PHILADELPHIA, April 8, 2020 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today announced that it is set to meet
with the U.S. Food and Drug Administration (FDA) on June 9, 2020 to plan next steps for the clinical
advancement of its biosimilar insulin glargine partnered product
candidate. 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.
"We are pleased that the FDA granted our request for a
Biosimilar Biological Product Development (BPD) Type II meeting, in
which the FDA will provide specific guidance regarding the
ongoing development program of our biosimilar insulin glargine
partnered product," said Tim Crew,
chief executive officer of Lannett. "We expect our discussion
with the FDA to include the design and endpoint of any additional
human studies required for filing a Biologics License Application
(BLA) and approval of insulin glargine as a biosimilar."
The company previously 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). The trial confirmed that the Lannett/HEC
biosimilar insulin glargine matches US-approved Lantus®
(the reference biologic) in terms of pharmacokinetics (PK) and
pharmacodynamics (PD) safety. 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.