LANNETT PROVIDES UPDATE ON PIVOTAL CLINICAL TRIAL FOR BIOSIMILAR INSULIN GLARGINE

Rhea-AI Summary

Lannett Company (NYSE: LCI) announced progress in its pivotal clinical trial for biosimilar insulin glargine, with approximately half of the planned participants having received the first dose and no serious adverse events reported. The study is on schedule, expecting topline results by the end of 2022. If successful, Lannett plans to file a Biologics License Application in early 2023 and potentially launch the product in the first half of 2024, marking a significant opportunity in its pipeline.

Positive

• Approximately 50% of planned subjects have received the first dose.
• No serious adverse events reported.
• Study is progressing on schedule.
• Topline results expected by end of 2022.
• Potential BLA filing in early 2023 for biosimilar insulin glargine.

Negative

• Regulatory hurdles could delay product launch beyond first half of 2024.

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.

Contact:
Robert Jaffe
Robert Jaffe Co., LLC
(424) 288-4098

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SOURCE Lannett Company, Inc.

FAQ

What is the current status of Lannett's clinical trial for biosimilar insulin glargine?

Approximately half of the planned subjects have received their first dose, and the trial is on schedule.

When are the topline results for the insulin glargine trial expected?

Topline results are expected by the end of 2022.

What are the potential next steps if the insulin glargine trial is successful?

Lannett plans to file a Biologics License Application in early 2023 and launch the product in the first half of 2024.

What is the significance of the biosimilar insulin glargine for Lannett?

This product represents the most significant opportunity in Lannett's current pipeline.

What risks could affect Lannett's insulin glargine product launch?

Regulatory hurdles may delay the launch beyond the first half of 2024.