诺和诺德突然提前Tresiba上市申请，赛诺菲措手不及

诺和诺德突然提前Tresiba上市申请，赛诺菲措手不及

  发布日期：2015-03-29  来源：生物谷  

2年前，FDA以安全性为由拒绝批准Tresiba，此次诺和诺德强势回归，胜算超9成，赛诺菲来得时将迎来一场血战。

丹麦制药巨头诺和诺德（Novo Nordisk）近日突然宣布，将在一个月内向FDA重新提交长效胰岛素Tresiba的上市申请，比之前预期的提前不少。而诺和诺德这一重磅消息，无疑给赛诺菲即将上任的新CEO Olivier Brandicourt带来了巨大压力，因为Tresiba就是冲着赛诺菲年销70亿美元的胰岛素来得时（Lantus）而来。目前，赛诺菲正在重新布局美国糖尿病市场战略，诺和诺德计划的提前，也意味着留给赛诺菲的时间更少了，该公司当下正密集筹划将来得时患者尽可能快地转向其救星——新一代基础胰岛素Toujeo。

本周五，在一份短短2句话的声明中，诺和诺德宣布了上述计划，受此消息刺激，公司股票在哥本哈根股市早盘飙升13%创下历史新高。而时间拉回到2年前，即2013年，当时诺和诺德满怀欣喜向FDA提交申请后，却遭FDA当头一棒。FDA要求开展费钱费时的心血管预后研究证明Tresiba的安全性，并告知在此之前不能重新提交申请。之后诺和诺德便一直在开展研究进一步调查Tresiba的潜在心血管风险。

有分析师表示，鉴于诺和诺德之前的言词，该公司此次提前递交申请的行动，似乎表明该公司目前掌握的数据已证明Tresiba不会增加心血管风险，这也意味着Tresba可能在今年10月或11月获得FDA批准，并于2016年提前登录美国市场。

花旗集团分析师认为，这一次FDA批准Tresiba的机会大于90%。目前Tresiba已在欧盟、日本、墨西哥上市。汤姆森路透之前曾保守估计，到2020年Tresiba的年销售额将达到22亿美元，但随着该药在美国上市信心的走强，这一数字预计将大幅上涨。

来得时的救星Toujeo在上个月获得FDA批准，赛诺菲已计划在下周一新CEO Brandicourt上任当天，将Toujeo推向美国市场。有分析师预计，到2018年，Toujeo的年销售额将达到15亿美元。目前，来得时也正面临勃林格-礼来糖尿病联盟的另一种生物仿制药的竞争，该仿制药预计也将在2016年与诺德诺德Tresiba同时登陆市场，这也意味着届时来得时将被2者夹击。

英文原文：Novo Nordisk surges on plan to resubmit rejected insulin in U.S.

(Reuters) -Denmark's Novo Nordisk is to resubmit its new insulin Tresiba to U.S.regulators based on interim analysis data from a clinical trial, bringing itsbiggest new drug hope closer to the world's top market.

Shares in thecompany leapt 13 percent to an all-time high in early trade in Copenhagen onFriday after it said it would file with the U.S. Food and Drugs Administration(FDA) within the next month. The drug was rebuffed by the FDA two years ago.

The plan, announcedlate on Thursday, is a big relief to investors, since a decision not to use theearly data on Tresiba and related drug Ryzodeg would have further delayed aU.S. launch. Tresiba is already available in Europe and other markets.

Novo, the world'stop insulin maker, is now in a position to get a U.S. approval for Tresiba assoon as October or November, putting it on track to launch by early 2016,according to industry analysts.

Citigroup's PeterVerdult said he believed the odds of U.S. approval were greater than 90percent, given a small group of Novo staff sitting behind a communications"firewall" had already discussed the data with FDA.

The FDA asked Novoto conduct a dedicated cardiovascular risk trial, known as DEVOTE, afterrefusing to approve Tresiba in 2013 because of worries it might be linked tohigher rates of heart attacks or strokes.

Novo had previouslysaid it would decide during the first half of this year whether to submitinterim or full trial results. Waiting for full results would have scupperedits hope of getting to market in 2016 and put it behind in a highly competitivesector.

Novo vies withSanofi and Eli Lilly in supplying insulins to diabetics. A Tresiba launch inthe United States within the next year may help see off rival products, notablySanofi's new insulin Toujeo, which is designed to succeed the French company'sLantus.

Tresiba, anultra-long-acting form of insulin that is also known as degludec, is currentlyforecast to generate annual sales of $2.2 billion by 2020, according toconsensus estimates compiled by Thomson Reuters Cortellis.

谢谢分享

真是峰回路转啊，研发的事情真是难说。

新药的研发真的是很高深莫测，需要一个很好很强大的合作团队！

感谢分享！

谢谢分享，竞争依然激烈