PMDA Adds Licenses of GastroPlus®

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

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190521005222/en/

Simulations Plus Investor RelationsMs. Renee Bouche661-723-7723renee@simulations-plus.com

Hayden IRMr. Cameron Donahue651-653-1854cameron@haydenir.com

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