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Analyst Upgrade- PSI-7977
Considering that Citi's analyst tripled his price target I suspect he overlooked the angle on the GT2/GT3 population. A launch date of 2014 in this subgroup is more realistic (note safer) than the date I proposed. The Phase 2b data in the Fall along with a licensing/partnership agreement with a company large enough to handle the U.S. roll-out will determine whether the FDA accepts such an early NDA filing.
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.
VRUS/BMY Start All-Oral Phase-2a Trial of PSI-7977 + BMS-790052:
#msg-63589775
$$$ cha-ching $$$
PSI-7977 on the market by 2012?
Since I wasn't cut to threads with this overly ambitious post on the Biotech Values MB I thought I would add it here.
I feel there's a strong case for an early NDA filing and priority review of PSI-7977 plus SOC in GT2/GT3 patients at the beginning of 2012 for the following reasons.
1- Data on 450 patients treated with PSI-7977/SOC (genotypes 1-6) will be released this Fall. Exceptional efficacy and safety in all groups so far.
2- Near 100% efficacy in the GT2/GT3 cohort. 24 of 25 reaching SVR12 with one drop out, after taking one pill, at the beginning of the study.
3- Over 700,000 patients in the U.S. with GT2/GT3. Latest approvals will bring increased attention by the public and the FDA to those in need of better treatment.
There are two other drugs in phase 2 GT2/GT3 testing worth mentioning. RG7128/SOC can't match PSI-7977 on any metric though it has a slight lead in development. It's not clear how BMS-790052/SOC will read out in GT2/GT3. There are unanswered questions on resistance to viral breakthrough in BMS' DAA study using 790052 which hasn't been seen so far in VRUS' two drug nuke/nuke study sans SOC.
If PSI-7977/SOC in GT2/GT3 reaches SVR24 without any safety issues it could be on the market by this time next year.
Pharmasset to Present at Two Upcoming Investor Conferences
PRINCETON, N.J., April 28, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Deutsche Bank Healthcare Conference being held May 2 to 4, 2011 at the InterContinental Hotel, Boston, MA, and at the Bank of America Merrill Lynch Healthcare Conference being held May 10 to 12, 2011, at the Encore at Wynn, Las Vegas, NV. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the Deutsche Bank conference on Monday, May 2, 2011 at 8:40 AM (ET) and at the Bank of America Merrill Lynch conference on Wednesday, May 11, 2011 at 8:00 AM (PDT).
To access simultaneous webcasts of Mr. Price's overviews 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 for 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 conferences. The investor presentations will be available for download in PDF format immediately following the presentations in the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm.
Pharmasset to Webcast an Investor Event From the EASL Meeting
PRINCETON, N.J. , March 28, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) today announced that it will webcast an investor event from the European Association for the Study of the Liver (EASL) on Saturday, April 2, 2011 starting at 8:00pm CET . During this webcast, management will review Pharmasset 's progress on the programs that are the subject of presentations at EASL.
To 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.
PSI-7977
Abstract (oral)
"Once Daily PSI-7977 plus PegIFN/RBV: Rapid Virologic Suppression in Treatment Naive Patients with HCV GT2/GT3 in a Phase 2b Trial" will be presented in the HCV Drug Development session on Friday, April 1 at 4:15pm CET . Authors of the study are Lalezari, J. et al.
Abstract 1372
"Once Daily PSI-7977 Plus Peg-IFN/RBV in HCV GT1: 98% Rapid Virologic Response, Complete Early Virologic Response: The PROTON Study" will be presented in a late breaker poster session on Thursday, March 31 . Authors of the study are Nelson, DR. et al.
PSI-938
Abstract 1235
"PSI-352938, A Novel Purine Nucleotide Analog, Exhibits Potent Antiviral Activity and No Evidence of Resistance in Patients With HCV Genotype 1 Over 7 Days" will be presented in a poster session on Saturday, April 2 . Authors of the study are Rodriguez-Torres M. et al.
Abstract 1217
"Mechanism of HCV Replicon Resistance to PSI-352938, a Cyclic Monophosphate Prodrug of 2'-alpha-F-2'-beta-C-Methylguanosine" will be presented in a poster session on Saturday, April 2 . Authors of the study are Lam A. et al.
Abstract 1370
"Once Daily Dual-Nucleotide Combination of PSI-938 and PSI-7977 Provides 94% HCV RNA Thursday, March 31 . Authors of the study are Lawitz E. et al.
finally rolling over. eom
where is the discussion for this spectacular short squeeze ? eom
Dew D, looking for your input here .
