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2014-7-21 国内、国际新药信息大杂烩
1、7月18日CDE重要新药受理一览 发布日期：2014-07-21 来源：大智慧阿思达克通讯社
下图为根据国家食药监总局公开信息，整理的7月18日重要新药受理信息，按注册类型排序，供参考。
关键词： CDE 新药受理
2、Paladin外生殖器和肛周疣局部用药Veregen在加拿大上市
发布日期：2014-07-21 来源：新药汇 Paladin Labs于7月16日宣布，10% Veregen（sinecatechins）软膏在加拿大上市，用于18岁及以上免疫功能正常患者外生殖器和肛周疣（尖锐湿疣）的局部用药。
Paladin Labs于7月16日宣布，10% Veregen（sinecatechins）软膏在加拿大上市，用于18岁及以上免疫功能正常患者外生殖器和肛周疣（尖锐湿疣）的局部用药。
临床上常见的疣在性生活频繁的成年人中的发病率可达1%，使得生殖器疣成为了最常见的性传播感染性疾病。
研究表明，对于患有外部生殖器疣的个体而言，他们生活质量的降低幅度与中度至重度哮喘或骨关节炎患者生活质量的降低幅度是类似的。
“我们很高兴宣布Veregen在加拿大上市，”Paladin Labs首席执行官Mark Beaudet说，“性传播感染性疾病（性病），如外生殖器疣会给患者造成巨大的心理压力。患有外部生殖器疣的加拿大患者现在拥有一种新的非侵入性、有效且耐受性良好的局部用药治疗选择。”
Paladin Labs于2014年5月从MedigeneAG公司获得Veregen在加拿大的销售专有权。
3、InterMune治疗特发性肺纤维化药物紧跟勃林格殷格翰获得 FDA“突破性”认定
发布日期：2014-07-21 来源：fiercebiotech
InterMune公司正在开发的一种治疗罕见肺部疾病的药物获得了FDA的突破性疗法认定，与勃林格殷格翰打成了平手，两家公司将各占美国市场的一角。
InterMune公司正在开发的一种治疗罕见肺部疾病的药物获得了FDA的突破性疗法认定，与勃林格殷格翰打成了平手，两家公司将各占美国市场的一角。
InterMune的药物名为吡非尼酮，用于治疗经常致命的特发性肺纤维化（IPF），这种肺疤痕病变会抑制机体对氧的吸收，导致呼吸和肺功能较差急促。 FDA的突破标签保证该药物进行快速审查，并递交至该机构的高级审核团队，但InterMune公司对该药物获得批准的时间并不期待。
InterMune公司在一封电子邮件中表示，吡非尼酮已经赢得了FDA优先审查的承诺，而增加了一个突破性认定标签不会影响该机构审核的速度。但尽管如此，FDA承诺“调用美国FDA高级管理人员，并提供额外的资源，以协调跨学科的审查”，这可以使审查时间加速，但InterMune公司称这完全由该机构自行决定。
InterMune公司预计将在11月前获得吡非尼酮批准，如果一切按计划进行准备在2015年的第一季度启动该药物上市。
这项突破性认定标志仅比勃林格殷格翰晚了一天，勃林格是InterMune在IPF治疗领域的竞争对手，也获得了同样的认定。两家公司一样，勃林格的nintedanib也已经赢得了优先审查的认定，但这家德国制药商没有透露审批的预期时间表。
InterMune公司的药物早在2010年遭到FDA的拒绝，但是该公司重新递交了一些新的有价值的3期数据后，这家生物技术公司赢回了审查机构的青睐，在5月重新提交该药物审查。
肺纤维化协会称，每年因IPF死亡的人数约40,000人，但该领域没有FDA批准的药物。吡非尼酮一直是在海外市场销售了几年，但尚未产生任何显着的销售势头，去年仅带来了7020万美元。
分析家推测，美国IPF药物市场峰值将超过20亿，但InterMune或勃林格都声称是否有这么大的市场份额还需要讨论。目前这两种药物在3期试验中都表现出了不俗的成绩，但两者都已在后期试验中错过了至少一个次要终点。
吡非尼酮通过抑制两种细胞因子发挥作用，一个是TGF-β，它控制细胞功能的转换，也是纤维化的一部分，另一个是TNF-α，它在炎症中发挥积极作用。在关键性研究中，与安慰剂相比，该药物显著延缓患者的肺部功能衰退，6分钟步行试验也达到了次要终点。
信源地址：http://www.fiercebiotech.com/story/intermune-bags-breakthrough-nod-its-own-race-boehringer/2014-07-17
4、医学联络官助力临床研究
发布日期：2014-07-21 来源：医药经济报 在今年的中国医学事务国际峰会（China Medical Affairs Summit）上，医学联络官（Medical Science Liaison）一词被反复提及，在过去十年中，医学联络工作在整个制药行业的创新和临床推广中的作用日益凸显。亚洲市场设有该职位的公司比例从7%提高到21%
有报告显示，美国前十大生物制药公司拥有的医学联络官团队在2005～2013年间增长了76%。目前已有92%的生物制药企业配备相关团队；在欧洲，2010年仅有41%的公司设置医学联络队伍，两年后，这个数字增加到67%。
从亚太地区来看，这一趋势尤为明显：近两年，亚洲市场设有医学联络官的公司比例从7%提高到了21%。在市场机遇与合规风险并存的医药市场环境中，医学联络官的需求或将不断攀升。
医学信息的桥梁
医学联络官是指经过高级科学培训的各个治疗领域的专业人士，他们擅长向不同的利益相关者传达复杂的科学和医学信息。其首要任务是与肿瘤、心血管等治疗领域的学术领导者（KOL）保持密切的关系。此外，他们还是各自制药公司内部的专家，负责开发教学材料并为项目提供支持。
“医学联络官是非常罕见的人才。”昆泰公司亚太地区新业务负责人James Cornwall认为，一方面，他们都是有学识的高素质科学家，一般是医学、药学专业的博士，对某个疾病领域的治疗方案、药物研发进展都非常熟悉，能够与KOL就医药前沿信息进行交流；第二，在高度监管的环境下进行合规操作，确保药物的合理使用。
“实际上，医学联络官以专业优势与KOL建立平等、持续的信息交流关系，有利于推动新药临床研究及上市后临床研究工作的开展。”昆泰公司现实世界及后期研究部总裁Cynthia Verst表示。
