Pharmasset Inc. (fka VRUS)

[Penny Roger$]

~ $VRUS ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $VRUS ~ Earnings expected on Monday *
This Week In Earnings: Earnings are coming or are already posted! This is what the charts look like! If you play the earnings these posts can be very helpful to you!
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








http://stockcharts.com/h-sc/ui?s=VRUS&p=D&b=3&g=0&id=p88783918276&a=237480049




http://stockcharts.com/h-sc/ui?s=VRUS&p=W&b=3&g=0&id=p54550695994



~ Barchart: http://barchart.com/quotes/stocks/VRUS?
~ OTC Markets: http://www.otcmarkets.com/stock/VRUS/company-info
~ Google Finance: http://www.google.com/finance?q=VRUS
~ Google Fin Options: hhttp://www.google.com/finance/option_chain?q=VRUS#
~ Yahoo! Finance ~ Stats: http://finance.yahoo.com/q/ks?s=VRUS+Key+Statistics
~ Yahoo! Finance ~ Profile: http://finance.yahoo.com/q/pr?s=VRUS
Finviz: http://finviz.com/quote.ashx?t=VRUS
~ BusyStock: http://busystock.com/i.php?s=VRUS&v=2
~ CandlestickChart: http://www.candlestickchart.com/cgi/chart.cgi?symbol=VRUS&exchange=US
~ Investorshub Trades: http://ih.advfn.com/p.php?pid=trades&symbol=VRUS
~ Investorshub Board Search: http://investorshub.advfn.com/boards/getboards.aspx?searchstr=VRUS
~ Investorshub PostStream Search: http://investorshub.advfn.com/boards/poststream.aspx?ticker=VRUS
~ Investorshub Goodies Search: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18582&srchyr=2011&SearchStr=VRUS
~ Investorshub Message Search: http://investorshub.advfn.com/boards/msgsearch.aspx?SearchStr=VRUS
~ MarketWatch: http://www.marketwatch.com/investing/stock/VRUS/profile
~ E-Zone Chart: http://www.windchart.com/ezone/signals/?symbol=VRUS
~ 5-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRUS
~ 10-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRUS&size=l&frequency=10&color=g
~ 30-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRUS&size=l&frequency=30&color=g
~ 60-Min Wind: http://www.windchart.com/stockta/analysis?symbol=VRUS&size=l&frequency=60&color=g


http://investorshub.advfn.com/boards/post_prvt.aspx?user=251916

*If the earnings date is in error please ignore error. I do my best.

[Penny Roger$]

Whoa.. -100%

[oc631]

Done deal


Congrats to all investors


http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1647455&highlight=

[surf1944]

The VRUS trade has worked for me, the general market can take a stock like this down even more in the near term. Again, this has just been a trade for me, I make many trading calls that are days/week and take profits. I don't try to over analyze a trade like this & will likely be covering this coming week.

[DewDiligence]

…many investors stated that GILD was overpaying.

Many, but not everyone. In a survey I conducted at the time of the deal announcement, 60% of the participants thought GILD overpaid: #msg-69242677. (I was one of the votes for the “about the right amount” answer.)

Today's news didn't appear help the long side.

Today’s news makes GILD somewhat less valuable, but it doesn’t make any material difference in how much VRUS is worth because GILD does not have an opt-out clause for PSI-938.

[surf1944]

Been short since the buyout offer at $133, really just staying short VRUS because I thought it was overpriced as many investors stated that GILD was overpaying. Today's news didn't appear to help the long side. I was also short INHX until this morning and if it wasn't for my INHX cover I may have covered VRUS. My shorts in biotech usually have little to do with how I believe in the pipeline of that company, it because I view the stock as overextended on the chart and an overpriced value given to them.


Why does the large arb spread (9.7% after today’s move) make you inclined to short? I would have thought it would have the opposite effect(the offer price may be revalued by the market)

[DewDiligence]

Why does the large arb spread (9.7% after today’s move) make you inclined to short? I would have thought it would have the opposite effect.

[oc631]

Great day to cover IMO.

[surf1944]

Been short since the buyout offer at $133, so hopefully the risk/reward keeps me on lite side of losses.

Started this board 4 years ago, so I do understand VRUS and made money on the long side and hope to make some on the short side. I am here to make money...

[oc631]

May be worth a short position in VRUS

At least you would know how much you stand to lose.

[surf1944]

May be worth a short position in VRUS, still too a large a gap in offer price...

[Da Ghost]

REPOST IHUB ADMINS THIS WAS NOT SPAM IT WAS A GOOD POST YOU GUYS



SPAM gimme a break RESTORE POST 165 OR TELL ME WHY IT IS SPAM




VRUS


Yeahhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh!!!!!!!!
Gilead Sciences Inc. (GILD) agreed to acquire drug developer Pharmasset Inc.
(VRUS) in a deal valued at about $10.4 billion that is expected to accelerate
the development of treatments for hepatitis C.






Congrats!!



Take


Yipeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee!