Thnx
Pharmasset to Present at Three Upcoming Investor Conferences
prnewswire
this move can't be from conference news
Press Release Source: Pharmasset, Inc. On Friday February 25, 2011, 4:20 pm EST
PRINCETON, N.J., Feb. 25, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Citi Healthcare Conference to be held March 1 - 3, 2011 at the Hilton New York Hotel, New York, NY, at the RBC Healthcare Conference to be held March 2 - 3, 2011 at the New York Palace Hotel, New York, NY and at the Cowen and Co. 31st Annual Healthcare Conference to be held March 7 - 9, 2011. Schaefer Price, President and Chief Executive Officer, will provide an overview of the company at the Citi conference on Tuesday, March 1, 2011 at 8:30 AM (ET), at the RBC conference on Wednesday, March 2, 2011 at 3:05 PM (ET) and at the Cowen and Co. conference on Tuesday, March 8, 2011 at 8:45 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.
Pharmasset to Present at Three Upcoming Investor Conferences
PRINCETON, N.J., Feb. 25, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Citi Healthcare Conference to be held March 1 - 3, 2011 at the Hilton New York Hotel, New York, NY, at the RBC Healthcare Conference to be held March 2 - 3, 2011 at the New York Palace Hotel, New York, NY and at the Cowen and Co. 31st Annual Healthcare Conference to be held March 7 - 9, 2011. Schaefer Price, President and Chief Executive Officer, will provide an overview of the company at the Citi conference on Tuesday, March 1, 2011 at 8:30 AM (ET), at the RBC conference on Wednesday, March 2, 2011 at 3:05 PM (ET) and at the Cowen and Co. conference on Tuesday, March 8, 2011 at 8:45 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.
Pharmasset Prices Public Offering of Common Stock
PRINCETON, N.J. , Jan. 21, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the pricing of an underwritten public offering of 3,300,000 shares of its common stock at an offering price of $46.33 per share. Of the shares being sold, Pharmasset is selling 2,300,000 shares and the selling stockholders are selling 1,000,000 shares. Pharmasset expects to receive net proceeds, after deducting the underwriting discount and estimated offering expenses, of approximately $101.5 million . Pharmasset will not receive any proceeds from the sale of shares by the selling stockholders. In addition, Pharmasset has granted the underwriters a 30-day option to purchase up to an additional 495,000 shares of common stock. The offering is expected to close on January 26, 2011 , subject to customary closing conditions. Citi is serving as sole book-running manager for the offering. Morgan Stanley & Co. Incorporated is serving as the co-lead manager, and BofA Merrill Lynch, Leerink Swann LLC and Wedbush PacGrow Life Sciences are serving as co-managers.
The shares described above are being offered pursuant to an automatic shelf registration statement filed by Pharmasset with the Securities and Exchange Commission on January 18, 2011 , which became effective upon filing.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus supplement and accompanying base prospectus relating to this offering may be obtained from Citi at Brooklyn Army Terminal , 140 58th Street , 8th Floor, Brooklyn, NY 11220, Attention: Prospectus Department, 800-831-9146.
Pharmasset offering up to 2,450,000 shares
PRINCETON, N.J., Jan. 18, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that it has commenced an underwritten public offering, subject to market and other conditions, of 3,000,000 shares of its common stock pursuant to an effective shelf registration statement. Of the shares being sold, Pharmasset is selling 2,000,000 shares and the selling stockholders are selling 1,000,000 shares. Pharmasset intends to grant to the underwriters a 30-day option to purchase up to an additional 450,000 shares of common stock. Citi is serving as sole book-running manager and Morgan Stanley is serving as co-lead manager for the offering.
Pharmasset intends to use the net proceeds from the sale of the shares by Pharmasset for general corporate purposes, which may include, but are not limited to, the funding of clinical trials, the funding of in-licensing agreements for product candidates, the funding of additional technologies or other forms of intellectual property and the acquisition of assets or businesses that are complementary to its existing business.
The shares described above are being offered by Pharmasset and the selling stockholders pursuant to an automatic shelf registration statement filed earlier today with the Securities and Exchange Commission, which became effective immediately upon filing.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus supplement and accompanying base prospectus relating to this offering may be obtained from Citi at Brooklyn Army Terminal, 140 58th Street, 8th Floor, Brooklyn, NY 11220, Attention: Prospectus Department, 800-831-9146.
