TEL AVIV, Israel--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announce that data from the UNITE study presented today at the World Congress of Neurology in Montreal, Canada, show that AJOVY® (fremanezumab) reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder.

以色列特拉维夫-（商业电线）-梯瓦制药工业有限公司（纽约证券交易所和塔斯：梯瓦）宣布，今天在加拿大蒙特利尔世界神经病学大会上发表的UNITE研究数据显示，AJOVY®（fremanezumab）减轻重性抑郁症偏头痛患者的偏头痛发作和抑郁症状。

AJOVY® is currently approved for the preventive treatment of migraine in adults..

AJOVY®目前被批准用于成人偏头痛的预防性治疗。。

Depression is one of the most prevalent psychiatric co-morbidities in migraine and patients with comorbid depression experience an increased risk of migraine ‘chronification’.1 This is characterised by an increase in the number of headache days, a greater degree of headache disability, decreased quality of life and a poorer response to migraine treatments.2,3,4,5.

抑郁症是偏头痛中最常见的精神病合并症之一，合并抑郁症患者的偏头痛“慢性化”风险增加.1其特征是头痛天数增加，头痛残疾程度增加，生活质量下降，对偏头痛治疗的反应较差.2,3,4,5。

UNITE6 is a double-blind, randomised, placebo-controlled, Phase 4 study sponsored by Teva investigating the efficacy, safety, and impact of fremanezumab on patients with migraine and major depressive disorder.

UNITE6是由Teva赞助的一项双盲，随机，安慰剂对照的4期研究，研究fremanezumab对偏头痛和重度抑郁症患者的疗效，安全性和影响。

Data revealed in an oral presentation by Dr Verena Ramirez Campos, Global Senior Medical Director at Teva, showed that patients in the study treated with fremanezumab experienced a significant reduction in Monthly Migraine Days (MMD) compared to patients on placebo, a reduction in MMD of –5.1 vs –2.9 for fremanezumab vs placebo (p<0.0001).

Teva全球高级医疗总监Verena Ramirez Campos博士在口头报告中显示，与安慰剂组患者相比，接受fremanezumab治疗的研究患者每月偏头痛天数（MMD）显着减少，MMD降低fremanezumab与安慰剂相比为-5.1 vs-2.9（p<0.0001）。

Furthermore, a significantly higher number of patients (33%), receiving fremanezumab achieved ≥50% reduction in MMD compared to placebo (13%) during the 12 week double blind period (p<0.0001), with a sustained reduction over the longer-term.7.

此外，在12周双盲期间，接受fremanezumab治疗的患者数量（33%）显着高于安慰剂组（13%）（p<0.0001），MMD降低≥50%，持续降低长期。

Commenting on the data, Dr. Verena Ramirez Campos said: “Patients who suffer from migraine and mental health disorders such as depression face a far greater burden than those suffering from either migraine or depression alone. The UNITE data presented at WCN provides further insights into the potential efficacy, safety, and quality of life benefits of AJOVY® for people with migraine and major depressive disorder.”.

评论数据，博士。Verena Ramirez-Campos说：“患有偏头痛和抑郁症等精神疾病的患者比单独患有偏头痛或抑郁症的患者面临更大的负担.WCN提供的UNITE数据进一步深入了解了潜在的疗效，安全性和AJOVY®对偏头痛和重性抑郁障碍患者的生活质量益处“。

Two further data sets were presented as posters on the study’s secondary endpoints that evaluated the impact of fremanezumab on depression8 and disability. 9

另外两个数据集作为研究次要终点的海报展示，评估了fremanezumab对抑郁症和残疾的影响8。9

Treatment with fremanezumab resulted in significant reductions in depression symptoms as measured by two commonly used depression rating scores. The mean change at week 12 for fremanezumab and placebo using the Hamilton Rating Scale for Depression (HAM-D 17) was -6.7 vs -5.4 respectively (p=0.0228) and using the Patient Health Questionnaire-9 (PHQ-9) score was -7.8 vs -6.3 respectively (p=0.0108)..

