t*******o
发帖数: 1464 | 1 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 to the U.S. Food and Drug
Administration (FDA) for telaprevir in the second half of 2010 for both
treatment-naïve and treatment-failure patients.
2010 summer 提交FDA， 2011 FDA出结果
trial 3结果 New England Journal of Medicine
http://finance.yahoo.com/news/New-England-Journal-of-bw-299329553.html?x=0&.v=1
http://www.reuters.com/article/idCNN2110591320100421?rpc=44
http://www.minyanville.com/businessmarkets/articles/hepatitis-treatments-merck-pegintron-rebetol-boceprevir/4/15/2010/id/27805?camp=syndication&medium=portals&from=yahoo
http://finance.yahoo.com/news/Our-Top-Biotech-Takeout-Picks-ms-4183040978.html?x=0&.v=1 | h*****8
发帖数: 4754 | 2 谢谢猫猫SHARE。
transplant
【在 t*******o 的大作中提到】
: 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 to the U.S. Food and Drug
: Administration (FDA) for telaprevir in the second half of 2010 for both
| t*******o
发帖数: 1464 | 3 要增发了
Vertex re-ups directors, plans stock offering
http://www.masshightech.com/stories/2010/05/10/daily41-Vertex-re-ups-directors-plans-stock-offering.html
transplant
【在 t*******o 的大作中提到】
: 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 to the U.S. Food and Drug
: Administration (FDA) for telaprevir in the second half of 2010 for both
| g**********1
发帖数: 399 | 4 when to buy?
last year there was rumor that novartis was a potential buyer, then no news
【在 t*******o 的大作中提到】
: 要增发了
: Vertex re-ups directors, plans stock offering
: http://www.masshightech.com/stories/2010/05/10/daily41-Vertex-re-ups-directors-plans-stock-offering.html
:
: transplant
| t*******o
发帖数: 1464 | 5 昨天我已经买了，38不到的价格。今天股东大会出了消息要增发12m股普通股，这个股
现在200m股普通股。股数多了6%，不算大的稀释。
看看这个，今天的WSJ。
http://online.wsj.com/article/BT-CO-20100513-714393.html?mod=WSJ_latestheadlines
(VRTX) will report late-stage data on its hepatitis C treatment in coming weeks from the first of three key studies, and Wall Street will be watching the numbers to gauge how telaprevir will fare in a competitive market.
Many expect the study to be positive, based on extensive prior clinical data on the drug, and the stock is pricing in a lot of success for telaprevir. But the data from the so-called Advance trial, due by the end of June, could provide further gains as confidence grows in the drug's role in the lucrative but increasingly competitive hepatitis C market.
"Expectations are relatively high, but I think there is a reasonable amount of money on the sidelines," said analyst Brian Abrahams of Oppenheimer & Co., projecting telaprevir sales of $1.47 billion by 2013. Abrahams said the study will reduce the perceived risk in developing telaprevir and help investors feel more comfortable in investing in the company.
Vertex plans to market the drug itself in North America. Johnson & Johnson (JNJ) will help sell telaprevir overseas, with Mitsubishi Tanabe Pharma Corp. (4508.TO) holding rights in Japan and some Asian countries.
Although it has several promising pipeline products, Vertex's $7.7 billion market valuation is primarily tied to the success of telaprevir.
The stock, recently trading at $38.64, has largely traded between $38 and $44 since early November when an earlier trial of the drug showed positive results. Analysts project the stock moving into the mid-$40s on positive data, but that reaction will depend on the nuances of the data.
Unlike many clinical trials, the issue with the Advance study--along with the other two trials coming later this year--is not whether it succeeds, but the level of the success. Failure is seen as highly unlikely because of the success of multiple earlier studies, but such a development would be a major setback.
Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure.
There is no cure for the disease, but sustained virologic response, or SVR--when the virus isn't detected in the blood for six months after treatment--is pretty close and relapse is rare.
Last year, Johnson & Johnson projected the hepatitis C market would grow from $3.3 billion in 2008 to $7 billion in 2013, driven by sales of drugs like telaprevir.
The standard therapy, a combination of interferon injections and ribavirin pills over 48 weeks, achieves an SVR in up to about 50% of patients, according to the Centers for Disease Control. When telaprevir is used with those drugs, which can have severe side effects, it can cut the length of therapy to 24 weeks in most patients.
