LANNETT ANNOUNCES SUBMISSION OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR BIOSIMILAR INSULIN GLARGINE

Rhea-AI Summary

Lannett Company has submitted an Investigational New Drug (IND) application to the FDA for a pivotal clinical trial of its biosimilar insulin glargine, co-developed with HEC Group. CEO Tim Crew emphasized this submission as a significant milestone towards offering a more affordable treatment for diabetes. The pivotal trial is expected to start in March 2022, with a potential Biologics License Application (BLA) filing in early 2023 and product launch by early 2024, pending trial success. The trial will also be conducted in South Africa under approved regulatory oversight.

Positive

• Submission of IND application marks a critical milestone.
• Potential for a more affordable biosimilar insulin glargine for diabetes patients.
• Pivotal trial commencement anticipated in March 2022.
• BLA filing expected in early 2023, with potential product launch by early 2024.
• Trial approval also received from South Africa Health Products Regulatory Authority.

Negative

• None.

PHILADELPHIA, Dec. 20, 2021 /PRNewswire/ -- 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.

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, as well as 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 significance of Lannett's IND submission for biosimilar insulin glargine?

The IND submission is a key milestone, moving Lannett closer to offering a more affordable diabetes treatment.

When is Lannett expected to start its pivotal clinical trial for insulin glargine?

Lannett plans to commence the pivotal clinical trial around March 2022.

What are the expected next steps after the pivotal trial for Lannett's insulin glargine?

If successful, Lannett anticipates filing a Biologics License Application in early 2023.

Is Lannett conducting the clinical trial outside the US?

Yes, the trial will also take place in South Africa, where it has received regulatory approval.

What did the previous pilot study indicate about Lannett's insulin glargine?

The pilot study suggested that Lannett's product would be biosimilar to US-approved Lantus in key pharmacokinetic and pharmacodynamic endpoints.