Philadelphia, PA /PRNewswire/ - Lannett Company, Inc. (NYSE: LCI) today announced that it is set to meet with the U.S. Food and Drug Administration (FDA) on June 9, 2020 to plan next steps for the clinical advancement of its biosimilar insulin glargine partnered product candidate. 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.
"We are pleased that the FDA granted our request for a Biosimilar Biological Product Development (BPD) Type II meeting, in which the FDA will provide specific guidance regarding the ongoing development program of our biosimilar insulin glargine partnered product," said Tim Crew, chief executive officer of Lannett. "We expect our discussion with the FDA to include the design and endpoint of any additional human studies required for filing a Biologics License Application (BLA) and approval of insulin glargine as a biosimilar."
The company previously 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). The trial confirmed that the Lannett/HEC biosimilar insulin glargine matches US-approved Lantus® (the reference biologic) in terms of pharmacokinetics (PK) and pharmacodynamics (PD) safety. 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.