[oc631]

Pharmasset to Present at the Lazard Capital Markets Healthcare Conference




PRINCETON, N.J. , Nov. 13, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announces that management will present at the Lazard Capital Markets 8th Annual Healthcare Conference to be held November 15 to 16, 2011 at the Pierre Hotel, New York . Schaefer Price , Pharmasset's President and Chief Executive Officer, will provide an overview of the company on Tuesday, November 15 at 3:00 PM (ET) .To access a simultaneous webcast of Mr. Price's overview via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm. Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.

A replay of the webcasts will be available on Pharmasset's website for thirty days following the conference. The investor presentation will be available for download in PDF format immediately following the presentation in the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm.

[DewDiligence]

MRK confirmed a phase-2 trial of Victrelis+RG7128+peg/riba in null responders—see slide set in #msg-68854887.

[oc631]

VRTX&MRK- Reasons to give thanks to the competition


The shared goal of VRTX and MRK are to diagnose and treat as many GT1 patients as possible before the arrival of all-oral therapy. Once a GT1 patient is diagnosed that patient then has to decide whether to start interferon-based treatment or wait for the possibility of an oral.

Here's the kicker. One out of every four HCV patients in the U.S. and one out of every three patients in Europe are non-GT1 patients. While competition races to diagnose and treat GT1 patients they are filling the warehouse with patients from other genotypes which indirectly benefits Pharmasset.

[oc631]

Pharmasset to Present at Credit Suisse First Boston Healthcare Conference






PRINCETON, N.J., Nov. 8, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Credit Suisse First Boston Healthcare Conference to be held November 8 to 10, 2011 at the Biltmore Hotel, Phoenix, Arizona. Patrick Higgins, Pharmasset's Executive Vice President, will provide an overview of the company at the Credit Suisse First Boston conference on Wednesday, November 9, 2011 at 1:30 PM (CT).
To access a simultaneous webcast of Mr. Higgins's overview via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm. Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.

A replay of the webcasts will be available on Pharmasset's website for thirty days following the conference. The investor presentation will be available for download in PDF format immediately following the presentation in the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events

[DewDiligence]

It follows PFE's webcast tonight from ACR. A perfect way to spend a Sunday evening :- )

[oc631]

Pharmasset to Webcast an Investor Event from the AASLD Meeting




Pharmasset, Inc. (Nasdaq:VRUS - News) today announced that it will webcast an investor event from the American Association for the Study of Liver Diseases (AASLD) on Sunday, November 6, 2011 starting at 6:30pm PT. During this webcast, management will review Pharmasset's progress on the programs that are the subject of presentations at AASLD.

To download a slide presentation and access a simultaneous webcast of this event via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm . Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.

The following abstracts are available on the AASLD website (AASLD.org).

PSI-7977

Abstract 372

"Lack of Effect of the Nucleotide Analog Polymerase Inhibitor PSI-7977 on Methadone Pharmacokinetics and Pharmacodynamics" will be presented in a poster session on Saturday, November 5. Authors of the study are J. M. Denning et al.

Abstract 391

"PSI-7977 Has No Effect on QTcF Intervals at Therapeutic or Supratherapeutic Doses" will be presented in a poster session on Saturday, November 5. Authors of the study are M. Cornpropst et al.

Abstract 34

"Once Daily PSI-7977 plus RBV: Pegylated interferon-ALFA not required for Complete Rapid viral response in Treatment-naive Patients with HCV GT2 or GT3" will be presented in the HCV: Refining the use of Direct-Acting Antivirals session on Sunday, November 6 at 3:45pm PT. Authors of the study are E. J. Gane et al.

Abstract 225

"Once-Daily PSI-7977 Plus Peg/RBV in Treatment-naive Patients with HCV GT1: Robust End of Treatment Response Rates are Sustained Post-treatment" will be presented in the Presidential Plenary III: Viral Hepatitis session on Tuesday, November 8 at 8:30pm PT. Authors of the study are E. Lawitz et al.

[oc631]

New 12 Week, Interferon-Free Treatment Arms Added to All-Oral Combination Study of PSI-7977 and Daclatasvir (BMS-790052) for HCV Genotype 1







PRINCETON, N.J.--(BUSINESS WIRE)-- Pharmasset, Inc. (Nasdaq:VRUS - News) and Bristol-Myers Squibb Company (NYSE:BMY - News) announced today the addition of four treatment arms to the ongoing Phase IIa trial evaluating the combination of Pharmasset’s PSI-7977, a nucleotide polymerase inhibitor, and Bristol-Myers Squibb Company’s (NYSE:BMY - News) daclatasvir (BMS-790052), an investigational NS5A replication complex inhibitor, for the treatment of chronic hepatitis C (HCV). This trial is the result of a clinical collaboration agreement between Pharmasset and Bristol-Myers Squibb announced in January 2011.



“Recent data from Pharmasset’s ELECTRON trial as well as other all-oral DAA combination studies have demonstrated the potential of 12 week treatment regimens,” stated William Symonds, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "This study will evaluate whether the potent antiviral activity and high barrier to resistance, seen in Phase II studies of PSI-7977, may enable shorter treatment durations with an interferon-free regimen than the current standard of care.