COB Steven Burrill resigns. Replaced by Herbert Conrad.
On January 18, 2011, G. Steven Burrill notified the board of directors (the "Board") of Pharmasset, Inc. (the "Company") of his resignation as Chairman of the Board, Chairman of the Audit Committee of the Board and as a member of the Compensation Committee of the Board. At a meeting held after its receipt of notice of Mr. Burrill's resignation, the Board appointed Herbert J. Conrad to succeed Mr. Burrill as Chairman of the Board and as a member of the Audit Committee and Robert F. Williamson III to succeed Mr. Burrill as Chairman of the Audit Committee. Mr. Burrill's position on the Compensation Committee will not be filled, which leaves the Compensation Committee with three remaining members (Robert F. Williamson III (Chair), Elliot F. Hahn and Michael K. Inouye). The Board has determined that Mr. Williamson qualifies as an "audit committee financial expert" under the rules and regulations of the Securities and Exchange Commission and possesses financial sophistication in accordance with the requirements of The NASDAQ Stock Market, LLC.
Bristol-Myers Squibb and Pharmasset Enter into a Clinical Collaboration Agreement for Proof of Concept Combination Study in Patients Chronically Infected with Hepatitis C
-Study is the first cross-company collaboration combining two oral, direct-acting antivirals
-Study to evaluate the combination with and without ribavirin in treatment-naïve patients
This will be the first of many DAA collaborations, and by no means does it indicate a lack of confidence in a dual nuke DAA. It's affirmation that nucleoside analogs will be a requirement in future therapy without SOC. Next up VRTX.
Bristol-Myers Squibb Company (NYSE:BMY - News) and Pharmasset (NASDAQ:VRUS - News) announced today that the companies have entered into a clinical collaboration agreement to evaluate the utility of BMS-790052, Bristol-Myers Squibb’s NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset’s nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus (HCV).
This proof of concept study will evaluate the potential to achieve sustained viral response 24 weeks post treatment with an oral, once-daily treatment regimen in patients across HCV genotypes. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of BMS-790052 in combination with PSI-7977, with and without ribavirin, in treatment-naïve patients chronically infected with HCV genotypes 1, 2, and 3. The study is planned to start in the first half of 2011. This collaboration represents the first cross-company collaboration combining two oral agents to address a significant unmet medical need in the treatment of HCV.
“Bristol-Myers Squibb is committed to the goal of helping patients prevail over hepatitis C by investigating multiple therapeutic platforms,” said Brian Daniels, senior vice president, Development. “We are pleased to partner with Pharmasset on this important study to advance the scientific understanding of the potential for an all-oral regimen to treat hepatitis C. Conducting this study highlights Bristol-Myers Squibb’s ability to collaborate with other companies to develop innovative combination therapies in areas of high unmet need.”
”We are excited to be working with Bristol-Myers Squibb and to be investigating PSI-7977 with a different class of direct acting antivirals,” stated Michelle Berrey, MD, MPH, Chief Medical Officer. “This collaboration represents one of many approaches we are pursuing with our portfolio of nucleoside/tide analogs that include both interferon free and interferon sparing regimens. We believe the development of an all oral treatment regimen represents an important evolution in the treatment of HCV.”
Slightly negative bias to positive news this morning.
Pharmasset Reports Positive Results from its HCV Clinical Programs
- PSI-7977 400mg QD with pegylated interferon and ribavirin was generally safe and well tolerated while demonstrating potent viral suppression in patients with HCV genotype 2 or 3 over 12 weeks of dosing
- PSI-938 300mg QD monotherapy was generally safe and well tolerated over 14 days of dosing and demonstrated potent antiviral activity and no viral breakthrough
PRINCETON, N.J. , Jan. 6, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS), announced today positive data from interim analyses of two of its clinical programs: the HCV genotype 2 or 3 (GT2/3) arm of the PSI-7977 Phase 2b trial and the 14 day PSI-938 monotherapy cohort of the dual nucleotide study.
