PHILADELPHIA, June 5, 2019 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced the commencement of a human 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). The trial, being conducted in South Africa, is the first clinical study to directly compare the Lannett/HEC insulin glargine to US Lantus® as part of the effort to file a biosimilar Biologics License Application with the U.S. Food and Drug Administration. Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar.
The clinical trial is a single center, single-dose, double-blind, randomized, two-period crossover study, designed to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of the Lannett/HEC-insulin glargine to US-approved Lantus®, after a single subcutaneous dose in at least 24 healthy male adult human volunteers. In addition, a secondary objective of the trial is to assess the safety profiles of the Lannett/HEC-insulin glargine to US-Lantus® after single subcutaneous doses. Study results are expected in September 2019.
"Initiating a first-in-human clinical trial of our partnered insulin glargine product is a major milestone in the progression of this project," said Tim Crew, chief executive officer of Lannett. "We look forward to the clinical advancement of the product as an affordable treatment option, especially with 29 million Americans suffering with type 1 or type 2 diabetes."
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 timing and outcome of 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 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.