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& y7 k- O: G' ~( t& R p; L/ Z这个标签扩展是根据一个叫做COSMOS的开放标签二期临床。按理说标签扩展应该是好事，但Olysio虽然才上市不到一年实际上已是日落西山。
d! p( E8 y: j0 g& A9 ?. COlysio的经历可谓奇特，也反映了当前药品市场的复杂。Olysio是继默克的Victrelis （boceprevir，博赛泼维）和Vertex的Incivek （telaprevir，特拉泼维）之后第三个上市的NS3/4A蛋白酶抑制剂。Incivek曾经是制药史上最成功的药物上市之一，只用3个季度便超过10亿美元销售。然而天有不测风云，新一代丙肝药物如Sovaldi的出现使这个刚上市两年的明星药物去年被低价转让。Olysio作为第三个上市的me-too型药物虽然治疗时间短于Incivek和Victrelis，副作用也略小，但在sovaldi的威胁之下上市之初并不被看好。记得当时分析家预测的年销售是3500万美元。
然而Olysio上市第一年的表现却出乎包括强生管理层的意料，今年的销售可达20亿美元左右。这是为什么呢？这又得回到《顽主》那个经典镜头了。瘦骨嶙峋的马青："我看谁TMD敢惹我？" 一壮汉："我TMD敢惹你！" 马青："那，，，，，，那，，，，，，谁TMD敢惹咱俩儿？"。既然打不过Sovaldi那就和它合作。强生的这个COSMOS实验可谓神来之笔，正是这个实验为他们今年挣了这20亿美元。这个实验结果早就公布了，根据这个结果权威的美国肝病研究协会很早就向医生推荐标签外使用Olysio和Sovaldi联用。Sovaldi成为历史上比Incivek强10倍（不是形容词，真是差不多10倍，Sovaldi前两个季度卖了60几亿）的产品上市，因此Olysio也跟着鸡犬升天，成为史上最成功的药品上市之一。据说iPhone 6也就和Incivek的吸金速度差不多，比sovaldi还有差距。
但是Olysio好日子马上就要到头了，因为吉利德科学自己的全口服复方Harvoni刚刚上市，12周只有94，000美元，较轻的病人只需用8周只要63，000美元。而Olysio标价66，000美元，加上Sovaldi的89，000美元价格上远远超过Harvoni，而且还得服用两片药而Harvoni是单片复方。所以除非Olysio大幅度降价，它借着Sovaldi狐假虎威的日子已经结束了。9 [: n6 i) n. I8 S- g! d6 N
Can J&J score sales with FDA's new Olysio-plus-Sovaldi approval?Johnson & Johnson ($JNJ) just scored a marketing goal: Its hepatitis C drug Olysio won FDA approval as part of a two-drug cocktail that also stars Gilead Sciences' ($GILD) Sovaldi. The question now is how much that approval will help Olysio withstand competition, both current and forthcoming.
First problem: The Olysio nod follows FDA approval for Harvoni, Gilead's combo pill that combines Sovaldi with a new agent, ledipasvir. As a two-drug, interferon-free drug, it's set to compete head-to-head with any other all-oral match-up. Including Olysio plus Sovaldi.
Second problem: AbbVie ($ABBV) is on the verge of winning approval for its brand-new hep C suite of products. The three-drug combo would also line up as one of the Olysio-plus-Sovaldi rivals.
Third problem: Price. As high as the $94,500 price tag on Harvoni is, it's not nearly as high as the sum cost for Olysio and Solvadi. J&J set the price for Olysio at $66,000. Sovaldi has a list price of $84,000. Total: $150,000.
Could J&J slash Olysio's price enough to make its Sovaldi cocktail competitive? Simple math says that would put Olysio at a $10,500 list price. Of course, with rebates and and payer negotiations, the math isn't really all that simple. Still, J&J might well be reluctant to offer enormous rebates. Pay-for-performance? Maybe. J&J has done that sort of deal with payers before. Volume discounts?
J&J says it will work with payers on costs. And it has a targeted approach in mind. After all, hepatitis C comes in several genotypes, and the various drugs have varying scores among subgroups of patients.
"The availability of multiple treatment options is important to physicians and patients so optimal treatment decisions can be made, given the complexity of the disease and diversity of patient population," Dr. Eric Lawitz, lead author of the Olysio-Sovaldi study submitted to the FDA, said in a statement.
A J&J spokeswoman put it more succinctly. "There are a lot of different patient needs," spokeswoman Rebecca Tillet told Bloomberg. "We think Olysio will play a meaningful role in that mix."
Whatever the strategy, investors and even J&J execs fear Olysio's blockbuster days are numbered. Despite impressive sales so far this year, sales projections for the drug are not so impressive going forward.
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http://www.fiercepharma.com/stor ... approval/2014-11-06, s) Y8 b( q% P% i
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