2014年11月27日讯 /生物谷BIOON/ --安进和阿斯利康公司最近合作研发的药物再传捷报。两家医药巨头联合开发的治疗斑块性银屑病药物brodalumab在临床三期对比研究中击败了强生公司的畅销药物Stelara。这一研究结果也将有利于brodalumab在欧盟和美国市场的药物审批过程。
根据公司披露的数据，此次临床三期研究主要采用了100%皮肤清洁度（PASI 100）和75%皮肤清洁度（PASI 75）两项指标。结果显示，在brodalumab治疗组中，210mg剂量组、体重依赖剂量组、140mg剂量组达到PASI 100指标的患者比率分别为44.4%、33.6%、25.7%；而Stelara治疗组和对照组的这一数字仅为21.7%和0.6%。而210mg brodalumab治疗组和Stelara治疗组在PASI 75这一指标上也表现出明显的差异：前者达到了86.3%，后者为70%。
显然,阿斯利康公司将这一药物作为公司全球研发战略的一项重要内容，分析人士预测，brodalumab上市后的年销售额将可达到5亿美元到15亿美元之间。根据两家公司的协议，安进公司将获得该药物在美国市场的销售权。
不过，现在并不是安进公司和阿斯利康公司高兴的时候，因为他们还面临着更强的挑战。仅仅几周之前，诺华公司开发的IL-17药物secukinumab同样取得了出色的研究成果，其效果令FDA的专家委员会交口称赞。而礼来的同类药物也正处于临床中期研究的阶段。此外，默沙东的MK-3222和强生公司开发的IL-23药物guselkumab都是安进和阿斯利康公司在这一市场上强有力的竞争者。因此，安进公司和阿斯利康公司真正需要考虑的是这一药物如何在强敌环生的市场上杀出一条血路。
详细英文报道：
Amgen and AstraZeneca have racked up their third straight Phase III win forbrodalumab in plaque psoriasis, beating J&J's Stelara in a head-to-head study. The news comes just two weeks after the pharma partners posted their latest positive results, positioning them for a run at regulators on both sides of the Atlantic.
There are two key scores in this study, dubbed AMAGINE-2; 100% skin clearance (PASI 100) and 75% clearance (PASI 75).
The numbers: 44.4% of patients in the brodalumab 210-mg group, 33.6% of patients in the brodalumab weight-based group, 25.7% of patients in the brodalumab 140-mg group, 21.7% of patients in the Stelara group and 0.6% of patients in the placebo group achieved total clearance of skin disease (PASI 100). The showdown numbers were a bit mixed for PASI 75: 86.3% of patients in the brodalumab 210-mg group, 77% of patients in the brodalumab weight-based group, 66.6% of patients in the brodalumab 140-mg group, 70% of patients in the Stelara group and 8.1% of patients in the placebo group achieved PASI 75.
The two pharma giants, though, have other rivals than Stelara to worry about.
Novartis ($NVS) is already in front of regulators with its IL-17 program forsecukinumab, which earned a unanimous nod recently from an outside group of FDA advisers. Eli Lilly ($LLY) is in the midst of Phase III with its IL-17-blockingixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) IL-23 inhibitor guselkumab.
Back when AstraZeneca ($AZN) was making its case against a megamerger with Pfizer ($PFE), AstraZeneca assessed brodalumab's market potential at $500 million to an ambitious $1.5 billion a year, based on the analysts it listens to. But Amgen ($AMGN) stands to gain the lion's share of the sales revenue. AstraZeneca put up $50 million in cash to partner with Amgen on brodalumab and a portfolio of anti-inflammatories back in 2012. Amgen took the lead on brodalumab, retaining commercial rights to the big U.S. market.
"Results from AMAGINE-2 underscore that treatment with brodalumab could help a significant number of moderate-to-severe plaque psoriasis patients achieve total clearance of their skin disease, and the great majority achieve at least a 75 percent improvement in their disease," said Amgen R&D chief Dr. Sean Harper in a statement. "AMAGINE-2 is the third and final pivotal study in our Phase III psoriasis program and the robust data from these studies will form the basis of our global filing plan. We look forward to discussions with regulatory authorities."