2020年5月18日，中国上海 – 梯瓦医药信息咨询（上海）有限公司今日宣布旗下创新药物安泰坦®（氘代丁苯那嗪片）经中国国家药品监督管理局（NMPA）优先审评审批后，正式获批用于治疗与亨廷顿病（HD）有关的舞蹈病及成人迟发性运动障碍（TD）。中国是美国之后全球第二个批准该药物的国家。安泰坦®使用的氘代技术给予了活性成分良好的药代动力学曲线，从而允许减少给药频率，同时显示出对HD舞蹈病和成人迟发性运动障碍患者的有效性和可接受的安全性和耐受性。
May 18th, 2020, Shanghai—Teva China today announced that the China National Medical Products Administration (NMPA) has approved AUSTEDO® (Deutetrabenazine Tablet) for the treatment of chorea associated with Huntington's disease (HD) and Tardive Dyskinesia (TD) in adults after a priority review. China is the second country in the world after the U.S. to have approved AUSTEDO®. The deuterium technology used in AUSTEDO® confers a favorable pharmacokinetics profile of the active ingredient, so as to allow a reduced dosing frequency, while demonstrating efficacy in HD chorea and in TD patients with an acceptable safety and tolerability profile, .
亨廷顿病是一种罕见的致命的神经退化性疾病，亚洲每十万人中大约有0.4人患病，平均发病年龄为40岁。舞蹈病 - 无意识的，随机和突然的，扭动和/或转动的运动 – 是这种疾病最为显著的表现之一并发生在大约90%的病人当中。
A rare and fatal neurodegenerative disorder, Huntington's Disease has an overall prevalence rate in Asian of 0.40/100,000, with an average age at onset of 40 years.3 Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of this disease and occurs in approximately 90% of patients.
迟发性运动障碍是一种使人衰弱的运动紊乱，以舌头、嘴唇、脸、躯体和四肢部位的重复且不可控的运动为特征。TD在长期接受抗精神病药治疗的中国的精神分裂症患者当中的患病率为33.7%， 可能是由某些用于治疗精神健康状况的药物引起的，这意味着使用这些药物的精神分裂症患者中有三分之一可能患有TD。这种疾病不仅影响患者的治疗依从性，也影响患者的生活质量和他们的社会功能。目前在中国尚无对TD明显有效的治疗。
Tardive dyskinesia is a debilitating movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The prevalence of TD in China is 33.7%4 in individuals with Schizophrenia receiving long-term treatment with antipsychotics and can be caused by certain medications used to treat mental health conditions, which means that up to one third of treated Schizophrenia patients may have TD. The disease not only affects the treatment adherence of patients, but also affects their quality of life and their social functioning5. Currently, there is no obviously effective treatment for TD available in China.
“与亨廷顿病有关的舞蹈病以及成人迟发性运动障碍均属于严重的神经系统疾病，影响着患者的日常生活功能和生活质量。由于传统治疗方案极为有限且缺乏循证指南依据，患者亟待安全且高效的新型疗法出现。”中山大学附属第一医院神经内科裴中教授表示，“安泰坦®拥有经临床试验验证的数据，是首个被FDA批准为突破疗法的TD治疗。该药为中国HD和TD患者提供了新的治疗方法，使他们的生活质量进一步提高成为可能。
"Chorea associated with HD as well as TD in adults are serious neurological disorders, which impact the daily functionality of patients and their quality of life. Because traditional therapies are extremely limited and there are no evidence-based guidelines to follow, patients really need new therapies that are safe and effective.” said Professor Pei Zhong, Director of the Neurology Department, the First Hospital of Sun Yat-sen University, “With its proven data from clinical trials, AUSTEDO® provides a novel treatment for China’s population with HD chorea and TD, making it possible to further improve their quality of life with an acceptable safety profile."