In mid-stage clinical trials that use a similar treatment regimen to the coming data, telaprevir showed an SVR rate of 61% to 69%, compared to 41% to 46% among patients taking a placebo, said Vertex Chief Medical Officer Robert Kauffman.
Another midstage study had more than 80% of patients achieving an SVR. That study, dubbed C-208, included more measures to manage a rash that can occur in some patients and used "response-guided therapy" that assesses whether patients should use the drug for a longer duration based on their initial response.
The results may have also been boosted because that study occurred in Europe, where patients SVRs are higher for unknown reasons, Dr. Kauffman said.
The Phase III program includes response-guided therapy and rash-related changes, but are being conducted in both the U.S. and Europe. Those factors have analysts generally expecting the SVR rate in the Advance trial to exceed 70%.
"Above 75%, things start to get interesting," RBC Capital Markets analyst Jason Kantor said, noting that such a high level would give "the bears very little to talk about."
But if the rate comes in below 70% it could prove to be disappointing to investors, even though the approval process for the drug will be still be able to move forward. The company expects to file for approval by the end of the year, Dr. Kauffman said, and hopes to get a six-month review from the Food and Drug Adminstration.
"From a regulatory perspective and changing clinical practice...a 68% SVR rate would be a slam dunk; however, one of the issues with Vertex is future competition," Kantor said.
Telaprevir is likely to face competition from Merck & Co.'s (MRK) boceprivir, which is on a similar development time line, and many companies are developing hepatitis C treatments, including Bristol-Myers Squibb Co. (BMY), Gilead Sciences Inc. (GILD) and Roche Holding AG (RHHBY, ROG.VX). | g**********1
发帖数: 399 | 6 六月份出结果，还要大于70%，WSJ要求有点高，我再等等，data现在恐怕还没全呢 | t*******o
发帖数: 1464 | | t*******o
发帖数: 1464 | | t*******o
发帖数: 1464 | | t*******o
发帖数: 1464 | 10 given这个trial，现在38一点都不贵，去年前期trial成功后已经有38了，那时评级价
格都在45-48一线。这可是blockbuster药啊，这个夏天提交FDA。
【在 t*******o 的大作中提到】
: 盘后 +12.67%
: http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20100525007084&newsLang=en
: 75%， beat！
: 赫赫，我出水了。
| | | t*******o
发帖数: 1464 | 11 这个股绝对值得关注，trial 3 so far不错。
目前这个领域的旗舰在研药， market potential巨大，而且下半年又有FDA event。
如果下半年FDA气氛好，肝病sector 的小bio也都有联动空间
hepatitis C drug research InterMune(ITMN Quote), Pharmasset(VRUS Quote),
Idenix，Pharmaceuticals(IDIX Quote) and Anadys Pharmaceuticals(ANDS Quote). | j*****7
发帖数: 4348 | | L********3
发帖数: 2272 | 13 现在都38.31，厉害
【在 j*****7 的大作中提到】
: 我买了, 可惜买贵了, 买在了37.
| t*******o
发帖数: 1464 | 14 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) led to a 75 percent cure rate in a pivotal trial of previously untreated
patients, the company said on Tuesday.
The results from the first late-stage Phase III study of telaprevir came in
at the high end of expectations for a cure rate of 70 to 75 percent, with
slightly lower discontinuation rates due to side effects than previously
seen.
Vertex shares, which have slumped recently, were up 12 percent in after-
hours trading.
Telaprevir is expected to become a multibillion-dollar drug for Vertex if
approved by the U.S. Food and Drug Administration.
Seventy-five percent of patients who received 12 weeks of telaprevir in
combination with current standard treatment of pegylated interferon and
ribavirin, followed by either 12 or 36 weeks of standard treatment achieved
a sustained virologic response, or SVR, which is tantamount to a cure.
That compared with a 44 percent SVR rate for patients who received the usual
48-week regimen of the standard drugs.
"I think it is a bellwether day for hepatitis C drug development. It's
really impressive to see a 75 percent SVR rate in a Phase 3 pivotal trial,"
said Sanford Bernstein analyst Geoffrey Porges.
He said the result "sets a very high hurdle for competitors."
Porges previously had said a telaprevir SVR rate below 65 percent would be a
disappointment and anything north of 80 percent would send the stock
skyrocketing.
A member of Porges' household maintains a long position in Vertex, according
to the BernsteinResearch website.
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.
Through mid-stage studies, most analysts have said the Vertex drug as
superior.
