s******y
发帖数: 28562 | 1 Merck公司推出的新药Boceprevir对丙型肝炎Hepatitis C病毒有很好的抑制效果。
这个药最早是由 Schering-Plough开发的，这个公司在２００９年被 Merck 买下.
Boceprevir 属于蛋白酶抑制剂，特异性的抑制hepatitis C virus 的一个蛋白酶NS3
protease ，而导致病毒蛋白不能被完全处理而无法组装和成熟.
由于丙种肝炎病毒的寄主特异性和在体内的感染过程的特殊性。该病毒目前没有有效的
体外细胞培养系统，也缺乏可以大规模筛选的动物模型，所以无法采用小分子筛选方式
。该药的开发几乎是纯粹由蛋白结构研究和binding prediction 推导开的，在对NS3
protease进行结晶之后，研究组在一些已知信息的基础上，对蛋白酶的活性基团serine 的侧链进行了抑制物设计
。在得出了最初的蛋白多肽lead 之后进行了进一步的优化，
最终得出了一个最有效的分子结构。
Federal health officials say a highly-anticipated drug to treat hepatitis C
made ... 阅读全帖 |
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h***e
发帖数: 20195 | 2 【 以下文字转载自 Biology 讨论区 】
发信人: grasshopper (大肚子哥哥 (singing crickets)), 信区: Biology
标 题: Re: Merck's Boceprevir appears effective to Hepatitis C
发信站: BBS 未名空间站 (Mon Apr 25 15:45:27 2011, 美东)
我现在就在做这个structure based druig design， 没有啥鼓舞人心的
这个跟摸彩票差不多 |
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j****x
发帖数: 1704 | 3 缺乏小动物模型直至今日也依旧如此，但是早已不缺乏体外细胞培养系统了。这个难题
在2006年左右被突破，随后几件逐步完善，目前已经广泛应用于药物筛选评价。当然，
在这个药物最开始研发的时候，该系统并未完全建立了，不过那个时候还是有基于蛋白
酶活力检测的indirect assay来评价蛋白酶抑制剂，早期HIV药物删选走过的老路。基
于这些细胞模型的方法得到几个候选也已经到了phase II了，怎么说呢，这个
Boceprevir比较鼓舞也确实是很幸运的事情。 |
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t*m
发帖数: 4414 | 4 FDA will review two NS3/4A protease inhibitors, Merck’s boceprevir on April
27 and Vertex’s telaprevir on April 28.
Vertex is a little more aggressive in the pre-market promotions because
Vertex is a company with one product and it is telaprevir. So it has got to
work for them.
by |
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t*******o
发帖数: 1464 | 5 Telaprevir is in a race with a similar drug called boceprevir being
developed by Merck & Co (MRK.N).
Data from two more Phase III trials of telaprevir, including results in
patients who failed with previous treatment, is expected in the third
quarter. The first boceprevir late-stage data will be released later this
year.
======================================
http://www.reuters.com/article/idCNN2520494620100525?rpc=44
A hepatitis C treatment being developed by Vertex Pharmaceuticals Inc (VRTX.
O... 阅读全帖 |
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y*****l
发帖数: 5997 | 6 http://www.rttnews.com/CorpInfo/FDACalendar.aspx?Node=B8
Date Company Name Ticker Drug Event Outcome Details
08/20/2011 Regeneron Pharmaceuticals REGN VEGF Trap-Eye (BLA)
FDA decision on VEGF Trap-Eye for neovascular form of age-related macular
degeneration (wet AMD).
