Simulations Plus Awarded New Cooperative Agreement with FDA

Software: GastroPlus®
Division: Simulations Plus

Simulations Plus, Inc. (NASDAQ: SLP), the leading provider of consulting services and software for pharmaceutical discovery and development, today announced that it had been notified by the U.S. Food and Drug Administration (FDA) that the company has been awarded a second cooperative agreement for $200,000 per year for up to three years. This award is in addition to the similar project the company was awarded last year, and which was recently renewed for the second year. This new project is for the development of PBPK simulation for long-acting injectable microspheres.

Dr. Viera Lukacova, team leader for simulation technologies and product manager for the company’s flagship GastroPlus™ software, is the principal investigator for the cooperative agreement. Dr. Lukacova said, “We are very pleased to have another opportunity to work with the FDA on an important simulation and modeling project. GastroPlus captures the best current understanding of the complex interplay between drug product attributes and human physiology. This project will contribute substantially to improvements in the program, specifically directed toward the behavior of long-acting injectable microsphere dosage forms which are typically subcutaneous or intramuscular doses that release drugs over long periods, often weeks or months. We expect the developments under this agreement will aid the FDA in developing regulatory science and policies in the area of drug absorption from long-acting injectable microspheres, 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 drug absorption and pharmacokinetics models for long-acting injectable microspheres. FDA scientific and program staff will assist and participate in project activities in a partnership role. As principal investigator, Dr. Lukacova will have primary responsibility for the scientific, technical, and programmatic aspects of the award, and for the day-to-day management of the project.

Walt Woltosz, chairman and chief executive officer 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 long-acting injectable microsphere dosage forms. We look forward eagerly to collaborating with the FDA on this important project.”

Funding for this collaboration was made possible by the Food and Drug Administration through grant 1 U01 FD005463-01. 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.