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PMDA Adds Licenses of GastroPlus®

May 21, 2019 Off By BusinessWire

Japanese government organization to train reviewers to efficiently
analyze PBPK model submissions

LANCASTER, Calif.–(BUSINESS WIRE)–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
received an order from the Pharmaceuticals and Medical Devices Agency
(PMDA) in Japan to add licenses to its GastroPlus^® software
suite.

John
DiBella, Lancaster division president for Simulations Plus, said:
“The adoption of physiologically based pharmacokinetic (PBPK) modeling
to support various applications during the drug development process has
increased over the years, partly driven by encouragement from global
regulatory agencies. The U.S. Food and Drug Administration (FDA) and
European Medicines Agency (EMA) have led these efforts, and it is
exciting to see PMDA invest in the GastroPlus platform in anticipation
of more submissions coming to them for review. This news is most
welcomed by the >30, and growing, domestic Japanese pharmaceutical
companies that have been utilizing our technologies for years, as they
will hopefully engage more frequently with PMDA to identify how the
simulation results can potentially be applied to reduce time to market
and get medicines to patients more cost effectively.”

Views expressed in this press release do not necessarily reflect the
official policies of the Pharmaceuticals and Medical Devices Agency; nor
does any mention of trade names, commercial practices, or organization
imply endorsement by the Japanese 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
services for regulatory submissions and quantitative
systems pharmacology models for drug-induced
liver injury, drug-induced
kidney injury, and nonalcoholic
fatty liver disease. 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 www.simulations-plus.com.

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.