Simulations Plus Receives New Grant Award from the FDA

Novel PBPK/PD modeling strategies for ophthalmic drug products will inform regulatory decision-making

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 notice from the U.S. Food and Drug Administration (FDA) that it has been awarded a new funded cooperative agreement, for up to $400,000 over three years, to develop physiologically based pharmacokinetics/pharmacodynamics (PBPK/PD) approaches to support interspecies translation for ocular drug delivery in GastroPlus^®.

“The FDA’s Office of Generic Drugs (OGD) continuously evaluates alternatives to conventional bioequivalence approaches to determine the likelihood that a new locally-acting formulation will be bioequivalent to an approved dosage form in the target patient population,” said Dr. Viera Lukacova, Director of Simulation Sciences for Simulations Plus. “Through this grant, we will work with the FDA to improve the well-established Ocular Compartmental Absorption and Transit™ (OCAT™) model within the GastroPlus software platform to validate new strategies to establish scientific and regulatory standards for supporting innovative development and performing bioequivalence assessments for ocular drug products through PBPK/PD modeling and simulation. We look forward to working with the FDA and our industry partners on this important project.”

Under the cooperative agreement, FDA scientific and program staff will assist and participate in project activities in a partnership role with several leading pharmaceutical and generic drug companies. Drs. Jessica Spires and Maxime Le Merdy will serve as project leads and have primary responsibility for the scientific, technical, and programmatic aspects of the award.

John DiBella, President of the Lancaster division for Simulations Plus, added: “Our relationship with the FDA on enhancements to the OCAT model dates back to 2014, and the funding, scientific interactions, and resulting publications have established it as the preeminent in silico approach in the area of absorption of drugs applied to the eye. Similar to previous awards, Simulations Plus will own all intellectual property developed within the GastroPlus program, and updates will be integrated into future versions and made available to clients. We continue to invite future collaborations to drive advances to modeling and simulation science which benefit our entire user community and, most importantly, the patients that we serve.”

Funding for this collaboration is made possible by the Food and Drug Administration through grant 1U01FD006927-01. 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/development software and 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 used to conduct drug research by major pharmaceutical, biotechnology, chemical, 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 provider for physiologically based pharmacokinetic modeling and simulation. Visit us online 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.

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Contacts

Simulations Plus Investor Relations
Ms. Renee Bouche

661-723-7723

renee@simulations-plus.com

Hayden IR
Mr. Cameron Donahue

651-653-1854

slp@haydenir.com