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首页 » FDA信息 » 阿斯利康乐开花——$22亿交易未完成COPD新药已上市在望

阿斯利康乐开花——$22亿交易未完成COPD新药已上市在望

来源:生物谷 2014-09-27 11:07

2014年9月27日讯 /生物谷BIOON/ --导读:阿斯利康(AZN)近日收获了一个大好消息。正在进行的一笔收购交易中的一种COPD复方药Duaklir Genuair,在审批方面获得了欧盟CHMP建议批准的积极意见,简直乐开了花。欧洲药品管理局(EMA)通常都会采纳CHMP的建议,因此该药预计将于今年年底批准上市。

今年7月,阿斯利康宣布耗资21亿美元收购西班牙Almirall公司的呼吸系统业务,尽管该笔收购尚未完成,但该业务中的一种慢性阻塞性肺病(COPD)复方药Duaklir Genuair,在审批方面已收到了欧盟CHMP建议批准的积极意见。CHMP已建议批准该药作为一种维持性支气管扩张剂,用于缓解COPD患者的症状。

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)。

该笔收购将于2014年底完成。交易完成后,阿斯利康将拥有Almirall现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。

根据协议,Almirall旗下专注于创新专有设备研发的子公司Almirall Sofotec,也将转让给阿斯利康。

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。我们非常欢迎Almirall的员工加入我们的队伍。(生物谷Bioon.com)

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英文原文:Almirall's aclidinium bromide/formoterol fumarate recommended for approval in Europe to treat COPD

Positive CHMP opinion is an important step in making this new respiratory therapy available to treat Chronic Obstructive Pulmonary Disease (COPD)

Marketing authorisation in the European Union is expected before the end of the year

Aclidinium/Formoterol will be marketed in Europe under the trademarks Duaklir® Genuair® and Brimica® Genuair®

Barcelona, September, 25 2014. - Almirall S.A. (ALM) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the regulatory approval of Duaklir® Genuair® (aclidinium bromide/formoterol fumarate) in all EU member states as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).1

Aclidinium bromide/formoterol fumarate is a fixed dose combination of two approved long-acting bronchodilators. Aclidinium bromide is a novel anticholinergic or long acting muscarinic antagonist (LAMA). Formoterol fumarate is a long-acting beta-agonist (LABA).2

As part of its assessment, CHMP reviewed efficacy and safety data of aclidinium bromide/formoterol fumarate BID from more than 2,000 patients. The clinical program included 11 clinical studies conducted in 29 countries worldwide.2

"We are very pleased with the CHMP positive recommendation for aclidinium bromide/formoterol fumarate" said Thomas Eichholtz, Chief Scientific Officer at Almirall. "The Committee's positive opinion today marks a significant step forward in bringing this new treatment option to patients with COPD."

In the EU, the European Commission generally follows the recommendations of the CHMP (EMA) and delivers its final decision within three months after the CHMP recommendation. The decision will be applicable to all 28 EU member states plus Iceland and Norway. Aclidinium bromide/formoterol fumarate will be marketed in Europe by Almirall under the trade name Duaklir®Genuair® and Brimica® Genuair®.

Almirall's respiratory franchise is complemented by aclidinium bromide, a long-acting inhaled muscarinic receptor antagonist (LAMA) for COPD. Aclidinium bromide was approved by the EMA and by the US Food and Drug Administration (FDA) in 2012 and is available in in 24 countries marketed under the trade names Eklira® Genuair®, Bretaris® Genuair®, Tudorza™ Pressair™ and Tudorza™ Genuair™. Further compounds in development include abediterol, a novel long acting beta-2 adrenergic agonist (LABA) for asthma and COPD, two novel dual action long-acting muscarinic antagonist beta-2 agonist MABA compounds plus PAN-JAK and PI3Kδ inhibitors.

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