U.S. FDA Expands Simulations Plus Software Licenses

Division: PBPK

Simulations Plus, Inc. (AMEX: 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 for additional licenses for the Company’s GastroPlus™ simulation software and new licenses for the Company’s DDDPlus™ software as well. DDDPlus is the world’s only in vitro dissolution software for the formulation scientist.

Ron Creeley, vice president of marketing and sales for Simulations Plus, said: “These software licenses are in addition to the GastroPlus license announced last January. We’re excited that FDA scientists will have both GastroPlus and DDDPlus to assist in their simulation and modeling activities. GastroPlus continues to enjoy ‘gold standard’ status in the pharmaceutical industry, and DDDPlus remains the only software of its kind. Industry licenses for both products have increased nicely during this fiscal year.”

Walt Woltosz, chairman and chief executive officer of Simulations Plus, said: “As we noted in January, the FDA’s position in advocating for better simulation and modeling tools was expressed in its well-known white paper entitled “Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products” released in March 2004. In it, the FDA stated: ‘. . . a new product development toolkit – containing powerful new . . . methods such as . . . computer-based predictive models . . . is urgently needed. . . . The medical product development process is no longer able to keep pace with basic scientific innovation. Only a concerted effort to apply the new biomedical science to medical product development will succeed in modernizing the critical path.'”