Simulations Plus Software Used in Regulatory Submittals

US FDA, UK MHRA, and European EMA Accept Simulation Results in Applications

LANCASTER, Calif.--(BUSINESS WIRE)-- Simulations Plus, Inc. (NAS: SLP) , a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that results of simulations using its GastroPlus™ software have been submitted to major regulatory agencies as part of applications by its customers.


John DiBella, vice president of marketing and sales for Simulations Plus, noted, "The first submittal to a regulatory agency was reported by Pfizer in 2008, which resulted in Pfizer being allowed to forego a human trial after GastroPlus simulations showed that it would not be necessary. In the past 12 months, four additional customers have submitted simulation results to the U.S. Food and Drug Administration (FDA), the European Medical Agency (EMA), and the British Medical Health Regulatory Agency (MHRA). Each of these involved a consulting contract with Simulations Plus to assist the sponsor with the GastroPlus simulations and model development. Simulations Plus also provided assistance in preparation of the submittals to the regulatory agencies. The acceptance of simulation results by these agencies is an indication of the growing importance of simulation and modeling technology in pharmaceutical research and development."

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: "The four submittals John describes resulted in:

  1. Eliminating a clinical trial to demonstrate that fasted and fed states would not produce significantly different results for the absorption of the drug candidate.
  2. Identifying the particle size specification for a re-engineered product to ensure bioequivalence to an existing product.
  3. Explaining the variations observed in different formulations.
  4. Scaling complex processes involving metabolism and carrier-mediated transport from adult to pediatric/neonate populations.

These four submissions signal a developing trend for the use of simulation and modeling results to reduce the cost and time to bring new drug products to market. Note that these four involved Simulations Plus consulting services. A number of other submittals have been made by sponsors on their own. Regulatory agencies in the U.S., Europe, China, and Japan all have GastroPlus for their internal use, so sponsors can submit GastroPlus input files to these agencies to make evaluation of results fast and convenient. In time, we believe other sponsors will increasingly utilize powerful simulation software to help streamline the regulatory process and provide regulators with accurate data for evaluation purposes."

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation and modeling software, which is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, agrochemical, and food industry companies worldwide. We also provide a productivity tool called Abbreviate! for PCs. Simulations Plus, Inc., is headquartered in Southern California and trades on the NASDAQ Capital Market 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. 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 as filed with the Securities and Exchange Commission.



Simulations Plus Investor Relations
Ms. Renée Bouché
661-723-7723
renee@simulations-plus.com
or
Hayden IR
Mr. Cameron Donahue
651-653-1854
cameron@haydenir.com

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