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首页 » FDA信息 » 11月底医药股重点关注:辉瑞,史赛克,Tetraphase制药

11月底医药股重点关注:辉瑞,史赛克,Tetraphase制药

来源:生物谷 2014-11-26 10:02

2014年11月26日讯 /生物谷BIOON/ --上周,受全球仿制药巨头阿特维斯(Actavis)660亿美元“抢婚”肉毒杆菌制造商艾尔健(Allergan)以及激进投资者比尔·阿克曼(Bill Ackman)20亿美元收购兽药公司Zoetis 10%股份等劲爆消息刺激,医疗板块跑赢大盘,标普500指数(SP500)上涨1.16%,医疗指数ETF-SPDR上涨1.58%。

随着艾尔健-Valeant制药传奇故事的终结,医药领域并购活动的关注焦点也将转移到辉瑞(Pfizer)和史赛克(Stryker )这2家公司身上,双方将分别有机会接近阿斯利康(AZN)和施乐辉(Smith & Nephew)并就并购出价。此外,有消息传出,赛诺菲(Sanofi)正在考虑从外部物色新CEO取代最近离职的CEO魏巴赫,潜在人选包括阿斯利康现任CEO Pascal Soriot、施乐辉CEO Olivier Bohuon、优时比离职CEO Roch Doliveux。另外,Tetraphase制药也表示,将为自己寻找潜在买家,包括Actelion制药和罗氏(Roche)。

本周由于赶上感恩节,股市将于周四收盘而周五仅开盘半天,医药板块预计将保持平稳,不过有一些关键的监管批准将如期公布。另外,医疗板块的财报季节已接近尾声,仅有少数几家公司将在本周公告,包括Enanta制药、Arrowhead Research公司、GW制药。

诺华(Novartis):

诺华的肢端肥大症药物Signifor LAR本周一获得欧洲药品管理局(EMA)批准。肢端肥大症(acromegaly)是一种罕见的激素失调症,欧盟患者总数超过1万例。今年5月,FDA已批准Signifor LAR用于相同适应症。

辉瑞(Pfizer):

11月26日,将标志着辉瑞为期6个月冷静期的结束,辉瑞可以再次接近阿斯利康重新提交收购要约。今年5月,阿斯利康拒绝辉瑞1180亿美元收购,按照英国法律,辉瑞将不得不等待6个月才能重新提交报价。然而,美国财政部近期出台的税收新规,可能会对该笔交易形成威慑,之前该新规已导致艾伯维(AbbVie)与Shire价值550亿美元的收购案流产。截止目前,辉瑞尚未就新规实施后如何实施税收倒置交易的未来战略发表任何声明。有分析师认为,辉瑞重新报价的可能性仅在20%-30%。

史赛克-施乐辉:

施乐辉(Smith & Nephew)是总部位于英国的医疗设备制造商,今年上半年,业界猜测该公司将成为美国史赛克(Stryker)税收倒置交易的下一个目标。随着施乐辉股价受业界猜测大涨,根据英国收购委员会要求,史赛克被迫宣告其关于潜在收购的意图。尽管史赛克承认一直在考虑施乐辉作为其收购目标,但该公司同时表示不会出价。由此引发的6个月冷静期,也将在本月底结束。已经有传言爆出,史赛克将出价200亿美元收购施乐辉。

FDA监管批准:

本周,FDA预计将批准数个候选药物。Valeant公司的痤疮药物Onexton有望获得FDA批准,PDUFA目标日期为11月30日。同时,FDA也将于11月26日就Avanir制药公司的偏头痛药物AVP-825做出审查决定。不过,Avanir公司上周透露,不大可能赢得FDA批准,因为FDA曾要求开展额外的人为因素测试。AVP-825旨在通过患者的鼻子递送sumatriptin粉末,而额外的测试将评估药物递送装置的安全性。因此,AVP-825的监管审查很可能会被延迟。(生物谷Bioon.com)

英文原文:Pharma Stocks To Watch This Week: Pfizer Inc. (PFE), Stryker Corporation (SYK), Tetraphase Pharmaceuticals Inc (TTPH)

Here are the key events from the Healthcare sector for the upcoming, holiday-shortened week

The Healthcare sector outperformed the broader market last week following news of Allergan, Inc. (NYSE:AGN) and Actavis plc’s (NYSE:ACT) merger, as well as Bill Ackman taking a significant stake in Zoetis Inc (NYSE:ZTS). The S&P 500 INDEX (INDEXCBOE:SPX) climbed 1.16%, while the Health Care SPDR (ETF) (NYSEARCA:XLV) rallied 1.58%.

