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

Mountain View, California (ots/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 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.

Web site: http://www.pharsight.com

Originaltext: Pharsight Corporation
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Pressekontakt:
Investors, Douglas Sherk or Jennifer Beugelmans, +1-415-896-6820, or
media, Steve DiMattia, +1-917-620-0590, all of EVC Group, for
Pharsight Corporation