Inotiv, Inc. Expands Safety Pharmacology Offering to Include Cardiopulmonary Telemetry
May 04 2023 - 7:33AM
Inotiv, Inc. (Nasdaq: NOTV), a leading contract
research organization specializing in nonclinical and analytical
drug discovery and development services, and research models and
related products and services, announced today the expansion of the
Company’s safety pharmacology offering with the validation and
verification of a cardiopulmonary telemetry study model in
cynomolgus macaques. Offered through Inotiv’s Discovery and Safety
Assessment business, telemetry allows for the continuous
observation of ECG, respiratory rate and volume, blood pressure and
other cardiovascular parameters during preclinical safety studies.
“The ICH S6 regulatory guidance on Preclinical Safety Evaluation
of Biotechnology-Derived Pharmaceuticals indicates that safety
pharmacology studies should be completed to reveal any test article
related functional effects on the major organ systems including
cardiovascular, respiratory, and central nervous system,” said
Tyler Speece, Director of Safety Pharmacology at Inotiv. “The
cynomolgus macaque is frequently the only pharmacologically
relevant species for the testing of biologics due to their anatomic
and physiologic similarities to humans.”
Speece continued, “We’re pleased to offer combined telemetry
study models that assess potential test article related effects on
the cardiovascular and respiratory systems, performed
simultaneously in the same animals—an added benefit of which aligns
with the principles of the 3Rs: Replacement, Reduction and
Refinement. Researchers can reduce the number of animals needed for
testing, minimize distress caused by repeated testing, and
ultimately improve animal welfare.”
Together with cardiopulmonary telemetry study offerings in other
rodent and non-rodent species, Inotiv can now provide complete Good
Laboratory Practice (GLP) safety pharmacology testing solutions to
assist with the development of biologics as well as small
molecules. With this newly added offering and available capacity,
the Company expects to further enable clients to confidently
navigate the regulatory landscape and accelerate the development of
their products.
"Inotiv is dedicated to providing our clients with innovative
and reliable solutions that meet their project needs," said John
Sagartz, Chief Strategy Officer. "This expanded offering allows us
to provide our clients with the high-quality, GLP safety
pharmacology testing solutions they need by combining evaluation of
cardiac and respiratory endpoints within the same study, thereby
minimizing the need for separate experiments to achieve these
goals."
About Inotiv
Inotiv, Inc. is a leading contract research
organization dedicated to providing nonclinical and analytical drug
discovery and development services and research models and related
products and services. The Company’s products and services focus on
bringing new drugs and medical devices through the discovery and
preclinical phases of development, all while increasing efficiency,
improving data, and reducing the cost of taking new drugs to
market. Inotiv is committed to supporting discovery and development
objectives as well as helping researchers realize the full
potential of their critical R&D projects, all while working
together to build a healthier and safer world. Further information
about Inotiv can be found here: https://www.inotivco.com/.
This release may contain forward-looking
statements that are subject to risks and uncertainties including,
but not limited to, risks and uncertainties related to the impact
of recent events related to non-human primate matters on the
Company’s business, operations, results, financial condition, cash
flows, and assets, the Company’s ability to comply with covenants
under its credit agreement, changes in the market and demand for
the Company’s products and services, the development, marketing and
sales of products and services, changes in technology, industry and
regulatory standards, the timing of acquisitions and the successful
closing, integration and business and financial impact thereof,
governmental regulations, inspections and investigations, claims
and litigation against or involving the Company, its business
and/or its industry, the impact of site closures and
consolidations, expansion and related efforts, and various other
market and operating risks, including those detailed in the
Company's filings with the U.S. Securities and Exchange
Commission.
Company Contact |
|
Investor Relations |
Inotiv, Inc. |
|
The Equity Group Inc. |
Beth A. Taylor, Chief Financial Officer |
|
Devin Sullivan |
(765) 497-8381 |
|
(212) 836-9608 |
btaylor@inotivco.com |
|
dsullivan@equityny.com |
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