2015年1月29日讯 /生物谷BIOON/ --花费巨额研发投入的安进公司正面临被拆分的危险，是否拆分将由今年一系列药物能否被审核通过决定。
这个生物科技巨头正因一年同时申请5个药物和注射剂而饱受批评，而它在2015年的表现将决定其高额研发投入政策的成败。安进的研发投入去年增长了5%至43亿美元，高达其销售总额的21%！
安进手里的王牌是后期临床药物是evolocumab，这是一个降LDL-C（低密度脂蛋白胆固醇）药物，但是其正面临赛诺菲与再生元联合研发的alirocumab（市场名Repatha）激烈竞争，evolocumab将在8月27之前获得FDA的决定，预计比alirocumab晚一个月。两个药都是针对控制增加血液中胆固醇含量的PCSK9蛋白设计，分析师预计该单抗药物可带来30亿美元的收入峰值。
另一个新药是与阿斯利康联合开发的治疗银屑病的抗炎药brodalumab，同时该药还在进行哮喘适应症的后期临床数据。安进这周还向FDA申请扩宽Kyprolis的适应症，该药是通过花100亿美元收购奥尼克斯制药公司而得到的治疗癌症药物。
目前安进同时还有两个已经被延期的药在等最终答复，分别是治疗皮肤癌的talimogene 和心脏衰竭的ivabradine。前者是一个针对转移性黑色素瘤的溶瘤细胞疫苗，在推迟3月后，将在10月27日前得到FDA最终答复，而Ivabradine（伊伐布雷定，Corlanor）是一种口服、特异性If电流阻滞剂，是首个纯粹的降心率因子、首个选择性特异性If抑制剂，有望在5月28前得到答复。
如果安进申请的以上新药能够大获全胜，那些批评其巨额研发政策的人恐怕就可以闭嘴了。对冲基金经理Daniel Loeb和Bernstein 分析师Geoffrey Porges两位批评者都建议，安进公司应该一分为二，一个是囊括传统产品如Aranesp和Enbrel 低投入高利润的药物公司，另一个开发在研药物如evolocumab 和T-Vec，预算更自由专攻研发的公司，Loeb在去年10月的一个会议上就曾说：“安进具有所有隐藏价值的特征，这也是我们投资最喜欢的主题之一。”
显然，安进对之嗤之以鼻，并且已经采取了减少开支的措施。2014年就砍掉了3亿美元预算，预期2015年能节省5亿美元。同时2015年安进将裁员20%，并且在研发布局上将更加谨慎，以期到2018年能减少15亿美元开支。
到底安进能否大获全胜亦或被那些批评家说中，我们将拭目以待！
英文原文：
Amgen faces a make-or-break 2015 with its late-stage pipeline
Amgen ($AMGN)， a big R&D spender facing calls for a breakup， is headed for a major referendum on its strategy in 2015 as a slew of its pipeline assets come up for regulatory review or late-stage results.
The Big Biotech is slated to pull off as many as 5 drug approvals--or rejections--on the year， and its performance will either affirm its penchant for moonshot R&D or embolden critics who claim the company spends too much on research. Amgen's R&D budget jumped 5% to $4.3 billion last year， amounting to about 21% of the company's sales.
Amgen's biggest late-stage asset is evolocumab， an LDL cholesterol-lowering drug in a race with partners Sanofi ($SNY) and Regeneron ($REGN). The drug， to be marketed as Repatha， is up for an FDA decision by Aug. 27， about a month after the expected approval of Sanofi and Regeneron's alirocumab. Each treatment blocks the protein PCSK9， which stands in the way of the body's ability to clear "bad" cholesterol from the blood， and analysts expect the antibodies to bring in about $3 billion apiece at their peak.
Then there's brodalumab， an AstraZeneca ($AZN)-partnered anti-inflammatory drug the company expects to submit as a psoriasis treatment this year， while at the same time awaiting late-stage data in asthma. And Amgen this week filed an FDA application to expand the indication for Kyprolis， the cancer treatment at the heart of the company's roughly $10 billion buyout of Onyx Pharmaceuticals.
The company is also expecting final word on two delayed therapies： talimogene laherparepvec for skin cancer and ivabradine for heart failure. The former--T-Vec， for short--is an oncolytic vaccine targeting metastatic melanoma， and， after a three-month delay in its FDA review， Amgen is expecting a yes or no by Oct. 27. Ivabradine， to be marketed as Corlanor， is up for approval by May 28.
If Amgen can run the table， it could go a long way toward silencing critics of its R&D strategy， a chorus that includes hedge fund manager Daniel Loeb and Bernstein analyst Geoffrey Porges. Each has advocated the company split in two， shifting legacy products like Aranesp and Enbrel into a low-spending， high-margin drug company and placing in-development assets like evolocumab and T-Vec in the hands of a more liberally budgeted biotech with a focus on R&D. Amgen "has all the hallmarks of a hidden-value situation，" Loeb said at a conference in October， "one of our favorite investment themes."
Amgen has demurred to the suggestion， and， perhaps in response， the company has enacted a broad cost-cutting plan， trimming $300 million from its budget last year and expecting to save $500 million more in 2015. Amgen is laying off about 20% of its staff throughout the year and promising to be more selective with its R&D operation， part of an effort to save up to $1.5 billion by 2018.