“我们非常感谢国家药品监督管理局药品审评中心对于罕见病创新药物的重视，使得安泰坦®被纳入临床急需境外新药名单（第一批），并且进入优先审评审批通道，在短短4个月内完成获批。自此，安泰坦®成为中国首个获批的氘代药物，中国也成为该药在全球范围内获批的第二个国家。”梯瓦大中华区总经理Larry E. Merizalde表示。
“对梯瓦而言，引入全新疗法以满足患者未尽需求的意义重大，也令人无比激动。”梯瓦全球市场执行副总裁Gianfranco Nazzi补充道，“作为仿制药和特色药领域的全球领导者，我们始终致力于提供高质量的创新药物，提升药物可及性并改善患者生活质量。未来，我们将继续聚焦中国患者最迫切的临床需求，积极携手社会各界的合作伙伴，加速创新药物的引进，助力实现“健康中国2030”的美好愿景。”
"We are very grateful to the Center for Drug Evaluation, NMPA, for taking innovative rare disease drugs so seriously, putting AUSTEDO® on the List of Overseas New Drugs Urgently Needed in Clinical Settings (the First Batch) and granting it priority review, so that it could be approved in just 4 months for the benefit of Chinese patients. This makes AUSTEDO® the first deuterated drug approved in China, and also makes China the second country to approve AUSTEDO® after the United States." said Larry E. Merizalde, Greater China General Manager at Teva.
"This is an inspiring opportunity for Teva, to bring a new treatment option for conditions where the unmet need is so significant," added Gianfranco Nazzi, Executive Vice President International Markets at Teva. "As a global leader in generic and specialty medicines, we are dedicated to providing high-quality drugs, increasing accessibility to medicines and improvingpatients' health worldwide. We will continue to focus on urgent clinical needs of Chinese patients, working closely with various stakeholders to facilitate the launch of innovative drugs in China and help achieve the 'Healthy China 2030' vision."
关于安泰坦®
安泰坦®于2017年4月获得美国FDA批准，是FDA首次批准的氘代产品，也是针对与亨廷顿病有关的舞蹈病的历史上第二个药物。目前，该药已经在美国和中国两个国家获批，在美国的获批适应症包括与亨廷顿病（HD）有关的舞蹈病以及成人迟发性运动障碍（TD）。FDA对安泰坦®的批准代表了HD患者的一个重要的新治疗选择，并强调了对这个服务不足的患者群体更多治疗资源的需求，TD适应症被批准为突破性治疗。我们相信，治疗迟发性运动障碍的医生会欣赏到该疗法的剂量灵活性，以及专注于直接治疗运动障碍而不破坏正在进行的基础疾病治疗的能力。
About AUSTEDO®
AUSTEDO® was approved by the U.S. Food and Drug Administration (FDA) in April 2017. It is the first deuterated product approved by the FDA and only the second product approved in Chorea associated with Huntington's disease (HD).6 Currently, the drug is approved in two countries: the U.S. and China. Approved indications in the U.S. include Chorea associated with Huntington's disease (HD) and Tardive Dyskinesia (TD) in adults. The FDA’s approval of AUSTEDO® represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community, and the TD indication was approved as breakthrough therapy. We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition7.
关于与亨廷顿病有关的舞蹈病获批临床试验
安泰坦®获批用于治疗与亨廷顿病有关的舞蹈病，是基于一项90名患有明显亨廷顿病相关的舞蹈病患者参与的随机，双盲，安慰剂对照，多中心试验，主要临床评价指标为舞蹈病症状最高总评分（Total Maximal Chorea Score, TMC评分）。研究结果表明安泰坦®：
- 具有显著的治疗效果：氘代丁苯那嗪组平均TMC评分改善幅度为4.4（安慰剂组1.9，P＜0.0001），TMC评分提升6分以上的患者比例为33%（安慰剂组2%）。根据统一评定量表（Unified Huntington Disease Rating Scale, UHDRS），氘代丁苯那嗪组平均改善幅度为7.4（安慰剂组3.4，P=0.002）。
- 可显著提高治疗成功率：根据患者整体印象变化量表（Patient Global Impression of Change, PGIC），氘代丁苯那嗪组治疗成功率为51%（安慰剂组20%，P=0.002）；根据临床疗效总评量表（Clinical Global Impression of Change, CGIC），氘代丁苯那嗪组治疗成功率为42%（安慰剂组13%，P=0.002）。
- 具有良好的安全性，在开始治疗的患者中神经精神事件的发生率较低.
About Clinical Trial of Huntington's disease (HD)
The efficacy of AUSTEDO® as a treatment for chorea associated with Huntington's disease was established in a randomized, double-blind, placebo-controlled, multi-center trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s disease, the main clinical evaluation index was Total Maximal Chorea (TMC) Scores of HD. The research results showed that AUSTEDO®:
- Had a significant treatment effect: TMC score for patients receiving AUSTEDO® improved by approximately 4.4 units from baseline to the maintenance period (compared to 1.9 units in the placebo group, P<0.001). 33% of patients increased TMC score by at least 6 units (compared to 2% of patients in the placebo group). According to Unified Huntington Disease Rating Scale (UHDRS), the average improvement for patients receiving AUSTEDO® was 7.4 units (compared to 3.4 units in the placebo group, P=0.002).
