欧洲药品管理局（EMA）人用医药产品委员会（CHMP）给梯瓦制药助了一臂之力。日前，该委员会建议说，梯瓦针对阿斯利康肺病药物信必可（Symbicort）所仿制的产品应该在欧洲获准上市。

然而，这一积极的建议对阿斯利康来说将是一大担忧，因为信必可去年的销售收入增长了10%，达到35亿美元。现在，阿斯利康将眼睁睁看着自己失去相当大的一笔收入。让阿斯利康感到些许宽慰的也许是，信必可在美国市场上表现很好：2013年的净销售额同比增长了23%。但CHMP的建议不太可能被更改，并应该会在未来三个月里被正式确定。

信必可还受到来自竞争对手（比如葛兰素史克生产的药物Breo）的压力。

梯瓦开发的信必可仿制药由它的Spiromax多剂量干粉吸入器（以品名DuoResp Spiromax销售）实施给药，用于哮喘的常规治疗及严重慢性阻塞性肺病（COPD）患者的对症治疗。梯瓦首席科学官迈克尔·海登（Michael Hayden）说：“我们已经计划要在呼吸道治疗领域里取得业绩的强劲增长。”

梯瓦表示，到这个十年期末，这一产品预计将成为价值高达数十亿美元的专营产品，目前在欧洲地区的申请是首站，还将会陆续在全世界一些主要国家申请上市。

梯瓦负责全球专业药品的总裁罗布·克里曼斯（Rob Koremans）说：“CHMP针对DuoResp Spiromax的注册文件给予了积极的看法，这标志着梯瓦在向哮喘和COPD患者提供有价值的新治疗选择上迈出了重要的一步。我们期待着获得欧盟委员会的最终决定。”

与此同时，DuoResp Spiromax用于持续性哮喘患者的两项后期试验预计将在今年得出结果。不过，欧盟委员会的最终批准并不依赖于这些结果。

在欧洲，COPD影响到了2300万人，每年导致110万人住院治疗；3000万人患有哮喘，并导致大约82000人住院治疗。

Teva's Symbicort generic backed for EU approval

AstraZeneca braces for competition to COPD drug

AstraZeneca's combination respiratory drug Symbicort could shortly face competition in the EU after a generic version of the product from Teva was recommended for approval.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Teva's DuoResp Spiromax (budesonide and formoterol fumarate dihydrate) for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD).

If approved by the European Commission, DuoResp will be a direct competitor for Symbicort, which remains one of AZ's biggest-selling products with sales rising 10 per cent to $3.48bn last year.  It will also be sold under the BiResp brand name in some markets.

Basic patents on both the active ingredients in Symbicort have expired for some time, but AZ has protected Symbicort in a number of markets using additional intellectual property, covering the use of the two drugs in combination, formulations and the inhaler device used in the product.

The combination patent expired in the EU in 2012 and is due to go in the US later this year, although AZ claims it has formulation patent valid until 2018 in the EU and 2023 in the US.

Teva has predicted strong growth for its respiratory portfolio and sees DuoResp as a flagship product in the category, according to Michael Hayden, the company's chief scientific officer. The company expects respiratory to be a "multibillion dollar franchise by the end of the decade," he added.

The firm claims the design of the Spiromax inhaler is central to that ambition, as it is easy to use and provides consistent delivery of medicine to patients.

Two ongoing phase III studies are comparing the benefits of DuoResp to Symbicort in patients with persistent asthma are expected to complete in 2014. Teva noted that the trials are not required for final approval in Europe.

Symbicort and GlaxoSmithKline's rival product Advair/Seretide (fluticasone and salmeterol) have dominated the market for combination inhaled corticosteroids/beta agonists. However, the arrival of generics - as well as a new generation of combination drugs such as GSK's Breo(fluticasone/vilanterol) and Anoro (umeclidinium bromide and vilanterol) that promise to improve efficacy – are likely to take their toll on sales in the coming years.

Last December, Denmark became the first EU country to approve a generic equivalent to $8bn-a-year Advair from Sandoz and Vectura, although analysts have predicted the initial take-up for the generic will be slow. The Advair generic, called AirFluSal Forspiro, has since been given a green light in Germany and Sweden.

AZ is developing a new generation of respiratory drugs to try to maintain its position in the respiratory category, including COPD combination therapy PT003 (glycopyrrolate and formoterol fumarate), acquired with Pearl Therapeutics last year. The drug is due to be filed for approval in 2015 in the US and 2016 in the EU.

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