“Hepatitis C is a rapidly evolving field of research. As the science evolves, we are evolving our clinical development programs to continue to drive advances in HCV research,” said Brian Daniels, senior vice president, Development, Bristol-Myers Squibb. “Shorter duration, all-oral therapy and effective treatment options for patients who have failed approved triple therapy regimens are clear unmet medical needs in HCV. With this study, we aim to understand the potential for daclatasvir to help address these needs, as part of a novel combination treatment regimen.”



About the Trial



This Phase IIa trial completed enrollment in September 2011 with approximately 84 subjects with chronic HCV genotypes 1, 2 or 3 who have not been treated previously. The primary endpoint of the trial is sustained virologic response (SVR). Subjects were randomized equally across each of the following arms:



•PSI-7977 400mg QD for 7 days, then add daclatasvir 60mg QD for a further 23 weeks in genotype 1 subjects;
•PSI-7977 400mg QD for 7 days, then add daclatasvir 60mg QD for a further 23 weeks in genotype 2 or 3 subjects;
•PSI-7977 400mg QD and daclatasvir 60mg QD for 24 weeks in genotype 1 subjects;
•PSI-7977 400mg QD and daclatasvir 60mg QD for 24 weeks in genotype 2 or 3 subjects;
•PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 24 weeks in genotype 1 subjects;
•PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 24 weeks in genotype 2 or 3 subjects.


Four new treatment arms are now being added to the study; two in genotype 1 treatment-naïve subjects and two in subjects who have failed therapy with pegylated interferon and ribavirin in combination with telaprevir or boceprevir. One hundred and twenty patients will be enrolled in the following four arms (2:2:1:1):



•PSI-7977 400mg QD and daclatasvir 60mg QD for 12 weeks in HCV genotype 1 treatment-naïve patients;
•PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 12 weeks in HCV genotype 1 treatment-naïve patients;
•PSI-7977 400mg QD and daclatasvir 60mg QD for 12 weeks in genotype 1 HCV patients who have previously failed telaprevir or boceprevir treatment;
•PSI-7977 400mg QD, daclatasvir 60mg QD and ribavirin for 12 weeks in HCV genotype 1 patients who have previously failed telaprevir or boceprevir treatment

[oc631]

Pharmasset Announces the Initiation of an Interferon-Free Phase 3 Program with PSI-7977 for HCV


- Three pivotal studies planned to evaluate PSI-7977 400 mg QD plus ribavirin for 12 weeks in patients with HCV
- Anticipated US and EU marketing submissions in second half of 2013





PRINCETON, N.J., Nov. 1, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) today announced the initiation of a Phase 3 program with the hepatitis C virus (HCV) nucleotide analog, PSI-7977. This pivotal program will evaluate a 12-week, all-oral, interferon-free regimen of PSI-7977 and ribavirin in patients with HCV, independent of viral genotype or their ability to take interferon therapy.

"After recent discussions with Health Authorities, we are excited to be initiating the first of a series of pivotal studies to explore an interferon-free regimen of PSI-7977 in broad populations of individuals with HCV," said Michael Rogers, Ph.D., Pharmasset's Chief Development Officer.

The first trial, FISSION, will enroll approximately 500 treatment-naive patients with HCV genotype 2 or 3, and will evaluate the safety and efficacy of a 12-week interferon-free regimen of PSI-7977 and ribavirin compared to 24 weeks of pegylated interferon and ribavirin. The primary endpoint of the study is sustained virologic response 12 weeks after the completion of treatment (SVR12).

Pharmasset plans to initiate a second 12-week duration, interferon-free Phase 3 trial, POSITRON, in early 2012. This trial will enroll approximately 225 patients with HCV genotype 2 or 3 who cannot take interferon.

In mid-2012, Pharmasset intends to initiate a third 12-week duration, interferon-free Phase 3 trial, NEUTRINO. This trial will enroll patients who cannot take interferon, and will include patients with HCV regardless of viral genotype, including those with HCV genotype 1. The final study design will be based on emerging data from ELECTRON and from PSI-7977 plus RBV-containing arms in the ongoing QUANTUM study.

"Based on encouraging results to date, we have selected an IFN-free regimen of PSI-7977/RBV for our registrational program," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We continue to believe that interferon remains the greatest impediment to care for a majority of the millions of individuals living with HCV. PSI-7977 has demonstrated high cure rates, without viral resistance, and across HCV genotypes; we hope to confirm these benefits in these registrational studies."

About FISSON

FISSION will be conducted at more than 100 centers in the US, Europe and other territories. The trial will enroll approximately 500 treatment-naive patients with HCV genotype 2 or 3 into one of two open-label regimens:


•PSI-7977 400 mg QD with ribavirin for 12 weeks
•the current standard-of-care for HCV GT2/3, pegylated interferon and ribavirin for 24 weeks




The study will include patients with and without cirrhosis, and will enroll a greater proportion of patients with HCV genotype 3, who are less likely to achieve an SVR with the currently available therapy, pegylated interferon and ribavirin. The primary endpoint of the trial will be SVR12. Enrollment is anticipated to begin by the end of 2011.

