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Simulations Plus Enters into New Research Collaboration Agreement with the FDA

July 16, 2019 Off By BusinessWire

Center for Veterinary Medicine to apply GastroPlus® to assess product bioequivalence in canines

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 entered into a new five-year Research Collaboration Agreement with the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine to evaluate alternative approaches for determining product bioequivalence (BE) for locally-acting drugs in animals.

“It is always exciting to announce ground-breaking collaborations with the FDA and reinforce our partnership as we advance science in new areas,” said Viera Lukacova, director of Simulation Sciences for Simulations Plus and principal investigator on the project. “Under this agreement, the FDA, using GastroPlus with in vitro and in vivo data, will investigate how BE of non-systemically absorbed products can be evaluated in canines without the need for clinical endpoint trials. Ideally, through verification of the methods and results, a framework can be provided to support these approaches for other drugs.”

John DiBella, Lancaster division president for Simulations Plus, added, “Our technology is already assisting companies and regulatory agencies with the ‘3 Rs’: reducing, replacing, and/or refining animal use. We look forward to these interactions with the FDA staff to better understand model performance on additional veterinary medicines and identify further advances to the GastroPlus platform to support biowaiver applications.”

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.