Urinary Bladder, Overactive

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX) announced that its stockholders have voted today to adopt Axonics’ merger agreement with Boston Scientific Corporation (NYSE: BSX). According to preliminary voting results from the special meeting of stockholders held earlier today, a majority of the shares of Axonics’ common stock outstanding and entitled to vote at the special meeting voted in favor of adopting the merger agreement. Final voting results, as tabulated by an independent inspector of election, will be reported on a Form 8-K to be filed with the U.S. Securities and Exchange Commission. “We want to thank Axonics’ stockholders for their strong support of our transaction with Boston Scientific,” said Raymond W. Cohen, chief executive officer of Axonics. “Our team is looking forward to the global impact we can make as part of Boston Scientific as we endeavor to bring our life-changing therapies to more patients than ever before.” The closing of the transaction is expected to occur in the first half of 2024 and remains subject to certain conditions, including receipt of approvals or clearances, or the expiration, termination or waiver of applicable waiting periods under U.S. and foreign antitrust laws. About Axonics Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022. Axonics® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid®, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. For more information, visit . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like “may,” “will,” “likely,” “should,” “expect,” “anticipate,” “future,” “plan,” “believe,” “intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,” “continue,” and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics’ ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by and among Axonics, Boston Scientific Corporation (“Boston Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific (“Merger Sub”), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the “Merger”), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics’ ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics’ current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics’ business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics’ industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics’ competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics’ markets, and risks related to other factors described under “Risk Factors” in other reports and statements filed with the U.S. Securities and Exchange Commission (“SEC”), including Axonics’ most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics’ website at and on the SEC’s website at . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. View source version on businesswire.com: Contacts Axonics contact: Neil Bhalodkar IR@axonics.com Source: Axonics, Inc. View this news release online at:

