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大事记!2014年生物医药产业十大重磅消息!

来源:生物谷 2014-12-03 09:06

2014年12月1日讯 /生物谷BIOON/ --作为近年来世界上发展最为迅速的产业之一,生物医药产业每一天都会爆出大量的新闻。今天,小编就带领大家盘点一下生物医药产业2014年最为吸引人的十件大事。

一、 安进公司裁员2900人,重组研发单位

生物医药产业近些年来的一个重要主题就是生物医药公司的研发单位重组。随着医药公司全球化的发展和专利悬崖的到来,许多公司意识到要对自己的研发部门进行改革。而其中安进公司大刀阔斧的对公司位于西雅图的研发部门进行裁员,名单高达2900多人,引起了市场的广泛关注。而这一变化理所当然的引起了众多分析人士的关注和支持。

不唯安进公司,其他许多生物医药巨头如葛兰素史克公司也都纷纷进行了类似的改革,以期使公司的研发体系更具竞争力。而安进公司的这一新闻也可以看做是生物医药产业变化的一个缩影。

二、 凯特琳癌症研究中心CAR-T疗法两名患者死亡

如果说2014年生物医药产业研发工作有什么亮点,那么嵌合抗原受体-T细胞疗法绝对是当之无愧的热点。许多生物医药巨头和产业分析人士都将这一疗法看做是新一代癌症疗法的希望。

不过,今年美国凯特琳癌症研究中心进行的CAR-T项目中两名患者因为细胞激素释放症候群而死亡,导致该项目紧急停止。这一结果也引起了FDA等机构的警惕。而包括诺华、Juno公司等CAR-T疗法研发的先驱也意识到了细胞因子风暴的威胁,进一步完善试验设计。可以说,这一事件促使所有的CAR-T研发竞争者们都更全面的思考他们所面临的问题和挑战。

三、 Ono公司开发的抗PD-1药物nivolumab获得日本市场的上市批准在世界生物医药领域拔得头筹

2014年,无论是医药管理部门还是生物医药公司对癌症免疫疗法研究的重视程度都达到了无以复加的水平。而Ono公司则在PD-1药物研发领域中拔得头筹。公司开发的抗PD-1肿瘤药物nivolumab获得日本相关医药管理部门的审核批准,成功登陆日本市场。

尽管日本市场对众多生物医药公司来说并不具有十分关键的战略意义,但是nivolumab作为世界首个上市的抗PD-1药物仍然赢得了全世界的瞩目。而其背后的巨头施贵宝公司无疑会在PD-1药物研发这场竞争中占尽先机。(相关阅读:全球No.1免疫疗法nivolumab又有新动作——百时美联手巨头新基开发新免疫组合疗法

四、 辉瑞1010亿美元收购阿斯利康风波

今年在生物医药产业企业收购重组的话题之王当属辉瑞公司与阿斯利康公司的收购兼并案之争。这一收购案的影响甚至贯穿全年,对两大生物医药巨头乃至整个生物医药产业都造成了巨大影响。

一方面是辉瑞公司希望将阿斯利康公司据为己有从而在癌症免疫疗法中占据先机同时降低公司的税率;另一方面是阿斯利康公司坚持认为公司的价值不止于此,公司管理层通过无数努力终于说服股东未接受这一提案。而这一收购案结束以来,阿斯利康公司在研发方面取得的一系列成绩也证明了阿斯利康公司在生物医药产业方面不可撼动的地位。

此外,这一收购案的影响也上升到了政府层面,英国政府担心这一收购案会极大挫伤本国生物医药产业的发展,从而从中作梗。而今年以来美国许多公司通过海外兼并的方式转移公司的注册地点以回避美国本土高额税率也使得奥巴马政府出台更为严厉的管理措施,控制美国生物医药公司的外迁。随着11月的过去,辉瑞收购案为期3个月的犹豫期已经终结,这或许标志着辉瑞公司已经正式放弃收购阿斯利康的努力。(相关阅读:辉瑞收购阿斯利康传闻惊业界 生物制药或引爆