通过两种常用的抑郁评分评分测量，用fremanezumab治疗导致抑郁症状显着减少。使用汉密尔顿抑郁量表（HAM-D 17）的fremanezumab和安慰剂在第12周的平均变化分别为-6.7和-5.4（p=0.0228），并且使用患者健康问卷-9（PHQ-9）评分为分别为-7.8和-6.3（p=0.0108）。。

Furthermore, fremanezumab demonstrated clinically meaningful improvements in disability outcomes in the study patients with a sustained reduction in their disability over the longer term. The mean change at week 12 for fremanezumab and placebo using the Headache Impact Test score (HIT-6) was -8.8 vs -5.2 respectively, (p≤0.0001) and using the Clinical Global Impression-Severity (CGI-S) score was -1.1 vs -0.8 respectively (p=0.0030)..

此外，在长期持续减少残疾的研究患者中，fremanezumab在残疾结局方面表现出临床意义上的改善。使用头痛影响测试评分（HIT-6）的fremanezumab和安慰剂在第12周的平均变化分别为-8.8和-5.2（p≤0.0001），使用临床总体印象严重度（CGI-S）评分为-1.1 vs-0.8（p=0.0030）。。

These encouraging results indicate that fremanezumab has the potential to reduce the symptoms and cumulative burden of migraine and associated depression.

这些令人鼓舞的结果表明，fremanezumab有可能减轻偏头痛和相关抑郁症的症状和累积负担。

Study lead author Richard Lipton M.D., Department of Neurology, Psychiatry and Behavioural Sciences at Albert Einstein College of Medicine, New York said: “Depression is commonly associated with migraine, and clinicians are increasingly aware of the impact of co-morbidities. We are moving towards more personalised treatment decisions in migraine which are tailored to the patient’s profile, and it is very important for treatments to demonstrate efficacy and safety in migraine patients with this particular co-morbidity.”.

研究主要作者Richard Lipton M.D.，阿尔伯特爱因斯坦医学院神经病学，精神病学和行为科学系，纽约说：“抑郁症通常与偏头痛有关，临床医生越来越意识到合并症的影响，我们正在朝着偏头痛的个性化治疗决策迈进，这些决策是根据患者的情况量身定制的，对于治疗以证明具有这种特殊共病的偏头痛患者的有效性和安全性“。

AJOVY® (fremanezumab), a humanized monoclonal antibody (mAb) developed by Teva Pharmaceuticals, selectively targets the calcitonin gene-related peptide (CGRP), and is approved for the prevention of migraine in adults who have at least 4 migraine days per month.

由Teva Pharmaceuticals开发的人源化单克隆抗体（mAb）AJOVY®（fremanezumab）选择性靶向降钙素基因相关肽（CGRP），并被批准用于预防偏头痛至少4天的成年人每月。

NOTES TO EDITORS

编辑注释

About AJOVY▼ (fremanezumab-vfrm) injection

关于AJOVY▼ （fremanezumab vfrm）注射液

AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections.

AJOVY适用于每月至少有4天偏头痛的成年人预防偏头痛。AJOVY可以在预填充注射器中以225 mg/1.5 mL单剂量注射，或者在某些国家/地区使用预填充笔。有两种给药方案可供选择：每月一次皮下注射225mg（每月一次），或每三个月675mg（每季度一次），以三次皮下注射给药。

AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment..

AJOVY可以由医疗保健专业人员或患者或护理人员在家中进行管理。开始治疗不需要起始剂量。。

About Teva

关于Teva

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, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area.

梯瓦制药工业有限公司（纽约州和塔斯：梯瓦）一直在开发和生产药物来改善人们的生活一个多世纪。我们是仿制药，生物仿制药和特种药物的全球领导者，几乎在每个治疗领域都有3500多种产品组合。

Around 200 million people around the world take a Teva medicine every day and 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.

