LANNETT ANNOUNCES SUBJECT DOSING COMPLETE FOR PIVOTAL CLINICAL TRIAL OF BIOSIMILAR INSULIN GLARGINE
No Reported Serious Adverse Events; Topline Results Expected Later This Year
TREVOSE, Pa., Aug. 31, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that subject dosing has been completed in 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). No serious adverse events have thus far been reported.
"We achieved the subject enrollment goal to meet our statistical endpoints," said Tim Crew, chief executive officer of Lannett. "Dosing of all subjects has now been completed in the healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin glargine. We continue to expect top-line data and analytics to be available toward the end of this calendar year. We then anticipate filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus® Solostar in the Spring of 2023 and potentially launching the product in the first half of 2024."
Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.
Lantus® is a registered trademark of Sanofi S.A.
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.
Robert Jaffe Co., LLC
SOURCE Lannett Company, Inc.