LANNETT ANNOUNCES SUBJECT DOSING COMPLETE FOR PIVOTAL CLINICAL TRIAL OF BIOSIMILAR INSULIN GLARGINE

Rhea-AI Summary

Lannett Company (NYSE: LCI) has completed subject dosing in the pivotal trial for its biosimilar insulin glargine, developed in partnership with HEC Group. No serious adverse events have been reported. The company achieved its enrollment goals for statistical endpoints and expects to reveal top-line data later this year. The Biologics License Application (BLA) is anticipated to be filed in Spring 2023, with a potential product launch in the first half of 2024. Current U.S. sales for long-acting insulin glargine are estimated at $10 billion annually.

Positive

• Completion of subject dosing in pivotal trial.
• No serious adverse events reported.
• Enrollment goals met for statistical endpoints.
• Top-line data expected by year-end.
• BLA filing for biosimilar insulin glargine expected in Spring 2023.
• Potential product launch in first half of 2024.
• Significant market opportunity with estimated U.S. sales of $10 billion annually.

Negative

• None.

No Reported Serious Adverse Events; Topline Results Expected Later This Year

TREVOSE, Pa., Aug. 31, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that subject dosing has been completed in 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). No serious adverse events have thus far been reported.

"We achieved the subject enrollment goal to meet our statistical endpoints," said Tim Crew, chief executive officer of Lannett. "Dosing of all subjects has now been completed in the healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin glargine. We continue to expect top-line data and analytics to be available toward the end of this calendar year. We then anticipate filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus^® Solostar in the Spring of 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. Recent estimated U.S. sales of long acting insulin glargine are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.

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 are the results of Lannett's clinical trial for biosimilar insulin glargine?

Lannett reported that subject dosing has been completed in the pivotal clinical trial, with no serious adverse events reported.

When does Lannett expect to release top-line data for the insulin glargine trial?

Top-line data is expected to be available towards the end of this calendar year.

What is the market potential for Lannett's biosimilar insulin glargine?

The current U.S. sales of long-acting insulin glargine are estimated to be approximately $10 billion annually.

What are the next steps for Lannett following the trial of biosimilar insulin glargine?

Lannett plans to file a Biologics License Application (BLA) in Spring 2023 and potentially launch the product in the first half of 2024.