About POSITRON

POSITRON will be conducted at more than 100 centers in the US, Europe and other territories. The trial will enroll patients with HCV genotype 2 or 3 who cannot take interferon into one of two blinded regimens:


•PSI-7977 400 mg QD with ribavirin for 12 weeks
•placebo PSI-7977 and placebo ribavirin




POSITRON will enroll approximately 225 patients with or without cirrhosis. The primary endpoint of the trial will be SVR12. Enrollment is anticipated to begin in the first quarter of 2012.

About NEUTRINO

NEUTRINO will enroll approximately 280 patients who cannot take interferon. The study will be conducted at more than 100 centers in the US, Europe and other territories. The final design of the trial will be based on emerging data from ongoing studies, including ELECTRON and QUANTUM. We anticipate the study will enroll patients with HCV regardless of viral genotype, and including those with HCV GT1. Enrollment is anticipated to begin in mid-2012.

Pharmasset anticipates submitting data from all three phase 3 trials in the second half of 2013 to support the marketing approval of PSI-7977 in the US and European Union.

[DewDiligence]

I replied in #msg-68219579.

[oc631]

Check out the article from Adam Feuerstein. Don't forget to read the comments. Also check the YMB.

[DewDiligence]

This is the ABT info that is causing the VRUS selloff today:

#msg-68216224

[oc631]

Pharmasset Announces Further Expansion of ELECTRON Trial in Hepatitis C





**Added PSI-7977 monotherapy arm in treatment-naive patients with HCV GT1
**Added PSI-7977/RBV arm in treatment experienced patients with HCV GT2/3
**Modified previously-announced treatment regimen in HCV GT1 prior null responders to explore IFN-free regimen of PSI-7977/RBV



PRINCETON, N.J. , Oct. 10, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the addition of two treatment arms to the ELECTRON trial of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV). The rapid and consistent antiviral effects and high barrier to resistance demonstrated with PSI-7977 to date provided the rationale for additional exploratory regimens in this setting. The protocol amendment adds one arm exploring 12 weeks of PSI-7977 monotherapy in treatment naive patients with HCV genotype 1 (GT1), and one arm of PSI-7977 and ribavirin (RBV) in treatment-experienced patients with HCV genotype 2 (GT2) or genotype 3 (GT3). In addition, the previously announced arm in HCV GT1 patients with a prior "null" response to an interferon (IFN) containing regimen, which was planned to assess PSI-7977/IFN/RBV, has been modified to an IFN-free 12-week regimen of PSI-7977/RBV.
"We look forward to reporting SVR12 results from Part 1 and interim data from the PSI-7977 monotherapy arm of ELECTRON on Sunday, November 6th, 2011 at the upcoming 2011 American Association for the Study of Liver Diseases (AASLD) annual meeting. The preliminary results to be discussed at AASLD led us to expand the study to add an arm of PSI-7977 monotherapy for HCV GT1," said Michelle Berrey , MD, MPH, Pharmasset 's Chief Medical Officer. "We and others continue to explore the potential of PSI-7977 for IFN-free and monotherapy treatment regimens in a broader group of individuals living with HCV of all genotypes and regardless of their response to prior treatment."
In addition to previously announced interferon-free studies of PSI-7977 by Bristol Myers Squibb and Tibotec, The National Institute of Health (NIH) recently initiated an interferon-free 24 week study of PSI-7977 400mg QD with and without ribavirin, in 60 treatment naive patients with HCV genotype 1 (GT1) in the US.



About ELECTRON
ELECTRON is an exploratory study of PSI-7977 for the treatment of chronic HCV infection. Part 1 of the trial is evaluating 12-week regimens of interferon-free PSI-7977 400mg QD with ribavirin (RBV), and three abbreviated duration peginterferon (Peg-IFN) regimens of 4, 8, or 12 weeks in treatment-naive patients with HCV GT2 or GT3. The primary endpoint of the trial is the safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without Peg-IFN. On May 11, 2011 , Pharmasset announced the completed enrollment of Part 1 of ELECTRON:
PSI-7977 400 mg with Peg-IFN and RBV for 12 weeks (GT2/3)
PSI-7977 400 mg with RBV for 12 weeks, Peg-IFN weeks 1-8 only (GT2/3)
PSI-7977 400 mg with RBV for 12 weeks; Peg-IFN weeks 1-4 only (GT2/3)
PSI-7977 400 mg with RBV for 12 weeks (GT2/3)

In Part 2 of ELECTRON, a 5th cohort was added to explore PSI-7977 monotherapy in treatment naive patients with HCV GT2 or GT3:
PSI-7977 400 mg monotherapy for 12 weeks (n=10 GT2/3)