- Significantly improved the treatment success rate: According to Patient Global Impression of Change (PGIC), the success rate for patients receiving AUSTEDO® was 51% (compared to 20% in the placebo group, P=0.002). According to Clinical Global Impression of Change (CGIC), the success rate for patients receiving AUSTEDO® was 42% (compared to 13% in the placebo group, P=0.002).
- Has a favorable safety profile, with low rates of neuropsychiatric events in patients starting therapy.
关于成人迟发性运动障碍的临床试验
安泰坦®获批用于治疗成人迟发性运动障碍，是基于两项III期随机，双盲，安慰剂对照，平行组研究的结果，研究结果证明安泰坦®：
- 具有显著的治疗效果：治疗第12周氘代丁苯那嗪组的异常不自主运动量（Abnormal Involuntary Movement Scale，AIMS）评分改善幅度为3.3（安慰剂组1.5，P<0.001），AIMS评分提升50%以上的患者比例为33%（安慰剂组12%，P=0.007）。
- 可显著提高治疗成功率：在ARM-TD和AIM-TD研究的一项综合分析中，在第12周时，使用氘代丁苯那嗪的患者治疗成功的几率是使用安慰剂的患者的两倍多（2.1；P=0.005），并且使用氘代丁苯那嗪的患者的平均CGIC评分（48%）高于安慰剂（30%）
- 具有良好的安全性和耐受性。氘代丁苯那嗪对嗜睡、体重或心脏代谢因素的测量没有负面的影响。
About Clinical Trial of Tardive Dyskinesia (TD) in Adults9
The approval was based on results from two Phase III randomized, double-blind, placebo-controlled, parallel group studies, which proved that AUSTEDO®:
- Has a significant treatment effect: Abnormal Involuntary Movement Scale (AIMS) score for patients receiving AUSTEDO® improved by 3.3 units in the week 12 (compared to 1.5 units in the placebo group, P<0.001). 33% of patients increased AIMS score by 50% (compared to 12% of patients in the placebo group, P=0.007).
- Improved the treatment success rate: In a pooled analysis of the ARM-TD and AIM-TD studies, the odds of treatment success in patients treated with deutetrabenazine were more than double the odds in those given placebo (2.1; P=0.005), and mean CGIC score was higher in deutetrabenazine-treated patients (48%) compared with placebo (30%) at Week 12.
- Has a favorable safety profile and is well tolerated. Deutetrabenazine does not adverselyimpact measures of somnolence, weight, or cardiometabolic factors.
关于梯瓦
梯瓦是一家总部位于以色列的全球性医药公司，是全世界最大的“药柜”，拥有超过1,800个分子化合物，35,000个产品。在美国，平均每7个处方就会用到1个梯瓦公司的产品，在过去的10年里，梯瓦公司为美国的医疗系统累计节省一共超过2150亿美金。我们的使命是成为全球仿制药和生物制药的领导者，提高和改善病患的生活质量。目前梯瓦在全球约有45,000名员工，在超过60个国家开展业务，2018年全年销售额接近190亿美金。
现在梯瓦已经来到中国，作为全球使命的一部分，梯瓦中国将会在未来的几年里大力拓展本土业务，我们计划在明年上半年上市第一款由我们创新研发的原研药品安泰坦®, 以高品质药品为中国数百万患者提供帮助。在未来，梯瓦承诺会为中国的病患，以更快的速度带来更新更好的药物。
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every dayand are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
The approval of AUSTEDO® represents an important step for Teva’s presence in China, and we look forward to continuing to provide patients in the Chinese market with products of high quality and efficacy. We plan to launch AUSTEDO® in the first half of next year, to help millions of patients in China with high-quality innovative drugs.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch of AUSTEDO® for treating Chorea associated with Huntington's Disease and Tardive Dyskinesia in adults in China, 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:
• uncertainty of the commercial success of AUSTEDO;
• uncertainty inherent in product development, including the receipt of approval for additional geographies and indications;
• our ability to successfully launch additional products in China;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
• compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing timeincluding due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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.
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