With an end to the Allergan-Valeant Pharmaceuticals Intl Inc (NYSE:VRX) saga, the sector’s mergers and acquisition activity-related focus will now shift to Pfizer Inc. (NYSE:PFE) and Stryker Corporation (NYSE:SYK), which will now have the opportunity to approach AstraZeneca plc (ADR) (NYSE:AZN) and Smith & Nephew plc (ADR) (NYSE:SNN), respectively, with merger bids. Moreover, there has been speculation that Sanofi SA (ADR) (NYSE:SNY) is considering Smith & Nephew’s CEO Olivier Bohuon to replace its recently ousted CEO Chris Viehbacher.

Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH) is also said to be looking to sell itself to potential buyers, such as Actelion Ltd (OTCMKTS:ALIOF) and Roche Holding Ltd. (ADR) (OTCKMTS:RHHBY).

The week is expected to remain slow, with market closed on Thursday and open for only half-day on Friday due to Thanksgiving, but a number of key regulatory approvals for large pharmaceuticals and biotechs are due. The earnings season for the Healthcare sector is near its end, with only a few companies reporting this week. These include Enanta Pharmaceuticals Inc (NASDAQ:ENTA), Arrowhead Research Corp (NASDAQ:ARWR), and GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH)

Novartis
Novartis AG (ADR) (NYSE:NVS) received the European Medicines Agency’s (EMA) approval today for its drug signifor as a treatment of acromegaly, a rare hormonal disorder estimated to affect over 10,000 individuals in the member states of the European Union. The drug was approved for the same indication by the US Food and Drug Administration (FDA) in May this year.

Pfizer – AstraZeneca
November 26 will mark the end of the six-month cooling-off period for Pfizer, which can now once again approach AstraZeneca with a renewed bid. Pfizer, looking to exploit lower corporate tax rates, had approached UK-based AstraZeneca with a $118 billion bid, one of the biggest ones, in May. However, the latter refused the bid. As per British laws, Pfizer has had to wait six months before making a renewed offer. It has been vocal about its intentions of looking for a merger, but the recent steps taken by the US Treasury may have been a deterrent for the pharmaceutical giant. The Treasury was successful in terminating the $55 billion AbbVie Inc (NYSE:ABBV) and Shire PLC (ADR) (NASDAQ:SHPG) deal. Pfizer has not made any statements regarding its future strategies regarding tax-inversion post the implementation of new regulations.

Stryker – Smith & Nephew

 Smith & Nephew, another UK-based medical device maker, was being speculated to be the next tax-inversion target for a US company, with Stryker Corporation leading the race. As Smith & Nephew stock surged on speculations, Stryker was forced to declare its intentions about a potential offer to the former under the British Takeover Panel’s requirements. While Stryker admitted that it had been in the early stages of considering Smith & Nephew as an acquisition target, it said it will not be making an offer. This triggered a six-month cooling-off period, which will be completed at the end of the month. Rumors are already surging that Stryker might approach the company with around a $20 billion bid.

FDA Approvals
The FDA is expected to give its verdict on a number of drug candidates, with their Prescription Drug User Fee Act (PDUFA) dates scheduled for this week.

Valeant’s acne treatment Onexton is also expected to receive approval this month. The PDUFA date for the drug is set for November 30.

The FDA will take a decision about Avanir Pharmaceuticals Inc (NASDAQ:AVNR) migraine treatment, AVP-825, on November 26. However, the company announced last week that an approval is unlikely as the regulatory body had asked for additional human factor testing. The treatment is designed to deliver the sumatriptin powder through the patient’s nose. The additional required testing will evaluate the safety of the device used to deliver the powder. Hence, the decision will most likely be delayed.

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