No Reported Serious Adverse Events; Topline
Results Expected Later This Year
TREVOSE,
Pa., Aug. 31, 2022 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today announced that subject dosing has
been completed in the pivotal clinical trial of biosimilar insulin
glargine, a product the company is co-developing with its strategic
alliance partners within the HEC Group of companies (HEC). No
serious adverse events have thus far been reported.
"We achieved the subject enrollment goal to meet our statistical
endpoints," said Tim Crew, chief
executive officer of Lannett. "Dosing of all subjects has now been
completed in the healthy volunteer pharmacokinetics (PK) and
pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin
glargine. We continue to expect top-line data and analytics to be
available toward the end of this calendar year. We then anticipate
filing the Biologics License Application (BLA) for a biosimilar and
interchangeable insulin glargine to Sanofi's Lantus®
Solostar in the Spring of 2023 and potentially launching the
product in the first half of 2024."
Biosimilar insulin glargine is the most significant opportunity
in the company's current pipeline. Recent estimated U.S. sales of
long acting insulin glargine are approximately $10 billion annually, according to IQVIA,
although manufacturer reported sales are less.
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 statement, including, but not limited to,
advancing the development of biosimilar insulin glargine, the
outcome of the pivotal trial, as well as the timing and outcome of
FDA approval and successfully commercializing the product, whether
expressed or implied, is subject to market and other conditions,
and 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
risk factors discussed in the Company's Form 10-K and other
documents filed with the SEC from time to time, including the
prospectus supplement related to the proposed offering to be filed
with the SEC. 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:
Robert Jaffe
Robert Jaffe Co., LLC
(424) 288-4098
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SOURCE Lannett Company, Inc.