2014-9-19国内、国际新药信息大汇总（二）

            2014-9-19国内国际新药信息大汇总（二）

1、FDA批准“速效伟哥”Stendra，15分钟起效！

   发布日期：2014-09-19  来源：Reuters  

美国生物医药公司Auxilium和Vivus近日宣布，勃起功能障碍（ED）药物Stendra（avanfil）补充新药申请（sNDA）获FDA批准，该药是FDA批准的唯一一种起效时间短至15分钟的ED药物，被誉为“速效伟哥”，特点是立竿见影，服药15分钟后即可见效，可实现足够长时间的勃起帮助完成性生活。而辉瑞（Pfizer）的重磅药物万艾可（Viagra，伟哥），需在性生活前30分钟-1个小时服药。

Stendra于2012年首次获批时的处方信息推荐性生活前30分钟服药，该药有多个剂量可供选择（包括50mg、100mg和200mg片剂），同时可以配合食物及适量饮酒服药。在临床试验（TA-501）中，与安慰剂相比，Stendra可在约15分钟内帮助更多的ED患者实现勃起，并维持足够长的时间成功完成性生活。

Stendra属于一类名为5型磷酸二酯酶（PDE5）抑制剂的处方药，用于18岁及以上功能勃起障碍（ED）患者，帮助增加血流流向阴茎。Vivus拥有Stendra在全球的开发和商业化权利（除某些亚洲国家和环太平洋地区），Auxilium则拥有Stendra在美国和加拿大的独家销售权，同时赛诺菲拥有在非洲、中东、土耳其、独立国家联合体（包括俄罗斯）的商业化授权。Stendra在欧盟以品牌名Spedra销售。

Auxilium公司周三表示，不会撤回对加拿大眼科制药商QLT公司的收购要约，此前几天Auxilium公司便已宣布裁员计划，坚定不移地朝兼并QLT公司的目标前进，一旦兼并完成，Auxilium公司的的税率将从目前美国35%降至加拿大的15%。在同一天，Auxilium公司收到了美国制药商远藤国际（Endo International）不请自来的22亿美元收购要约，Auxilium已启动了一项“毒丸计划”，QLT公司也已同意该计划，以抵制远藤的“敌意收购”。

英文原文：Faster-acting erectile dysfunction drug gets FDA approval

(Reuters) - An erectile dysfunction drug that reduces by half the time patients need to take the pill before sexual activity has been approved by the U.S. Food and Drug Administration.

Developed by Auxilium Pharmaceuticals Inc and Vivus Incs, the drug, Stendra, is the first FDA-approved erectile dysfunction drug that can be taken about 15 minutes prior to sexual activity.

Pfizer Inc's blockbuster erectile dysfunction drug, Viagra, can be taken about an hour before sex.

Stendra, first approved in 2012, is available in multiple dosages (50 mg, 100 mg and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks), the companies said on Thursday.

It belongs to a class of drugs called phosphodiesterase type 5 inhibitors, which are used to help increase blood flow to the penis.

Vivus owns the worldwide development and commercial rights to Stendra for use in sexual dysfunction, with the exception of certain Asian countries in the Pacific Rim.

Auxilium has exclusive marketing rights to Stendra in the United States and Canada, while Sanofi SA holds a license to commercialize it in Africa, the Middle East, Turkey, and the Commonwealth of Independent States including Russia.

The drug is sold as Spedra in the European unio.

Auxilium said on Wednesday it would not withdraw its offer to buy Canadian eye drug maker QLT Inc and adopted a poison pill, a day after receiving an unsolicited buyout offer from Endo International Plc.

