PMDA Adds Licenses of GastroPlus®

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

LANCASTER, CA, May 21, 2019 - 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.

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