-News
08/10/2011 Gilead Sciences Inc. GILD Truvada/TMC278 (refiled NDA)
FDA decision on Truvada/TMC278 for HIV-1 infection in adults
-Drug Status
07/28/2011 Pacira Pharmac... 阅读全帖 |
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y**s
发帖数: 563 | 7 2014年8月27日讯 /生物谷BIOON/ --丙肝治疗领域，吉利德可谓独领风骚，其明星药物
Sovaldi（sofosbuvir）在今年上半年的销售额突破58亿美元，为其带来了滚滚财源。
然而，这一格局即将打破。
近日，百时美施贵宝（BMS）丙肝新药Daklinza（daclatasvir）获欧盟批准，联合其他
药物，用于所有1、2、3、4基因型慢性丙型肝炎（HCV）成人感染者的治疗。Daklinza
是一种强效的泛基因型NS5A复制复合体抑制剂，在临床试验中，当与吉利德明星药
Sovaldi组成一种全口服、无干扰素鸡尾酒疗法（Daklinza+Sovaldi）时，取得了100%
的治愈率，包括伴有晚期肝脏疾病、基因型3 HCV及既往经蛋白酶抑制剂治疗失败的患
者群体。
目前，吉利德也在开发一种基于Sovaldi的丙肝鸡尾酒疗法ledipasvir/Sovaldi（LDV/
SOF），百时美Daklinza/Sovaldi鸡尾酒疗法的获批，对吉利德LDV/SOF鸡尾酒疗法形成
了直接威胁。
Daklinza/Sovaldi是一种每日一次、全口服、治愈率达100%的丙肝鸡尾酒疗法，为... 阅读全帖 |
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y**s
发帖数: 563 | 8 2014年8月27日讯 /生物谷BIOON/ --丙肝治疗领域，吉利德可谓独领风骚，其明星药物
Sovaldi（sofosbuvir）在今年上半年的销售额突破58亿美元，为其带来了滚滚财源。
然而，这一格局即将打破。
近日，百时美施贵宝（BMS）丙肝新药Daklinza（daclatasvir）获欧盟批准，联合其他
药物，用于所有1、2、3、4基因型慢性丙型肝炎（HCV）成人感染者的治疗。Daklinza
是一种强效的泛基因型NS5A复制复合体抑制剂，在临床试验中，当与吉利德明星药
Sovaldi组成一种全口服、无干扰素鸡尾酒疗法（Daklinza+Sovaldi）时，取得了100%
的治愈率，包括伴有晚期肝脏疾病、基因型3 HCV及既往经蛋白酶抑制剂治疗失败的患
者群体。
目前，吉利德也在开发一种基于Sovaldi的丙肝鸡尾酒疗法ledipasvir/Sovaldi（LDV/
SOF），百时美Daklinza/Sovaldi鸡尾酒疗法的获批，对吉利德LDV/SOF鸡尾酒疗法形成
了直接威胁。
Daklinza/Sovaldi是一种每日一次、全口服、治愈率达100%的丙肝鸡尾酒疗法，为... 阅读全帖 |
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y*****l
发帖数: 5997 | 9 http://www.thestreet.com/story/11016605/1/biotech-calendars-201
By Adam Feuerstein 02/22/11 - 07:36 AM ES
Stock quotes in this article:HGSI, OPTR, XNPT, SPPI, DRRX, PATH
BOSTON (TheStreet) -- I've updated the 2011 FDA drug approval calendar.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regul... 阅读全帖 |
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y*****l
发帖数: 5997 | 10 Date Company Name Ticker Drug Event Outcome Details
04/30/2011 GlaxoSmithKline PLC GSK, GSK.L Lamictal-XR (sNDA) FDA
decision on Lamictal-XR for conversion to monotherapy for treatment of
partial seizures FDA approved Lamictal XR for conversion to monotherapy
for treatment of partial seizures on Apr.25
-Drug Status
-Approved in Other Countries
04/29/2011 Spectrum Pharmaceuticals Inc SPPI Fusilev (sNDA) FDA
action on Fusilev for additional use in c... 阅读全帖 |
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v**********m
发帖数: 5516 | 11 由于这个？
Dendreon Agrees to Sell VICTRELIS(TM) (boceprevir) Royalty Interest for $125
Million
SEATTLE, Dec 06, 2011 (BUSINESS WIRE) -- Dendreon Corporation DNDN -0.11%
today announced that it has agreed to sell for $125 million in cash its
royalty interest related to intellectual property licensed to Schering-
Plough Ltd. and Schering Corporation (collectively Schering, each now a
wholly owned subsidiary of Merck & Co., Inc.) and associated with VICTRELIS(
TM) (boceprevir), a treatment for chronic... 阅读全帖 |
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g*****j
发帖数: 1211 | 14 As far as I know, the new drug boceprevir is highly effective for certain
genetype of hepatitis C. However, I think you might have difficulty finding
a specialist willing to initiate treatment, because usually a follow-up is
critical for treatment.
I think you should talk to some hepatologist directly for options of
diagnosis and treatment. I am sure pretty soon this medicine will be
available in china as well, because it is all about profit. |
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a**********2
发帖数: 3726 | 15 There is no medication approved yet for cirrhosis. Is IFN-alpha the only
medication he takes for HCV? No ribavirin? Telaprevir or boceprevir? |
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l*h
发帖数: 4124 | 16 hepatitis C is curable in high percentage.
for genotypes 2 and 3, the cure rate is over 95% with pegylated interferon-
alpha-2a/b with ribavirin for about 11 months.
genotype 1 is more difficult to treat. pegylated interferon-alpha-2a/b with
ribavirin for 11 months gives up to 50% cure rate. boceprevir or telaprevir
is recommended to be added to the regimen ( not sure about the cure rate for
this regimen).
