PHILADELPHIA,?March 10, 2021?/PRNewswire/ --?Lannett Company, Inc. (NYSE:?LCI) today announced that it recently received feedback from the U.S. Food and Drug Administration (FDA) regarding biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC). Lannett sought and received comments from the FDA related to the pivotal trial protocol and statistical analysis plan (SAP) for the development program. At a Biosimilar Biological Product Development (BPD) Type 2 meeting in?June 2020, representatives from Lannett spoke with and received guidance from the FDA on the clinical advancement program of its biosimilar insulin glargine partnered product candidate. At that meeting, FDA requested Lannett submit a protocol for the pivotal trial for review before Lannett submitted an Investigational New Drug Application (IND). In?November 2020, the company responded to that request and provided the proposed protocol and SAP. The FDA recently provided its feedback and comments to the company's proposal and the company has now incorporated the feedback into the design of the pivotal trial, including the type and size of the trial, as well as primary and secondary endpoints, to meet the FDA's requirements. The company said it was comfortable with the feedback, which is aligned with ongoing development work. Testing related to the production of a commercially scaled batch is underway, so the company believes it remains on track to submit an IND to the FDA later this calendar year. Subsequent to filing an acceptable IND, the company anticipates commencing the pivotal trial early in calendar year 2022, filing the BLA later in 2022 and launching the product in 2023. The company noted that the proposed pivotal trial, albeit with a larger number of proposed participants, is similar to the previously completed first human volunteer pilot study, which indicated that the Lannett/HEC insulin glargine product was biosimilar to US-approved Lantus^??(the reference biologic) in terms of meeting all pharmacokinetics (PK) and pharmacodynamics (PD) safety endpoints in the study. Lantus^??is a registered trademark of Sanofi S.A. 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 statements, including, but not limited to, advancing the development of biosimilar insulin glargine, as well as receiving FDA approval and successfully commercializing the product, whether expressed or implied, are 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 difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully manufacture and commercialize products upon approval, including acquired products, and Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time.? 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 SOURCE Lannett Company, Inc.