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Exelixis Announces Settlement of CABOMETYX (Cabozantinib) Patent Litigation With Cipla Limited and Cipla USA

Exelixis Announces Settlement of CABOMETYX (Cabozantinib) Patent Litigation With Cipla Limited and Cipla USA

Exelixis宣布与Cipla Limited和Cipla USA就CABOMETYX(卡博赞替尼)的专利诉讼达成和解
伊克力西斯 ·  05/20 12:00

ALAMEDA, Calif.--(BUSINESS WIRE)--May 20, 2024-- Exelixis, Inc. (Nasdaq: EXEL) today announced that it has entered into a Settlement and License Agreement (Agreement) with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla). This settlement resolves two patent litigations brought by Exelixis in response to Cipla's Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX (cabozantinib) tablets prior to the expiration of the applicable patents. The first case (Civil Action No. 23-287), filed on March 16, 2023, relates to Cipla's ANDA for a 60 mg cabozantinib dosage strength. The second case (Civil Action No. 24-565-RGA), filed on May 9, 2024, relates to a recent amendment to Cipla's ANDA, for the primary purpose of seeking additional approval for 20 mg and 40 mg cabozantinib dosage strengths.

加利福尼亚州阿拉米达--(美国商业资讯)--2024年5月20日-- Exelixis, Inc. 纳斯达克股票代码:EXEL)今天宣布,它已与Cipla Ltd.和Cipla USA, Inc.(统称Cipla)签订了和解和许可协议(协议)。该和解协议解决了Exelixis针对Cipla的缩写新药申请(ANDA)提起的两起专利诉讼,该诉讼要求在适用专利到期之前批准CABOMETYX(卡博赞替尼)片剂的仿制药上市。第一起案件(民事诉讼编号23-287)于2023年3月16日提起,涉及Cipla对60毫克卡博赞替尼剂量强度的ANDA。第二起案件(民事诉讼编号24-565-RGA)于2024年5月9日提起,涉及Cipla最近对ANDA的修正案,其主要目的是寻求20毫克和40毫克卡博赞替尼剂量强度的额外批准。

Pursuant to the terms of the Agreement, Exelixis will grant Cipla a license to market generic versions of CABOMETYX in the United States beginning on January 1, 2031, if approved by the U.S. Food and Drug Administration and subject to conditions and exceptions common to agreements of this type.

根据协议条款,如果获得美国食品药品监督管理局的批准,Exelixis将授予Cipla从2031年1月1日起在美国销售CABOMETYX仿制药的许可,但须遵守此类协议中常见的条件和例外情况。

Additionally, in accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Exelixis and Cipla regarding CABOMETYX patents pending in the U.S. District Court for the District of Delaware.

此外,根据协议,双方将终止Exelixis和Cipla之间所有正在进行的有关CABOMETYX专利的Hatch-Waxman诉讼,该诉讼正在美国特拉华特区地方法院审理。

The Agreement is confidential and subject to review by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice. The lawsuits will be dismissed after a period of time to allow for FTC review.

该协议是保密的,须接受美国联邦贸易委员会 (FTC) 和美国司法部的审查。诉讼将在一段时间后被驳回,以便联邦贸易委员会进行审查。

About Exelixis

关于 Exelixis

Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Exelixis是一家雄心勃勃的全球肿瘤公司,致力于在癌症治疗的最前沿创新下一代药物和方案。在卓越的药物发现和开发能力的推动下,我们正在迅速发展我们的产品组合,通过我们具有临床差异化的小分子、抗体药物偶联物和其他生物疗法产品线,靶向越来越多的肿瘤类型和适应症。这种全面的方法利用数十年来对我们的科学和合作伙伴关系的强劲投资,来推进我们的研究计划,扩大我们的旗舰商业产品CABOMETYX(卡博赞替尼)的影响力。Exelixis以大胆的科学追求为动力,致力于创造变革性疗法,为更多患者带来对未来的希望。有关该公司及其帮助癌症患者康复、更长寿的使命的信息,请访问 www.exelixis.com,关注 @ExelixisInc 在 X(Twitter)上,比如 Exelixis, Inc. 在 Facebook 上关注吧 Exelixis 在领英上。

Forward-Looking Statements

前瞻性陈述

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' obligations under the Agreement, including Exelixis' granting of a license to Cipla to market generic versions of CABOMETYX in the United States beginning on January 1, 2031 and termination by the parties of all ongoing Hatch-Waxman litigation regarding CABOMETYX patents; and the expectation that the lawsuits will be dismissed after a period of time following FTC review. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Exelixis' ability to effect its obligations under the Agreement; and other factors detailed from time to time under the caption "Risk Factors" in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

本新闻稿包含前瞻性陈述,包括但不限于与以下内容相关的陈述:Exelixis根据协议承担的义务,包括Exelixis向Cipla授予自2031年1月1日起在美国销售CABOMETYX仿制版本的许可,以及双方终止所有正在进行的有关CABOMETYX专利的Hatch-Waxman诉讼;以及预计诉讼将在联邦贸易委员会结束一段时间后被驳回审查。任何提及对未来事件或情况的预期、预测或其他描述的陈述均为前瞻性陈述,并基于Exelixis当前的计划、假设、信念、预期、估计和预测。前瞻性陈述涉及风险和不确定性。由于这些风险和不确定性,实际业绩和事件发生时间可能与前瞻性陈述中的预期存在重大差异,其中包括但不限于:Exelixis履行协议义务的能力;以及Exelixis最新的10-K表年度报告和随后的10-Q表季度报告以及Exelixis未来向其提交的其他文件中 “风险因素” 标题下不时详述的其他因素证券交易委员会。本新闻稿中的所有前瞻性陈述均基于截至本新闻稿发布之日Exelixis获得的信息,除非法律要求,否则Exelixis没有义务更新或修改此处包含的任何前瞻性陈述。

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

Exelixis、Exelixis 徽标和 CABOMETYX 是 Exelixis 在美国的注册商标。

Investors:
Susan Hubbard
EVP, Public Affairs and Investor Relations
(650) 837-8194
shubbard@exelixis.com

投资者:
苏珊·哈伯德
公共事务和投资者关系执行副总裁
(650) 837-8194
shubbard@exelixis.com

Media:
Claire McConnaughey
Senior Director, Public Affairs
(650) 837-7052
cmcconn@exelixis.com

媒体:
克莱尔·麦康纳
公共事务高级董事
(650) 837-7052
cmcconn@exelixis.com

Source: Exelixis, Inc.

来源:Exelixis, Inc.

译文内容由第三方软件翻译。


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