Salmeterol Xinafoate

Teva to provide two generic inhaler products to Direct Relief for its network of free and charitable clinicsThe program, launching this month, will run for a minimum of three years PARSIPPANY, N.J., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of a new patient access program, in partnership with Direct Relief, to supply inhalers to eligible patients in the United States free of charge. “In the United States, while 93% of Teva’s inhaler medicines are generic products with access at lower prices – particularly for insured patients – there still remain uninsured patients who cannot access affordable generic inhalers,” said Chris Fox, Executive Vice President, U.S. Commercial at Teva. “The aim of this program is to help address an unmet need in underserved communities nationwide, enhancing patient access to safe and affordable medicines delivered via inhalers, including both maintenance and rescue inhalers.” Teva will make two inhaler products available through this program: generic versions of the AirDuo®RespiClick® (fluticasone propionate/salmeterol xinafoate maintenance inhaler) and ProAir® HFA (albuterol sulfate rescue inhaler). Teva will donate the inhalers to Direct Relief for distribution by request to free & charitable clinics, to then be dispensed to uninsured patients served by these clinics. "Direct Relief is deeply grateful to Teva for this critical donation which will connect patients with respiratory treatments they otherwise would not have access to," said Katie Lewis, Regional Director, U.S. Programs for Direct Relief. "Free and charitable clinics offer quality care for underserved communities, and this donation will allow them to reach even more patients with these medications." The program will continue for a minimum of three years to ensure reliable and continuous supply to these patients. In addition to donating the inhalers, Teva will make a cash donation to Direct Relief to cover the costs of administering this program. Direct Relief, Teva’s long-time partner on access to medicines programs in the U.S. and around the world, is a nonprofit humanitarian organization that provides medical resources to resource-poor communities. It operates, by its own account, the largest charitable medicine program in the United States. Through its network, Direct Relief supports the dispensing of high-quality, no-cost medicines to low-income, uninsured patients at the point of care, thereby facilitating patient access to necessary medicines. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com. Cautionary Note Regarding Forward-Looking Statements This document and the presentation at the conference may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our to successfully make our two inhaler products available through the new patient access program; our ability to successfully compete in the marketplace including our ability to successfully execute our Pivot to Growth strategy; our substantial indebtedness; our business and operations in general including the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2024 and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections captioned "Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. IR Contacts TevaIR@Tevapharm.com PR Contacts United States Kelley Dougherty (973) 658-0237 Israel Yonatan Beker Eden Klein (973) 264 7378 972 (3) 906-2645

编译：沈丹蕾，南京白令信息科技有限公司总经理 吸入产品从开发到生产再到上市的过程复杂繁琐，这促使美国食品药品监督管理局（FDA）和欧洲药品管理局（EMA）开始联合制定思路，以降低成本并节省时间。 与口服制剂相比，仿制吸入产品为开发者带来了更多挑战。开发者不仅需要证明药物本身与原研药具有等效性，还需向监管机构证明药物与其递送装置的组合也具有等效性。 开发时间表也与原研吸入产品有所不同。对于原研药，从研发到上市的整个过程可能需要十年或更长时间，因此不需要在一开始就确定最终的设备设计；然而，对于仿制药，较短的开发时间意味着最终设备设计的选择不能被推迟。 在美国，FDA要求开发任何仿制产品的公司证明其符合三个标准：药学等效性、生物等效性和治疗等效性。 • 药学等效性：仿制药需包含与参比药相同的活性成分，使用相同的剂型和给药途径，具有相同的强度，并符合所有质量、纯度和标识的药典标准。 • 生物等效性：在作用部位上，活性成分的吸收速率和程度没有显著差异。对于吸入产品，作用部位是肺部的黏膜表面，因此直接测量非常困难。 • 治疗等效性：开发者需证明仿制药可以替代参比药，并在标签规定的条件下具有相同的临床效果和安全性。 尽管可能存在等效但不可替代的产品，但要实现替代性，仿制药必须满足上述三个标准。 01 吸入药物等效性挑战 吸入药物是复杂的产品系统，其性能取决于配方、设备和患者的相互作用。此外，生产过程也会影响药物的表现。参比药物的批次间性能差异增加了比较的难度。 02 欧盟的不同方法 欧盟的审批方法与美国略有不同，但两者有一些共同点（见图1）。无论在哪种情况下，都需要使用相同的药物和相同类型的设备。然而，欧盟没有替代性的概念；仿制药需通过药物递送等效性测试，无论是通过实验室测试、药代动力学（PK）或药效动力学（PD）实验，还是通过临床试验来证明。而在美国，除了这些要求外，还需评估产品是否具有与参比药相同的操作说明。符合此要求的产品可按照美国505(j)ANDA路径获得批准；否则则需按照505(b)2新药申请（NDA）路径审批。 03 FDA的权衡证据方法 FDA对生物等效性采用“权衡证据”方法，考虑设备和配方设计，并需通过PK、PD或临床比较研究进行支持。FDA还发布了产品特定指南，例如2013年首个针对吸入产品的指南（沙美特罗/氟替卡松吸入粉末组合）。目前，大多数口服吸入药物产品都有相应的指南，依据权衡证据获得简化新药申请（ANDA）批准。 04 设备设计与开发早期考量 设备的相似性是FDA对吸入仿制药的核心关注点，2017年FDA发布的指南详细说明了设备等效性的信息要求和用户界面的允许差异范围。例如，Mylan公司在 2019年推出的Wixela® Inhub®吸入器（沙美特罗/氟替卡松）是一个成功案例。 05 新兴测试方法 FDA正在研究新的测试方法，例如Q3测试，旨在更好地理解气溶胶药物递送的物理过程、肺部沉积和吸收。Q3测试有望减少临床试验的需求，但其科学依据需在提交前得到FDA验证。 06 欧盟的分步方法 与FDA不同，EMA采用分步方法定义生物等效性，包括体外相似性测试、肺部沉积和PK数据。如果这些不相似，则需要PD数据或三期临床研究。大多数仿制药通过体外和PK数据包获得批准。 — 总结 — 吸入药物的监管环境复杂，但为开发复杂仿制药提供了机会和路径。设备设计、产品稳健性和早期规模化生产是成功的关键。新的体外测试方法和产品表征方法有助于降低开发成本和时间，使开发者能够以前所未有的方式表征产品。 作者介绍 Martin Oliver是Vectura公司的高级副总裁，负责DPI和pMDI平台的交付管理。他同时担任Vectura在中国的合资企业天津康诺华制药有限公司的副董事长，致力于在该地区推广DPI产品。他拥有英国布拉德福德大学的药学学士学位。 文章来源：How the EU and US Are Aligning Guidance for Inhalation Products，PMPS 同写意媒体矩阵，欢迎关注↓↓↓