PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ -- Lannett Company,
Inc. (NYSE: LCI) today announced that the U.S. Food and Drug
Administration (FDA) has notified the company that they have
completed the safety review of the Investigational New Drug (IND)
application for biosimilar insulin glargine, a product the company
is co-developing with its strategic alliance partners within the
HEC Group of companies (HEC), and concluded that the company may
proceed with the proposed clinical investigation. The company said
it anticipates the pivotal clinical trial to commence by
March 2022 and be completed by early
2023.
"We are on track to initiate the dosing of subjects later this
quarter," said Tim Crew, chief
executive officer of Lannett. "If the trial is successful, we would
anticipate filing the Biologics License Application (BLA) in early
2023 and, if then approved, potentially launching the product by
early 2024. Biosimilar insulin glargine is a key product in our
durable product pipeline; we look forward to bringing this
critically important and more affordable biosimilar medicine to the
large and growing number of patients living with diabetes."
Crew added, the clinical trial will be conducted in South Africa at the same site and use the same
clinical design as the previously completed first human volunteer
pilot study. With FDA's review of the IND, the necessary regulatory
clearances (both in the U.S. and South
Africa) to conduct the study have been received. The pivotal
trial will be conducted using the proposed final to-be-marketed
formulation of the Lannett/HEC biosimilar insulin glargine.
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, as well
as timing and outcome of the pivotal clinical trial, 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:
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Robert
Jaffe
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|
Robert Jaffe Co.,
LLC
|
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(424)
288-4098
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SOURCE Lannett Company, Inc.