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Simulations Plus Receives New Grant Award from the FDA

September 12, 2018

LANCASTER, Calif.--(BUSINESS WIRE)--Sep 12, 2018--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 $250,000 per year for up to two years, to integrate drug product quality attributes into the mechanistic Transdermal Compartmental Absorption and Transit (TCAT™) model in GastroPlus™.

Dr. Viera Lukacova, director – simulation sciences, said: “We have had the pleasure of working with the FDA over the past 4 years on different funded research programs, and we are delighted to have earned their confidence, through a competitive bidding process, to extend our relationship with another project. This grant award will focus on the incorporation of drug product quality attributes into dermal physiologically-based pharmacokinetic (PBPK) models developed for dermatological topical dosage forms and transdermal delivery systems. The TCAT model in GastroPlus is already heavily utilized within the different markets we serve to support internal research and development activities. We expect the developments under this new agreement will aid the FDA and other regulatory agencies in developing guidelines and policies in the area of drug absorption from dermal products.”

Under the cooperative agreement, FDA scientific and program staff will assist and participate in project activities in a partnership role with a number of leading pharmaceutical, generic, cosmetic, and contract research organizations as part of the newly formed Consortium for Dermal Absorption Modeling (CDAM). Dr. Jessica Spires, senior scientist II, will serve as principal investigator and have primary responsibility for the scientific, technical, and programmatic aspects of the award, and for the day-to-day management of the project.

John DiBella, president – Lancaster division, added: “This new award nicely complements the activities we are doing as part of the previously announced funded collaboration with the large European consortium, and the end product will result in a comprehensive, cross-market dermal absorption/PBPK modeling platform that supports product development and risk assessment activities. 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 as an optional add-on module. We cannot wait to get started working with the FDA and CDAM on this important project.”

Funding for this collaboration is made possible by the Food and Drug Administration through grant 1U01FD006526-01. 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 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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View source version on businesswire.com:https://www.businesswire.com/news/home/20180912005093/en/

CONTACT: Simulations Plus Investor Relations

Ms. Renee Bouche

661-723-7723

renee@simulations-plus.com

or

Hayden IR

Mr. Cameron Donahue

651-653-1854

cameron@haydenir.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL RESEARCH FDA SCIENCE

SOURCE: Simulations Plus, Inc.

Copyright Business Wire 2018.

PUB: 09/12/2018 08:30 AM/DISC: 09/12/2018 08:30 AM

http://www.businesswire.com/news/home/20180912005093/en

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