五、 艾伯维丙肝新药提交FDA审批

提到丙肝药物,吉利德公司的Sovaldi一定是一个无法回避的话题。Sovaldi神乎其技的疗效和它高昂的价格都将这种丙肝鸡尾酒疗法推上了风口浪尖。不过一个无法改变的事实就是Sovaldi在未来数年都会给吉利德公司带来数以十亿计的收益。而这也就成为众多生物医药公司眼红的原因。

艾伯维公司就是垂涎于这一市场的一个强有力的竞争者。2014年,艾伯维公司向FDA提交了自己开发的丙肝鸡尾酒疗法,希望能够在这一价值上百亿的市场中占得一席之地。除了吉利德公司外,艾伯维公司还需要应对默沙东等生物医药巨头强有力的竞争。因此,谁能最终在风云变幻的丙肝治疗市场中笑傲群雄,还需要时间的检验。(相关阅读:不再高不可攀,Abbvie新药或将撼动吉利德Sovaldi霸主地位

六、 FDA拒绝批准礼来公司SGLT2糖尿病药物empagliflozin上市

随着近年来世界各国人民生活水平的不断提高,糖尿病患病人群呈现了不断增加的趋势,而这一状况也导致糖尿病市场成为各大医药巨头都希望进入的一大市场,而礼来公司就是其中一员。

然而今年八月份,FDA最终作出决定,拒绝批准礼来公司开发的SGLT2糖尿病药物empagliflozin上市,给这家生物医药巨头在糖尿病领域方面的布局以沉重打击。同时,在过去的几年中,礼来公司在研发方面已经遭受了一系列打击。更令其难以忍受的是,这家老牌生物医药巨头不久前被Actavis公司挤出了十大生物医药公司的榜单。不论如何,希望礼来公司在即将到来的2015年能够转运。(相关阅读:礼来糖尿病新药empagliflozin遭FDA拒绝

七、 诺华公司心衰药物LCZ696临床三期研究成果显著

诺华公司在2014年取得了不小的成绩。公司此前做出了将心血管部门作为公司支柱部门之一的决定。此前诺华对其开发的serelaxin寄予厚望,然而现实总是残酷的,一系列研究数据证明要想扩大诺华公司在心血管病领域的影响,公司需要另寻一个突破口。就在这时,LCZ696出色的临床三期研究结果使诺华公司看到了新的希望。公司CEO Joe Jimenez甚至表示这一药物一旦上市,其年销售额将达到20亿-50亿美元之间。最近又传来消息,LCZ696又获得了欧盟心血管历史上收购加速评估资格,这些都使得诺华公司距离预定目标更进一步。(相关阅读:历史性突破!诺华心衰药LCZ696斩获欧盟心血管历史上首个加速评估资格

八、 默沙东两项肿瘤疗法pembrolizumab获得突破性药物认证

九、 默沙东MK-3475出现重大进展奠定公司在PD-1研发领域领先地位

对于默沙东公司来说,2014年可能是时来运转的一年。公司开发的肿瘤药物疗法pembrolizumab获得了FDA的突破性药物疗法地位,另一方面,默沙东的PD-1药物MK-3475也在今年获得了FDA的加速审批进程,FDA将会在今年做出是否批准其作为治疗黑色素瘤疗法上市的决定。这一成绩也使得默沙东公司在PD-1药物研发过程中超过施贵宝公司,占据领先地位。此次默沙东的肿瘤治疗领域取得众多成绩为公司奠定在肿瘤疗法领域地位做出了不可磨灭的贡献。(相关阅读:默克首创PD-1抑制剂Keytruda(pembrolizumab)能领衔黑色素瘤市场吗? 欧盟将开始审核默沙东PD-1抗癌药物