Following on the previously reported 100% SVR12 in treatment-naive subjects with HCV GT2/3 (PROTON), a 6th cohort was added to ELECTRON to explore an 8-week duration of PSI-7977Peg-IFN/RBV. The previously announced 7th cohort in HCV GT1 patients with a prior "null" response to Peg-IFN, has been modified to an interferon-free 12-week regimen of PSI-7977/RBV.
PSI-7977 400 mg with Peg-IFN/RBV for 8 weeks (n=10 GT2/3 treatment-naive)
PSI-7977 400 mg with RBV for 12 weeks (n=10 GT1 null)

In Part 3 of ELECTRON, two additional IFN-free regimens will be explored in treatment-naive patients with HCV GT1 and in treatment-experienced patients with HCV GT2 or GT3.
PSI-7977 400 mg monotherapy for 12 weeks (n=25 GT1 treatment-naive)
PSI-7977 400 mg with RBV for 12 weeks (n=25 GT2/3 treatment-experienced)

[$King]

2.2 MIL vol

[$King]

VRUS 82.37

[oc631]

Pharmasset to Present at Two Upcoming Conferences






Pharmasset, Inc. (Nasdaq: VRUS) announces that management will present at the UBS Global Life Sciences Conference to be held September 19 to 21, 2011 at the Grand Hyatt Hotel, New York and the JMP Securities Healthcare Conference to be held September 27 to 28, 2011 at the St. Regis, New York. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the UBS conference on Monday, September 19, 2011 at 10:30 AM (ET) and at the JMP conference on Wednesday, September 28 at 9:00 AM (ET)

[hptaxis]

I closed all positions at 1200. I am looking to get back in around 1150.

[oc631]

I guess you are out of MNTA too? That one seems quite undervalued.

[hptaxis]

I sold the position at $77.96. In fact, I sold ALL stocks once the S&P 1200 was hit! I am taking the move that there will be another move down to load back up.

[oc631]

Pharmasset Initiates QUANTUM, a Phase 2b Interferon-Free Trial of PSI-7977 and PSI-938 for All HCV Genotypes








PRINCETON, N.J. , Sept. 13, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that screening has begun in a Phase 2b, international study of PSI-7977 and PSI-938, two nucleotide analog polymerase inhibitors for the treatment of chronic hepatitis C (HCV). The QUANTUM trial will evaluate interferon-free regimens of PSI-7977 400mg QD and PSI-938 300mg QD with and without ribavirin over 12 or 24 weeks in patients with HCV who have not been treated previously. The trial will also evaluate the use of PSI-938 monotherapy.

"We are encouraged by the early efficacy and safety data being generated with our nucleotide analogs, PSI-7977 and PSI-938," stated Michelle Berrey , MD, MPH, Pharmasset 's Chief Medical Officer. "The QUANTUM trial is the first interferon-free, all-nucleotide study with an SVR endpoint. The ability to include all HCV genotypes was supported by data from the NUCLEAR study and the interferon free arms of the ELECTRON trial. Data from ELECTRON are expected later this year."

About the Phase 2b QUANTUM Trial

This study is designed to enroll approximately 450 patients with chronic HCV of all viral genotypes who have not been treated previously. The primary endpoint of the trial will be sustained virological response (SVR24). Patients will be equally randomized across the following arms:

•PSI-938 only
•PSI-938 and PSI-7977
•PSI-7977 and ribavirin
•PSI-938, PSI-7977, and ribavirin


All arms will be study for both 12 and 24 weeks with a placebo control of 24 weeks.

•Placebo for 24 weeks


HCV patients will be stratified by IL28B status and baseline HCV RNA to ensure balance across cohorts. Cirrhotic and non-cirrhotic patients will be enrolled in the study

[oc631]

Pharmasset to Present at Two Upcoming Conferences





PRINCETON, N.J., Sept. 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Robert W. Baird 2011 Healthcare Conference to be held September 7 to 8, 2011 at the New York Palace Hotel, New York and the Morgan Stanley Global Healthcare Conference to be held September 13 to 14, 2011 at the Grand Hyatt, New York. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the Baird conference on Thursday, September 8, 2011 at 9:00 AM (ET) and at the Morgan Stanley conference on Wednesday, September 14 at 9:45 AM (ET).To access a simultaneous webcast of Mr. Price's overview via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm. Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.

A replay of the webcasts will be available on Pharmasset's website for thirty days following the conference. The investor presentation will be available for download in PDF format immediately following the presentation in the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm.

[oc631]

Pharmasset Announces 91% SVR12 From the PROTON Trial in Subjects With Hepatitis C Genotype 1


-Intent to-treat SVR12 of 91% (43 of 47) following a 24-week treatment regimen incorporating 12 weeks of PSI-7977 400 mg QD






PRINCETON, N.J., Sept. 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News), announced today sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 400 mg dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 1 who have not been treated previously. 43 out of 44 (98%) evaluable subjects achieved an SVR12, defined as HCV RNA below the limit of detection (<15 IU/mL) 12 weeks after the completion of treatment. All enrolled subjects will be followed to determine SVR24, the primary efficacy endpoint of the study.

