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U.S. FDA Expands Simulations Plus Software Licenses

Business Wire, August 29, 2007

GastroPlus and DDDPlus Licenses Added

LANCASTER, Calif. -- 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[TM] simulation software and new licenses for the Company's DDDPlus[TM] 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.'"

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development software, which is licensed to and used in the conduct of drug research by pharmaceutical, biotechnology, and drug delivery companies worldwide. The Company has two other businesses, Words , Inc. and FutureLab([TM]), which are based on its proprietary software technologies. Simulations Plus, Inc., is headquartered in Southern California and trades on the AMEX under the symbol "SLP." For more information, visit our Web site 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. 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, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the Securities and Exchange Commission.

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COPYRIGHT 2008 Gale, Cengage Learning
 

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