Salix Pharmaceuticals Ltd.

LAVAL, Quebec, April 17, 2025 – Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), and its gastroenterology business Salix Pharmaceuticals, Inc., today announced the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Kennedy, et al. (Case No. 25-cv- 00091), denied Norwich’s motion for a preliminary injunction treated as a motion for summary judgment in its lawsuit against the U.S. Food and Drug Administration (FDA). Norwich had asked the District Court for a judgment declaring the FDA’s decision to issue tentative approval for Norwich’s Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg and failure to determine Teva Pharmaceuticals USA, Inc. (Teva) had forfeited its 180-day exclusivity were arbitrary, capricious, and contrary to law. Norwich sought an injunction directing the FDA to immediately grant Final Approval to Norwich’s ANDA for XIFAXAN® (rifaximin) 550 mg. Norwich argued that if upheld, FDA’s determination will prohibit Norwich from marketing those products until at least June 29, 2028, assuming Teva launches its rifaximin product in January 2028. Today, the District Court denied Norwich’s motion and granted summary judgment in favor of the FDA, Salix, and Teva, and closed the case. “We are pleased with the ruling issued today by the U.S. District Court. We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to XIFAXAN,” said Thomas J. Appio, CEO of Bausch Health. Management will release first quarter financial results after market close on Wednesday, April 30, 2025, followed by a conference call and live webcast at 5:00 p.m. U.S. EDT to discuss results and provide a business update. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. Forward-Looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.

一、品种概述1、基本情况国内：奥美拉唑碳酸氢钠干混悬剂主要有两规格：（Ⅰ）奥美拉唑20mg与碳酸氢钠1680mg；（Ⅱ）奥美拉唑40mg与碳酸氢钠1680mg。奥美拉唑碳酸氢钠干混悬剂（Ⅰ）的适应症主要有：1、用于活动性十二指肠溃疡的短期治疗，大多数患者在4周内愈合；2、胃食管反流病。而奥美拉唑碳酸氢钠干混悬剂（ Ⅱ ）的适应症为活动性良性胃溃疡的短期治疗（4～8周）。二者均为处方药，且均已被收录于国家医保乙类目录（2024年），但未被纳入国家集采目录中。国外：原研企业Santarus Inc有两个奥美拉唑碳酸氢钠的相关产品，分别为奥美拉唑碳酸氢钠干混悬剂和奥美拉唑碳酸氢钠胶囊。奥美拉唑碳酸氢钠干混悬剂（商品名：Zegerid，共有两个规格：20mg/packet；1.68gm/packet和40mg/packet；1.68gm/packet）于2004年6月被美国FDA批准上市。2、作用机制和优势作用机制：奥美拉唑碳酸氢钠干混悬剂为复方制剂，主要成分为奥美拉唑和碳酸氢钠。其中奥美拉唑通过特异性抑制胃壁细胞的H+- K+-ATP酶系统，从而抑制胃酸分泌；碳酸氢钠通过升高胃内pH值，从而保护奥美拉唑不被胃酸降解。优势：（1）作为干混悬剂：起效迅速，5min起效，15min达峰，显著快于PPI肠溶制剂；儿童和老年友好剂型，可口服或鼻胃管给药，更适合特殊群体（如吞咽困难、轻瘫患者）。（2）作为复方制剂：具有复方制剂的协同联动效应，1+1＞2。（3）其他优势：可睡前服用，更好控制夜间酸突破；不受餐食影响，提高患者服药依从性。表：奥美拉唑碳酸氢钠干混悬剂VS PPI肠溶制剂+碳酸氢钠口服制剂3、专利情况原研核心专利已过期。4、国内上市情况目前持有奥美拉唑碳酸氢钠干混悬剂（Ⅰ）上市批件的企业共有6家，持有奥美拉唑碳酸氢钠干混悬剂（II）上市批件的企业有2家。其中南京海纳医药奥美拉唑碳酸氢钠干混悬剂（Ⅰ）和（II）的批件均持有。表：奥美拉唑碳酸氢钠干混悬剂的国内上市情况5、国内注册情况目前共有4家企业进行了奥美拉唑碳酸氢钠干混悬剂的上市申请，均暂未获得批准。表：奥美拉唑碳酸氢钠干混悬剂的部分国内注册情况（ANDA）6、临床试验情况目前登记的奥美拉唑碳酸氢钠干混悬剂相关试验共有23条，已完成12条，近3年试验状态为进行中的试验只有2条。表：试验状态为进行中的奥美拉唑碳酸氢钠干混悬剂相关试验二、市场可行性分析1、适应症及流行病学胃食管反流病（GERD）：是常见的慢性消化系统疾病，是由胃十二指肠内容物反流至食管或口腔引起不适症状和（或）并发症的一种慢性疾病。烧心和反流是最常见的典型症状。GERD的进展会诱发食管癌，是已被证实是食管腺癌最重要的危险因素。GERD的药物治疗包括抑酸剂、抗酸剂（如碳酸氢钠）和胃肠促动药等。抑酸剂主要包括组胺Ｈ2受体阻断剂、PPI（如奥美拉唑）和P-CAB。流行病学特征：中国GERD近年来发病率较高，疾病负担较重，近10年呈现明显上升趋势，且GERD患病率和发病率随着年龄的增加不断上升，老龄化对我国GERD的发病率和患病率影响较大。2019年我国GERD新发病例数约3271.13万，现患病例数约8163.65万；2019年中国GERD发病率的粗率和标化率分别为2299.80/10万和1841.66/10万，2019年中国GERD患病率的粗率和标化率分别为5739.55/10万和4509.32/10万。GERD严重影响人群的健康和生活质量，也给社会医疗资源带来巨大负担，消化科处方药物中前5位均为GERD治疗用药。针对全球人群的研究结果显示，每周至少发作1次GERD症状的患病率约13%，而我国基于全人群的流调显示每周至少发作一次烧心症状的患病率为1.9%-7%，且发病率有升高趋势，市场空间广阔。2、指南/共识推荐表：胃食管反流病相关指南对奥美拉唑碳酸氢钠制剂的相关推荐3、相关竞品的分析表：奥美拉唑碳酸氢钠干混悬的竞品分析4、国内消化系统用药的市场规模米内网数据显示，2023年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端消化系统及代谢化药销售额接近1300亿元，同比下滑0.76%；2024H1其销售额超过648亿元，同比下滑6.42%。从治疗类别上看，消化系统及代谢化药涉及14个治疗亚类，其中糖尿病用药位列第一，占据的市场份额接近23%；治疗与胃酸分泌相关疾病的药物位列第二，市场份额超过21%；胆/肝疾病治疗药、维生素类分别位列第三、第四，市场份额均超过11%。中国公立医疗机构终端消化系统及代谢化药销售情况（单位：万元）数据来源：米内网质子泵抑制剂（PPI）是治疗与胃酸分泌相关疾病的重点药物，也是国家集采的重点对象之一，累计已有10个品种被纳入。米内网数据显示，质子泵抑制剂在中国公立医疗机构终端销售峰值为2019年的360亿元，随后受重点监控、带量采购等政策影响，2020-2023年分别下滑14.15%、13.94%、35.98%、12.41%。中国公立医疗机构终端质子泵抑制剂销售情况（单位：万元）数据来源：米内网5、奥美拉唑碳酸氢钠干混悬剂国内市场规模奥美拉唑碳酸氢钠干混悬剂市场情况：2021年-2023年的市场规模均处于增长状态，2024年较2023年小幅度下降，2024年奥美拉唑碳酸氢钠干混悬剂市场规模为826万元。从单品种的市场情况来看，奥美拉唑碳酸氢钠干混悬剂（Ⅰ）的市场规模近4年均在增长，2024年其市场份额为56.66%。从销售终端来看，医院端占据绝大部分，占比超过95%。奥美拉唑碳酸氢钠干混悬剂的市场优势未被纳入集采：价格弹性较高，可避免大幅降价压力；避开集采竞争，可保持一定的市场独占性，市场空间足够。属于医保乙类：可提升患者的普及性，有利于提升二级及以下医院/基层医院的覆盖率，可借助医保放量实现市场扩张。从近年个销售终端的市场占比来看，基层医院（城市社区、县级公立以及乡镇卫生）的市场份额在逐年提升。未来基层医院的市场放量将会更明显。未来市场情况：国内胃食管反流病的发病率和患病率高不断升高，患者数量也是在逐年升高，这将为本品提供广阔的市场空间，本品市场规模未来将会持续扩增。奥美拉唑碳酸氢钠干混悬剂市场规模奥美拉唑碳酸氢钠各销售终端情况数据来源：米内网END★点击下方卡片，发现更多精彩

