Simulations Plus Wins Cooperative Agreement with FDA

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the company has been awarded a $200,000 cooperative agreement to develop improved modeling and simulation capabilities for dosage forms designed to be applied to the eye. The initial award provides support for the first year of the project. Funding for a second and third year of effort, at $200,000 per year, is subject to the availability of funds and satisfactory progress of the project.

Dr. Michael Bolger, chief scientist at Simulations Plus and principal investigator for the cooperative agreement, stated: “We are very pleased to have this opportunity to work with the FDA on this project. Our GastroPlus™ software program captures the best current understanding of the complex interplay between drug product attributes and human physiology. The improvements to our ocular model to be developed under this agreement will aid the FDA in developing regulatory science and policies in the area of absorption of drugs applied to the eye, and it will aid the generic pharmaceutical industry in designing high quality products that meet public expectations for effectiveness.”

Under the cooperative agreement, the FDA's purpose is to support and stimulate Simulations Plus’ activities in the development of the improved ocular absorption model. FDA scientific and program staff will assist and participate in project activities in a partnership role. As principal investigator, Dr. Bolger will have primary responsibility for the scientific, technical, and programmatic aspects of the award, and for the day-to-day management of the project.

John DiBella, vice president for marketing and sales of Simulations Plus, noted that: “In addition to the partnership with the FDA, we have also established a consortium of leading pharmaceutical companies to assist with this project. These relationships will help ensure the scientific integrity of the improved model and maximize the impact on the industry. In a recent report, the global ophthalmic drugs market was valued at $16 billion in 2012 and is expected to reach an estimated value of $21.6 billion in 2018. Globally, the ophthalmic drugs market is witnessing significant growth due to increasing prevalence of eye disorders, such as diabetic retinopathy and macular degeneration. As a result, this market is expected to grow at a compound annual growth rate (CAGR) of about 5.2% during 2013-2018.”

Dr. Ted Grasela, president of Simulations Plus and its wholly owned subsidiary, Cognigen, said: “This award means additional support for our in-house product development and company growth. Although the science behind this model development effort is quite sophisticated, this award demonstrates the FDA’s confidence that GastroPlus provides a sound basis for related drug and formulation characteristics for ocular dosage forms. We look forward to collaborating with the FDA on this important project.”

Funding for this collaboration was made possible by the Food and Drug Administration through grant 1U01FD005211-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation software, which is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies worldwide. For more information, visit our Web site at www.simulations-plus.com.

In September 2014, Simulations Plus acquired Cognigen Corporation as a wholly owned subsidiary, increasing the total number of Simulations Plus employees from 30 to 65. Cognigen is a leading provider of population modeling and simulation contract research services for the pharmaceutical and biotechnology industries. For more information, visit Cognigen’s Web site at www.cognigencorp.com.

The combined company is a global leader focused on improving the ways scientists use knowledge and data to predict the properties and outcomes of pharmaceutical and biotechnology agents. Our innovations in integrating new and existing science in medicinal chemistry, computational chemistry, pharmaceutical science, biology, and physiology into our software have made us the leading software provider for physiologically based pharmacokinetic modeling and simulation.

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 products 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 U.S. Securities and Exchange Commission.