吉利德丙肝药Sovaldi今年称王无悬念

汤森路透4月17日集中其智囊分析师对今年最大“重磅炸弹”药品进行预测，似乎吉利德公司的Sovaldi称王已几无悬念。
　　

                               
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　　这个丙型肝炎新药每名患者8.4万美元的治疗花费已激起对于药品价格的举国争论，据此测算今年它的销售额约为24亿美元。葛兰素史克的呼吸道治疗药Anoro Ellipta排在第二位。汤森路透预计这两种药物将成为年销售收入超过10亿美元的“重磅炸弹”级新药，到2019年销售额分别为75亿美元和31亿美元。
　　第三位同样来自吉利德公司的血液癌症药物idelalisib，预计今年晚些时候获得FDA批准上市。预计该药到2019年销售额将达到11亿美元。吉利德公司在研发“重磅炸弹”级新药的道路上取得了巨大成功。事实上，该公司将成为有史以来最成功的新药研发制造商。分析人士预计，2014年首次踏足药品市场的新药销售额将达到100亿美元。
　　Anoro Ellipta是葛兰素史克取代已在美国和欧盟失去专利保护的老药舒利迭（Advair）的继任者。该药于2013年12月获FDA批准上市，是批准的首个长效毒蕈碱受体拮抗剂/长效β-肾上腺素受体激动剂（LAMA/LABA）组合药物。舒利迭是该公司最畅销的药物，销售额约占该公司总销售额的近1/5。
　　汤森路透首次承认其预测有偏差。例如，去年预测的顶级药物Amarin公司的降脂药Vascepa并没有达到预期的销量。研究人员预计，该药在2017年的销售额将达到29.6亿美元。但随后，FDA顾问小组以疗效和安全性数据不足为由压倒性票数反对扩大该药的适应症。现在，汤森路透修改了该药2019年的销售预测为5.75亿美元。同时，也把其他药物销售额预测年份更新到2019年，包括Celgene公司新的治疗多发性骨髓瘤药物Pomalyst（18亿美元），葛兰素史克的慢性阻塞性肺疾病治疗药Relovair（27.5亿美元）和罗氏的乳腺癌药物Kadcyla（41亿美元）。

Gilead's Sovaldi, GSK's Anoro stand out in 2014's blockbuster crop, report says

Want to take a guess ab0ut which three new drugs are marked for greatness in 2014? One of them is obvious. Another, not so much. And the third isn't approved yet.

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Gilead's Sovaldi

Gilead Sciences' ($GILD) hepatitis C pill Sovaldi is at the top of Thomson Reuters' annual list of drugs to watch, with GlaxoSmithKline's ($GSK) inhaled respiratory treatment Anoro Ellipta in second place. After crunching the numbers, Thomson Reuters figures both these drugs will break the blockbuster barrier and then some, with 2019 sales of $7.5 billion and $3.1 billion respectively.

And third on that list is Gilead's blood cancer drug idelalisib, expected to nab FDA approval later this year. The Thomson Reuters researchers see that product hitting $1.1 billion in sales by 2019.

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Obviously, Sovaldi is well on its way to blockbuster status already. In fact, it's expected to become the most successful drug launch ever, with some sales projections for 2014 topping the Thomson Reuters predictions five years hence. Analysts have predicted up to $10 billion in sales this year, its first on the market. Anoro Ellipta, one of the products GSK is counting on to rebuild its respiratory franchise as top seller Advair goes not-so-gently into the good night, won approval in January to less fanfare, but it's still an imp0rtant product in that market.

"These treatments are expected to be the highest performing from our list of drugs to watch in 2014," said Charlotte Jago, a Thomson Reuters senior editor and author of the Market Insight report

Several other new therapies are worth watching, however, Jago said. Among the other products highlighted in this year's report is Eli Lilly's ($LLY) diabetes hopeful dulaglutide, a once-weekly GLP-1 treatment that could grab half of that market.

Thomson Reuters is first to admit that its projections aren't infallible. Some of last year's top picks haven't delivered as expected, namely Amarin's ($AMRN) fish-oil-based drug for high triglycerides. The researchers had pegged Vascepa at $2.96 billion-plus in 2017 sales, but that was before an FDA expert panel recommended against a big label extension for the drug. Now, consensus sales estimates stand at $575 million by 2019, Thomson Reuters says. Other blockbuster predictions made last year have borne out so far, however, with sales forecasts updated to 2019. Those include Celgene's ($CELG) new multiple myeloma treatment Pomalyst ($1.8 billion), GlaxoSmithKline's chronic obstructive pulmonary disease treatment Relovair ($2.75 billion) and Roche's breast cancer med Kadcyla ($4.1 billion).

Unfortunately for pharma, however, these top performers could be the exception that proves a new rule. Last year's report questioned whether the year's most promising products would end up demonstrating the enduring power of the blockbuster model--or stand among the few products still able to generate $1 billion-plus in annual sales. The latest consensus sales forecasts "tend to suggest that the latter scenario is playing out," the researchers warn. "[T]he vast majority" of these new meds "are predicted to make sales of less than $1 billion by 2019."

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