从工作内容来看，医学联络官的工作与医学代表和销售代表不同，他们不做产品宣传销售工作，而只扮演一个传递知识的中枢角色，或者说是医学科学知识信息沟通的一个桥梁。James Cornwall指出，医学联络官还需要把新药临床研究数据、上市后研究数据及从其他文献所获得的数据与临床KOL、药学专家及包括保险公司在内的支付方进行沟通，以确保利益相关方能基于这些数据和信息作出有据可依的决策，同时对这些药物是否列入医保目录进行一个优先排序。
创新药撬动中国需求
职业门槛高是医学联络官的一大特点，培养该专业人才自然成为制药公司棘手的问题。目前的医学联络官团队有一些制药公司内部自建，也有一些将团队全部或部分进行外包。
“由于医学联络官对专业知识要求高、人员流动性大、聘用和管理复杂等诸多问题，尤其对于中国市场快速又特殊的发展模式，使得外包逐渐成为一种趋势。”昆泰公司大中华区总经理甄岭表示。
业内人士分析，医学联络官越来越受到重视，主要基于两个驱动因素：一是创新药推出，医学联络官能有效将创新产品与增长型市场联系起来，如将各治疗领域的KOL与医疗领域决策者聚集在一起，就创新药的价值和医护标准等问题展开讨论，从而做出决策，同时为一些颇具开发前景的治疗方法提出意见；二是业内对合规化和风险管理更加重视，传统的药品销售推广模式面临挑战，制药企业逐渐意识到医药科学信息的传递促进药物被合理、合规地使用才能减少管理风险。
据统计，目前国内有3000名左右的医学联络官人员，主要分布在外资制药企业。记者在招聘网站的信息上发现，包括先声等本土企业也在招聘医学联络官。“以往中国的制药企业大多数都在做仿制药，对医学联络官的需求不大，随着国内越来越多的创新药上市，无论是医生还是KOL，都需要更多的创新药信息，国内企业对这类人才的需要也将增加。”甄岭预测。
5、拜耳眼科新药 aflibercept solution临床III期效果显著
发布日期：2014-07-21 来源：bayerpharma 浏览次数：1
德国拜耳于7月18日宣布称，公司眼科药物阿柏西普(Aflibercept)的新适应症临床III期效果显著，此次新适应症是因糖尿病黄斑水肿引发的视力减退。 这项持续2年的临床III期研究显示，阿柏西普注射液能有效改善糖尿病黄斑水肿而引发的视力减退，最佳矫正视力比治疗前水平提升11.4个字母，远远超过激光光凝术所能恢复的0.7个字母。 阿柏西普(Aflibercept)商品名为Eylea，最早于2011年获得美国食品药品监督管理局（FDA）批准，主要适应症有年龄相关性黄斑变性和视网膜中央静脉阻塞后导致的黄斑水肿。
Two-Year Results From Phase 3 Trial Show Sustained Improvement in Vision for People with Diabetic Macular Edema
Berlin, July 18, 2014 – Bayer HealthCare today announced that in the Phase 3 VIVID-DME trial of aflibercept solution for injection into the eye for the treatment of vision impairment due to diabetic macular edema (DME), aflibercept solution for injection 2 milligrams (mg), in both treatment groups (dosed monthly or every two months), showed a sustained improvement from baseline in best corrected visual acuity (BCVA) at week 100, compared to laser photocoagulation. “Giving people whose eyesight has been affected by diabetes the opportunity to maintain vision as good as possible each and every day is critical so they can continue performing their daily activities such as driving and working,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development. “We are encouraged by these data, along with the previously reported two-year data from the similarly designed VISTA-DME study. If approved, we hope aflibercept solution for injection may offer people affected by diabetic vision loss a new option to improve and sustain their vision.”
Patients in the VIVID-DME trial were randomized to receive either aflibercept solution for injection into the eye every month (n=136), aflibercept solution for injection every two months (after an initial injection every month for five consecutive doses) (n=135), or the comparator treatment of laser photocoagulation (n=132). After two years, patients receiving aflibercept solution for injection every month had a mean gain from baseline in BCVA of 11.4 letters (10.5 letters at 52 