Lannett Announces Positive Results From Human Clinical Trial Of Biosimilar Insulin Glargine Versus US Lantus®
--Study Achieves All Primary Endpoints; Company to Set Meeting with FDA Regarding Pivotal Trial Design--
PHILADELPHIA, Dec. 4, 2019 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced positive results from the first human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies (HEC). 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.
"With the positive data from this human clinical trial, combined with the earlier comparative analytical assessment and animal studies, we are building certainty around our development program," said Tim Crew, chief executive officer of Lannett. "We expect to meet with FDA in the coming months to plan next steps for the clinical advancement of our product, including the design of the biosimilar product development plan."
"In a relatively short amount of time, we have built an impressive and significant amount of data that supports the biosimilarity of our insulin glargine product to the reference drug, US approved Lantus®," said Kristin Arnold, PhD, Lannett's vice president of research and development. "Importantly, our insulin glargine was safe and well tolerated, and no serious adverse events (SAEs) or serious adverse drug reactions related to the drug were observed during the study. In summary, the Phase I study, conducted in healthy volunteers, confirmed that biosimilar insulin glargine matches the reference biologic in terms of pharmacokinetics (PK) and pharmacodynamics (PD) safety."
The trial was the first clinical study in humans to directly compare the Lannett/HEC insulin glargine to US Lantus® as part of the effort to file a Biologics License Application with the U.S. Food and Drug Administration for this biosimilar product. The clinical trial was a single center, single-dose, double-blind, randomized, two-period crossover study, comparing the PK/PD of the Lannett/HEC-insulin glargine to US-approved Lantus®, after a single subcutaneous dose in 27 healthy male adult human volunteers. The trial also assessed the safety profile of the Lannett/HEC-insulin glargine to US approved Lantus® after a single subcutaneous dose. The study met all primary endpoints.
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.
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SOURCE Lannett Company, Inc.