编者按：本文来自药智头条，作者葵花籽；赛柏蓝授权转载，编辑yuki“专利悬崖”意指药品专利保护期届满后，其销售额与利润大幅下滑的现象。此种现象如同一道无形的悬崖，原研药即便在光辉成就之下，亦无法回避这一严峻现实。对于原研药企而言，在寻求新增长点与巩固专利“护城河”的过程中，均面临着诸多挑战。利拉鲁肽、达沙替尼、那他珠单抗等多款年销售额超5亿美元的大品种都将在今年先后失去美国专利保护。2024年在美专利到期的十大药物资料来源：Fierce Pharma01 达沙替尼（Sprycel）适应症：慢性粒细胞白血病研发企业：BMS2023年美国销售额：14.5亿美元生物类似药上市时间：2024年9月达沙替尼是百时美施贵宝（BMS）肿瘤学主打产品之一，是一种针对癌细胞中特定蛋白质并阻止癌细胞生长的药物。BMS财报显示，达沙替尼2023年全球销售额约为19.3亿美元，其中14.5亿美元来自美国市场。达沙替尼于2006年首次获FDA批准，用于对先前治疗药物（包括伊马替尼）具有耐药性或不耐受的费城染色体阳性慢性髓系白血病慢性期（Ph+CML-CP）成人患者以及用于对先前治疗药物具有耐药性或不耐受的Ph+ALL成人患者。BMS在一份年度证券文件中解释说，由于与Apotex和一些未披露名称的公司达成了和解协议，某些仿制药获准在2024年9月上市，或在某些情况下提前上市。据悉，目前Teva、Biocon、Lupin、Dr.Reddy's Laboratories、Alebmic的仿制药已获得FDA暂定批准。02那他珠单抗（Tysabri）适应症： 多发性硬化症、克罗恩病研发企业：渤健2023年美国销售额：9.98亿美元生物类似药上市时间：2024年下半年那他珠单抗于2004年获得FDA批准用于治疗多发性硬化症，2008年获批用于治疗克罗恩病。该药在2009年销售额高达11亿美元。根据渤健2023年第四季度财报，2023年该药在美国的销售额为9.98亿美元，较2022年的11.2亿美元下降约11%。在特拉华州联邦法院驳回百健对山德士的专利侵权诉讼约两个月后，山德士于2023年8月获得了美国首个、也是迄今为止唯一一个那他珠单抗生物类似药的批准。03米拉贝隆（Myrbetriq）适应症：膀胱过度活动症研发企业：安斯泰来2023年美国销售额：6.4亿美元生物类似药上市时间：2024年5月2012年6月，米拉贝隆在美国获批上市。2023年6月，美国特拉华州地区法院作出裁决，宣布该药2030年的一项关键专利无效，这促使安斯泰来公开回应，并强调该药在2024年5月前仍受专利保护。不久之后，安斯泰来又获得了一项2030年的膀胱过度活动症药物专利，并发起了新一轮针对仿制药公司的诉讼。安斯泰来寻求获得FDA禁令，禁止生物类似药在该专利到期前上市。FDA的桔皮书显示，米拉贝隆的监管专属期将于2024年9月到期。该药的部分专利将于2024年5月到期。与此同时，Lupin和Alkem两家公司的米拉贝隆仿制药已获得FDA批准，此外，Aurobindo的仿制药也获得了初步批准。04利拉鲁肽（Victoza）适应症：2型糖尿病研发企业：诺和诺德2023年美国销售额：5.25亿美元生物类似药上市时间：2024年6月作为诺和诺德第一代GLP-1糖尿病药物，利拉鲁肽自2010年获批以来已顺利享受了14年的独占期，包括将其专利悬崖延长至2024年的儿科独占期。目前，生物类似药竞争者Teva、山德士和晖致正急于蚕食利拉鲁肽已经日薄西山的销售额。根据诺和诺德2023年年度报告，2023年利拉鲁肽在美国的销售额为5.25亿美元，较2022年9.3亿美元大幅下降。根据美国证券交易委员会的一份文件，Teva、山德士和晖致为主要的仿制药公司。其中，Teva计划在2024年6月推出利拉鲁肽生物类似药。05Emflaza (deflazacort)适应症： 杜氏肌营养不良症研发企业：PTC Therapeutics2023年美国销售额：2.55 亿美元生物类似药上市时间：2024年2月在经历了之前的定价争议之后，PTC Therapeutics获批治疗杜氏肌营养不良症（DMD）的关键药物Emflaza已经面临着新的生物类似药竞争。印度Aurobindo公司在2024年2月获得FDA最终批准后，正在计划推出Emflaza生物类似药，该药的标签范围涵盖了5岁及以上患者。06注射用醋酸奥曲肽微球 (Sandostatin LAR) 适应症：肢端肥大症，类癌瘤引起的严重腹泻研发企业： 诺华2023年美国销售额：1.99 亿美元仿制药上市时间：2024年Sandostatin LAR于1998年首次获得FDA批准治疗肢端肥大症，还可用于治疗转移性类癌引起的严重腹泻和潮红。晖致总裁Rajiv Malik在今年1月举行的摩根大通医疗保健会议上表示，将Sandostatin LAR列为今年计划推出的仿制药之一。根据晖致最新消息，Sandostatin LAR仿制药申请正在接受FDA审查。虽然Sandostatin LAR此前一直保持着美国的独家经营权，但其销售额已逐年大幅下降。去年Sandostatin在美国的销售额为1.99亿美元，同比下降2%。07Dulera (糠酸莫米松+福莫特罗)适应症： 哮喘研发企业：欧加隆2023年美国销售额：1.56 亿美元仿制药上市时间：2024年下半年Dulera是一款皮质类固醇糠酸莫米松和长效β受体激动剂福莫特罗的复方制剂，通过吸入器给药。Dulera曾被视为潜在的“重磅炸弹”，2010年获批用于治疗哮喘，但2012年治疗慢性阻塞性肺病（COPD）的第二次申请遭 FDA拒批。尽管获批折戟，但其销售额仍呈上升趋势，2015年达到5.36亿美元的峰值。到2017年，由于价格竞争压力以及需求下降，Dulera的销售额缩水至2.87亿美元。2023年更是骤降至1.56亿美元。Dulera已于2020年失去了在美国的专利保护，但至今未有相关仿制药上市。印度仿制药巨头Lupin曾于2020年4月向FDA递交了Dulera仿制药的上市申请，但其申请在2022年底被FDA拒绝批准。上个月，该公司表示将在2024年5月之前对FDA的决定做出回应。08奥卡西平 (Oxtellar XR）适应症： 癫痫研发企业：Supernus Pharmaceuticals2023年美国销售额：1.13 亿美元仿制药上市时间：2024年9月2012年，奥卡西平作为辅助疗法获得批准后销售额逐年攀升；2019年，奥卡西平作为单药疗法获批，销售额继续增长，2021年首次突破1亿美元，2023年在美国的销售额为1.13亿美元。十年前，Actavis和TWi Pharma首次对奥卡西平发出仿制药挑战。Supernus分别于2017年和2018年在针对仿制药生产商的侵权案中胜诉，因为法院判决其专利期有效至2027年。奥卡西平失去专利保护对其的影响并不大。在2月份的季度电话会议上，Supernus首席执行官Jack Khattar表示，预计仿制药竞争要到9月份才会开始。2024年奥卡西平和Trokendi XR的合并净销售额将在1.25亿美元到1.35亿美元之间。09Venofer (蔗糖铁)适应症：慢性肾病患者缺铁性贫血研发企业：CSL2023年美国销售额：0.9亿美元仿制药上市时间：2024年Venofer于2000年获得FDA批准用于治疗慢性肾病成人患者的缺铁性贫血。多年来，Venofer一直在回击潜在的仿制药挑战者。晖致在2月的投资者推介会上称其Venofer仿制药正在接受监管审查。CSL在2021年底以117亿美元收购Vifor Pharma时获得该药，据CSL投资者报告，该药物2023年的全球销售额为1.8亿美元，预计其中二分之一来自美国市场。10Prolensa (bromfenac)适应症：白内障手术后的术后眼部炎症研发企业：Bausch + Lomb2023年美国销售额：0.415亿美元仿制药上市时间：2024年1月FDA于2013年批准Bausch+Lomb的Prolensa滴眼液作为白内障手术患者术后炎症的治疗药物，但它并不是第一款进入美国市场的含有非甾体抗炎药物溴芬酸活性成分的滴眼液产品。Prolensa最初是由日本公司Senju开发，2000年在日本上市。ISTA公司于 2002年获得该药在美国的使用权，ISTA后来被Bausch+Lomb收购。2005年，该产品在美国获批上市，商品名为Xibrom（溴芬酸0.09%），作为白内障手术后眼部炎症的每日2次滴眼液选择。