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Simulations Plus : US FDA Procures DILIsym Software License Package

05/08/2018 | 08:30am EDT

US FDA Continues Its Goal of Propelling Model-Based Drug Development Forward

DILIsym Services, Inc., a Simulations Plus company (NASDAQ: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety, today announced that the U.S. Food and Drug Administration has secured an annual government license for its flagship QSP (quantitative systems pharmacology) modeling software, DILIsym®.

DILIsym is the product of an ongoing public-private partnership (the DILI-sim Initiative – www.DILIsym.com) that involves scientists from the pharmaceutical industry, academia and the FDA. The software incorporates properties determined in the laboratory for new drug candidates to predict whether they will be safe for the liver in patients. The use of modeling and simulation tools like DILIsym is being promoted by FDA Commissioner Dr. Scott Gottlieb to improve the efficiency of drug development (https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/).

Dr. Paul Watkins, chair of the DILI-sim Scientific Advisory Board, said: “Since the inception of the DILI-sim Initiative to drive the development of DILIsym, our stated goal has always been widespread evaluation and use of the DILIsym software. We are excited to see this mission moving forward through this licensing arrangement with the FDA.”

Dr. Brett Howell, President of DILIsym Services, added: “The number of pharmaceutical and biotech companies now benefitting from DILIsym in the first part of 2018 has nearly doubled over all of 2016. Investigations have included analyses comparing lead and backup compounds, comparing the company’s compound with a competitor, combination therapy analysis, safety prediction for a new dose for opening a new IND, biomarker safety analysis for review board and regulatory presentations, hepatocyte loss simulations, and mechanistic analysis of compounds based on safety concerns, among others. The information from such studies serves to guide go/no-go decisions on major projects, potentially avoiding the disastrous financial effects of failed clinical trials or better, providing assurances that drug-induced liver injury will not be an insurmountable obstacle to establishing the safety of a new compound or dose. Getting more FDA reviewers trained on and using the platform will be very helpful as they evaluate the liver safety of new drugs.”

About DILIsym Service, Inc.

DILIsym Services, Inc. was founded in 2015 in Research Triangle Park, North Carolina, and is the leading provider of drug-induced liver injury simulation software and related consulting services to the pharmaceutical industry. The company spun out of the former Hamner Institutes, acquiring all of the intellectual property, software, documentation, and other materials for the DILIsym software. The company’s other products include MITOsym® for simulating in vitro mitochondrial function and NAFLDsym™ for the study of nonalcoholic fatty liver disease – a worldwide disease with few available treatment options. More information is available on the company’s Web site at https://www.dilisym.com.

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. The company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. Our software is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology 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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