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2015年开年，瑞士制药巨头诺华（Novartis）便迎来了开门红，业界备受期待的重磅单抗药物Cosentyx（secukinumab）几乎同一时间拿下欧美2大主要市场。就在2天前，Cosentyx拿到欧盟批文，而近日，该药又拿下了FDA批文，这也标志着诺华在该领域已超越其他对手一大步。
Cosentyx是全球首个白细胞介素17（IL-17）单克隆抗体，获欧盟和FDA批准用于中度至重度斑块型银屑病（plaque psoriasis）成人患者的治疗。该药的获批，标志着银屑病临床治疗的重大里程碑。在III期临床项目中，Cosentyx相对于安慰剂显著改善了皮肤症状，同时疗效优于另外2种重磅药物：强生的Stelara和安进的Enbrel。
当前，银屑病市场由TNF阻断剂（抗肿瘤坏死因子单抗）统治，包括最畅销的Enbrel（恩利，2013年销售额83美元）和Humira（修美乐，2013年全球销售额106亿美元）。然而有高达40%的患者对TNF阻断剂治疗不足或无反应；另据美国银屑病基金会（National Psoriasis Foundation）调查，有高达52%的患者表示对自身疾病管理不满意。因此，诺华认为，IL-17抑制剂有能力打破TNF抑制剂的统治地位。而在临床试验中，Cosentyx能够击败重磅药物Stelara（2013年销15亿美元）和Enbrel，这为Cosentyx提供了一个相当大的市场机会。
当下，诺华正在积极推进Cosentyx的其他临床项目，不断扩大该药的潜在适应症，其中银屑病关节炎项目已处于III期，强直性脊柱炎和类风湿性关节炎计划在今年提交申请。如果一切顺利，业界认为，到2020年，Cosentyx的年销售额将突破10亿美元。
不过，尽管诺华Cosentyx是上市的首个IL-17阻断剂，但分析师预计，该市场将很快迎来其他竞争产品，紧跟其后的是安进和阿斯利康开发的类似药物brodalumab，该药在银屑病和银屑病关节炎III期临床中均创下了骄人的成绩。此外，礼来的IL-17阻断剂ixekizumab和默沙东的MK-3222及强生（JNJ）的IL-23阻断剂guselkumab也已进入III期临床开发。
诺华的另一劲敌：重磅口服银屑病药物Otezla
另一方面，生物技术巨头新基（Celgene）重磅银屑病口服药物Otezla近日获得欧盟批准，该药是过去20年中获批的首个银屑病口服药物，在相关临床试验中，Otezla已被证明能够使患者病情取得具有临床意义的显著持久改善，该药将为广泛的银屑病患者群体提供了一种有价值的治疗选择，包括以前使用过生物制剂或常规系统性药物治疗的患者群体。
业界认为，尽管面临着注射型药物肿瘤坏死因子（TNF）抑制剂的竞争，尤其是全球最畅销的药物Humira（修美乐，2013年销售额106亿美元）和Entrel（恩利，2013年销售额83亿美元），但Otezla临床用药不需要常规的实验室监测，而且该药是一种口服药物，相比市售注射药物，Otezla具有巨大优势，该药将为患者和医生提供一种重要的治疗选择。业界预期，Otezla的销售峰值将突破20亿美元。
英文原文： Novartis scores the first victory in a blockbuster psoriasis race
Novartis ($NVS) has picked up FDA and European approvals to sell its secukinumab as a treatment for psoriasis, the first steps in the company's plot to build a global anti-inflammatory contender and outpace its rivals.
The injected treatment, to be marketed as Cosentyx, blocks an inflammation-related signaling protein called interleukin-17 to beat back the itchy, flaky scales that characterize psoriasis. In its sweeping Phase III program, Novartis' antibody significantly improved skin clarity compared to placebo and proved superior to Johnson & Johnson's ($JNJ) Stelara and Amgen's ($AMGN) Enbrel, two blockbuster therapies.
The FDA's decision, handed down Wednesday, comes two days after European authorities gave the treatment a green light. And, with its global launch to come, secukinumab becomes the first IL-17 inhibitor cleared for psoriasis, beating out Amgen and AstraZeneca's ($AZN) brodalumab and Eli Lilly's ($LLY) ixekizumab among treatments expected to change the standard of care for the disease.
As it stands, the most common options for psoriasis sufferers are injected therapies that inhibit tumor necrosis factor (TNF), including Enbrel and AbbVie's ($ABBV) top-selling Humira. But Novartis believes IL-17 blockers can disrupt the market, pointing to a National Psoriasis Foundation survey in which 52% of patients surveyed said they were dissatisfied with their disease management. And secukinumab's victories over Stelara, a $1.5 billion drug, and Enbrel, which brings in $9 billion a year, suggest a sizable market opportunity.
Now Novartis is at work expanding the potential indications for secukinumab, running late-stage programs in psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis with plans for follow-on filings this year. If everything goes according to plan, analysts say the treatment could bring in $1 billion in annual sales by 2020.
"The FDA's approval of Cosentyx signifies a turning point for psoriasis patients, who can now benefit from the first and only approved treatment targeting the IL-17 pathway, which is proven to play a key role in the development of plaque psoriasis," Novartis pharma chief David Epstein said in a statement. "This important milestone will now allow patients to receive a treatment that has the proven ability to offer clear or almost clear skin."
But Novartis' rivals are close on its heels. Amgen and AstraZeneca expect to file brodalumab this year, and Lilly is on a similar timeline with ixekizumab. Meanwhile, Merck ($MRK) is working through Phase III with the IL-23-blocking tildrakizumab, and J&J has begun late-stage testing on its similar guselkumab.
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