–Announces positive results of animal PK study on insulin aspart Versus American NovoLog®—
–Analysis of insulin glargine pivotal trial results nearing completion, BLA filing schedule slightly delayed, but potential launch schedule remains within range–
TREVOSE, Pa., January 4, 2023 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today provided an update on the clinical progress and development of its biosimilar insulin aspart and biosimilar insulin glargine products. Lannett is developing both products with its strategic alliance partner, the HEC Group of Companies (HEC).
Company Reported Study Results of Lannett/HEC Biosimilar Insulin Aspart Compared to US NovoLog® (the reference biologic) indicated that the products were highly comparable when the animals received equal amounts of drugs subcutaneously. The study data will be submitted to the FDA as part of the company’s application, expected in the first half of 2023, for a Type II biosimilar biologics (BPD) development meeting.
“The positive study results are a major step forward in the clinical advancement of our biosimilar insulin aspart,” said Tim Crew, CEO of Lannett. “We expect to file an Investigational New Drug (IND) application this summer, begin the pivotal trial by fall 2023, and complete the pivotal trial in the summer of 2024. If successful, we expect to file the Biologics License Application (BLA) by the end of calendar year 2024 and potential product launch in calendar year 2025.”
The company also said analysis of results from the pivotal trial for its biosimilar insulin glargine is continuing, although it now expects frontline data to be available by the end of February 2023.
Crew added: “A reputable UK lab has completed testing of over 95% of the pivotal trial’s raw data samples; however, testing has been halted for equipment maintenance and recalibration. This delay has been further aggravated since the tests were conducted statistical analysis of the data will begin as soon as all samples have been tested.
“While we expect the BLA filing for our biosimilar insulin glargine to be pushed back approximately two months to mid-2023, our potential launch target at the end of the first half of the calendar year 2024 remains within range. Additionally, we continue to believe that the trial will be successful in meeting its clinical endpoints and we expect to take advantage of an FDA pre-submission meeting to increase the likelihood of first-pass approval and potentially shorten review time.
Novo Log® is a registered trademark of Novo Nordisk A/S.
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 press release contains certain statements of a forward-looking nature concerning future events or future business performance. Any such statement, including, but not limited to, the timeline and positive endpoint of the biosimilar insulin glargine pivotal clinical trial, and the timeline and outcome of FDA approval and successful commercialization of the product, and the continued positive development of the biosimilar insulin aspart, and the timing and outcome of FDA approval and successful commercialization of the product, whether expressed or implied, are subject to market and other conditions, and subject to risks and uncertainties that may cause actual results to differ materially from those currently anticipated due to a number of factors including, but not limited to, the recent significant increase in the number of Covid cases in China as well as 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 relating to the proposed offering to be filed with the SEC. These forward-looking statements represent the judgment of the Company as of the date of this press release. The Company disclaims any intention or obligation to update these forward-looking statements.
Robert Jaffe Co., LLC
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SOURCE Lannett Company, Inc.