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FDA and Pharsight Continue to Collaborate Under CRADA

FDA Modeling and Simulation Infrastructure Now Incorporates Three Pharsight


MOUNTAIN VIEW, Calif., Dec. 11 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today provided an update on its Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). The CRADA collaboration directly supports FDA's Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug product development process.

Since the initiation of the five-year CRADA in June 2006, Pharsight has successfully worked with FDA to install Pharsight(R) Knowledgebase Server(TM) (PKS(TM)) into the Agency's IT environment. PKS is a market-leading, high- productivity, regulatory-compliant enterprise data repository that manages modeling and simulation data. Pharsight has conducted training classes for FDA staff on PKS and has also trained FDA staff on WinNonlin(R) and Trial Simulator(TM), which FDA had previously installed. Pharsight has also introduced Drug Model Explorer(R) (DMX(R)) to FDA.

Importantly, Pharsight has worked with FDA to streamline the process of loading data from New Drug Applications (NDAs) into PKS by integrating the FDA's internal data management tools with Pharsight's PKS data connector technology. This integration allows FDA reviewers to build analysis datasets from NDAs submitted in Clinical Data Interchange Standards Consortium (CDISC) and non-CDISC formats. These analysis datasets can then be imported into WinNonlin or PKS. FDA expects to use these installed Pharsight tools to review clinical trial data, especially for clinical pharmacology and clinical safety reviews, and will provide feedback to Pharsight.

"We remain excited about our ongoing collaboration with FDA and reaching our common goal of developing PKS into a repository for the vast amount of data needed for modeling and simulation projects," said Shawn O'Connor, president, CEO, and chairman of Pharsight. "We look forward to FDA's feedback on our other software tools, which should provide valuable insight as we continue to introduce enhancements to our existing products and launch new innovative tools. Currently, we are utilizing the Agency's feedback to further customize PKS to meet industry data management and analysis needs. We believe that our software tools offer tremendous value to drug developers and believe that FDA's positive engagement in our CRADA underscores this belief. Pharsight has already gained valuable insights by interacting with FDA through our CRADA and expects to continue to benefit from this relationship in the future."

Under the terms of the five-year CRADA, initiated in June 2006, Pharsight is collaborating with FDA using Pharsight software for the analysis, visualization, storage, reporting and review of pharmacokinetic/pharmacodynamic (PK/PD) data. A focal point of the collaboration is to develop Pharsight's enterprise PK/PD data management system, PKS, into a repository for the data needed for modeling and simulation, support Clinical Data Interchange Standards Consortium (CDISC) data formats, and interact with other FDA databases.

About PKS

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 FDA's Critical Path Initiative. Companies also use PKS to build PK/PD data management architecture that complies with 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 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. Pharsight'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

Forward Looking Statements

The statements in this press release related to the functionality, performance, and benefits of the Pharsight software 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 and customers may not perceive the benefits of PKS 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 November 9, 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, Pharsight Knowledgebase Server, PKS, Drug Model Explorer, DMX, Trial Simulator and WinNonlin are trademarks or registered trademarks of Pharsight Corporation. All other brand or product names mentioned in this documentation are trademarks or registered trademarks of their respective companies or organizations.

SOURCE Pharsight Corporation
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