LANNETT ANNOUNCES PATENT LICENSES FOR THE PEN INJECTOR DELIVERY DEVICE TO BE USED FOR ITS INSULIN GLARGINE AND INSULIN ASPART DEVELOPMENT PROGRAM
Lannett Company (NYSE: LCI) has announced a significant agreement with Ypsomed AG concerning its biosimilar insulin development programs. This agreement entails a patent sublicense for a pen injector device, enhancing Lannett's ability to market biosimilar insulin products in the U.S. and other territories. Clinical trials for biosimilar insulin glargine have reported no serious adverse events, with top-line data expected by year-end. Lannett plans to submit a Biologics License Application for insulin glargine by Spring 2023, aiming for a potential product launch in early 2024.
- Secured a patent sublicense for the pen injector device from Ypsomed AG.
- No serious adverse events reported in the pivotal clinical trial for biosimilar insulin glargine.
- Anticipates filing Biologics License Application in Spring 2023.
- Financial terms of the agreement are confidential, leaving uncertainty about costs involved.
TREVOSE, Pa., Nov. 7, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into an agreement with Ypsomed AG, the manufacturer and supplier of the pen injector device to be used in connection with its biosimilar insulin glargine and biosimilar insulin aspart development programs, that will provide a patent sublicense to the company and its strategic alliance partner within the HEC Group of companies (HEC).
Under the agreement, Lannett and HEC will, in exchange for its financial contribution, receive a sub-license to a licensing arrangement between Ypsomed and Sanofi-Aventis Deutschland GmbH, the holder of various patents related to the pen injector device. The financial terms of the agreement are confidential.
"With this agreement, we have removed uncertainty with respect to the pertinent device patents and have secured a supply agreement with Ypsomed regarding the pen injector for use with biosimilar insulin glargine, biosimilar insulin aspart and potentially other products in the U.S. and certain other territories," said Tim Crew, chief executive officer of Lannett. "In short, we have significantly improved our ability to freely market our biosimilar insulin products, once approved."
Lannett previously said that subject dosing has been completed in the pivotal clinical trial of Lannett/HEC's biosimilar insulin glargine and no serious adverse events were reported. The company continues to expect top-line data and analytics to be available toward the end of this calendar year, anticipates filing the Biologics License Application (BLA) for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus® in the Spring of 2023 and potentially launching the product in the first half of 2024.
Lantus® is a registered trademark of Sanofi-Aventis Deutschland GmbH.
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, the company successfully commercializing the biosimilar insulin glargine, biosimilar insulin aspart and potentially other products in the U.S. and certain other territories as a result of the licensing agreement, 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.
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