LANNETT PROVIDES UPDATE ON PIVOTAL CLINICAL TRIAL FOR BIOSIMILAR INSULIN GLARGINE
Approximately Half of the Planned Number of Subjects Have Received the First Dose, With No Reported Serious Adverse Events
Study Progressing On Schedule
Topline Results Expected Later This Year
TREVOSE, Pa., June 1, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today provided an update on its ongoing 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).
"We are pleased to report that to date approximately one half of the planned number of subjects in the study have received the first of two doses in the healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin glargine. In addition, approximately one third of the subjects have received a second dose," said Tim Crew, chief executive officer of Lannett. "Importantly, no serious adverse events have been reported. The study remains on track and we continue to believe top line results of the study will be available toward the end of this calendar year."
Crew added that if the study is successful, the company anticipates 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. Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline.
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.
Robert Jaffe Co., LLC
SOURCE Lannett Company, Inc.