十、 派对药(Party drug)有可能成为治疗抑郁症新疗法

今年以来,中国地区许多明星都卷入吸毒事件。一时间让中国上下都纷纷谈毒色变。其实不唯中国,西方国家对于毒品的管控也都十分严格。

不过最近一项研究显示这些"派对药"有可能作为治疗抑郁症的新型疗法,甚至一些最难以治愈的抑郁症患者都对这些药物有所反应。该消息一出,立刻吸引了大批"不明真相群众"的围观。不过,各位瘾君子千万不要高兴太早,因为研究结果显示使用这些药物存在着许多副作用,同时这种疗法从疗效上看持续时间较为短暂,只能作为一种权宜之计。(生物谷Bioon.com)

详细英文报道:

And immuno-oncology unquestionably dominates the top stories of the year

Last year at this time, the daily reports we produce in the life sciences group were opened about 93,000 times per day, on average. Now, that opener number has swelled to 125,000 with a group of subscribers that exceeds 270,000, and web traffic is reliably more than one million visits per month. In October, we hit 1.3 million.

It's a more global audience than ever. Share of readership in Europe, after launching the EuroBiotech Report, has edged up to about 18% of the total atFierceBiotech, with the U.S. at 71% and Asia at 10%. Early next year, we'll be starting our new twice-weekly Asia pub, FiercePharmaAsia, and we expect our Asian audience will grow as well.

So what has this expanded group of readers been clicking on? Our editorial mission at FierceBiotech is to put the news in context, highlighting the implications and trends behind the headlines. Our audience has clearly responded with considerable enthusiasm. Four of these 10 stories are about the emerging immuno-oncology drug market, which promises to fundamentally change the way cancer is treated--now. Big news for readers also meant following big programs at big companies. One of our core areas of expertise is covering emerging biotech companies, but you won't find any in the top 10. While not a day goes by we don't do something about a small biotech company, those stories don't always qualify for the biggest audience.

In biotech, here are the top 10 news stories of the year so far, based on web traffic.

Amgen axing up to 2,900 staffers, shuttering R&D campus in revamp

Last year saw some continuing major realignments in research as Big Pharma continued to try and refashion its big and expensive global R&D organizations. This year, the world's biggest biotech--which sometimes looks like another Big Pharma--tackled the same task. With its late-stage efforts pumped up with a PCSK9 program,  new cancer drugs and more, Amgen ($AMGN) whipped out the budget ax. Out: Its Seattle R&D campus. And rather than stick with nearly 3,000 company-wide layoffs, Amgen later bumped the total to 4,000. As usual, analysts loved to see the cutbacks. Restructuring global R&D has been a theme now among the big players for the past 5 years. Now a number of them, including GlaxoSmithKline ($GSK), are making a fresh round of changes to try and spur more productivity. This is one story among many more to come.

Two deaths force MSK to hit the brakes on engineered T cell cancer study

This was our top immuno-oncology story on the web. FierceBiotech was tipped off early that there was trouble in this program. Cytokine release syndrome, or a cytokine storm, killed two patients in a CAR-T study, in which investigators adapt T cells to fight cancer. This particular story emerged unexpectedly at a conference and then went viral. Investigators tailored the study and changed the way they recruited patients, highlighting the big safety threat involved in these advanced therapies. It wasn't long before regulators gave them a green light to proceed after this temporary setback. And the company involved--Juno--is now prepping one of the most highly anticipated biotech IPOs of the year. Cytokine storms remain a key threat to patients, but all investigators have been adapting their trials to limit the risks involved for patients.

Anti-PD-1 cancer star nivolumab wins world's first regulatory approval

And let's stay on immuno-oncology. This world's first approval happened in Japan--not your biggest market but an important one nonetheless. Ono Pharmaceuticalpicked up the Japanese rights to the drug--and future bragging rights--in a collaboration deal with Medarex that dates back 9 years. Bristol-Myers owns the bulk of the global rights, though, and it wouldn't be long before the renamed Opdivo was filed with the FDA as Bristol angled for the lead on lung cancer--which promises to be a big market.

