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Lannett 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, or 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.

Lannett announced that it has received approval from the FDA to manufacture Numbrino, the company's branded topical anesthetic product, at its main plant in Seymour, Indiana. The company previously manufactured Numbrino and other liquid drug products at its Carmel, New York plant, which it sold in March of this year as part of a restructuring and cost reduction plan.

Societal CDMO (SCTL) announced that it has signed an amendment to its license and supply agreement with Lannett Company (LCI) for the marketing of Verapamil PM and Verelan SR products. Under terms of the amendment, Societal will now receive improved overall economics, including a 10% increase in the profit share component of revenue from Verapamil PM product sales, as well as immediate and scheduled increases in manufacturing prices. Additionally, the amendment awards Societal potential new GMP manufacturing agreements targeting injectable products for multiple additional Lannett development projects. "We immediately and aggressively undertook discussions with Lannett on a restructuring of our Verapamil PM and Verelan SR marketing agreement following the unexpected decline in sales that were reported during the first quarter. We were pleased with Lannett's willingness to work collaboratively to put an amendment in place that can benefit both parties and we look forward to continuing a positive relationship," said David Enloe, chief executive officer of Societal CDMO. "As part of our discussions with Lannett, it was important to Societal that we not only implement new terms that allow us to continue to achieve the desired financial results related to Verapamil PM product sales, but also to recognize further meaningful revenue opportunities through our relationship with the company. We believe that the amendment serves those purposes well and provides a pathway for Lannett and Societal to continue in a mutually beneficial partnership."

Lannett provided an update on its ongoing 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, or HEC. "We are pleased to report that to date approximately one half of the planned number of subjects in the study have received the first of two doses in the healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study of Lannett/HEC's biosimilar insulin glargine. In addition, approximately one third of the subjects have received a second dose," said Tim Crew, chief executive officer of Lannett. "Importantly, no serious adverse events have been reported. The study remains on track and we continue to believe top line results of the study will be available toward the end of this calendar year." Crew added that if the study is successful, the company anticipates filing the biologics license application, or BLA, for a biosimilar and interchangeable insulin glargine to Sanofi's Lantus Solostar in early 2023 and potentially launching the product in the first half of 2024. Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline.