PHILADELPHIA, March 10, 2021 /PRNewswire/ -- Lannett
Company, Inc. (NYSE: LCI) today announced that it recently received
feedback from the U.S. Food and Drug Administration (FDA) regarding
biosimilar insulin glargine, a product the company is co-developing
with its strategic alliance partners within the HEC Group of
companies (HEC). Lannett sought and received comments from the FDA
related to the pivotal trial protocol and statistical analysis plan
(SAP) for the development program.
At a Biosimilar Biological Product Development (BPD) Type 2
meeting in June 2020, representatives
from Lannett spoke with and received guidance from the FDA on the
clinical advancement program of its biosimilar insulin glargine
partnered product candidate. At that meeting, FDA requested Lannett
submit a protocol for the pivotal trial for review before Lannett
submitted an Investigational New Drug Application (IND). In
November 2020, the company responded
to that request and provided the proposed protocol and SAP. The FDA
recently provided its feedback and comments to the company's
proposal and the company has now incorporated the feedback into the
design of the pivotal trial, including the type and size of the
trial, as well as primary and secondary endpoints, to meet the
FDA's requirements.
The company said it was comfortable with the feedback, which is
aligned with ongoing development work. Testing related to the
production of a commercially scaled batch is underway, so the
company believes it remains on track to submit an IND to the FDA
later this calendar year. Subsequent to filing an acceptable IND,
the company anticipates commencing the pivotal trial early in
calendar year 2022, filing the BLA later in 2022 and launching the
product in 2023. The company noted that the proposed pivotal trial,
albeit with a larger number of proposed participants, is similar to
the previously completed first human volunteer pilot study, which
indicated that the Lannett/HEC insulin glargine product 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 receiving 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 manufacture and 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.