TREVOSE,
Pa., Nov. 7, 2022 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today announced that it has entered into
an agreement with Ypsomed AG, the manufacturer and supplier of the
pen injector device to be used in connection with its biosimilar
insulin glargine and biosimilar insulin aspart development
programs, that will provide a patent sublicense to the company and
its strategic alliance partner within the HEC Group of companies
(HEC).
Under the agreement, Lannett and HEC will, in exchange for its
financial contribution, receive a sub-license to a licensing
arrangement between Ypsomed and Sanofi-Aventis Deutschland GmbH,
the holder of various patents related to the pen injector device.
The financial terms of the agreement are confidential.
"With this agreement, we have removed uncertainty with respect
to the pertinent device patents and have secured a supply agreement
with Ypsomed regarding the pen injector for use with biosimilar
insulin glargine, biosimilar insulin aspart and potentially other
products in the U.S. and certain other territories," said
Tim Crew, chief executive officer of
Lannett. "In short, we have significantly improved our ability to
freely market our biosimilar insulin products, once approved."
Lannett previously said that subject dosing has been completed
in the pivotal clinical trial of Lannett/HEC's biosimilar insulin
glargine and no serious adverse events were reported. The company
continues to expect top-line data and analytics to be available
toward the end of this calendar year, anticipates filing the
Biologics License Application (BLA) for a biosimilar and
interchangeable insulin glargine to Sanofi's Lantus® in
the Spring of 2023 and potentially launching the product in the
first half of 2024.
Lantus® is a registered trademark of Sanofi-Aventis
Deutschland GmbH.
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, the
company successfully commercializing the biosimilar insulin
glargine, biosimilar insulin aspart and potentially other products
in the U.S. and certain other territories as a result of the
licensing agreement, 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.