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WOODCLIFF LAKE, N. J. , Jan. 18, 2024 (GLOBE NEWSWIRE) — Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) provided an update on its portfolio of bendamustine intellectual assets.
On January 16, 2024, the U. S. Court of Appeals for the Federal Circuit ruled that the U. S. Court of Appeals for the U. S. Supreme Court of Appeals for the U. S. Supreme Court of Appeals for the United States of America and the U. S. Court of Appeals for theThe U. S. District Court upheld the U. S. District Court’s previously announced ruling. The U. S. District Court for the District of Delaware determined that the 505(b)(2) drug programs referencing BELRAPZO® submitted through Slayback Pharma Limited Liability Company (“Slayback”)1 and Apotex Inc. and Apotex Corp. (“Apotex”) did not infringe the ‘483 patent issued in the past through Eagle. Slayback, Apotex, and Baxter Healthcare Corporation (“Baxter”) introduced their respective products in December 2022.
Eagle also announces that the U. S. Patent and Trademark Office will be issuing a new patent and trademark office. The U. S. Patent No. 11844783 (the “‘783 Patent”) and the U. S. Patent 11872214 (the “‘214 Patent”) covering Eagle’s innovative liquid formulations of bendamustine. The patents are indexed in the Orange Book of BENDEKA® and BELRAPZO.
On January 17, 2024, Eagle filed a lawsuit alleging that 505(b)(2) products with reference to BELRAPZO advertised through Slayback, Apotex, and Baxter infringed one or more claims of the recently issued ‘783 and ‘214 patents and seeking damages. for any damages. Infringing sales of the parties’ respective infringing products. Eagle intends to seek lost profits and other damages resulting from all infringing sales of Defendants’ bendamustine products, as well as an injunction compelling Defendants to halt all sales of their infringing products until the patents expire in 2031.
“We are pleased to maximize our intellectual assets for the Bendamustine franchise and will continue to take appropriate action for our rights similar to the recently issued patents,” said Michael Graves, interim CEO and interim executive chairman of Eagle’s board of directors.
Eagle cannot wait for the timing or final results of the litigation described above or the effect of such litigation on its business. In addition, Eagle has made the allegations described above only on the basis of information that has been released lately. I had to. These allegations have not been fully challenged and the data and assumptions underlying those allegations would possibly be replaced after the date of the present. Further, notwithstanding Eagle’s allegations and reviews of the merits of this litigation, the litigation is inherently dubious and there can be no guarantee that the court will agree with Eagle’s allegations or its interpretation of applicable laws or regulations, or that Eagle will succeed in such litigation. Accordingly, the allegations described above are not statements of fact that Eagle’s shareholders or potential investors may depend on.
About Eagle Pharmaceuticals, Inc. Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS® through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states, and the company is focused on developing medicines with the potential to become part of the personalized medicine paradigm in cancer care. Additional information is available on Eagle’s website at www.eagleus.com.
Forward-Looking Statements This press release comprises “forward-looking statements” 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 past facts. Words and words like “planned”, “go ahead”, “will”, “could”, “may also simply”, “may”, “intend”, “remain”, “prospective”, “prepare”, “expected “, “believe”, “plan”, “seek”, “continue”, “estimate” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding: the Company’s expectations regarding BENDEKA and BELRAPZO, adding similar litigation, adding the Company’s allegations related to infringement of its ‘783 and ‘214 patents and possible similar damages, and the expectations of the Company related to the fulfillment of its rights to intellectual assets; the issuance and registration of patents for BENDEKA and BELRAPZO in the FDA Orange Book and the resulting consequences; the Company’s ability to expand cutting-edge medicines that result in significant improvements in patients’ lives; the ability of the Company’s products and product applicants to address underserved healing spaces in multiple disease states; and the company’s ability to develop drugs that can also become part of the personalized medicine paradigm in cancer treatment. All such statements are subject to certain dangers and uncertainties, many of which are difficult to expect and are sometimes beyond the control of the Company, which may also cause actual effects to differ materially from those expressed, implied or projected. through prospective data. and statements. Array These dangers and insecurities include, but are not limited to: the final touch of the review and preparation of the Company’s monetary statements and internal control over monetary reporting and disclosure controls and procedures and the timing of the same; the discovery of additional data; additional delays in the filing of the Company’s monetary reports, compounded by unforeseen items; the Company’s ability to meet its legal responsibilities under its credit agreement; the option that the Company may not be able to return to, or continue to comply with, Nasdaq Board rules or suffer violations of additional Nasdaq Board rules; the option of Nasdaq possibly delisting the Company’s securities; the Company’s ability to address weaknesses in its internal control over monetary reporting; the Company’s ability to recruit and hire a new Chief Executive Officer; the effects of the post-COVID-19 environment and geopolitical issues such as the conflicts between Russia and Ukraine and between Gaza and Israel; wait or fail to discharge regulatory approval of applicants for the Company’s products or their components and comply with the Federal Medicines Administration, the European Medicines Agency and other government regulations applicable to product approvals; adjustments in the regulatory environment; uncertainties and timing of the regulatory approval process; whether the Company can fortunately position itself in the market and position its products in the market; the good fortune of the Company’s relationships with its components; the final results of the litigation; the strength and ability to enforce the Company’s intellectual asset rights or the rights of third party components; festival of other pharmaceutical and biotechnology corporations and festival of new generics in market position; unanticipated knowledge of protection or effectiveness observed in clinical trials; decrease activation or recruitment rates to clinical trial sites than expected; dangers inherent in drug progression and the conduct of clinical trials; dangers inherent in estimates or judgments relating to the Company’s critical accounting policies, or any estimates or projections of the Company, which may prove to be inaccurate; unforeseen points in addition to the foregoing that may also have an effect on the Company’s monetary and business projections and guidance and may also cause the Company’s actual effects and effects to differ materially from its estimates, projections and guidance; and the known dangers and uncertainties in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (the ” SEC”) on March 23. 2023. , the company’s quarterly reports on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 2023, and for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023. and its other upcoming filings with the SEC. Readers are cautioned not to place undue reliance on such forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date on which they are made. Except as required by law, the Company undertakes no legal responsibility to update such statements to reflect occasions occurring or cases existing after the date they were made.
Investor Relations for Eagle Pharmaceuticals, Inc.: Lisa M. WilsonIn-Site Communications, Inc. T: 212-452-2793 E: [email protected]
Eagle Pharmaceuticals, Inc. Public Relations: Faith Pomeroy-WardT: 817-807-8044E: Faith@eagleus. com
_____________________________________1 On September 27, 2023, Azurity Pharmaceuticals acquired Slayback Pharma.