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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. (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™.

Dr. 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.”

John DiBella, 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 services 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 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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