--First Patient Dosed, Topline Study Results Expected
Later This Year; Potential BLA Filing in Early 2023
and Launch in the First Half of 2024--
TREVOSE,
Pa., March 29, 2022 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today announced that it has initiated 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).
"Biosimilar insulin glargine is by far the biggest and most
important opportunity in our pipeline, and initiating the pivotal
clinical trial is a major step forward in bringing a high quality,
more affordable insulin to the millions of patients in the U.S.
with diabetes," said Tim Crew, chief
executive officer of Lannett. "The first subject in the pivotal
trial has been dosed and we believe top line results of the study
will be available toward the end of this calendar year. If
successful, we anticipate 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."
As previously reported, the pivotal trial is being conducted at
the same site, using the same overall clinical design, as the
previously completed first human volunteer pilot study. The first
study, which the FDA reviewed, suggested that the Lannett/HEC
insulin glargine product would be biosimilar to US-approved
Lantus® (the reference biologic) in terms of meeting the
study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
The pivotal trial uses clinical material produced at commercial
scale from a large, new dedicated insulin facility, which will be
used to supply the US market.
Crew added, "Given the positive results of the earlier study,
repeated analytical comparability with US Sanofi Lantus®
and FDA's acceptance of the Investigational New Drug (IND)
application with no comments, we are optimistic of a successful
outcome for the pivotal study. A new biosimilar insulin glargine
from Lannett/HEC would be good and welcome news to those with
diabetes, particularly those patients struggling with the cost of
their insulin regimens."
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.