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Simulations Plus Expands Marketing and Sales Operations in South America Through Partnership with the Institute of Pharmaceutical Sciences

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New distribution channel will accelerate adoption of software and services in emerging markets

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has entered into a distribution agreement with the Institute of Pharmaceutical Sciences (ICF) to provide marketing, sales, and technical support to organizations within South America.

Founded in 2002, ICF is one of the largest pharmaceutical research centers in Latin America and the first commercial Brazilian laboratory to be fully certified by the Brazilian Health Regulatory Agency (ANVISA) to conduct bioavailability and bioequivalence trials. In addition to running clinical trials, ICF has expertise developing complex formulation products such as patches, nasal sprays, and inhalers for organizations globally. With a staff of over 200 highly qualified scientists, ICF will provide extensive connections throughout industry, academia, and regulatory agencies to increase awareness of GastroPlus®, ADMET Predictor®, and related services from Simulations Plus.

"Even though South America has emerged as a global manufacturing hub, with expanded research facilities for pharmaceutical and generic drug companies, the use of model-informed drug development (MIDD) is in its infancy," said Dr. Leonardo de Souza Teixeira, CEO of ICF. "We are very happy forming this partnership with Simulations Plus to spread the knowledge and application of MIDD to support regulatory interactions."

"Latin America is one of the fastest growing generic drug markets in the world and expected to reach $48 billion in size by 2025," added John DiBella, Simulations Plus division president. "To capitalize on this opportunity, especially in the areas of specialty products and non-oral drug delivery systems, we are excited to be partnering with ICF, an established contract research organization (CRO) leader with strong relationships throughout Brazil and neighboring countries. We expect ICF’s expertise administering laboratory testing and clinical studies to complement our offerings to companies throughout the continent and, as a bonus, provide Simulations Plus with new research opportunities to continue advancing modeling and simulation science."

About Simulations Plus, Inc.
Simulations Plus, Inc. is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions. With our subsidiaries, Cognigen, DILIsym Services, and Lixoft, we offer solutions which bridge machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide. 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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View source version on businesswire.com: https://www.businesswire.com/news/home/20210126005222/en/

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