Lannett 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.
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 United States and certain other territories," said Tim Crew, CEO 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 said that it continues to expect top-line data and analytics to be available toward the end of this calendar year, anticipates filing the Biologics License Application 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.