weeks; p< 0.0001). This is equivalent to a gain of more than two lines on the ETDRS-eye chart, a standard chart for measuring vision. Patients receiving aflibercept solution for injection every two months had a mean gain from baseline in BCVA of 9.4 letters (10.7 letters at 52 weeks; p<0.0001). Patients in the laser photocoagulation treatment group had a mean change from baseline in BCVA of 0.7 letters (1.2 letters at 52 weeks; p < 0.0001 for each of the aflibercept solution for injection arms vs. laser). Additionally, one third of patients (31.1%) receiving aflibercept solution for injection 2 mg every two months achieved an increase of ?15 letters, a gain of three lines from baseline as one of the endpoints compared to the laser treatment group with only twelve percent (12.1%; p<0.0001) achieving a similar gain.
In this trial, aflibercept solution for injection was generally well tolerated with a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across the aflibercept solution for injection into the eye treatment groups and the laser treatment group. AEs were typical of those seen in other studies in patients with diabetes receiving intravitreal anti-VEGF therapy. The most frequent ocular AEs in the aflibercept solution for injection groups observed included conjunctival hemorrhage, cataract, and intraocular pressure increased. The most frequent non-ocular AEs in these groups included nasopharyngitis, hypertension, glycosylated haemoglobin increased. Arterial thromboembolic events as defined by the ´Anti-Platelet Trialists' Collaboration (non-fatal stroke, non-fatal myocardial infarction, and vascular death) were similar across the treatment groups and the laser group with events occurring in 8 out of 136 patients (5.9%) in the aflibercept solution for injection monthly group, 5 out of 135 patients (3.7%) in the aflibercept solution for injection every two months group, and 3 out of 133 patients (2.3%) in the laser group.
Full two-year data from the VIVID-DME trial will be presented at upcoming medical conferences. Both the VIVID-DME and the VISTA-DME trials will continue as planned up to 148 weeks.
Aflibercept solution for injection into the eye has been approved under the brand name EYLEA® in many countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD) and for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Regulatory submissions have been made in Europe, Japan, Asia Pacific, Latin America and the U.S., for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (myopic CNV). Furthermore a regulatory submission has been made in Europe and the U.S. for EYLEA for the treatment of visual impairment due to macular edema following branch retinal vein occlusion (BRVO).