近日，上海医药下属全资子公司上海上药信谊药厂有限公司的奥美拉唑碳酸氢钠干混悬剂（Ⅱ）收到国家药品监督管理局颁发的《药品注册证书》（证书编号：2025S00589），该药品获得批准生产。 基本情况 药物名称 奥美拉唑碳酸氢钠干混悬剂（Ⅱ） 剂型 口服混悬剂 规格 每袋含奥美拉唑40mg和碳酸氢钠1680mg 注册分类 化学药品3类 批件号 国药准字H20253507 审批结论 根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求，批准注册，发给药品注册证书。 相关信息 奥美拉唑碳酸氢钠干混悬剂（Ⅱ）（每袋含奥美拉唑40mg和碳酸氢钠1680mg）主要用于活动性良性胃溃疡的治疗（4-8周），由Salix Pharmaceuticals Inc公司研制生产，商品名为Zegerid，于2004年6月获得美国食品药品监督管理局（“FDA”）批准在美国上市。2023年3月，上药信谊就该药品向国家药监局提出注册上市申请，并获受理。 根据国家相关政策，按新注册分类获批仿制药的品种在医保支付及医疗机构采购等领域将获得更大的支持力度。因此上药信谊的奥美拉唑碳酸氢钠干混悬剂（Ⅱ）获得批准生产，有利于扩大该药品的市场份额，提升市场竞争力，同时为公司后续产品开展仿制药申报积累了宝贵的经验。 来源：【信谊良药】微信公众号