Cognigen Launches KIWI Version 4.0

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Cognigen Corporation, a Simulations Plus company (Nasdaq: SLP) and a leading provider of population pharmacokinetic and pharmacodynamic modeling and simulation services, today announced that it has released Version 4.0 of its KIWI„¢ Pharmacometric Communication and Collaboration Platform.

KIWI is a private cloud-based, validated platform to efficiently and consistently organize, process, visualize, evaluate, and communicate modeling and simulation results. Since the introduction of KIWI 1.0 in 2011, our mission has been to provide pharmacometricians with the most efficient analysis environment possible. The release of KIWI version 4.0 continues that mission with the introduction of the Model Wizard and the Covariate Analysis toolset.

A pharmacometric analysis is an evolutionary process “ one that often results in the creation of hundreds of new program files and code changes to hundreds more due to common typographical and programmatic errors. The Model Wizard and the Covariate Analysis toolset aim to significantly reduce the time spent creating models, correcting errors, and replicating program files for performing stepwise covariate analyses, allowing pharmacometricians to focus on advancing science. With continued feedback from KIWI license holders, various visualizations within KIWI 4.0 and the pharmacometric-specific Data Repository will continue to be updated with new features and functionality.

KIWI has been specifically designed to recognize the dynamic nature of the model building effort in an ongoing drug development program. KIWI provides the functionality to meet the scientists need for extensive documentation of the analysis pathway and collateral results, managements need for summaries of modeling and simulation highlights, and the regulatory agencies needs for transparency and reproducibility. KIWI continues to bring user experience to a new level through efficient and decisive model building. KIWI demonstrations will be available through Cognigen personnel attending the PAGE meeting this week in Stockholm, Sweden.

Dr. Sebastien Bihorel, director of Pharmacometrics and KIWI Applications, said: Our team continues to introduce exciting functionality into KIWI. The new Wizards greatly decrease the time and effort required to create model codes for 3 different industry-standard modeling platforms: NONMEM, mrgsolve, and Berkeley Madonna. They will significantly lower the learning curve for modelers who are new to these platforms while providing consistent coding standards to more experienced users.

Dr. Ted Grasela, president of Cognigen, added: Over the course of a typical drug development program, fit-for-purpose (F4P) models based on the current facts and available data are used to inform development decision making and aid in the design of clinical trials. These F4P models represent an important repository of knowledge which can be expanded as new knowledge emerges. The cloud-based KIWI platform serves a key role in this process by tracking the model refinement process and capturing development team insights and suggested improvements.

KIWI was featured at a NONMEM workshop held as part of the University of Buffalos annual PK/PD course held this past May, with international attendance from both academia and industry. Another workshop is now planned for September 23-25, 2019, at Johannes Gutenberg University in Mainz, Germany. Attendance is limited. Contact Jill Harlach ([email protected]) for further information.

About Cognigen Corporation

Cognigen Corporation is well-recognized as providing insightful analysis and reports that guide regulatory decision making and minimize follow-up questions from regulators, saving sponsors considerable time and money in getting new pharmaceutical products to market. Cognigen Corporation deployed KIWI in 2011 to provide pharmacometricians and clinical teams lead access to a dynamic modeling and simulation platform for population analyses. More information is available on the Cognigen section of the Simulations Plus website.

About Simulations Plus, Inc.

Simulations Plus, Inc., is a premier developer of drug discovery and development software as well as a leading provider of both preclinical and clinical pharmacometric consulting services for regulatory submissions and quantitative systems pharmacology models for drug-induced liver injurydrug-induced kidney injury, and nonalcoholic fatty liver disease. Our software is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, chemical, and consumer goods companies and regulatory agencies worldwide. 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. For more information, visit our website 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 and filed with the U.S. Securities and Exchange Commission.

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