In a third arm of the Phase III study, 69 percent of patients who received
the telaprevir combination for just eight weeks followed by either 16 or 40
weeks of the standard drugs achieved SVR, Vertex said.
The results were "in line with what the Street was looking for, but
certainly not above expectations, or below them for that matter," said Brian
Skorney, an analyst for Thinkequity.
There has been great hope for this new class of antiviral drugs for the
serious liver disease because of the potential for significantly higher cure
rates and the possibility of cutting the duration that the standard drugs
must be taken.
The tough to tolerate interferon and ribavirin offer cure rates in the 40
percent to 50 percent range, must be taken for 48 weeks, and often cause
debilitating flu-like symptoms, leading many patients to discontinue their
use.
"These results show that 75 percent of patients in the 12-week telaprevir
arm achieved a viral cure, with the majority receiving only 24 weeks of
therapy, marking what we believe may be a potentially dramatic improvement
in the future treatment of hepatitis C," Vertex Chief Medical Officer Robert
Kauffman said in a statement.
Several drugmakers, including Vertex, are working on next generation drugs
with the hope they could be combined with treatments like telaprevir and
eliminate the need for interferon altogether.
Telaprevir discontinuation rates due to adverse events were a bit lower than
those seen in Phase II studies.
"Discontinuations due to rash were lower," Skorney said.
The discontinuation rate was 6.9 percent in the 12-week telaprevir arm, 7.7
percent in the 8-week arm and 3.6 percent with the standard drugs alone.
Viral relapse rates -- patients who had achieved undetectable levels of the
virus in the blood only to relapse after completing treatment -- were much
lower in the telaprevir arms of the study.
The relapse rate was 8.6 percent among patients who received 12 weeks of
telaprevir and 9.5 percent for those who got the Vertex drug for 8 weeks.
That compared with a 28 percent viral relapse rate on the standard drugs.
"The results highlight that telaprevir-based combination regimens may
increase viral eradication rates and shorten treatment time for many
patients," Dr Ira Jacobson from Weill Cornell Medical College and a
researcher for the study, said in a statement. | t*******o
发帖数: 1464 | | w*******r
发帖数: 118 | | t*******o
发帖数: 1464 | 17 Adam在bash 前天的结果。
70% of the 75% of viral cures were in patients treated for 24 weeks.
...translates in 55% of telaprevir patients overall achieving viral cure
with a 24-week treatment regimen.
http://www.thestreet.com/_yahoo/story/10767632/1/vertex-pharma-five-reasons-to-worry-about-telaprevir.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
【在 w*******r 的大作中提到】
: VRTX 怎么了？ 狂泻。
| t*******o
发帖数: 1464 | 18 我是不割肉，hold till the summer for the pre run。
【在 t*******o 的大作中提到】
: Adam在bash 前天的结果。
: 70% of the 75% of viral cures were in patients treated for 24 weeks.
: ...translates in 55% of telaprevir patients overall achieving viral cure
: with a 24-week treatment regimen.
: http://www.thestreet.com/_yahoo/story/10767632/1/vertex-pharma-five-reasons-to-worry-about-telaprevir.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
| b******g
发帖数: 491 | 19 in for some yesterday
Thanks for the information.
【在 t*******o 的大作中提到】
: 我是不割肉，hold till the summer for the pre run。
| t*******o
发帖数: 1464 | 20 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 | | | y******z
发帖数: 491 | 21 日，今天成交了5000个Oct $50 calls, 5000 Oct $30 puts！我先拿一手放着，虽然感
觉还有点下跌空间。。。
【在 t*******o 的大作中提到】
: 我是不割肉，hold till the summer for the pre run。
| t*******o
发帖数: 1464 | 22 哪里看来得？我的broker里面没有那么多成交量啊。
这两天夏季的call 和 put应该要一起跌才对，因为前天的trial没有意外，Volatility
大降，买option的人哭，卖option的人笑。
【在 y******z 的大作中提到】
: 日，今天成交了5000个Oct $50 calls, 5000 Oct $30 puts！我先拿一手放着，虽然感
: 觉还有点下跌空间。。。
| y******z
发帖数: 491 | 23 ft, Yahoo上看的，果然不准。我自己broker和msn money的就一致了，不好意思～
Volatility
【在 t*******o 的大作中提到】
: 哪里看来得？我的broker里面没有那么多成交量啊。
: 这两天夏季的call 和 put应该要一起跌才对，因为前天的trial没有意外，Volatility
: 大降，买option的人哭，卖option的人笑。
|
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