Pipeline Update and 2011 Highlights
PSI-7977
In August 2010 , we began dosing of PSI-7977 in combination with pegylated interferon and ribavirin (Peg-IFN/RBV) in a Phase 2b study. This study is evaluating PSI-7977 200mg QD, 400mg QD, or placebo in combination with Peg-IFN/RBV in approximately 125 treatment-naive patients with HCV genotype 1 (GT1), and PSI-7977 400mg QD with Peg-IFN/RBV in an open-label arm in patients with HCV GT2 or GT3. HCV GT1 patients receive an RVR-directed regimen of 12 weeks of PSI-7977/Peg-IFN/RBV followed by 12 or 36 weeks of Peg-IFN/RBV. The HCV GT2/3 patients receive 12 weeks of PSI-7977/Peg-IFN/RBV with no additional therapy. The primary goal of the study is to assess the safety and tolerability of PSI-7977 in combination with Peg-IFN/RBV for 12 weeks. The primary efficacy endpoint of the study is the proportion of patients who achieve SVR12 and SVR24, defined as HCV RNA below the limit of detection (<15 IU/ml) 12 and 24 weeks, respectively, after the discontinuation of all therapy. Enrollment of this Phase 2b trial has been completed.
Twenty five treatment-naive patients with HCV GT2/3 patients were enrolled in the open label arm. 24/25 patients completed 12 weeks of PSI-7977 400mg QD with Peg-IFN/RBV; one patient was lost to follow-up after the first visit. A preliminary analysis of all data available at the end of 12 weeks of dosing revealed no serious adverse events and no discontinuations due to adverse events. The most commonly reported adverse events (AEs) overall were nausea, headache, chills, and fatigue; AEs were consistent in severity and frequency to historical Peg-IFN/RBV treatment. There were no clinically significant, treatment-emergent trends in any clinical laboratory parameters.
PSI-7977 with Peg-IFN/RBV resulted in rapid viral suppression, with all HCV GT2 or 3 patients (n=24) achieving both a rapid virologic response (RVR) and remaining below the limit of detection through the end of treatment at week 12 (EOT). No patient exhibited viral breakthrough. These HCV GT2 or 3 patients are now being monitored for an additional 24 weeks to assess SVR at 12 weeks (SVR12) and 24 weeks (SVR24) after the discontinuation of therapy. Initial data have been submitted for presentation at an upcoming major scientific conference scheduled to take place during the first half of 2011.
In addition to the ongoing Phase 2b dose-ranging study, we recently announced the initiation of an exploratory Phase 2 study of PSI-7977 and RBV with 0-12 weeks of interferon in patients with HCV GT2 or GT3. During the second quarter of 2011, we also expect to initiate a 24-week Phase 2b study of PSI-7977 with Peg-IFN/RBV.
PSI-938
In late November 2010 , we initiated Part 2 of a Phase 1 study that includes the first combination of a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for the treatment of HCV. The cohorts within Part 2 are evaluating PSI-938 300mg QD as monotherapy and in combination with PSI-7977 400mg QD. The primary objective is to assess the safety, tolerability and pharmacokinetics of PSI-938 alone and in combination with PSI-7977. The secondary objective of Part 2 is to evaluate the short-term change in HCV RNA.
Preliminary results with PSI-938 300mg QD administered as monotherapy for 14 days demonstrate:
PSI-938 was generally safe and well tolerated over 14 days
There were no serious adverse events, and no dose modifications or discontinuations
There were no clinically significant, treatment-emergent trends in any clinical laboratory parameters
PSI-938 demonstrated potent antiviral activity with a median HCV RNA change from baseline of 5.23 log10 IU/mL in the 8 patients receiving 300mg QD monotherapy for 14 days. HCV RNA declined rapidly and consistently throughout the 14 day dosing period, with no viral breakthrough noted. In the 8 subjects who received PSI-938 300mg QD monotherapy for 14 days, half (4 of 8) of the subjects achieved HCV RNA below the limit of detection (15 IU/mL), and 5 of 8 patients achieved HCV RNA below the limit of quantification (43 IU/mL). The median baseline HCV RNA in patients enrolled in Part 2 was approximately 1 log10 higher than in the Part 1 multiple ascending dose trial (6.95 log10 IU/mL versus 5.92 log10 IU/mL), allowing for a full assessment of the antiviral activity of the nucleotide analog.
Patients are now being enrolled in the second and third cohorts. Patients will receive monotherapy with either PSI-938 or PSI-7977 for days 1-7, followed by the combination of PSI-938 plus PSI-7977 for days 8-14. Following availability of data from these initial combination cohorts, the fourth and final cohort will receive both PSI-938 and PSI-7977 for 14 days. We anticipate reporting further data from this study during this quarter. In addition, we plan on initiating a Phase 2 study of PSI-938 in combination with PSI-7977 during mid-2011. This Phase 2 study will explore multiple treatment durations of PSI-938 and PSI-7977 with an SVR endpoint.