Ninety five treatment-naive patients with HCV genotype 1 were enrolled into two open-label arms of the PROTON trial, receiving either PSI-7977 200 mg QD (N=48) or 400 mg QD (N=47) for 12 weeks. Individuals in both arms received Peg-IFN/RBV for 24 weeks and were followed post-treatment to assess SVR12. Twenty-six subjects were enrolled in a placebo control arm and are receiving 48 weeks of Peg-IFN/RBV. Results from this study through the SVR12 endpoint are scheduled to be presented as part of a Presidential Plenary Session at the American Association for the Study of Liver Diseases (AASLD) meeting on Tuesday, November 8, 2011.

"I am very pleased with the results of this study which clearly demonstrate the benefit of the 400 mg dose of PSI-7977 with only 24 weeks of interferon for all subjects," stated Dr. Eric Lawitz, the study's principal investigator. "HCV therapy is becoming overly complex, and the elimination of 24 weeks of interferon and ribavirin as well as all response guided criteria for patients with HCV genotype 1 would be a welcomed simplification."

At the European Association for the Study of the Liver (EASL) in April 2011, Dr. David Nelson presented interim results from the PROTON trial showing that 43 out of 47 subjects receiving the 400 mg dose of PSI-7977 achieved an eRVR, defined as HCV RNA below the limit of detection (<15 IU/ml) at week 4 through week 12. Of those not achieving eRVR, 3 discontinued therapy early due to unrelated adverse events and 1 was lost to follow-up, as previously reported. Notably, one of these individuals went on to achieve an SVR12 in spite of the shortened course of therapy. The combination of PSI-7977, pegylated interferon and ribavirin was generally safe and well tolerated.

[oc631]

Ihub didn't account for today's split.

[WishingWell31]

did this really drop $60 and y

[oc631]

Welcome aboard.

I'm focused on the efficacy of PSI-7977/SOC in GT2/GT3 patients going into AASLD this November. The company continues to shorten the treatment duration (with one cohort down to 8 weeks) in what the CEO calls a game of limbo. At some point the drug combo will lose the 100% efficacy seen at 12 weeks but if all patients in the 8 week cohort achieve SVR's it would be unprecedented and the FDA may be willing to bring the drug to market early for the underserved GT2/GT3 market. There seems to be no safety or tolerability issues with this drug.

If this occurs even the most bullish analyst estimates may fall short next year.

[hptaxis]

I bought in at three times during August. Each under $115. This is a crazy ride. I wonder if thee will be a run up to $100 now. IIRC, one analyst had a PT >$200 ptr split. IF the drugs work out, this is reasonable. But, that is a ways off.

[oc631]

When is the the stock split recognized in the market?

Tomorrow. I guess this means you are long?

[hptaxis]

When is the the stock split recognized in the market?

[surf1944]

6:46AM Pharmasset receives fast track designation from the FDA for the treatment of chronic hepatitis C infection (VRUS) 125.21 : Pharmasset plans to initiate QUANTUM, an interferon-free combination trial with PSI-938 and PSI-7977 in the third quarter of 2011.

[oc631]

What are your thoughts on the following?

VRUS wouldn't be splitting their stock if they thought bad news was pending IMO. Other than that there is much more to get excited about than this split.

[PennyOT]

What are your thoughts on the following?


August 9, 2011 6:46 AM EDT
Pharmasset, Inc. (Nasdaq: VRUS) announces that its Board of Directorsdeclared a two-for-one split of Pharmasset's common stock, par value $0.001 per share, in the form of a 100% common stock dividend.

Stockholders of record as of the close of business on August 22, 2011 will receive one additional share of common stock for each share then owned. The distribution date for the new shares will be August 31, 2011.

[oc631]

Pharmasset to Present at Canaccord Genuity Growth Conference





PRINCETON, N.J., Aug. 7, 2011 /PRNewswire/ --- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Canaccord Genuity Growth Conference to be held August 10 to 11, 2011 at the Intercontinental Hotel, Boston, Massachusetts. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the Canaccord Genuity conference on Thursday, August 11, 2011 at 9:30 AM (ET).

[oc631]

Pharmasset Announces Final SVR Data from PROTON trial with PSI-7977 in Subjects Infected with Hepatitis C Infection Genotype 2 or 3







PRINCETON, N.J. , July 20, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the final sustained virologic response (SVR) results from its phase 2b PROTON study with PSI-7977 dosed once daily in combination with peginterferon alfa 2a and ribavirin (Peg-IFN/RBV) in subjects with hepatitis C virus (HCV) genotype 2 or 3 who have not been treated previously. Twenty four out of twenty four subjects (100%) who completed treatment achieved an SVR, defined as HCV RNA below the limit of detection (<15 IU/ml) 24 weeks after the completion of treatment. No subject exhibited breakthrough on treatment or relapse after treatment.
Twenty five treatment-naive subjects with HCV genotype 2 or 3 were enrolled in an open label arm of the PROTON trial, receiving PSI-7977 400mg QD with Peg-IFN/RBV for 12 weeks, with no Peg-IFN/RBV follow-up. At the European Association for the Study of the Liver (EASL) in April 2011 , Dr J. Lalezari presented interim results from this arm showing that 24 out of 24 subjects achieved an SVR12, defined as HCV RNA below the limit of detection (<15 IU/ml) 12 weeks after the completion of treatment. The combination was generally safe and well tolerated with one subject discontinuing treatment after day 1 and was lost to follow up. Overall PSI-7977 with Peg-IFN/RBV demonstrated potent viral suppression in subjects with HCV genotype 2 or 3 over 12 weeks of treatment.

