Market Overview

Simulations Plus Extends Funded Research Collaboration with the FDA


New functionality to mechanistic ocular absorption model in
GastroPlus™ supports FDA's future Innovation Initiative

Simulations Plus, Inc. (NASDAQ:SLP), the leading provider of modeling
and simulation solutions for the pharmaceutical, biotechnology,
chemicals, and consumer goods industries, today announced that it has
entered into a one-year funded extension to its previous cooperative
agreement (grant 1U01FD005211) with the U.S. Food and Drug
Administration (FDA) to further develop and validate the mechanistic Ocular
Compartmental Absorption and Transit (OCAT™)
model in GastroPlus™.

Viera Lukacova
, director – simulation sciences, said: "After the
successful completion of tasks outlined in the initial three-year
cooperative agreement, we are very pleased to have the opportunity to
continue working with the FDA to incorporate additional functionality
into our mechanistic ocular absorption model which will aid companies,
both innovator and generic, as they design new treatments and products
for various eye disorders. The model is already being utilized within
the industry to support internal research and development activities,
and we anticipate results from our technology will soon be helping to
inform regulatory interactions."

, president – Lancaster division, added: "This award funds
additional development services and demonstrates the FDA's confidence
that GastroPlus provides a sound basis for related drug and formulation
characteristics for ocular dosage forms. The outcomes from this
additional work will be integrated into the next versions of GastroPlus
and will continue to be made available to clients in the $22
billion (and growing) ophthalmic drug market
as an optional add-on
module. We look forward to continued collaboration with the FDA on the
next-generation ocular absorption modeling platform."

Views expressed in this press release do not necessarily reflect the
official policies of the Department of Health and Human Services; nor
does any mention of trade names, commercial practices, or organization
imply endorsement by the United States Government.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and
development software as well as a leading provider of both preclinical
and clinical pharmacometric consulting
for regulatory submissions and quantitative
systems pharmacology models
for drug-induced liver injury and nonalcoholic
fatty liver disease
. The company is a global leader focused on
improving the ways scientists use knowledge and data to predict the
properties and outcomes of pharmaceutical, biotechnology, and chemical
agents. Our software is licensed to and used in the conduct of drug
research by major pharmaceutical, biotechnology, chemical, and consumer
goods companies and regulatory agencies worldwide. Our innovations in
integrating new and existing science in medicinal chemistry,
computational chemistry, pharmaceutical science, biology, and physiology
into our software have made us the leading software provider for
physiologically based pharmacokinetic modeling and simulation. For more
information, visit our website at

Safe Harbor Statement Under the Private Securities Litigation Reform
Act of 1995
– With the exception of historical information, the
matters discussed in this press release are forward-looking statements
that involve a number of risks and uncertainties. Words like "believe,"
"expect" and "anticipate" mean that these are our best estimates as of
this writing, but that there can be no assurances that expected or
anticipated results or events will actually take place, so our actual
future results could differ significantly from those statements. Factors
that could cause or contribute to such differences include, but are not
limited to: our ability to maintain our competitive advantages,
acceptance of new software and improved versions of our existing
software by our customers, the general economics of the pharmaceutical
industry, our ability to finance growth, our ability to continue to
attract and retain highly qualified technical staff, our ability to
identify and close acquisitions on terms favorable to the Company, and a
sustainable market. Further information on our risk factors is contained
in our quarterly and annual reports and filed with the U.S. Securities
and Exchange Commission.

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