- Announces Positive Animal PK Study Results of Insulin Aspart Versus US NovoLog®
- Analysis of Pivotal Trial Results of Insulin Glargine Nearly Completed, BLA Filing Timeline Slightly Delayed, But Potential Launch Timing Remains in Range
Trevose, PA /PRNewswire/ - Lannett Company, Inc. (NYSE: LCI) today provided an update on the clinical advancement 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).
The company said results from the study of Lannett/HEC biosimilar insulin aspart versus US NovoLog® (the reference biologic) indicated the products were highly comparable when animals were dosed with equal quantities of the drugs via subcutaneous route. Data from the study will be submitted to the FDA as part of the company's request, expected in the first half of calendar 2023, for a Biosimilar Biological Product Development (BPD) Type II meeting.
"The study's positive results are a major step forward in the clinical advancement of our biosimilar insulin aspart," said Tim Crew, chief executive officer of Lannett. "We anticipate filing an Investigational New Drug (IND) application this Summer, commencing the pivotal trial by Fall 2023 and completing the pivotal trial in the Summer of 2024. If successful, we anticipate filing the Biologics License Application (BLA) the end of calendar year 2024 and potentially launching the product in calendar year 2025."
The company also said that analysis of the pivotal trial results for its biosimilar insulin glargine continues, though it now anticipates top-line data to be available by the end of February 2023.
Crew added, "A well-regarded UK-based laboratory has completed testing of more than 95% of the raw data samples from the pivotal trial; however, testing was paused for equipment maintenance and recalibration. That delay was further compounded since the testing was thus not completed by the lab's year-end shutdown. Once all samples have been tested, statistical analysis of the data will commence.
"While we anticipate filing the BLA for our biosimilar insulin glargine will be pushed back by about two months to mid-year 2023, our target for potential launch late in the first half of calendar 2024 remains in range. Moreover, we continue to believe the trial will be successful in meeting its clinical endpoints and expect to avail ourselves of an FDA pre-submission meeting to increase the likelihood of a first-pass approval and potentially shorten the review time."
NovoLog® 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 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 timing and positive final outcome of the pivotal clinical trial of biosimilar insulin glargine, as well as the timing and outcome of FDA approval and successfully commercializing the product, and the positive continued development of biosimilar insulin aspart, 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 recent significant rise 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 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.