Simulations Plus Wins Cooperative Agreement with FDA

Software: GastroPlus®
Division: Simulations Plus

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.