because the treatment is long and can cause serious adverse effects, the
patients should b... 阅读全帖 |
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c******n
发帖数: 5697 | 17 现在网络这么发达了，难道中国人还都活在山洞里？
美国治乙肝的最新药物多了，不说interferon了，那些最新被FDA批准的telaprevir，
boceprevir都能大大提高治愈率了 |
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l*****g
发帖数: 2087 | 18 查一下genotype,如果不是genotype 1，用PEG-interferon加ribavirin很大部分能治愈
现在有些小分子药,比如telaprevir和boceprevir，都很有效，FDA应该会在近几年内通
过。小分子药单用抗药性是主要问题，可能需要和干扰素一起用。
，8年
有些
正常 |
|
s******y
发帖数: 28562 | 19 这个是structure-based drug design 中比较鼓舞人心的一个进步 |
|
m*******r
发帖数: 7495 | 20 赞
最早愿意当小白鼠的病人，连这种动物试验数据都没有的aggressive药也敢试。。。 |
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t*m
发帖数: 4414 | 21 这个药年初file的， FDA用的快速 review，
估计不久就要出结果了。
这个药在 EU 也 file了。
C
effect.
million |
|
t*m
发帖数: 4414 | 22 您觉的没有动物实验，FDA会同意您做 clinical trial吗？ |
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m*******r
发帖数: 7495 | 23 okay...
"该药的开发几乎是纯粹由蛋白结构研究和binding prediction 推导开的"
看到这个，错误推断了
当然，主要我本身也不懂~ |
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s******y
发帖数: 28562 | 24 虽然当时没有大规模筛选可以用的模型，但是小规模的试验animal model还是有的
只是不能上个library随机海选而已... |
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g*********r
发帖数: 9366 | 25 我现在就在做这个structure based druig design， 没有啥鼓舞人心的
这个跟摸彩票差不多 |
|
|
g****1
发帖数: 261 | 27
Vertx has similar Hep C virus drug Telaprevir to be reviewed this week by
FDA as well. |
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f******s
发帖数: 288 | 28 我过去的老板之一就做hcv inhibitor 的筛选的。的确是，工程浩大，先从enzyme
assay开始，hcv的polymerase，helicase，protease，都能当target。 HTS 几百个觉
得有可能fit 的compound，算出ki,km，左右权衡利弊，挑几个用细胞模型选。研究hcv
的好处之一是，细胞模型（hcv replicon） 发展的还算比较成熟。不过，做到这一步
，然后后来就往往没下文了。。 |
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w**r
发帖数: 134 | 29 agree, 鼓舞人心的状态老早就发生了，基本还是绝望中寻找希望 |
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h********n
发帖数: 4079 | 30 说道动物模型, 其实不少病毒的动物模型比想象的难建立, 因为你拿某个病毒去感染老
鼠, 结果老鼠没事.
当年HPV建动物模型的时候, 花了很多办法让老鼠 vaginal epithelial cell感染HPV,
就是一个例子. |
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x**********g
发帖数: 327 | 31 Yes. With better safety profile. |
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I*****M
发帖数: 622 | 32 这个药没有办法作动物试验。HCV只感染人和chimp，如果不能直接进clinical trial，
不知道谁有本事弄很多chimp来试验。 |
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t*m
发帖数: 4414 | 33 tested on non-human primates |
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h****u
发帖数: 480 | 34
April
got to
Market is already anticipate big news for Vertex, the stock is up 12%
today. It's one of the most promising biotech company. |
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s******y
发帖数: 28562 | 35 FDA says Vertex hepatitis drug is highly effective
By The Associated Press
Tuesday, April 26, 2011
Federal health officials say a highly anticipated hepatitis C drug from
Vertex Pharmaceuticals successfully treats a clear majority of patients in
less time than older medicines that have been used for 20 years.