"We are encouraged by the initial results generated with PSI-7977 in combination with Peg-IFN/RBV over 12 weeks and with PSI-938 monotherapy over 14 days," stated Michelle Berrey , MD, MPH, Chief Medical Officer. "Both programs are progressing on schedule and we anticipate reporting further efficacy, safety and resistance data throughout 2011. We are excited to be moving PSI-938 into the combination phase of this study with PSI-7977, as this may provide a preliminary proof-of-concept for an all oral, nucleotide combination regimen."
Calendar Year 2011 Anticipated Milestones:
-- Pharmasset expects to report SVR12 data from its ongoing phase 2b trial with PSI-7977 in HCV genotype 2/3 patients in the second quarter of 2011
-- Pharmasset expects to report the 12 week interim analysis from its PSI-7977 Phase 2b genotype 1 arms in the second quarter of 2011
-- Pharmasset expects to initiate a 24 week Phase 2b trial with PSI-7977 in the second quarter of 2011
-- Pharmasset expects to initiate a Phase 2 study with PSI-7977 and PSI-938 in mid-2011
-- Pharmasset plans to file an IND for PSI-661 in the first quarter of 2011 and to initiate a phase 1 trial in the second quarter of 2011
-- Roche expects to initiate INFORM-SVR with RG7128 and RG7227 in the first quarter of 2011
-- Roche expects to initiate a phase 2 study with RG7128 in HCV genotype 2/3 patients in the first half of 2011
-- Roche expects to initiate a phase 3 program with RG7128 in 2011
Pharmasset to Present at the 29th Annual J.P. Morgan Healthcare Conference
PRINCETON, N.J. , Jan. 4, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that management will present at the 29th Annual J.P. Morgan Healthcare Conference to be held January 10-13, 2011 at the Westin St. Francis Hotel , San Francisco, CA. Schaefer Price , President and Chief Executive Officer, will provide an overview of the company on Wednesday, January 12, 2011 at 9:00 AM (PT) .
IMO this agreement highlights Pharmasset's willingness to move PSI-7977 quickly into Phase 3 with or without a large partner.
BASi Announces Partnership With Pharmasset
ShareretweetEmailPrintPress Release Source: BASi (Bioanalytical Systems, Inc.) On Wednesday December 29, 2010, 10:24 am EST
WEST LAFAYETTE, IN--(Marketwire - 12/29/10) - BASi (Bioanalytical Systems, Inc.) (NASDAQ:BASI - News), a life sciences company in the Purdue Research Park, has entered into a Preferred Provider Agreement (PPA) with Princeton, New Jersey-based Pharmasset Inc. (NASDAQ:VRUS - News), a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, to provide preclinical services for pre-IND and post-IND activities. The agreement includes provisions to provide exclusive toxicology services as well as pharmaceutical analysis and bioanalytical services as needed.
BASi President and Chief Executive Officer, Anthony S. Chilton, Ph.D., stated, "The agreement between Pharmasset and BASi is an important strategy and commitment for both companies. It represents a significant step in BASi's strategy to work closely with our partners in the pharmaceutical industry. We look forward to developing our relationship and continuing to contribute to the successful development of Pharmasset's future medicines."
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir™ for the treatment of human immunodeficiency virus (HIV). Research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. Pharmasset currently has four clinical-stage product candidates. RG7128 is in two Phase 2b clinical studies in combination with Pegasys® plus Copegus® and is also in the INFORM studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys® and Copegus® to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Other clinical stage HCV candidates include PSI-7977, an unpartnered nucleotide analog that has recently initiated 12 weeks of dosing in a Phase 2b study, and PSI-938, an unpartnered nucleotide analog in a Phase 1 study. Pharmasset also has in its pipeline an additional purine nucleotide analog, PSI-661, in advanced preclinical development. Racivir, for the treatment of HIV, has completed a Phase 2 clinical study.
Pegasys® and Copegus® are registered trademarks of Roche.
About Bioanalytical Systems, Inc.
BASi is a pharmaceutical development company providing contract research services and research instruments and supplies to the world's leading drug development companies and medical research organizations. The company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market. Visit www.BASInc.com for more about BASi.
This release contains forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to changes in the market and demand for our products and services, the development, marketing and sales of products and services, changes in technology, industry standards and regulatory standards, and various market and operating risks detailed in the company's filings with the Securities and Exchange Commission.
VRUS is not the first company to test an HCV drug with ribavirin without interferon. Idera has been doing it since 2009 (http://clinicaltrials.gov/ct2/show/NCT00990938 ), and Coley Pharmaceuticals (acquired by PFE) did it several years ago.
VRUS is the first company to test a second-generation nuke in this manner, however.
Pharmasset Initiates Exploratory Interferon Sparing Clinical Trial of PSI-7977 for Chronic Hepatitis C
I personally like everything about this trial. Though Pharmasset is focusing on the easiest to treat patients (treatment naive Genotype 2/3) they are the first company to run a interferon free single agent trial in combination with ribavirin. It's a bold statement that no other HCV company can match.
http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=536627
Favorable ruling for VRUS in Emory License Arbitration
http://investor.pharmasset.com/secfiling.cfm?filingid=1193125-10-278807
I agree with the reply: the article's comparison between VRUS and INHX is clueless.
No my secretary helped draft it. I knew you would be my first hit. Any comments?
Was that your own reply?
Reply to a horrendous article
http://seekingalpha.com/article/239220-inhibitex-a-biotech-gem-in-the-enormous-hepatitis-c-market?source=yahoo
James,
You failed to mention any of Pharmasset's (VRUS) HCV drugs by name in your article leading us readers to make assumptions. The VRUS drug in phase 2 testing that you compared Inhibitex's (INHX) INX-189 to must be PSI-7977. Surprisingly absent was mention of RG7128 which VRUS developed and than partnered with Roche. Not only is Roche paying all development costs for RG7128 but VRUS stands to make up to $135 million in milestone payments from Roche upon approval along with product royalties. Phase 3 testing begins next year and the resistance profile, efficacy, and safety all look promising.
If you want to to compare INX-189 to one of Pharmasset's four HCV drugs under development my choice would be PSI-938 or PSI-661. Not only are they guanine nucleotide analogs (like INX-189), but PSI-938 is in phase 1b testing and PSI-661 will be moving into clinical testing the first half of next year leaving INX-189 somewhere between the two in stage development. Of note PSI-938 and PSI-661 have proven equally potent in vitro against HCV wildtype virus and virus with the S282T mutation unlike INX-189*.
I have been following INHX for about a year now. The last two weeks INHX shot up more than 50% on speculation of a positive outcome for FV-100. This recent run up has nothing to do with INX-189. For you to state that "the market is discounting that value [of FV-100] down to zero and below" is insulting at best. More likely than not FV-100 will prove to be superior in efficacy compared to valacyclovir but if it doesn't, or if there's a safety issue, you can count on the stock being cut in half.
I like Inhibitex and personally feel the company will be successful. I liked it better two months ago when it was trading below $1.80. If you want to use your "discount back" analysis perhaps you shouldn't value Pharmasset and Idenix as one drug companies? Your model not only is unfair to these companies (VRUS,IDIX) but significantly overvalues the company you are pumping (I mean covering). Your approach is unfair to the unassuming investors that follow you on Seeking Alpha.
Evan
P.S....You just replied to another poster that you are not pumping INHX because you don't own it. Meanwhile at the bottom of your story it says you are "long INHX". Doesn't "long" mean you own the stock?
*Studies done by Pharmasset per 10K.
Pharmasset Initiates Dosing in a Combination Study of PSI-7977 and PSI-938 for Chronic Hepatitis C
- Phase 1 combination study of a pyrimidine (PSI-7977) and purine (PSI-938) nucleotide analog in patients with chronic hepatitis C
- Interim data expected in first quarter of 2011
Pharmasset, Inc. (Nasdaq:VRUS - News) announced today that dosing has begun in Part 2 of a Phase 1 study. This is the first clinical study combining a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for HCV, and is designed to evaluate once daily doses of PSI-7977 and PSI-938 in patients with HCV who have not been treated previously.
"We are excited to be initiating this combination study with two proprietary nucleotide analogs for HCV," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "Based on our in vitro data, we believe the combination of two nucleotide analogs could provide potent antiviral activity across multiple HCV genotypes and could also have a higher barrier to resistance compared to other DAA combinations. We believe nucleotide analogs have a number of key attributes that may make them ideal partners for other DAA combinations, in addition to a 'nuc-nuc' combination."