2、默沙东出售单抗tidrakizumab 聚焦丙肝新药研发

   发布日期：2014-09-19  来源：生物谷  

默沙东（Merck & Co）目前正经历着一场前所未有的变革，正以飞快的速度通过并购聚焦核心业务，同时剥离去除旧有非核心业务。目前，慢性丙型肝炎（HCV）是默沙东研发的优先重点。今年8月，默沙东耗资38亿收购Idenix公司，获得3个丙肝新药，目前正在评估这些新药纳入开发全口服、泛基因型固定剂量组合方案的潜力。

而默沙东自己的管线中也有几个丙肝药物，包括鸡尾酒疗法MK-5172/MK-8742。MK-5172和MK-8742均属于非常有前途的新一类抗病毒药物。此前，FDA于2013年10月授予MK-5172/MK-8742全口服方案突破性疗法认定。而默沙东也正在一个广泛的III期临床项目中评价MK-5172和MK-8742，包括多种HCV基因型感染初治患者、治疗失败的患者、以及其他重要的HCV亚群，如肝硬化和HCV/HIV合并感染。

近日，默沙东又有了新动作，将治疗性单抗tidrakizumab（MK-3222）出售给了印度太阳制药（Sun Pharma），该药目前正处于III期临床，调查用于慢性斑块型银屑病的治疗。默沙东表示，此次出售tidrakizumab的决定，是聚焦核心业务战略的一部分，使其重心集中于癌症、丙型肝炎、糖尿病及其他几个领域。

目前，银屑病领域研发相当活跃，已吸引多个竞争对手参与，市场阵容非常庞大。此次合作，对太阳制药而言，是其致力于在强劲增长潜力市场中，建设创新性皮肤科产品线的战略的一部分。

根据协议条款，太阳制药将支付一笔8000万美元的预付款，获得全球范围内tildrakizumab用于人类所有适应症的全部权力，默沙东将继续推进所有的临床开发及监管活动，但由太阳制药提供资金。产品上市获批后，太阳制药将负责监管活动，包括后续的意见书、药物警戒、上市后研究、生产及商业化。默沙东将有资格获得监管和销售里程碑款以及产品全球销售的特许权使用费。

Tildrakizumab是一种实验性人源化抗IL-23p19单克隆抗体，特异结合IL-23p19，从而选择性阻断细胞因子IL-23。人类遗传学表明，抑制IL-23可有效治疗炎症性疾病。在治疗慢性斑块型银屑病的临床试验中，tildrakizumab已表现出通过阻断IL-23阻断炎症的功效。该药其他潜在的适应症包括银屑病关节炎及克罗恩病。（生物谷Bioon.com）

英文原文：Sun Pharma and Merck & Co. Inc. Enter into Licensing Agreement for Tildrakizumab

WHITEHOUSE STATION, N.J., and MUMBAI, India--(BUSINESS WIRE)--Merck & Co., Inc., (NYSE:MRK), known as MSD outside the United States and Canada, and Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) through their respective subsidiaries, today announced an exclusive worldwide licensing agreement for Merck’s investigational therapeutic antibody candidate, tildrakizumab, (MK-3222), which is currently being evaluated in Phase 3 registration trials for the treatment of chronic plaque psoriasis, a skin ailment.

Under terms of the agreement, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of U.S. $80 million. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma. Upon product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product. Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage rates on sales.

“Consistent with our previously announced global initiative to sharpen our commercial and R&D focus, including prioritizing our late stage pipeline candidates, we are pleased to enter into this agreement with Sun Pharma to help realize the potential of tildrakizumab for patients with chronic plaque psoriasis,” said Iain D. Dukes, Ph.D., senior vice president, Business Development and Licensing, Merck Research Laboratories.

"Sun Pharma is very pleased to enter into this collaboration with Merck, a recognized leader in the field of inflammatory/immunology therapies, for this late-stage candidate for chronic plaque psoriasis,” said Kirti Ganorkar, senior vice president, Business Development, Sun Pharma. “This collaboration is a part of our strategy towards building our pipeline of innovative dermatology products in a market with strong growth potential.”

The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.

about Tildrakizumab

Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody that binds specifically to IL-23p19 and is therefore designed to selectively block the cytokine IL-23. Human genetics suggest that inhibiting IL-23 is effective for treating inflammatory conditions. In clinical studies for the treatment of chronic plaque psoriasis, tildrakizumab demonstrates efficacy in blocking inflammation by blocking IL-23. Other potential indications, which may be evaluated in future, include psoriatic arthritis and Crohn’s Disease.