2010年，ISTA开发的溴芬酸的每日1次滴眼液版本Bromday获批上市。在Prolensa获得FDA批准的同一年，Lupin曾向FDA提交溴芬酸的仿制药上市申请。经历了长达近3年的诉讼后，Lupin仿制药于2023年11月获得FDA 批准。除了Lupin之外，Metrics、Innopharma、Apotex和Paddock也向FDA提交了Prolensa的仿制药上市申请。END内容沟通：13810174402医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the Axonics R20™ rechargeable sacral neuromodulation (SNM) system has received CE Mark approval. The R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to once every 6 to 10 months for only one hour. The implant utilizes the same small 5cc form factor as the previous generation (Axonics R15™) and is paired with the same tined lead and intuitive, easy to use patient remote control. The R20 also provides physicians and their patients with enhanced programming capabilities and expanded MRI labeling. “Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said Raymond W. Cohen, chief executive officer. “Patients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The R20 represents another significant breakthrough for rechargeable neuromodulation devices and underscores Axonics’ commitment to continuous innovation. We are confident that our keen focus on the incontinence patient population has the potential to drive significant market expansion in both the U.S. and international markets in the years ahead.” Axonics expects to commence sales of the R20 to European customers in mid-April. The R20 received approval from the U.S. FDA in January 2023 and from Health Canada in December 2022. About Axonics Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022. Axonics® sacral neuromodulation systems provide adults with overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid®, provides safe and durable symptom relief to women with stress urinary incontinence. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. For more information, visit . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like “may,” “will,” “likely,” “should,” “expect,” “anticipate,” “future,” “plan,” “believe,” “intend,” “goal,” “seek,” “endeavor,” “estimate,” “project,” “continue,” and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics’ ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the “Merger Agreement”), by and among Axonics, Boston Scientific Corporation (“Boston Scientific”), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific (“Merger Sub”), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the “Merger”), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics’ ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics’ current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics’ business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics’ industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the “Medtronic Litigation”); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics’ competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics’ markets, and risks related to other factors described under “Risk Factors” in other reports and statements filed with the U.S. Securities and Exchange Commission (“SEC”), including Axonics’ most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics’ website at and on the SEC’s website at . Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events. Additional Information and Where to Find It In connection with the contemplated Merger, Axonics filed on February 22, 2024 with the SEC a definitive proxy statement relating to a special meeting of Axonics’ stockholders to be held for the purpose of obtaining stockholder approval of the Merger Agreement and other related matters (the “Proxy Statement”). The Proxy Statement was mailed to Axonics’ stockholders on or about February 22, 2024. Axonics may also documents with the SEC regarding the contemplated Merger. This document is not a substitute for the Proxy Statement or any other document that Axonics has filed or may the SEC in connection with the contemplated Merger. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF AXONICS ARE URGED TO READ THE PROXY STATEMENT, ANY AMENDMENTS OR SUPPLEMENTS THERETO, ANY OTHER SOLICITING MATERIALS AND ANY OTHER DOCUMENTS THAT ARE FILED OR WILL BE FILED WITH THE SEC IN CONNECTION WITH THE CONTEMPLATED MERGER OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT BECAUSE THEY CONTAIN OR WILL CONTAIN, AS APPLICABLE, IMPORTANT INFORMATION ABOUT AXONICS, BOSTON SCIENTIFIC AND THE CONTEMPLATED MERGER. Investors and security holders may obtain free copies of the Proxy Statement and other filings containing important information about Axonics on the SEC’s website at , on Axonics’ website at or by contacting Axonics’ Investor Relations department via email at IR@axonics.com. Participants in the Solicitation Axonics and its directors and executive officers may, under SEC rules, be deemed participants in the solicitation of proxies from the stockholders of Axonics in connection with the contemplated Merger. Information regarding the identity of potential participants in the solicitation of proxies in connection with the proposed Merger, and their direct or indirect interests, by security holdings or otherwise, is included in the Proxy Statement. Additional information regarding Axonics’ directors and executive officers is contained in the Proxy Statement, Axonics’ Definitive Proxy Statement on Schedule 14A for Axonics’ 2023 Annual Meeting of Stockholders, which was filed with the SEC on May 1, 2023 (and specifically, the following sections: “Security Ownership of Certain Beneficial Owners, Executive Officers and Directors”, “Certain Relationships and Related-Party Transactions”, “Executive Officers”, “Proposal 1–Election of Directors”, “Director Compensation”, and “Executive Compensation”) and in Axonics’ Current Report on Form 8-K, which was filed with the SEC on October 4, 2023. To the extent holdings of the Company’s securities by the directors or executive officers have changed since the amounts set forth in the Proxy Statement, such changes have been or will be reflected on Initial Statement of Beneficial Ownership of Securities on Form 3, Statement of Changes in Beneficial Ownership on Form 4, or Annual Statement of Changes in Beneficial Ownership on Form 5 filed with the SEC, which are available at EDGAR Search Results (sec.gov). These documents (when available) are available free of charge as described in the preceding section. View source version on businesswire.com: Contacts Neil Bhalodkar IR@axonics.com Source: Axonics, Inc. View this news release online at: