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.
Copyright Business Wire 2014