FDA’s Office of New Drug Products Places Order for 50 Additional Licenses to GastroPlus™

Software: GastroPlus®
Division: Simulations Plus

Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of consulting services and software for pharmaceutical discovery and development, today announced that the U.S. Food and Drug Administration’s (FDA) Office of New Drug Products, Division of Biopharmaceutics has placed an order for 50 additional licenses to the Company’s GastroPlus™ software. This brings to 70 the total number of GastroPlus licenses in use at the FDA. The licenses are spread across various divisions, including the Office of Generic Drugs, Center for Veterinary Medicine, Office of Clinical Pharmacology, and the National Center for Toxicological Research.

John DiBella, vice president of marketing and sales for Simulations Plus, said, “We are very pleased with the expanding use of our software products by regulatory agencies. The FDA Office of Generic Drugs has purchased 10 licenses to GastroPlus for many years. One of the reasons for an order for additional licenses of this magnitude is to meet the needs of other FDA divisions to review an increasing number of regulatory submissions referencing GastroPlus modeling. Scientists at the FDA want to understand how they can encourage more use of the software program to address questions related to complex drug product behaviors.”

Simulations Plus also recently announced that the company has been awarded a second cooperative agreement from the FDA for $200,000 per year for up to three years. This award is in addition to another project the company was awarded by the FDA last year, and which was recently renewed for the second year. This new project is for “Development of PBPK simulations for long-acting injectable microspheres.”

Dr. Ted Grasela, president of Simulations Plus and its wholly owned subsidiary, Cognigen, said, “We are pleased to build on our relationships with the FDA and industry-wide recognition of the value of our software products. The FDA continues to explore new ways of utilizing modeling and simulation in all aspects of research and development, and this is reflected in the need for additional licenses.”

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.