Further details of the Phase 3 clinical trials can be found at: http://clinicaltrials.gov

  

3、诺和诺德扫清减肥药Saxenda上市前最后一个障碍

   发布日期：2014-09-19  来源：生物谷  

长期以来，作为世界著名医药公司，诺和诺德给公众的第一印象就是与糖尿病相关领域直接相连。然而，或许在不久的将来，人们提到这家丹麦制药公司时或许将会为它再贴上一个肥胖症药物开发专家的标签。

本月早些时候，诺和诺德开发的第一种减肥药Saxenda已提交FDA并获得了FDA下属专家委员会的审核，这也意味着诺和诺德已经扫清了Saxenda上市前最后一个障碍。公司预计将于下月获得FDA最终批准决定。

Saxenda的上市并不仅仅意味着公司多了一种新药，而是宣告着诺和诺德将正式进入肥胖症药物这一市场并希望在这一市场建立类似其在糖尿病市场中的地位。而近日诺和诺德的首席科学官Mads Krogsgaard Thomsen在接受媒体采访时也表达出了公司的这一计划。他表示公司计划开辟一个单独的肥胖症研究部门，甚至公司已经初步将该部门的研发中心地点选在了美国西雅图。这也意味着最多将有500名研究人员在这里参与肥胖症药物的开发。

尽管由于目前肥胖症药物过于严重的副作用，肥胖症药物市场显得比预计中更为萧条，但是诺和诺德公司看待这一问题的眼光显然更为长远。随着社会进步，肥胖已经被正视为一种与糖尿病等类似的慢性疾病，而在全世界范围内肥胖症患者恐怕远远超出预计，因此这一市场的规模将空前庞大。而各大医药公司面临的问题则是如何生产出符合市场需求的产品以充分发掘这一市场。诺和诺德公司作为糖尿病治疗专家，在慢性病研究领域积累了非常丰富的经验，这些经验将有助于它在这一尚未成熟的市场中种下一颗种子，从而静待收获的季节。

此外，此次诺和诺德公司决定在西雅图设立研究中心的决定也无疑是给西雅图政府雪中送炭。因为今年七月份安进公司突然宣布将关闭公司位于西雅图的研发中心，这一计划将造成约400名研究人员失去工作，而诺和诺德的这一举动无疑填补了西雅图的损失并受到西雅图政府的欢迎。

详细英文报道：

In the midst of its first major foray into treating obesity, Novo Nordisk ($NVO) is liking what it sees in the space, and now the Danish giant plans to hire hundreds of researchers in a gambit to develop new treatments for the global scourge.

In an interview with Bloomberg, Novo Chief Science Officer Mads Krogsgaard Thomsen said the company is looking into making obesity a full-fledged business unit, using Saxenda, its first weight-loss candidate, as a springboard into building a portfolio of treatments. That would mean hiring upward of 500 researchers, Thomsen said, adding that Novo's existing Seattle facility would make a nice home for its new obesity wing.

In the short term, the diabetes magnate is already recruiting key opinion leaders in obesity, he said, seeking out partnerships with eminent academics and institutional innovators.

Meanwhile, Novo is expecting to win FDA approval next month for the injectable Saxenda, a higher dose of its blockbuster diabetes treatment Victoza (liraglutide) that the company hopes can pry open the market for weight-loss drugs and generate $1 billion a year from its new indication.

However, despite Novo's optimism about the demand for obesity treatments, recent history suggests it'll be an uphill battle. Two years ago, both Arena ($ARNA) and Vivus ($VVUS) won FDA nods for new obesity pills with with blockbuster hopes, but safety concerns and payer disinterest led to disappointing launches, and both companies have struggled to gain any market traction. Just last week, Orexigen ($OREX) picked up FDA approval for Contrave, its long-delayed weight-loss treatment, but investors worry that the drug's daunting list of potential side effects will doom it to the same fate.

But, looking at that landscape, Novo sees plenty of room for innovation, Thomsen told Bloomberg. As obesity is increasingly being treated like a disease, the industry is approaching it much the same way as diabetes, something the company and its $2 billion R&D operation know a thing or two about, he said.

