Simulations Plus Extends Funded Research Collaboration with the FDA
September 05 2018 - 8:30AM
Business Wire
New functionality to mechanistic ocular
absorption model in GastroPlus™ supports FDA’s future Innovation
Initiative
Simulations Plus, Inc. (Nasdaq:SLP), the leading provider of
modeling and simulation solutions for the pharmaceutical,
biotechnology, chemicals, and consumer goods industries, today
announced that it has entered into a one-year funded extension to
its previous cooperative agreement (grant 1U01FD005211) with the
U.S. Food and Drug Administration (FDA) to further develop and
validate the mechanistic Ocular Compartmental Absorption and
Transit (OCAT™) model in GastroPlus™.
Dr. Viera Lukacova, director – simulation sciences, said: “After
the successful completion of tasks outlined in the initial
three-year cooperative agreement, we are very pleased to have the
opportunity to continue working with the FDA to incorporate
additional functionality into our mechanistic ocular absorption
model which will aid companies, both innovator and generic, as they
design new treatments and products for various eye disorders. The
model is already being utilized within the industry to support
internal research and development activities, and we anticipate
results from our technology will soon be helping to inform
regulatory interactions.”
John DiBella, president – Lancaster division, added: “This award
funds additional development services and demonstrates the FDA’s
confidence that GastroPlus provides a sound basis for related drug
and formulation characteristics for ocular dosage forms. The
outcomes from this additional work will be integrated into the next
versions of GastroPlus and will continue to be made available to
clients in the $22 billion (and growing) ophthalmic drug market as
an optional add-on module. We look forward to continued
collaboration with the FDA on the next-generation ocular absorption
modeling platform.”
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 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 injury and nonalcoholic fatty liver disease.
The company is a global leader focused on improving the ways
scientists use knowledge and data to predict the properties and
outcomes of pharmaceutical, biotechnology, and chemical agents. 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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Simulations Plus Investor
RelationsMs. Renee Bouche,
661-723-7723renee@simulations-plus.comorHayden IRMr. Cameron Donahue,
651-653-1854cameron@haydenir.com
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