Pharmasset anticipates reporting the SVR12 results from the PROTON trial in genotype 1 HCV subjects in the second half of 2011.

About the PROTON Trial

The Phase 2b PROTON trial enrolled 121 subjects infected with HCV genotype 1 who have not been treated previously. The primary endpoint of the trial will be the assessment of safety and tolerability of PSI-7977 in combination with Peg-IFN/RBV over 12 weeks with response-guided therapy allowing discontinuation of Peg-IFN/RBV at week 24. The trial was conducted in the U.S. Subjects were randomized (2:2:1) into one of 3 arms:

•PSI-7977 200mg QD in combination with Peg-IFN/RBV for 12 weeks, followed by 12 or 36 weeks of Peg-IFN/RBV;
•PSI-7977 400mg QD in combination with Peg-IFN/RBV for 12 weeks, followed by 12 or 36 weeks of Peg-IFN/RBV;
•A control arm of matching placebo with Peg-IFN/RBV for 48 weeks.


In addition, 25 treatment-naive subjects with HCV genotype 2 or 3 were enrolled in a fourth, open label arm, receiving PSI-7977 400mg QD with Peg-IFN/RBV for 12 weeks, with no Peg-IFN/RBV follow-up. Subjects were followed for an additional 24 weeks after discontinuation of all therapy to assess SVR.

[oc631]

Pharmasset Enters into a Clinical Collaboration Agreement with Tibotec Pharmaceuticals for a Combination Study in Patients Chronically Infected with Hepatitis C

- Study to evaluate the combination of PSI-7977 and TMC435 with and without ribavirin in prior null responder, genotype 1 HCV patients


PRINCETON, N.J., July 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (NASDAQ: VRUS), announced today that it has entered into a clinical collaboration agreement with Tibotec Pharmaceuticals to evaluate in a Phase 2 study the safety and efficacy of PSI-7977, Pharmasset's investigational nucleotide polymerase inhibitor, in combination with TMC435, Tibotec Pharmaceuticals' investigational protease inhibitor, for the treatment of chronic hepatitis C virus (HCV).

This phase 2 proof of concept study will evaluate the potential to achieve sustained virologic response 12 weeks post treatment with an all oral, once-daily, interferon-free treatment regimen in patients infected with genotype 1 HCV. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of 12 and 24 weeks of PSI-7977 in combination with TMC435, with and without ribavirin, in patients chronically infected with HCV genotype 1 who had a prior null response to peginterferon alfa and ribavirin treatment. The study is planned to start in the second half of 2011.

"We are excited to be working with Tibotec to simplify and improve HCV treatment," stated Bill Symonds, PharmD, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "PSI-7977 is now being studied in interferon-free combinations with each of the three leading classes of direct-acting antivirals: Tibotec's protease inhibitor, Bristol-Myers Squibb's NS5a inhibitor, and our own nucleotide, PSI-938. This advances one of our key goals at Pharmasset: to develop our nucleotide analogs as the backbone of interferon-free HCV therapy."

[oc631]

Would Pharmasset consider signing a GT2/GT3 agreement for PSI-7977/SOC (exclusive of other genotypes) if early approval is in fact attainable?

I doubt it considering they want an experienced/well funded partner moving 7977/SOC into Phase 3 with the other genotypes. The possibility of an early filing increases the value of their asset substantially along with their leverage in doing a deal.

The situation with VRUS has changed since I started this thread and with it some ideas I have about how they will move forward. The big news from VRUS is them adding a PSI-7977 monotherapy arm in their phase 2b study. PSI-7977 monotherapy would move much more quickly through late stage testing than the dual nuke combination. PSI-938 hasn't had the chance to prove itself in phase 2 the way 7977 has so more extensive late stage testing can be expected with this combo.

So how else has the story changed?

My idea that VRUS wouldn't seek a partner exclusively for the rollout of PSI-7977/SOC* in GT2/GT3 patients no longer holds water for the simple fact that we may never see PSI-7977/SOC late stage testing in all genotypes. Late stage testing of PSI-7977 very well may be all oral consisting of PSI-7977 monotherapy and the PSI-7977/938 combo. PSI-7977 testing in combination with SOC in GT2/GT3 could also end at phase 2 if the FDA is open minded and allows an early NDA filing.


*It should be noted that the standard of care (SOC) which I refer to here is Pegylated interferon/Ribavirin when if fact the current SOC in HCV treatment is Peg/Riba in combination with a protease inhibitor.

