2014年11月26日讯 /生物谷BIOON/ --阿斯利康（AZN）近日宣布，慢性阻塞性肺病（COPD）复方新药Duaklir Genuair（阿地溴铵/富马酸福莫特罗，340/12 mcg）获得欧盟批准，用作一种维持性支气管扩张剂，以减轻COPD成人患者的疾病症状。该药是阿斯利康21亿美元收购西班牙Almirall公司呼吸系统业务的一部分。今年9月，尽管收购交易尚未完成，Duaklir Genuair在审批方面却获得了欧盟CHMP建议批准的积极意见，让阿斯利康乐开了花。目前，该笔交易已于上月底成功完成。
Duaklir Genuair是由2种已上市的长效支气管扩张剂组成的固定剂量复方药物，其中，bromide（阿地溴铵）是一种新颖的长效毒蕈碱拮抗剂（LAMA），formoterol fumarate（富马酸福莫特罗）是一种长效β2受体激动剂（LABA）。Duaklir Genuair通过干粉吸入器Genuair给药，每日2次，是首个与单药相比使呼吸喘促表现出统计学意义显著改善的LAMA/LABA复方药。
据估计，目前全球范围内大约有3亿慢性阻塞性肺病（COPD）患者，改善肺功能及管理日常症状（如喘促气短）对于COPD的临床管理非常重要。
收购完成后，阿斯利康获得了Almirall专有呼吸系统业务的开发和商业化权利，包括拥有来自Almirall现有合作伙伴关系的收入流及研发管线中实验性新颖疗法的权利。Almirall公司的呼吸系统专营权包括Eklira（aclidinium，阿地尼亚）、LAS40464（阿地尼亚+福莫特罗复方药，已在欧盟申请注册，在美国处于在研）、LAS100977（abediterol，一种每日一次的长效β2受体激动剂LABA，处于II期临床）、处于临床前开发（LAS191351，LAS194871）和I期临床（LAS190792）的M3拮抗剂β2受体激动剂（MABA）平台、多个临床前项目。同时，Almirall旗下专注于创新专有设备研发的子公司Almirall Sofotec，也已转让给阿斯利康。
此次业务合并，将使阿斯利康立即获得市场收入，将有助于促进公司收入增长的恢复。Almirall公司新颖的呼吸资产及其设备能力，将进一步加强阿斯利康的呼吸系统产品组合，包括Symbicort和Pulmicort及在研的实验性药物。而药物Eklira和LAS40464及专有的Genuair设备等资产，将使阿斯利康能够为患者提供横跨一系列分子和复方药物的干粉吸入器及计量吸入器设备的治疗选择。
阿斯利康首席执行官Pascal Soriot曾表示：“与Almirall之间的战略交易，将为阿斯利康强大的呼吸系统专营权带来战略性及长期价值。呼吸系统专营权是我们的主要增长平台之一，此次交易将使公司即刻获得并不断增长的产品收入。通过结合自身的创新组合，并充分利用阿斯利康的全球科学和商业能力，我们将加强在哮喘和慢性阻塞性肺病（COPD）整个护理范畴的应对能力。”
英文原文：Duaklir® Genuair® approved in the European Union for chronic obstructive pulmonary disease
AstraZeneca today announced that Duaklir? Genuair? (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Approximately 300 million people1 around the world live with COPD, a progressive and chronic disease where people find breathing difficult due to limited airflow. Improving the lung function and managing daily symptoms such as breathlessness are important to the management of COPD.
Duaklir is a fixed-dose combination of already-approved Eklira? (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair? dry powder inhaler device.
AstraZeneca owns the rights to develop and commercialise Duaklir Genuair in the European Union (EU) following the strategic business combination of Almirall¡¯s respiratory portfolio, which was completed last month. The EU approval of Duaklir Genuair marks an important further step in AstraZeneca's inhaled therapy strategy of providing physicians and patients a choice of products uniquely available in both dry powder and pressurised metered dose devices.
¡°We are pleased to receive European regulatory approval for Duaklir Genuair as an innovative treatment for patients with COPD. Patients need treatments that can help to improve their lung function and allow them to better manage the daily and debilitating symptoms of their condition, in turn improving their overall quality of life.¡± said Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.
The EU approval of Duaklir Genuair was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies, conducted in 29 countries worldwide. Results showed that Duaklir Genuair demonstrated statistically significant and sustained improvement in the lung function compared to monotherapy, providing a favourable benefit-to-risk profile.
The EC marketing authorisation applies to all member states of the EU and the European Economic Area. Aclidinium bromide/formoterol fumarate will be marketed in Europe by AstraZeneca under the trade name Duaklir Genuair.