PHILADELPHIA, Dec. 20, 2021 /PRNewswire/ -- Lannett Company,
Inc. (NYSE: LCI) today announced the submission of an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) for 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).
"This IND submission is a key milestone and brings us one step
closer to bringing this critically important and more affordable
biosimilar medicine to the large and growing number of patients
living with diabetes," said Tim
Crew, chief executive officer of Lannett. "We remain on
track to commence the pivotal clinical trial soon, around March of
2022. If successful, we would anticipate filing the Biologics
License Application (BLA) in early 2023 and potentially launching
the product by early 2024."
Crew noted that the pivotal trial will be conducted at the same
site and use the same clinical design as the previously completed
first human volunteer pilot study. That 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.
Submission of the IND kicks off the final regulatory process
before Lannett starts the pivotal trial. As part of that process,
the company has also recently received approval from the South
Africa Health Products Regulatory Authority (SAHPRA) to conduct the
trial in South Africa. The trial
site has experience with clinical insulin trials and has been used
by other innovator firms for their insulin clinical trials.
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 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.