The Food and Drug Administration posted its review of Vertex's telaprevir
ahead of a meeting Thursday where outside experts will vote on the benefits
of the drug. On Wednesday the experts w... 阅读全帖 |
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j****x
发帖数: 1704 | 36 注：
这篇帖子，大概是我去年底的时候，写给水木antiHBV版友的展望。对他们中的很多人
而言，最有意义问题的莫过于，何时能够出现彻底治愈乙肝的新药，可以从遥遥无期的
抗病毒治疗中解脱出来，进而从生理到心理上恢复为一个正常人。
版面上做肝病学相关研究的同修可能并不太多，在本版重贴旧帖，目的之一在于借HBV
受体这一新发现的讨论，引起更多不同领域研究者对这一问题的关注。或许，你手中就
掌握着解决这一医学难题的金钥匙，只是可能你还没有意识到这一点。
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
曙光渐露，充满期待的未来十年
即将过去的2011，对于从事肝脏病学临床实践与研究的人而言，无疑是激动人心的一年
。其中最重要的进展莫过于，Telaprevir和Boceprevir两种蛋白酶抑制剂用于治疗HCV慢
性丙型肝炎，临床效果非常显著，终于正式获得了FDA的新药批准。此外，目前共有约2
0种不同的anti-HCV新药候选正在进行不同阶段的临床研究。其中，病毒聚合酶抑制剂以
及其他数种病毒非结构蛋白抑制剂都显示... 阅读全帖 |
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r***o
发帖数: 162 | 37 Mind share some of your insight on boceprevir? :-) |
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s*****l
发帖数: 1844 | 38 Heard almost set for this year. Not sure about next year. Merck made a
mistake to buy SP, with several Ph3 drugs died, and the approved Boceprevir
facts a lot of competition and means nothing to Merck. However, they YY it
as a billion doller drug... |
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f*********e
发帖数: 1144 | 39 LOL for the last sentence :-)
Boceprevir
it |
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J********n
发帖数: 534 | 40 True. Exodus of SP people to other companies.
Boceprevir
it |
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J****s
发帖数: 413 | 41 看来管理层不如pfizer
Wyeth比SP好多了
Boceprevir
it |
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b******e
发帖数: 3348 | 42 Very true
Boceprevir
it |
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l******k
发帖数: 27533 | 43 Dificid™ (fidaxomicin) was finally approved for the treatment of C
difficile infection and may offer some advantage over vancomycin in
resistant infection. There are two new drugs, Victrelis™ (boceprevir)
and Incivek™ (telaprevir), for the treatment of Hepatitis C infection.
Another oral contraceptive, Orsythia™ Tablets (levonorgestrel and
ethinyl estradiol), has been approved. Edurant™ (rilpivirine) becomes
the fifth NNRTI approved for treating HIV. New generic ver... 阅读全帖 |
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X*****s
发帖数: 2767 | 44 YMYD。这里也是回答samma的问题。
DNDN的股价直接和药PROVENGE的销售额相关，所以直接去公司网站查前3个quarter的ER，
1.Net revenue for the quarter ended June 30, 2011 was $49.6 million
2.Net revenue for the quarter ended September 30, 2011 was $64.3 million
Announced approximately $66 million in gross PROVENGE sales in the third
quarter
3. Product revenue for the fourth quarter of 2011 was $77 million
Net income in the fourth quarter of 2011 was $38.1 million or $0.26 per
share, compared to a net loss of $91.8 million, or $0.64 per share, ... 阅读全帖 |
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t*******o
发帖数: 1464 | 45 Hepatitis C, or HCV, is a disease that leads to swelling of the liver. The
disease is asymptomaticand most people don't know that they have it until
severe liver damage is discovered. It's the leading cause of liver cancer,
cirrhosis, and the main reason that people in the US need a liver transplant
.
VRTX 是目前Hepatitis C领域走的最远最成功的=== Phase 3。去年Nov 1， Phase 3成
功时，股价 37-38。现在股价38。
A Phase 3 registration program for telaprevir is nearing completion, and
Vertex plans to submit a New Drug Application... 阅读全帖 |
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t*******o
发帖数: 1464 | 46 几个event要关注
1：VRTX这个trial剩下的还有两把数据要汇报
2: 竞争者默克boceprevir的试验结果，下半年。很难超过 VRTX
3：VRTX的summer FDA申请 |
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b*****h
发帖数: 783 | 47 HCV的传统治疗方法是用干扰素(INF)+Ribavirin. 属于第一代吧
目前各个公司根据HCV 病毒复制途径，开发抑制病毒第二，第三代药物。而且，这些药
物可以和第一代药浑成cocktail。增加治疗效果。
HCV 复制的靶点蛋白包括 NS3, NS4A, NS4B, NS5A 和NS5B
1) Protease inhibitors (NS3/4A protease):
VRTX的Telaprevir, MRK的 Boceprevir 以及 ACHN的ACH-1625
2) Nucleoside polymerase inhibitors (NS5B):
VRUS的 RG7128, PSI-7851 以及 PSI-938 (guanine nucleotide analog).
INHX的 INX-189(guanine nucleotide analog).
IDIX的 IDX184
3) Non-nucleoside polymerase inhibitors (NS5B):
ANDS的ANA598
IDIX的 IDX-375
从最近的收购趋势，看到大公司基本都在抢2）... 阅读全帖 |
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