Lannett Initiates Pivotal Clinical Trial for Biosimilar Insulin Glargine
First Patient Dosed, Topline Study Results Expected Later This Year; Potential BLA Filing in Early 2023 and Launch in the First Half of 2024
TREVOSE, Pa., March 29, 2022 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that it has initiated 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).
“Biosimilar insulin glargine is by far the biggest and most important opportunity in our pipeline, and initiating the pivotal clinical trial is a major step forward in bringing a high quality, more affordable insulin to the millions of patients in the U.S. with diabetes,” said Tim Crew, chief executive officer of Lannett. “The first subject in the pivotal trial has been dosed and we believe top line results of the study will be available toward the end of this calendar year. If successful, we anticipate filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi’s Lantus® Solostar in early 2023 and potentially launching the product in the first half of 2024.”
As previously reported, the pivotal trial is being conducted at the same site, using the same overall clinical design, as the previously completed first human volunteer pilot study. The 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. The pivotal trial uses clinical material produced at commercial scale from a large, new dedicated insulin facility, which will be used to supply the US market.
Crew added, “Given the positive results of the earlier study, repeated analytical comparability with US Sanofi Lantus® and FDA’s acceptance of the Investigational New Drug (IND) application with no comments, we are optimistic of a successful outcome for the pivotal study. A new biosimilar insulin glargine from Lannett/HEC would be good and welcome news to those with diabetes, particularly those patients struggling with the cost of their insulin regimens.”
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, 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.
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