DJ EMA Nod to Eli Lilly Drug Stokes Competition in Migraine Prevention Market

DJ EMA在预防偏头痛市场中与礼来百合的竞争

2018-09-21 22:44  道琼斯
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DJ EMA Nod to Eli Lilly Drug Stokes Competition in Migraine Prevention Market



By Donato Paolo Mancini

Eli Lilly & Co.'s (LLY) preventive migraine drug galcanezumab has received a positive marketing recommendation from the European Medicines Agency, the company and the regulator said separately on Friday, opening the door to competition in Europe.

The approval matters because the drug is one of a new class of compounds that inhibit the activity of a molecule involved in migraine attacks, for which there is currently no cure. It is the second monoclonal antibody therapy for the prevention of migraines that the EMA recommends, after it recommended the approval of Aimovig, made by competitors Novartis AG (NOVN.EB) and Amgen Inc. (AMGN), in May.

In the U.S., Teva Pharmaceutical Industries Ltd. (TEVA) also received approval from the Food and Drug Administration for its own fremanezumab, after months of delays had weighed on investor sentiment. The move was seen as a victory for chief executive Kare Schultz, who has been tasked with returning the company to profit.

Emgality, the branded name of Eli Lilly's drug, was also conditionally accepted by the U.S. Food and Drug Administration in June 2018, the company said. Novartis' Aimovig was also approved in the U.S. this year.

Analysts say the three drugs are largely identical, with the biggest difference being how often and the manner in which they are administered.

Increased competition will be good for patients, as they will have access to a drug that works for less, said Aaron Gal of Bernstein. "My expectation is that pricing in Europe will be fairly low, especially in countries that are good at getting companies to compete with each other," he added, predicting peak sales of $5 billion in the U.S. for the four drugs, and of $2 billion in Europe.

Overall, the challenge will be more about penetrating the market, raising awareness about the drug and negotiating on pricing and reimbursement, rather than seeing direct competition between the drugs, analysts said.

Indeed, proprietary survey data released by Barclays on Thursday showed that U.S. migraine patients still aren't switching, and that new prescription rates have slowed down after a first wave of enthusiasm earlier this year. Barclays cited anecdotal evidence suggesting access issues remained, constituting a main obstacle for physicians wishing to prescribe the drug. For Aimovig alone, Barclays forecasts a sales range of $123 million to $204 million in FY18, adding that it will be a modest contributor to the Swiss pharma giant's sales overall.

About 15% of the population in the European Union suffers from migraines, the EMA said. The positive opinion is an intermediate step for full approval, which usually comes after 60 days. Once approved, European states will be able to negotiate pricing and reimbursement individually.



Write to Donato Paolo Mancini at donatopaolo.mancini@dowjones.com; @donatopmancini



(END) Dow Jones Newswires

September 21, 2018 10:44 ET (14:44 GMT)

Copyright (c) 2018 Dow Jones & Company, Inc.

DJ EMA在预防偏头痛市场中与礼来百合的竞争



多纳托·保罗·曼奇尼

该公司和监管机构上周五分别表示,礼来公司(Eli Lilly&Co.)的预防偏头痛药物galcanezumab已收到欧洲药品管理局(European Medicines Agency)的积极营销建议,为欧洲的竞争打开了大门。

批准很重要,因为这种药物是一种新的化合物之一,它抑制与偏头痛发作有关的分子的活性,目前还没有治愈的方法。这是EMA推荐的第二种预防偏头痛的单克隆抗体疗法,在推荐Aimovig之后,由竞争对手诺华公司(Novartis AG)和安进公司(Amgen Inc.)生产。(AMGN),5月。

在美国,泰瓦制药工业有限公司。(Teva)也得到了食品和药物管理局(FDA)的批准,批准了它自己的自由zumab,此前数月的拖延打压了投资者的情绪。此举被视为首席执行官卡尔·舒尔茨(Kare Schultz)的一次胜利。舒尔茨的任务是让公司恢复盈利。

Eli Lilly‘s药品的品牌名称Emgality也在2018年6月被美国食品药品管理局有条件地接受,该公司说。诺华公司的Aimovig今年也在美国获得批准。

分析人士说,这三种药物在很大程度上是相同的,最大的区别在于它们使用的频率和方式。

伯恩斯坦公司的Aaron Gal说,增加竞争对病人是有利的,因为他们可以获得一种疗效较低的药物。“我的预期是,欧洲的价格将相当低,特别是在那些善于让企业相互竞争的国家,”他补充说。他预测,这四种药物在美国的最高销售额将达到50亿美元,在欧洲的销售额将达到20亿美元。

分析师表示,总体而言,挑战将更多地涉及渗透市场、提高人们对药物的认识,以及就定价和报销进行谈判,而不是看到药品之间的直接竞争。

事实上,巴克莱(Barclays)周四公布的专有调查数据显示,美国偏头痛患者仍未转向,新处方比例在今年早些时候的第一波热情过后已经放缓。巴克莱(Barclays)引用了一些轶事证据,表明准入问题依然存在,对希望开这种药的医生来说,这是一个主要障碍。巴克莱(Barclays)预计,仅Aimovig 18财年的销售额就在1.23亿至2.04亿美元之间,这对这家瑞士制药巨头的整体销售额贡献不大。

EMA说,欧盟大约15%的人口患有偏头痛。积极的意见是完全批准的中间步骤,通常在60天之后。一旦获得批准,欧洲国家将能够单独谈判定价和补偿。



致函Donato Paolo Mancini,电话:donatopaolo.mancini@dowjones.com@donatopmancini



(完)道琼斯通讯社

September 21, 2018 10:44 ET (14:44 GMT)

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风险提示:上文所示之作者或者嘉宾的观点,都有其特定立场,投资决策需建立在独立思考之上。富途将竭力但却不能保证以上内容之准确和可靠,亦不会承担因任何不准确或遗漏而引起的任何损失或损害。

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