Pharsight Signs Another Major Japanese Pharmaceutical Company as PKS(TM) Customer
MOUNTAIN VIEW, Calif., Sept. 11 /PRNewswire/ — Pharsight Corporation, a leading provider of software and strategic services for optimizing clinical drug development, today announced that it has signed another Top 50 Pharmaceutical company as a Pharsight Knowledgebase Server (PKS(TM)) customer. The company, one of the largest global healthcare companies headquartered in Japan, has signed an agreement for PKS user licenses and associated services. This new agreement brings Pharsight’s total number of PKS customers to 18. The new customer will also upgrade its existing licenses of WinNonlin®, Pharsight’s tool for non-compartmental analysis of pharmacokinetic and pharmacodynamic (PK/PD) data. The new PKS customer will use PKS as a central repository for PK/PD data and will access PKS from research and development sites in the US and Japan.
“This agreement is a positive milestone in our strategy to expand our presence in the Japanese market,” said Shawn O’Connor, president, chief executive officer, and chairman of Pharsight. “Modeling and simulation, on a global scale, continues to gain traction as an important part of the drug development process. The Food and Drug Administration’s emphasis on the implementation of this development methodology, coupled with a number of tangible benefits of modeling and simulation such as cost savings, continue to drive adoption. The productive, compliant PK/PD data management that PKS provides is fundamental to model-based drug development.”
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® (DMX®), 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®, NONMEM®, and SAS®, and data import from leading clinical data management and laboratory information management systems such as Watson LIMS(TM).
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 and benefit of the Pharsight® Knowledgebase Server (PKS) ‘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 the services 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 14, 2006. 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, 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.