全世界约有2亿人每天服用Teva药品，并由制药行业最大，最复杂的供应链之一提供服务。随着我们在仿制药领域的广泛应用，我们拥有重要的创新研究和运营，支持我们不断增长的专业和生物制药产品组合。

Learn more at www.tevapharm.com.

在www.tevapharm.com了解更多信息。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示

This press release contains 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.

本新闻稿包含1995年“私人证券诉讼改革法”含义内的前瞻性声明，这些声明基于管理层当前的信念和期望，并且存在可能导致我们未来结果的重大风险和不确定性，无论是已知的还是未知的，表现或成就与此类前瞻性陈述所表达或暗示的表现或成就大不相同。

You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance.

您可以使用“应该”，“期望”，“预期”，“估计”，“目标”，“可能”，“项目”，“指导”，“意图”，“计划”，“相信”等词语来识别这些前瞻性陈述。与未来运营或财务业绩的任何讨论相关的具有类似含义和表达的词语和条款。

Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, including AUSTEDO®, AJOVY, UZEDYTM and COPAXONE®, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us; our business and operations in general, including, the impact of global economic conditions and other.

可能导致或促成这种差异的重要因素包括与AJOVY的发展和商业成功有关的风险；我们成功竞争市场的能力，包括我们开发和商业化生物制药产品的能力，对我们创新药物（包括AUSTEDO®，AJOVY，UZEDYTM和COPAXONE®）的竞争，我们通过投资产品渠道获得预期成果的能力，我们开发和商业化其他药品的能力，以及我们专利的有效性和其他保护我们知识产权的措施；我们的重大债务可能会限制我们承担额外债务，进行额外交易或进行新投资的能力，可能会导致我们的信用评级进一步降级；以及我们无法以对我们有利的金额或条款筹集债务或借用资金；我们的一般业务和运营，包括全球经济状况和其他影响。

References:

参考文献：

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5 Walter S, Bigal ME. TEV-48125: a review of a monoclonal CGRP antibody in development for the preventive treatment of migraine. Curr Pain Headache Rep. 2015; 19:6.

5 Walter S，Bigal ME.TEV-48125：开发用于预防性治疗偏头痛的单克隆CGRP抗体的综述。Curr Pain Headache Rep.2015；19:6.

6 UNITE study protocol NCT04041284.

6 UNITE研究协议NCT04041284。

7 Lipton RB, et al. Efficacy of fremanezumab treatment in reducing monthly migraine days in patients with migraine and major depressive disorder: Results from the UNITE study. Presented at World Congress of Neurology (WCN); 15–19 October 2023; Montreal.

7 Lipton RB等。fremanezumab治疗偏头痛和重度抑郁症患者每月偏头痛天数的疗效：UNITE研究的结果。在世界神经病学大会（WCN）上发表；2023年10月15日至19日；蒙特利尔。

8 Lipton RB, et al. Efficacy of fremanezumab in reducing depression in patients with migraine and major depressive disorder: results of the UNITE study. Presented at World Congress of Neurology (WCN); 15–19 October 2023; Montreal.

8 Lipton RB等。fremanezumab在减轻偏头痛和重度抑郁症患者抑郁症中的疗效：UNITE研究的结果。在世界神经病学大会（WCN）上发表；2023年10月15日至19日；蒙特利尔。

9 McAllister P, et al. Impact of fremanezumab treatment on disability outcomes in patients with migraine and major depressive disorder: results of the UNITE study. Presented at World Congress of Neurology (WCN); 15–19 October 2023; Montreal.

9 McAllister P等。fremanezumab治疗对偏头痛和重度抑郁症患者残疾结局的影响：UNITE研究的结果。在世界神经病学大会（WCN）上发表；2023年10月15日至19日；蒙特利尔。