Second Lawsuit Filed Based on Cephalon’s Newly Issued Patent
Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) announced today that Cephalon, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., has moved to dismiss with prejudice its first lawsuit alleging that Eagle’s tentatively approved bendamustine hydrochloride injection infusion product infringes one of its patents, U.S. Patent No. 8,445,524. The case was filed in the United States District Court for the District of Delaware in October, 2013.
“We are pleased that this case is likely to resolve satisfactorily in the near future. This recent development begins to pave the way for the launch of our product,” said Scott Tarriff, President and Chief Executive Officer.
Eagle’s New Drug Application for its bendamustine product received tentative approval from the FDA on July 22, 2014. Due to orphan drug exclusivity held by Cephalon, the tentative approval will not convert to final approval until September 2015, unless, at an earlier date, Eagle is able to demonstrate that its bendamustine product, which itself has been granted an orphan drug designation by the FDA, is clinically superior to Cephalon’s currently-marketed formulation.
Cephalon recently filed a second lawsuit in the District of Delaware alleging that Eagle’s bendamustine product infringes Cephalon’s newly-issued U.S. Patent No. 8,791,270. That case remains pending.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. The Company’s strategy is to utilize the FDA's 505(b)(2) regulatory pathway. Additional information is available on the company’s website at www.eagleus.com.
Forward Looking Statements
This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "intends," "anticipate(s)," “look forward,” “upcoming,” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding the outcome of the cases filed against us by Cephalon, Inc., statements regarding whether FDA will approve our bendamustine product and if so, when such approval will take place, and statements regarding receipt of Orphan Drug Exclusivity for our bendamustine product. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Cephalon will file additional litigation against us in the future, whether we will be successful in defending the ongoing litigation with Cephalon, whether the FDA will approve our bendamustine product and when such approval might be granted, whether the FDA will grant Orphan Drug Exclusivity to our bendamustine product and when such award might be granted, and the other risk factors contained in our Prospectus filed with the Securities and Exchange Commission on February 13, 2014, and our other periodic and interim reports filed from time to time with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
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