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标题: 吉利德颤抖吧! 又一款乙肝神药面世(转) [打印本页]

作者: 空谷子    时间: 2016-4-18 02:38     标题: 吉利德颤抖吧! 又一款乙肝神药面世(转)


吉利德颤抖吧! 又一款乙肝神药面世,血清病毒水平可降低99.99%
生物谷   2016/04/15

http://www.bioon.com/3g/id/6681540/

2016年4月15日讯 /生物谷BIOON/ --近日,乙肝药物领域风云再起,美国生物技术公司Arrowhead发布旗下乙肝候选药物ARC-520 临床IIb期积极数据,通过与百时美施贵宝(BMS)乙肝药Baraclude (entecavir)联合,用于治疗难治性HBeAg阴性慢性乙型肝炎患者。结果显示,ARC-520+Baraclude治疗组,患者血清HBV DNA水平可显著降低99.99%,以奇效惊艳了业界。

消息发布当日,Arrowhead公司股价暴涨16.35%,最高位6.12美元,最终收盘5.94美元,当日涨幅12.93%。同时,Arrowhead公司吸引了大批医药公司跟进洽谈收购,其中以吉利德为首。

ARC-520,是一款基于RNA干扰(RNAi)技术设计的药物,通过作用于信使RNA(mRNA)靶点,干扰乙肝病毒逆转录过程,用于治疗慢性乙型肝炎。ACR-520采用了Arrowhead公司独有的Dynamic Polyconjugates输送系统,其原理是通过RNA干扰作用来封闭乙肝病毒某些蛋白的表达,导致病毒无法增殖,然后再利用人体免疫系统对剩余病毒进行清除,实现免疫清除状态(immune clearant state),特征为乙肝表面抗原(HBsAg)血清学转阴以及有或无血清学转换。

目前,全球约有4亿人口深受乙肝困扰,其中1600万患病人口分布在美国和欧洲地区。全球平均每年乙肝新发病例约达到1000-3000万人次,平均每分钟就会有1-2人死亡。乙肝病毒感染后,随着疾病进展,可逐渐发展成肝硬化和肝癌。有资料显示,80%的原发性肝癌与乙肝病毒感染有关。

众所周知,预防性乙肝疫苗自1982年起便开始投入使用,对预防乙肝传播确实功不可没。而乙肝病毒感染后,当前治疗药物仍无法达到完全根治,若ARC-520可真正实现所宣称的“功能性治愈’,那无疑有望成为乙肝领域新型重磅油炸弹,对乙肝领域的当局者——吉利德、百时美施贵宝、强生、ContraVir Pharmaceuticals而言,可谓压力山大。

对于该喜讯,Arrowhead公司CEO Anzalone先生则笑言,IIb期临床试验对ARC-520治疗乙肝的突出疗效进行确证后,我们将继续开展有关ARC-520的多剂量和多组合疗法的试验研究,评价在ARC-520的辅助下,可否实现自体免疫系统对乙肝病毒的清除和防御,从而获得乙肝的功能性根治。

有分析预测,ARC-520有望于2020年上市,预计达到45亿美元年销售总额。而这对于吉利德而言,着实造成不小挑战。目前吉利德已上市乙肝治疗药物主要包括:Hespera和Viread,另还有三款候选药物仍处在临床阶段。Viread是一款核苷酸类逆转录酶抑制剂,FDA于2008年批准其上市,这几年逐渐成为吉利德一代吸金利器。据统计,Viread 2015年度销售额突破11.1亿美元,与去年同期相比增长4.73%。分析称,2016年有望继续保持11.2亿美元销售前景。

除了面临其他医药公司推出乙肝治疗新品种的压力,吉利德自身乙肝产品线研发也陷入僵局。去年5月,吉利德与GlobeImmune合作开发的治疗性疫苗GS-4774在治疗慢性乙型肝炎病毒(HBV)感染的II期临床试验(GS-US-330- 0101)中未到达主要终点,未能有效减少乙肝表面抗原(HBsAg)的血清水平。加之这次ARC-520疗效大获肯定,对吉利德而言无疑是雪上加霜,其旗下两种乙肝药所得营收与业界对ARC-520的预期相比显得有些相形见绌了。

面对乙肝市场无新品、丙肝市场增速放缓的危机,若吉利德能抓住此契机成功收购Arrowhead以拓宽自身乙肝治疗线,借力巩固乙肝霸主之位指日可待。

新一轮收购争夺战即将拉响,最终Arrowhead会花落谁家,让我们拭目以待!(生物谷Bioon.com)

原始出处: Arrowhead Pharmaceuticals Inc Attractive for Gilead

作者: welkinchen    时间: 2016-4-18 09:55

希望成功
作者: HILARYTRUMP    时间: 2016-4-18 10:36

能降低表面抗原吗?
作者: 201105    时间: 2016-4-18 11:11

我觉得还是平常心更好。
作者: 又见UFO    时间: 2016-4-18 20:47

回复 201105 的帖子

是的,以一平常心而对惊喜!!!
作者: 恋曲HBV    时间: 2016-4-19 08:49

本帖最后由 恋曲HBV 于 2016-4-19 13:58 编辑

心在颤抖一下,在颤抖,至于你信不信、、、、,反正我信啦
作者: 恋曲HBV    时间: 2016-4-19 08:54

本帖最后由 恋曲HBV 于 2016-4-19 13:51 编辑

神药问世啦,再顶顶,神药
作者: nycmj    时间: 2016-4-19 09:19

新闻在arrowhead的公司网站上面可以看到:

http://arrowheadpharma.com/news-and-events/

Apr 13, 2016
Arrowhead Pharmaceuticals Presents Promising ARC-520 Hepatitis B Data at The
International Liver Congress™ 2016

