartmental modeling, deconvolution and nonparametric analysis of crossover studies. Finally, WinNonlin's chart and table wizards, and automatic chart output from modeling, produce high-quality output for study reports.
About DMX
DMX(R) is a software visualization and communication tool to explore model-based results of a compound's product profile. Through the DMX interface the development team can address key strategic development questions by comparing probabilistic outcomes for different endpoints, treatment strategies, and patient populations, against competing products. DMX results are presented as a series of plots and tables that can be quickly updated based on pre-simulated models of clinical effect. Results are accessible from networked desktop or laptop computers for individual exploration, interactive team discussion, and communication of development strategies and program alternatives with senior decision-makers.
About Trial Simulator
Pharsight Trial Simulator balances ease-of-use with patented technology for defining and testing interactive drug models, exploring and communicating study design attributes, and performing statistical and sensitivity analysis through graphical and statistical summaries. Trial Simulator models encapsulate existing scientific knowledge, to help the entire clinical development team communicate and test ideas, and plan relevant, effective trials for every phase of clinical testing. Pharsight Trial Simulator helps development teams anticipate risks and preview the range of expected trial results before R&D dollars are committed to further development of a drug, and human subjects are exposed to experimental therapies. Development team members of diverse disciplines use Pharsight Trial Simulator to conduct a series of "what if" simulations comparing different trial, patient and drug activity scenarios. By varying simulation input parameters, development teams can test the impact on trial results of changes in known information, assumptions about the drug and subjects, and variations in the trial design.
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 design and performance of the Pharsight Knowledgebase Server product 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 Pharsight Knowledgebase Server 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. 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(R) WinNonlin(R), and DMX(R) are registered trademarks and Pharsight(R) Knowledgebase Server(TM), Drug Model Explorer(TM), PKS(TM), and Pharsight Trial Simulator(TM) are trademarks of Pharsight Corporation. NONMEM(R), Watson LIMS(TM) and SAS(R) are trademarks or registered trademarks of their respective holders.
Pharsight CorporationCONTACT: investors, Douglas Sherk, +1-415-896-6820, or JenniferBeugelmans, +1-415-896-6820, or media, Steve DiMattia, +1-646-277-8706, allof EVC Group
Web site: http://www.pharsight.com//