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, wher the companies share equally the profits from sales of EYLEA, except for Japan wher Regeneron receives a percentage of net sales.
about the Phase 3 DME Program
The Phase 3 DME program consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST-DME, and one open label single arm safety trial in Japanese patients (VIVID-Japan). All three double masked studies have three treatment arms, wher patients are randomized to receive either aflibercept solution for injection 2 mg monthly, aflibercept solution for injection 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. The primary endpoint of these three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standardized tool used in research to measure visual acuity, at 52 weeks. The VIVID-DME, VISTA-DME and VIVID-EAST-DME studies are ongoing.
about Diabetic Macular Edema (DME)
Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) are common microvascular complications in people with diabetes. Diabetic Retinopathy is a disease affecting the blood vessels of the retina. DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
DME is the most frequent cause of blindness in young and mid-aged adults. The treatable population for DME globally is estimatedatabout 6.2 million people. The incidence of diabetes has been steadily climbing and it is projected that up to seven percent of all people with diabetes will develop DME during their lifetime.
about VEGF and Aflibercept solution for injection into the eye
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. It is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema.
Aflibercept solution for injection into the eye is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.
about Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 56,000 employees (Dec 31, 2013) and is represented in more than 100 countries. More information is available at www.healthcare.bayer.com.
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Follow us on Twitter: https://twitter.com/BayerHealthCare
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to updat these forward-looking statements or to conform them to future events or developments.
6、研究表明TDP-43蛋白或与阿尔茨海默病有关 发布日期：2014-07-21 来源：firstwordpharma
在阿尔茨海默病协会国际会议(AAIC)上发布的研究结果中，研究人员认为TDP-43蛋白可能与阿尔茨海默病相关。
在阿尔茨海默病协会国际会议(AAIC)上发布的研究结果中，研究人员认为TDP-43蛋白可能与阿尔茨海默病相关。主要作者Josephs表示称，目前的研究重点一直是β-淀粉样蛋白和tau蛋白，它们形成的脑内斑块，被认为是阿尔茨海默病的标志，但“TDP-43正在成为一种新的靶点。”
作为试验研究的一部分，研究者通过尸体解剖检查了342名确诊患有阿尔茨海默病患者的大脑，发现57%的患者携带异常形式的TDP-43。在对变量如β-淀粉样蛋白和tau蛋白沉积、年龄及遗传风险进行调整之后，研究人员确定，携带这种蛋白的个体患者在死亡时与那些没有TDP-43沉积的患者相比，更可能有认知损伤，并且有10倍之多。
此外，研究者指出，98%携带这种蛋白的患者在死前显示认知下降，相比之下，未显示有TDP-43沉积的患者这一比例为81%。
百健艾迪发言人Altimari表示，该公司正进行临床前测试，以揭开TDP-43作为一种神经退行性疾病靶点的可能性，同时，波士顿大学阿尔茨海默病中心的Wolozin正在推动一家名叫Aquinnah制药的公司来开发以这种蛋白为靶点的制剂。
信源地址：http://www.firstwordpharma.com/node/1224774?tsid=28®ion_id=5#axzz37g3hoXK5
7、GSK黑素瘤组合药物trametinib（Mekinist）3期临床数据击败罗氏Zelboraf
发布日期：2014-07-21 来源：fiercebiotech
葛兰素史克日前公布了旗下正在研发的黑色素瘤复方制剂的3期结果，称其药物在总生存期数据上击败了罗氏的Zelboraf，试验的独立顾问委员会也因此建议提前结束临床研究。
葛兰素史克日前公布了旗下正在研发的黑色素瘤复方制剂的3期结果，称其药物在总生存期数据上击败了罗氏的Zelboraf，试验的独立顾问委员会也因此建议提前结束临床研究。
葛兰素史克公司正在以罗氏的药物为对照，测试MEK抑制剂trametinib（批准名为Mekinist）和BRAF基因阻断剂dabrafenib（Tafinlar）对BRAF基因突变型皮肤黑素瘤患者的治疗效果。中期分析中，复方制剂相比Zelboraf整体生存率更高，超过预先设定的终点，葛兰素史克公司表示，其独立数据监控委员会建议试验提前结束。
信源地址：http://www.fiercebiotech.com/sto ... hase-iii/2014-07-17
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