点进去就可以看到pdf版本的新闻稿。


April 13, 2016
Arrowhead Pharmaceuticals Presents Promising ARC
-
520 Hepatitis B Data at The
International Liver Congress™ 2016
PASADENA, Calif.
--
(BUSINESS WIRE)
--
Arrowhead Pharmaceuticals, Inc.
(
NASDAQ
: ARWR) today announced that three
presentations are being made on ARC
-
520, its investigational medicine for the treatment of chronic hepatitis B infection, at
The International Liver Congress™ 2016 (ILC 2016), in
Barcelona, Spain
,
April 13
-
17, 2016
.
Collectively, these presentations demonstrate several important findings from Arrowhead's clinical and nonclinical studies of
ARC
-
520, including the following:
Š
ARC
-
520 and entecavir produced rapid HBV DNA suppression with all hepatitis B e
-
antigen (HBeAg) positive,
treatment naïve patients achieving serum HBV DNA reductions of up to 5.5 log (99.9997%), and all HBeAg negative,
treatment naïve patients achieving reductions that put them below the limit of quantitation
Š
ARC
-
520 effectively inhibited HBV cccDNA
-
derived mRNA with observed viral protein reduction in HBV patients of up
to 2.0 log (99%) after a single dose
Š
Based on HBsAg epitope profile analysis, poster authors and Arrowhead collaborators had previously identified a
predictive hepatitis B surface
-
antigen (HBsAg) Clearance Profile associated with HBsAg clearance in antiviral therapy
cohorts
Š
There was a significant association between the development of an HBsAg Clearance Profile and ARC
-
520 therapy in
HBV patients
Š
Complexed HBsAg antibodies (anti
-
HBs) were developed and detected in HBV patients treated with ARC
-
520, which
may represent a recovery of the immune system response
Š
After monthly administration of 6
-
11 doses of ARC
-
520 in chimpanzees chronically infected with HBV, the ARC
-
520
target site sequences remained virtually unchanged, indicating that no drug resistance developed during the
treatment period
Chris Anzalone
, Ph.D., president and CEO of
Arrowhead Pharmaceuticals
, said: "These are exciting results that
continue to show that ARC
-
520 can reduce the production of HBV viral proteins. We have ongoing multiple
-
dose and
combination studies designed to assess if this will allow the body's natural immune defenses to control the virus and lead to
a functional cure."
Copies of the poster presentations are currently available as ePosters to ILC 2016 attendees, and we have also made them
available on the Arrowhead website on the Events and Presentations page.
About ARC
-
520
Arrowhead's RNAi
-
based candidate ARC
-
520 is being investigated in the treatment of chronic HBV infection. The small
interfering RNAs (siRNAs) in ARC
-
520 intervene at the mRNA level, upstream of the reverse transcription process where
current standard of care nucleotide and nucleoside analogues act. Arrowhead is investigating ARC
-
520 specifically to
determine if it can be used to achieve a functional cure, which is an immune clearant state characterized by hepatitis B s
-
antigen negative serum with or without seroconversion. Approximately 350
-
400 million people worldwide are chronically
infected with the hepatitis B virus, which can lead to cirrhosis of the liver and is responsible for 80% of primary liver cancers
globally. Arrowhead is currently conducting Phase 2b multiple dose and combination studies in chronic HBV patients. In
clinical studies to date, the most common reported adverse events in all subjects completing treatment were upper
respiratory infection and headache.
About
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals
develops medicines that treat intractable diseases by silencing the genes that cause them.
Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA
interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a
mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a
specific protein. Arrowhead's RNAi
-
based therapeutics leverage this natural pathway of
gene silencing. The company's
pipeline includes ARC
-
520 and ARC
-
521 for chronic hepatitis B virus, ARC
-
AAT for liver disease associated with alpha
-
1
antitrypsin deficiency, ARC
-
F12 for hereditary angioedema and thromboembolic disorders, ARC
-
LPA for cardiovascular
disease, and ARC
-
HIF2 for renal cell carcinoma.
For more information please visit
www.arrowheadpharma.com
, or follow us on Twitter
@ArrowheadPharma
. To be added to
the Company's email list and receive news directly, please visit
http://ir.arrowheadpharma.com/alerts.cfm
.
Safe Harbor Statement under the Private Securities Litigation Reform Act:
This news release contains forward
-
looking statements within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of
the date hereof. Our actual results may differ materially and adversely from those expressed in any forward
-
looking
statements as a result of various factors and uncertainties, including our ability to finance our operations, the future success
of our scientific studies, our ability to successfully develop drug candidates, the timing for starting and completing clinical
trials, rapid technological change in our markets, and the enforcement of our intellectual property rights. Our most recent
Annual Report on Form 10
-
K and subsequent Quarterly Reports on Form 10
-
Q discuss some of the important risk factors
that may affect our business, results of operations and financial condition. We assume no obligation to update or revise
forward
-
looking statements to reflect new events or circumstances.
DYNAMIC POLYCONJUGATES
is a trademark of
Arrowhead Pharmaceuticals, Inc.
Source:
Arrowhead Pharmaceuticals, Inc.
View source version on
businesswire.com
:
http://www.businesswire.com/news/home/20160413005533/en/
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone
, 626
-
304
-
3400
CFA
[email protected]
or
Investor Relations:
The Trout Group
Chad Rubin
, 646
-
378
-
2947
[email protected]
or
Media:
Russo Partners
Matt Middleman
, 212
-
845
-
4272
M.D.
[email protected]
Source:
Arrowhead Pharmaceuticals, Inc.
News Provided by Acquire Media

作者: nana2ferrari    时间: 2016-4-23 11:54

问题是什么时候引进到中国来啊




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