PHILADELPHIA, Dec. 4, 2019 /PRNewswire/ -- Lannett Company,
Inc. (NYSE: LCI) today announced positive results from the first
human study evaluating insulin glargine that Lannett is developing
with its strategic alliance partners within the HEC Group of
companies (HEC). Insulin glargine is a long-acting insulin
used to treat adults with Type 2 diabetes, as well as adults and
pediatric patients with Type 1 diabetes, for the control of high
blood sugar.
"With the positive data from this human clinical trial, combined
with the earlier comparative analytical assessment and animal
studies, we are building certainty around our development program,"
said Tim Crew, chief executive
officer of Lannett. "We expect to meet with FDA in the coming
months to plan next steps for the clinical advancement of our
product, including the design of the biosimilar product development
plan."
"In a relatively short amount of time, we have built an
impressive and significant amount of data that supports the
biosimilarity of our insulin glargine product to the reference
drug, US approved Lantus®," said Kristin Arnold, PhD, Lannett's vice president of
research and development. "Importantly, our insulin glargine
was safe and well tolerated, and no serious adverse events (SAEs)
or serious adverse drug reactions related to the drug were observed
during the study. In summary, the Phase I study, conducted in
healthy volunteers, confirmed that biosimilar insulin glargine
matches the reference biologic in terms of pharmacokinetics (PK)
and pharmacodynamics (PD) safety."
The trial was the first clinical study in humans to directly
compare the Lannett/HEC insulin glargine to US Lantus®
as part of the effort to file a Biologics License Application with
the U.S. Food and Drug Administration for this biosimilar
product. The clinical trial was a single center, single-dose,
double-blind, randomized, two-period crossover study, comparing the
PK/PD of the Lannett/HEC-insulin glargine to US-approved
Lantus®, after a single subcutaneous dose in 27 healthy
male adult human volunteers. The trial also assessed the
safety profile of the Lannett/HEC-insulin glargine to US approved
Lantus® after a single subcutaneous dose. The
study met all primary endpoints.
Lantus® is a registered trademark of Sanofi S.A.
About Lannett Company, Inc.:
Lannett Company, founded
in 1942, develops, manufactures, packages, markets and distributes
generic pharmaceutical products for a wide range of medical
indications. For more information, visit the company's
website at www.lannett.com.
This news release contains certain statements of a
forward-looking nature relating to future events or future business
performance. Any such statements, including, but not limited
to, advancing the development of biosimilar insulin glargine, as
well as timing and outcome of FDA approval and successfully
commercializing the product, whether expressed or implied, are
subject to risks and uncertainties which can cause actual results
to differ materially from those currently anticipated due to a
number of factors which include, but are not limited to, the
difficulty in predicting the timing or outcome of FDA or other
regulatory approvals or actions, the ability to successfully
commercialize products upon approval, including acquired products,
and Lannett's estimated or anticipated future financial results,
future inventory levels, future competition or pricing, future
levels of operating expenses, product development efforts or
performance, and other risk factors discussed in the company's Form
10-K and other documents filed with the Securities and Exchange
Commission from time to time. These forward-looking
statements represent the company's judgment as of the date of this
news release. The company disclaims any intent or obligation
to update these forward-looking statements.
Contact:
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Robert
Jaffe
|
|
Robert Jaffe Co.,
LLC
|
|
(424)
288-4098
|
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SOURCE Lannett Company, Inc.