[oc631]

Counter point- Talking to myself again




If the strategy is to bring PSI-7977 monotherapy to market as a first generation oral compound there are clearly advantages to this line of thinking. By November PSI-7977 will have been through extensive phase 2 testing and it and will move much quicker through late stage testing than the dual nuke combination. That is if monotherapy is a viable option. The lack of interferon should also help expedite the process.

[oc631]

Random thoughts on trial expansion




Testing PSI-7977 as a monotherapy is a bold statement yet I wouldn't expect this to be thought of as a future treatment option. It's more of a in-house default option in case there were safety issues with 7977 in combination with PSI-938. If 7977/938 proves safe the stronger resistance profile would make this combo the obvious choice.


The 8 week GT2/GT3 study with SOC shouldn't come as a surprise to most considering the incredible, previously reported results.


I'm happy to see them beginning to test GT1 nulls and I look forward to seeing those results.

[oc631]

Not too long ago the naysayers said two DAA's would never work without SOC. They claimed three or four drugs would be necessary to achieve a SVR. Now VRUS is testing PSI-7977 as a monotherapy.



Pharmasset Announces the Expansion of the ELECTRON Trial in Chronic Hepatitis C






PRINCETON, N.J. , June 8, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the addition of three treatment cohorts to the ELECTRON trial of PSI-7977, a nucleotide analog polymerase inhibitor, for the treatment of chronic hepatitis C (HCV). The rapid and consistent antiviral effects and high barrier to resistance demonstrated with PSI-7977 to date provide the rationale for additional exploratory regimens in this setting. This amendment will add one arm exploring 12 weeks of PSI-7977 monotherapy (without peginterferon and ribavirin) and two arms of interferon-sparing therapy: one for 8 weeks of PSI-7977 plus peginterferon and ribavirin (Peg-IFN/RBV) in patients with HCV genotype 2 (GT2) or 3 (GT3) and one for 12 weeks of PSI-7977 plus Peg-IFN/RBV in patients with HCV genotype 1 (GT1) prior null responses.

"The combination data reported at EASL demonstrated that SVRs were achievable with two oral DAAs in the absence of peginterferon and ribavirin," stated Bill Symonds , PharmD, Pharmasset 's Senior Vice President of Clinical Pharmacology and Translational Medicine, "We continue to explore the potential for removing peginterferon and ribavirin from the HCV treatment regimen. Given the encouraging data we are seeing in ELECTRON, we have decided to expand the study to investigate PSI-7977 monotherapy, as well as shorter treatment regimens based on the promising data we reported at EASL from PROTON."

Pharmasset anticipates reporting results from the first four arms of the trial (n=40) during the second half of 2011. We have submitted a number of abstracts to the 2011 American Association for the Study of Liver Diseases (AASLD) meeting, including data from the ELECTRON and PROTON trials.

About the Trial

The ELECTRON trial is an exploratory study of PSI-7977 for the treatment of chronic HCV infection. Part 1 of the trial is evaluating 12-week regimens of PSI-7977 400mg QD in combination with ribavirin (RBV) only, and in separate arms with abbreviated durations of Peg-IFN for 4, 8, or 12 weeks in treatment-naive patients with HCV GT2 or GT3. The primary endpoint of the trial is the safety and tolerability of PSI-7977 400mg QD and RBV for 12 weeks, administered with or without Peg-IFN. On May 11, 2011 , Pharmasset announced the completed enrollment of Part 1 of ELECTRON in patients with HCV GT 2 or GT 3:

* PSI-7977 400mg with RBV for 12 weeks (no peginterferon);
* PSI-7977 400mg with RBV for 12 weeks; Peg-IFN weeks 1-4 only;
* PSI-7977 400mg with RBV for 12 weeks, Peg-IFN weeks 1-8 only;
* PSI-7977 400mg with Peg-IFN and RBV for 12 weeks.


In Part 2 of ELECTRON, Pharmasset will enroll an additional 30 patients into exploratory regimens of monotherapy and abbreviated durations of total therapy. Following on the first four Cohorts of ELECTRON a 5th cohort will be added to explore 7977 400mg monotherapy in treatment-naive patients with HCV GT2 or GT3:

* PSI-7977 400mg monotherapy for 12 weeks.


With the previously reported 100% SVR12 in naive GT2/3 subjects in PROTON, a 6th and 7th cohort will be added to ELECTRON to explore shorter treatment durations in both GT2/3 naive subjects and HCV GT1 subjects who have documented null responses (less than 2 log(10) IU/mL reduction in HCV RNA after 12 weeks of Peg-IFN/RBV):

* PSI-7977 400mg with Peg-IFN/RBV for 8 weeks
* PSI-7977 400mg QD with Peg-IFN/RBV for 12 weeks.

[oc631]

Citi's analyst raised his 52-week price target from $70 to $200 and said he expects early approval of PSI-7977 in GT2/GT3 in 2014. He originally was calling for approval in 2015???




http://finance.yahoo.com/news/Ahead-of-the-Bell-Pharmasset-apf-1319724263.html?x=0&.v=1