Simpson Iain
Consultant, Cambridge, UK.
Ther Deliv. 2019 Feb;10(2):91-97. doi: 10.4155/tde-2018-0071.
This industry update covers the period from 1 to 31 October 2018 and is based on information sourced from company press releases, scientific literature, patents and various news websites. With the expiry in Europe of AbbVie's (IL, USA) principal patent on Humira this month, the first biosimilar versions of the drug have been launched. AstraZeneca (Cambridge, UK) announced that is has out-licensed two none core drugs to Grunenthal (Aachen, German), while Pfizer (NY, USA) announced the creation of a new company, set up in collaboration with Bain Capital (MA, USA) to exploit Pfizer's clinical and preclinical assets in the neuroscience field. In digital health, 23andMe (CA, USA) announced that the US FDA has authorized marketing of one of its consumer genetic tests, that assesses the genetic factors that affect drug metabolization, hence the safety and efficacy of some drugs. Novartis (Basel, Switzerland) continued to grow its activities in digital health with the creation of the Novartis Biome, an incubator and support program for early-stage companies in this area. Novartis also announced that it has filed applications in the EU and USA for the approval of siponimod, a drug targeting secondary progressive multiple sclerosis and Roche (Basel, Switzerland) gained FDA approval for an antiviral treatment for influenza. Janssen (Beerse, Belgium) announced it had won a label extension for its blood glucose-lowering drug, Invokana, for the reduction of cardiovascular events in diabetes. Roche presented data at ECTRIMS, a major annual conference on multiple sclerosis (MS), held in Berlin, Germany this month (10-12 October 2018), showing the potential benefits of administering its drug, Ocrevus, earlier in the treatment pathway for MS compared with other standard treatment. At the same event, Celgene (NJ, USA) presented results from a survey that showed MS patients' concern around brain atrophy and cognitive loss in MS, highlighting that the disease has a neurodegenerative as well as an inflammatory component. Novartis also presented a significant amount of data supporting its marketed drugs as well as its development pipeline in the disease. This month, presentation of data from two studies at the American Academy of Ophthalmology annual meeting (27-30 October 2018, Chicago, IL, USA) further supporting the potential of eye scans in the early detection of Alzheimer's. A paper by a research team at the University of Rochester (NY, USA) demonstrated the feasibility of a new mechanism to transport drugs across the blood-brain barrier, which could help development more effective CNS drugs.
本行业动态涵盖2018年10月1日至31日期间，所依据的信息来源包括公司新闻稿、科学文献、专利及各类新闻网站。本月，艾伯维公司（美国伊利诺伊州）在欧洲的修美乐主要专利到期，该药物的首批生物类似药已上市。阿斯利康公司（英国剑桥）宣布已将两种非核心药物授权给格伦泰科公司（德国亚琛），而辉瑞公司（美国纽约）宣布与贝恩资本（美国马萨诸塞州）合作成立一家新公司，以开发辉瑞在神经科学领域的临床和临床前资产。在数字健康领域，23andMe公司（美国加利福尼亚州）宣布，美国食品药品监督管理局已批准其一项消费者基因检测产品上市，该检测可评估影响药物代谢的基因因素，进而评估某些药物的安全性和有效性。诺华公司（瑞士巴塞尔）通过创建诺华生物群落继续拓展其在数字健康领域的业务，诺华生物群落是该领域早期公司的孵化器和支持项目。诺华公司还宣布已在欧盟和美国提交申请，寻求批准西波尼莫德，这是一种针对继发进展型多发性硬化症的药物；罗氏公司（瑞士巴塞尔）的一种抗流感病毒治疗药物获得了美国食品药品监督管理局的批准。杨森公司（比利时贝尔瑟）宣布其降血糖药物安达唐获得标签扩展，可用于降低糖尿病患者的心血管事件风险。罗氏公司在本月（2018年10月10 - 12日）于德国柏林举行的欧洲多发性硬化症治疗和研究委员会年度大会（ECTRIMS）上公布数据，显示与其他标准治疗相比，在多发性硬化症治疗过程中更早使用其药物奥瑞珠单抗的潜在益处。在同一次会议上，新基公司（美国新泽西州）公布了一项调查结果，该结果显示多发性硬化症患者对脑萎缩和认知功能丧失的担忧，突出表明该疾病具有神经退行性和炎症性成分。诺华公司也公布了大量数据，支持其在该疾病领域的已上市药物及其研发产品线。本月，在美国眼科学会年会（2018年10月27 - 30日，美国伊利诺伊州芝加哥）上公布的两项研究数据进一步支持了眼部扫描在早期检测阿尔茨海默病方面的潜力。美国罗切斯特大学（美国纽约）的一个研究团队发表的一篇论文证明了一种将药物输送过血脑屏障的新机制的可行性，这可能有助于开发更有效的中枢神经系统药物。