Say what? Pfizer's $101B buyout pitch to AstraZeneca sparks a megadebate

Megadeals, you'll remember, were as out of fashion in the pharma industry as bell-bottom pants for men when Pfizer sprung a stunning buyout proposal on AstraZeneca ($AZN). Pascal Soriot, though, had only recently taken the helm at the U.K. pharma giant and wasn't about to let go without a fight. Bizarrely, Pfizer pressed on--even though it had to endure taunts about its R&D acumen. Most analysts assumed that the tax benefits then available through an inversion to a low-tax haven was the real motivation in the merger. And Pfizer finally relented after AstraZeneca, with the help of the U.K.'s political class, gradually forced the U.S. company to give up--at least for a bit. U.K. biopharma investment guru Neil Woodford, a big Astra supporter, still thinks there's a very good chance Pfizer will come back and try again.

AbbVie heads to the FDA with its hep C combo in a race with Gilead, Merck

Gilead ($GILD) made waves with its pioneering approval of the hep C drug Sovaldi… and the price tag it attached. And coming up in its wake are two more big players, with AbbVie ($ABBV) gaining some star quality with its antiviral cocktail. At stake are billions in revenue as new drugs radically alter the standard of care with drugs that are much more effective--and much less harsh--than the interferon-based remedies that once dominated the market. Outside of immuno-oncology and cancer, hepatitis C has faced one of the biggest revolutions in the standard of care. And we cover drug R&D revolutions like no one else.

FDA rejects Eli Lilly's SGLT2 diabetes drug empagliflozin

When it bleeds, it leads, as they say on the evening news. And there's been lots of blood at Lilly ($LLY) in recent years. This year has actually been pretty good at Eli Lilly, topped with an approval for dulaglutide. In this particular case, a manufacturing issue blocked the drug, but in early August Lilly bounced back and nabbed an OK for the therapy--now marketed as Jardiance. A late entrant into an already crowded field, analysts don't expect to see great things from this drug, which is unfortunate. Lilly, freshly knocked out of the top 10 list of Big Pharma companies by a growing Actavis ($ACT), needs all the help it can get.

Novartis' LCZ696 kindles megablockbuster projections with impressive PhIII heart data

Once upon a time, serelaxin represented Novartis' ($NVS) big hope for the cardio franchise. But the drug never lived up to the big expectations that the pharma giant created. But right as serelaxin was foundering amid considerable bluster from company execs, LCZ696 made a sudden and unexpected appearance. This story was one of many we have written about this blockbuster hopeful, which CEO Joe Jimenez bullishly believes is destined to earn $2 billion to $5 billion a year. It's by no means clear sailing yet--any drug that attempts to compete against cheap generics faces some tough challenges. But it's a heavyweight contender at a time Novartis needs a great new drug hope to come along.

Merck wins breakthrough FDA approval for blockbuster cancer contender pembrolizumab | Merck's hot immuno-oncology prospect MK-3475 grabs clear lead in blockbuster race

Here's a two-for-one immuno-oncology special. Breakthrough status was hardly needed to highlight the potential of Merck's pembrolizumab, which now represents a pipeline in itself for the pharma giant. The rapid progress, accelerating from Phase I straight into registration studies with a big complement of combination studies now underway, marks the success of Roger Perlmutter, who took over R&D at a time the company was beginning to blunder from one mistake to the next. Merck's rep is all about smart drug development, but a long stretch without major approvals left a black mark on the reputation and questions hanging over the company's future. Immuno-oncology isn't going to be enough to fix its problems by itself. But it's laid to rest nagging questions about whether Merck could get its act together.

Party drug turned 'miracle' cure for depression spurs hype and stubborn hope

The mainstream media loves this story. And evidently it played well for us as well--despite the skepticism that should have been more than apparent. Investigators know by now that demonstrating again that the generic anesthetic ketamine--better known in some circles as Special K, a party drug with some harsh and frightening side effects--also works well as a temporary treatment for depression. Even the hardest-to-treat patients tend to respond to this drug. The problem, though, is that it's a temporary solution at best. Pharma companies, meanwhile, have been poking around for years now looking for a reformulated version that can drop the "party" and prolong the antidepressant effect. But AstraZeneca and others have found this a hard nut to crack. Never fear, though, a New Year approaches and no doubt we'll be treated to a fresh round of quickie studies on Special K and depression.

 

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