Approximately Half of the Planned Number of
Subjects Have Received the First Dose, With No
Reported Serious Adverse Events
Study Progressing On Schedule
Topline Results Expected Later This
Year
TREVOSE,
Pa., June 1, 2022 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today provided an update on its ongoing
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).
"We are pleased to report that to date approximately one half of
the planned number of subjects in the study have received the first
of two doses in the healthy volunteer pharmacokinetics (PK) and
pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin
glargine. In addition, approximately one third of the subjects have
received a second dose," said Tim
Crew, chief executive officer of Lannett. "Importantly, no
serious adverse events have been reported. The study remains on
track and we continue to believe top line results of the study will
be available toward the end of this calendar year."
Crew added that if the study is successful, the company
anticipates filing the Biologics License Application (BLA) for a
biosimilar and interchangeable insulin glargine to Sanofi's
Lantus® Solostar in early 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.
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.