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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宣佈與Cipla Limited和Cipla USA就CABOMETYX(卡博贊替尼)的專利訴訟達成和解
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.

加利福尼亞州阿拉梅達--(商業新聞)--2024年5月20日-- 伊克力西斯公司(納斯達克代碼:EXEL)今天宣佈,與西普拉制藥及其子公司西普拉美國公司(Cipla)達成了一項和解和許可協議(協議),解決了伊克力西斯作爲響應西普拉的縮寫新藥申請(ANDA)而提起的兩起專利訴訟,這些新藥申請尋求在適用專利的到期前獲得CABOMETYX (卡博替尼)片劑的通用版本上市批准。第一起案件(第23-287民事訴訟),於2023年3月16日提起,與西普拉申請的60毫克卡博替尼劑量有關。第二起案件(第24-565-RGA民事訴訟),於2024年5月9日提起,與西普拉的ANDA的最近修正有關,該修正的主要目的是尋求額外的20毫克和40毫克卡博替尼劑量批准。

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.

根據該協議的條款,伊克力西斯將授權西普拉在美國推出通用CABOMETYX版本,前提是該版本獲得美國食品和藥物管理局的批准,並且符合此類協議的普遍條件和例外情況,時間是從2031年1月1日開始。

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,根據協議,雙方將終止在特拉華州聯邦地區法院涉及CABOMETYX專利的所有正在進行的Hatch-Waxman訴訟。

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.

該協議屬於機密文件,受美國聯邦貿易委員會(FTC)和美國司法部審查。 訴訟將在一段時間後解除,以便FTC進行審查。

About Exelixis

關於 伊克力西斯

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.

伊克力西斯是一家全球性的腫瘤學公司,正在創新下一代腫瘤治療藥物和療法。憑藉藥物發現和開發卓越性,我們正在迅速發展我們的產品組合,以針對越來越多的腫瘤類型和指標,我們的臨床差異化小分子、抗體-藥物聯合物和其他生物治療技術管線。這種全面的方法利用了我們科學和合作夥伴關係中幾十年的堅實投資,以推進我們的研究項目和延長我們旗艦產品CABOMETYX(卡博替尼)的影響。伊克力西斯的驅動力是大膽的科學追求,致力於創造改變未來的治療方式,爲更多患者帶來希望。有關該公司及其幫助癌症患者恢復更強大、生存更久的使命的信息,請訪問其網站 www.exelixis.com,在X(Twitter)上關注@ExelixisInc,在Facebook上點贊Exelixis, Inc.,在LinkedIn上關注Exelixis。 @伊克力西斯公司在X(推特)上,像伊克力西斯股份有限公司在臉書上關注伊克力西斯

Forward-Looking Statements

前瞻性聲明

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.

本新聞稿包含前瞻性聲明,包括但不限於與協議相關的伊克力西斯的義務,包括伊克力西斯授權西普拉在2031年1月1日開始推出CABOMETYX的通用版本,並終止雙方之間涉及CABOMETYX專利的所有正在進行的Hatch-Waxman訴訟;以及預計訴訟將在FTC審核後一段時間後被解除。任何涉及對未來事件或情況的預期、預測或其他描述的聲明都屬於前瞻性聲明,基於伊克力西斯目前作出的計劃、假設、信念、預期、估計和預測。前瞻性聲明涉及風險和不確定性。由於這些風險和不確定性,實際結果和事件的時間可能與前瞻性聲明中預期的結果和事件發生時間有所不同,這些風險和不確定性包括但不限於:伊克力西斯履行其在協議中的義務的能力;以及Exelixis在“風險因素”標題下定期詳細介紹的其他因素,包括在最新的“10-K年度報告”和隨後的“10-Q季度報告”中詳細介紹的其他因素,以及Exelixis今後在美國證券交易委員會提交的其他文件中詳細介紹的其他因素。本新聞稿中的所有前瞻性聲明均基於伊克力西斯截至本新聞稿發佈之日可獲得的信息,伊克力西斯不承擔更新或修訂本新聞稿中包含的任何前瞻性聲明的義務,除非法律規定要求。

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

伊克力西斯、伊克力西斯公司商標和CABOMETYX爲伊克力西斯的註冊美國商標。

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

投資者:
蘇珊·哈伯德
公共事務和投資者關係執行副總裁
(650) 837-8194
shubbard@伊克力西斯.com

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

媒體:
克萊爾·麥考納希
高級主任,公共事務
(650) 837-7052
cmcconn@伊克力西斯.com

Source: Exelixis, Inc.

來源:伊克力西斯股份有限公司。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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