"Being pioneers in this therapeutic area is logical for Novo Nordisk," Thomsen said. "We are used to chronic diseases."

Beyond its implications on drug development, Novo's possible Seattle splash would have a huge impact on a suddenly in-flux biotech ecosystem. In July, Amgen ($AMGN) unveiled plans to shut down its operations in the city and its suburbs, shuttering a 750,000-square-foot research campus and axing 660 local jobs by 2015.

Novo's grand designs on diabetes come just on the heels of major setback in anti-inflammatory R&D that has led the company to abandon its work in that space. After its top prospect failed in a midstage study in rheumatoid arthritis, Novo decided to pull the plug on its whole inflammation pipeline earlier this month, affecting about 400 staffers.

  

                              4、   首个中国伟哥“金戈”有望成为销量5亿-10亿元的明星药物

   发布日期：2014-09-19  来源：新药汇  

白云山金戈有望在未来3-5五年，实现5亿-10亿元的销量。

“金戈”以50毫克/粒的计量单位，将在不同市场采用不同包装规格，分为1粒装、2粒装、3粒装、4粒装和10粒装5种包装。

昨日，获得国内首仿生产批文的广药白云山版国产“伟哥”于广州亮相，命名为“金戈”(枸橼酸西地那非片)。广药白云山负责人表示，“金戈”将在今年10月底正式铺货，未来有望成为销量5亿-10亿元的明星药物。

年9月2日，广药获得国家食品药品监督管理总局的“金戈”生产批文，正式获得“出生证”。昨天的产品发布会上，“金戈”产品的包装等详细资料首次对外公布，该产品包装以橘、绿、粉、蓝各色搭配，药片呈粉色。

据了解，ED(勃起功能障碍)是男性生殖系统发病率最高的四大疾病之一，国内40岁以上男性ED发病率约为46%，约有1.27亿患者，市场潜力高达百亿。“金戈”的问世有望打破外资药企对国内抗ED市场的垄断局面，与美国辉瑞的“万艾可”形成正面PK.

广药白云山没有公布“金戈”的定价，但预计国产仿制药的定价必然具有市场竞争力。目前，在华销售的外资药企3种抗ED药物售价达每粒90-136元。

据了解，“金戈”将在今年10月底正式铺货，抗ED药物80%以上的销售渠道在零售药店。白云山将与大参林、海王星辰等多家连锁药店签署合作协议，为“金戈”铺货打开渠道。

据白云山制药总厂厂长朱少璇介绍，早在上个世纪90年代，白云山制药总厂就开始研发枸橼酸西地那非原料和偏激，并按照我国化学药一类新药的要求申报临床批件，并于2003年获得原料和片剂一类新药证书，而由于辉瑞公司在中国申请的用途专利获得了批准，白云山暂停了生产批件的注册申请。

据了解，过去10年间，陆续有近20家药企对伟哥进行抢仿。在今年5月，“万艾可”专利到期后，白云山金戈之所以拔得头筹，除了研发启动较早之外，还有“伟哥之父”诺贝尔生理医学奖弗里德·穆拉德的加盟指导。

据广药白云山有关负责人表示，在产能方面，白云山制药总厂片剂车间设计产能达到40亿片/年，能够满足金戈的市场需求。公司预计，由于自供生产原料，白云山“金戈”有望以低价抢占市场，在未来3-5年，实现5亿-10亿元的销量，成为白云山新的利润增长点和大品种。

郭应禄院士表示，白云山金戈的获批生产，将结束外资药企在中国抗ED市场长达13年的垄断，这是中国医药行业的一件大事。对于加强患者教育，满足临床需求、降低药品费用，有着重要的社会效益和经济效益。

不过，广药白云山对金戈的定位远不止于此，“未来，白云山还将开发系列的伟哥产品，包括开发中药伟哥、抢仿其它抗ED原研药等，形成ED药物产品线。同时通过金戈这一能够引起社会关注的品种，进一步巩固和扩大白云山品牌在医药行业的影响力，从而带动整个大南药板块的发展。” 广药集团董事长李楚源说。

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