PHILADELPHIA, June 11, 2020 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today said that representatives from the
company spoke with and received guidance from the U.S. Food and
Drug Administration (FDA) on the clinical advancement program of
its biosimilar insulin glargine partnered product candidate.
Insulin glargine is a long-acting insulin used to treat adults with
Type 2 diabetes, as well as adults and pediatric patients with Type
1 diabetes, for the control of high blood sugar. Total U.S. sales
of the glargine related products, according to IQVIA, were
approximately $9.5 billion for the 12
months ending April 2020, although
actual biosimilar market values are expected to be lower.
"At the Biosimilar Biological Product Development (BPD) Type II
meeting held earlier this week the FDA provided positive feedback
on the clinical and CMC (Chemistry, Manufacturing and Controls)
advancement of our biosimilar insulin glargine that was consistent
with our expectations," said Tim
Crew, chief executive officer of Lannett. "Our path forward
is clear with regard to what is expected in the planned 351(k)
biosimilar application, which we anticipate will be filed in
calendar year 2022. We will work with our strategic partner to
complete all the necessary development activity, including human
clinical trials, in accordance with FDA's guidance."
Crew added, "Biosimilar insulin glargine represents a
significant opportunity for Lannett, given the notably large
addressable market. Moreover, we believe only a relatively small
number of competitors have the technical expertise and requisite
resources to develop and manufacture such a complex product."
The company previously announced positive results from the first
human study evaluating insulin glargine that Lannett is developing
with its strategic alliance partners within the HEC Group of
companies (HEC). The trial confirmed that the Lannett/HEC
biosimilar insulin glargine was biosimilar to US-approved
Lantus® (the reference biologic) in terms of meeting all
pharmacokinetics (PK) and pharmacodynamics (PD) safety endpoints in
the study.
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 statements, 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, are
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
difficulty in predicting the timing or outcome of FDA or other
regulatory approvals or actions, the ability to successfully
commercialize products upon approval, including acquired products,
and Lannett's estimated or anticipated future financial results,
future inventory levels, future competition or pricing, future
levels of operating expenses, product development efforts or
performance, and other risk factors discussed in the company's Form
10-K and other documents filed with the Securities and Exchange
Commission from time to time. 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.