–Company Anticipates Commencing Pivotal Clinical Trial in March 2022–

PHILADELPHIA, PA, USA I December 20, 2021 I Lannett Company, Inc. (NYSE: LCI) today announced the submission of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for 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).

“This IND submission is a key milestone and brings us one step closer to bringing this critically important and more affordable biosimilar medicine to the large and growing number of patients living with diabetes,” said Tim Crew, chief executive officer of Lannett. “We remain on track to commence the pivotal clinical trial soon, around March of 2022. If successful, we would anticipate filing the Biologics License Application (BLA) in early 2023 and potentially launching the product by early 2024.”

Crew noted that the pivotal trial will be conducted at the same site and use the same clinical design as the previously completed first human volunteer pilot study. That first study, which the FDA reviewed, suggested that the Lannett/HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study’s pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.

Submission of the IND kicks off the final regulatory process before Lannett starts the pivotal trial. As part of that process, the company has also recently received approval from the South Africa Health Products Regulatory Authority (SAHPRA) to conduct the trial in South Africa. The trial site has experience with clinical insulin trials and has been used by other innovator firms for their insulin clinical trials.

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.

SOURCE: Lannett Company