Pharsight and FDA Collaborate on Critical Path Initiative to Implement State-of-the-Art Infrastructure for Model-Based Drug Development

Pharsight and FDA Collaborate on Critical Path Initiative to Implement State-of-the-Art Infrastructure for Model-Based Drug Development

June 12, 2006

    MOUNTAIN VIEW, Calif., June 12 /Xinhua-PRNewswire/ --
Pharsight Corporation (OTC Bulletin Board: PHST), a leading
provider of software and strategic services designed to
optimize clinical drug development, today announced that it
has entered into a Cooperative Research and Development
Agreement (CRADA) with the Food and Drug Administration's
(FDA) Center for Drug Evaluation and Research (CDER).

    Under the terms of the CRADA, Pharsight will
collaborate with FDA using Pharsight software for the
analysis, visualization, storage, reporting and review of
pharmacokinetic/pharmacodynamic data. Pharsight will make
available a comprehensive suite of software tools,
including Pharsight Knowledgebase Server(TM) (PKS(TM)), PKS
Validation Suite(TM), WinNonlin(R) Validation Suite(TM),
Drug Model Explorer(TM) (DMX(R)) and Pharsight Trial
Simulator(TM). FDA will use the Pharsight tools to review
clinical trial data, especially for clinical pharmacology
and clinical safety reviews, and will provide feedback to
Pharsight.

    The collaboration directly supports the 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.  The
purpose of the collaboration is to develop 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.  Pharsight will utilize the FDA's feedback from
the collaboration to further develop and customize PKS to
meet industry analysis requirements, and further develop
DMX to support Agency-sponsor interactions for the
visualization and communication of model-based product
profiles.

    "This collaboration between Pharsight and FDA
supports the Critical Path initiative to improve the
productivity and efficiency of the drug development
process," said Shawn O'Connor, president and chief
executive officer of Pharsight. "With the increasing
costs of new drug development, the FDA recognizes the
importance of utilizing innovative technologies, including
Pharsight's data management and modeling and simulation
tools, to accelerate review and increase the number of new,
safe and effective therapies available to patients."

    "This agreement is concrete evidence of the FDA's
commitment to the Critical Path Initiative," said Dr.
Robert Powell, Head of Pharmacometrics in FDA's Office of
Clinical Pharmacology.  "We believe these tools will
help us in applying model-based drug development skills to
regulatory decisions, recommendations and knowledge
sharing. Building the various model types (disease,
placebo, dropout, drug efficacy/safety) requires software
tools to acquire, preserve and share data and models in our
high-speed environment. Data standardization such as CDISC
(cdisc.org) and software tools are an important foundation
for our work. We are looking forward to evaluating and
employing these tools and we encourage further innovation
in this area."

    About Pharsight Corporation 

    Pharsight Corporation develops and markets products and
services that help pharmaceutical and biotechnology
companies improve their decision-making in drug development
and commercialization. By integrating scientific, clinical
and business decision criteria into a dynamic, model-based
methodology, Pharsight helps its customers optimize the
value of their drug development programs and portfolios
from discovery to post-launch marketing and any point in
between. Pharsight uses computer-based drug-disease models,
dynamic predictive market models, clinical trial simulation
and advanced valuation models to create a continuously
evolving view of its customers' development efforts and
product portfolios. This enables decision makers to make
explicit value-driven trade-offs throughout the development
and commercialization process. Pharsight Corporation is
headquartered in Mountain View, California. Information
about Pharsight is available on the World Wide Web at
http://www.pharsight.com . 

    Safe Harbor 

    This press release contains forward-looking statements
that involve risks and uncertainties, including statements
regarding Pharsight's anticipated software product
development and performance. Actual results may differ
materially from Pharsight's expectations due to a variety
of factors, including general market and business
conditions, uncertainties involved in pharmaceutical drug
development, changes in Pharsight's research and
development focus or operating strategies, the failure to
develop new products and services or to keep pace with
technological advancements, delays in the release of new
products and services, the failure of the market for
Pharsight's products and services to develop as expected,
and changes in government regulation of the pharmaceutical
industry. Further information on potential factors that
could affect actual results is included in Pharsight's
Quarterly Report on Form 10-Q, as filed with the Securities
and Exchange Commission on February 13, 2006. All
forward-looking statements are based on information
available to Pharsight as of the date hereof, and Pharsight
assumes no obligation to update such statements, whether as
a result of new developments or otherwise. 

    NOTE:  Pharsight, Pharsight Knowledgebase Server, PKS,
PKS Validation Suite, Drug Model Explorer, DMX, WinNonlin,
WinNonlin Validation Suite and Trial Simulator are
trademarks or registered trademarks of Pharsight
Corporation. 

    For more information, please contact:

    Investors contact: 

     Douglas Sherk or Jennifer Beugelmans, 
     EVC Group
     Tel: [phone]

    Media contact:

     Steve DiMattia, 
     EVC Group
     Tel: [phone]

     Web:  http://www.pharsight.com

SOURCE  Pharsight Corporation