U.S. FDA purchases more licenses to Simulations Plus' DDDPlus software

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of software for pharmaceutical discovery and development, today announced that it has received a purchase order from the U.S. Food and Drug Administration to expand the number of licenses for the Company's DDDPlus™ simulation software.

“An increasing number of generic drug companies license DDDPlus, and we expect that number to grow”

John DiBella, director of marketing and sales for Simulations Plus, said: "This purchase will add 10 more licenses for our DDDPlus software to those already held by the Office of Generic Drugs. DDDPlus is a unique program that simulates in vitro (laboratory) dissolution experiments, thereby enabling formulation scientists to better assess the effects of changing formulation variables such as the size of the drug particles and the amount of various excipients, as well as experimental parameters such as the composition of the fluid and the speed of agitation (stirring). Such simulations can provide agency scientists with valuable insight into the dissolution of generic formulations compared to innovator formulations when generic drug companies submit abbreviated new drug applications (ANDAs) to the agency. Another use is to assess how changing the experiment might provide greater discrimination between the dissolution rates of different formulations. Some experimental conditions might show little difference in dissolution rate, while others might amplify the differences more effectively. It's faster and less expensive to simulate the dissolution process than to physically dissolve tablets, make measurements, analyze the data, and clean up the lab. Once the experimental parameters have been identified, real experiments can be run to confirm the predictions."

"An increasing number of generic drug companies license DDDPlus, and we expect that number to grow," continued Mr. DiBella. "If you are in the generics business and know the FDA is going to analyze your data with DDDPlus, it behooves you to find out what the simulations show before you submit your ANDA."

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: "Simulations Plus continues to enjoy an excellent relationship with FDA scientists in labs across the country, and we're pleased that we can provide tools that help the agency in its daunting work of evaluating and approving new medicines. Dr. Michael Bolger and I will be at the FDA offices in Maryland next week to train 30 more scientists in the use of our GastroPlus™ software. FDA scientists are among the elite in the world of pharmaceutical science, so their selection of Simulations Plus software is extremely satisfying to our scientists, management, and shareholders."