Healthcare Industry News: U.S. Food and Drug Administration
News Release - October 30, 2017
Lannett And Celgene Enter Into Settlement And License Agreement Related To Thalomid(R)PHILADELPHIA, Oct. 30, 2017 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into a settlement and license agreement with Celgene Corporation that resolves patent infringement litigation in the U.S. related to Celgene's Thalomid®. The license agreement permits Lannett to manufacture and market in the U.S. its generic thalidomide product as of August 1, 2019 or earlier under certain circumstances. As mandated by the U.S. Food and Drug Administration (FDA), Thalomid® is subject to Risk Evaluation and Mitigation Strategies (REMS) program, which is designed and implemented during the commercialization of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks.
"I congratulate my staff and colleagues for showing the courage and resolve in successfully tackling such a complex project as thalidomide," said Arthur Bedrosian, chief executive officer of Lannett. "We believe our thalidomide will be the first entrant in the U.S. generic market."
Lannett is seeking approval from the FDA of its pending Abbreviated New Drug Application (ANDA) for thalidomide capsules 50 mg, 100 mg, 150 mg and 200 mg, the therapeutic equivalent to the reference listed drug, Thalomid® Capsules, 50 mg, 100 mg, 150 mg and 200 mg, of Celgene Corporation.
Subject to FDA approval of Lannett's ANDA for Thalidomide, the company intends to launch its product under the terms of the license agreement, which are confidential.
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, receiving FDA approval for and successfully commercializing Thalidomide Capsules 50 mg, 100 mg, 150 mg and 200 mg, 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 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.
Source: Lannett Company
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