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U.S. FDA Expands DDDPlusa" Software Licenses

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  Published in Science and Technology on Friday, August 13th 2010 at 5:11 GMT by Market Wire
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LANCASTER, Calif.--([ BUSINESS WIRE ])--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 Companya™s DDDPlusa" simulation software.

"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."

John DiBella, director of marketing and sales for Simulations Plus, said: aThis 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. Ita™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.a

aAn increasing number of generic drug companies license DDDPlus, and we expect that number to grow,a continued Mr. DiBella. aIf 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.a

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: aSimulations Plus continues to enjoy an excellent relationship with FDA scientists in labs across the country, and wea™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 GastroPlusa" 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.a

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995a" 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 abelieve,a aexpecta and aanticipatea 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.