About the Phase 1 Trial
In Part 1 of the Phase 1 multiple ascending dose study of PSI-938, suppression of HCV RNA below the limit of detection (LOD, <15 IU/mL) was observed in over half of the patients who received PSI-938 at daily doses of 200 mg or 300 mg for seven days. Part 2 of the study is designed to evaluate the combination of PSI-938 and PSI-7977. The primary objective is to assess the safety, tolerability and pharmacokinetics of PSI-938 administered alone for 14 days, and in combination with PSI-7977 for 7 to 14 days. The secondary objective is to evaluate viral kinetics of HCV RNA during monotherapy and combination nucleotide dosing. Approximately forty patients are expected to be enrolled into four cohorts as follows:
Pharmasset Initiates Dosing in a Combination Study of PSI-7977 and PSI-938 for Chronic Hepatitis C
- Phase 1 combination study of a pyrimidine (PSI-7977) and purine (PSI-938) nucleotide analog in patients with chronic hepatitis C
- Interim data expected in first quarter of 2011
PSI-938 QD administered as monotherapy for 14 days, followed by;
PSI-938 QD for 7 days followed by PSI-938 plus PSI-7977 QD for 7 days and
PSI-7977 QD for 7 days followed by PSI-938 plus PSI-7977 QD for 7 days, followed by;
PSI-938 plus PSI-7977 QD for 14 days
We expect to report preliminary results from Part 2 of this Phase 1 study during the first quarter of calendar year 2011. We also expect to initiate a Phase 2 study of PSI-938 in combination with PSI-7977 during mid-2011. This Phase 2 study proposes to explore durations of PSI-938 and PSI-7977 in interferon-free combinations with an SVR endpoint.
Absent in today's PR is mention of Roche's INFORM study of RG7128 in combination with RG7227. This doesn't bode well for INFORM yet Roche makes the final call.
PRINCETON, N.J., Nov. 23, 2010 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the fiscal year ended September 30, 2010. At fiscal year end Pharmasset held $127.1 million in cash and cash equivalents.
Pipeline Update and 2010 highlights
RG7128
Phase 2b PROPEL and JUMP-C trials
During February 2010, dosing in the Phase 2b PROPEL study was completed. Four hundred and eight treatment-naïve, genotypes 1 or 4 hepatitis C virus (HCV)-infected patients (cirrhotic and non-cirrhotic) were enrolled. The trial is evaluating the dose and duration of treatment of RG7128 in combination with pegylated interferon and ribavirin (SOC).
In November 2010 at the AASLD meeting, Roche presented results from a 12 week interim analysis of the PROPEL study. The results presented included:
RG7128 1000 mg BID in combination with SOC for 12 weeks achieved a high rate of complete Early Virologic Response (cEVR; <15 IU/mL) of 83% with no on-treatment viral breakthrough
The safety and tolerability of RG7128 1000 mg BID with SOC were comparable to placebo/SOC with no renal or hematologic safety signals, and a discontinuation rate similar to placebo/SOC
No drug resistance was observed in 367 patients treated with up to 12 weeks of RG7128
In early May 2010, Roche completed enrollment of 168 treatment naive, genotypes 1 or 4 HCV-infected patients in its JUMP-C trial.
An amendment to the PROPEL and JUMP-C trial has been implemented by Roche which allows patients who were initially randomized to the placebo/SOC arm and who are non-responders to receive open label RG7128 1000mg BID in combination with SOC for 24 weeks, followed by an additional 24 weeks of SOC.
In addition, Roche is planning to initiate a Phase 2b study of RG7128 in combination with SOC in patients with HCV genotypes 2 or 3 during the first half of 2011. Roche is also planning to initiate a Phase 3 program for RG7128 during 2011 and plans to submit a marketing application for RG7128 to one or more regulatory authorities in 2013.
PSI-7977
In January 2010, Pharmasset initiated a 28 day phase 2a dose-finding trial with PSI-7977 in combination with SOC. The trial enrolled 63 treatment-naïve, genotype 1 HCV infected patients who received either 100mg QD, 200mg QD, 400mg QD or placebo in combination with SOC for 28 days. In May 2010, we reported interim results from the trial which demonstrated that PSI-7977 was generally safe and well tolerated, as well as exhibiting potent antiviral activity (i.e. 94% RVR with 200 mg QD in combination with SOC). All patients receiving active PSI-7977 demonstrated continuous and substantial declines in HCV RNA with no viral breakthrough during the 28 days of therapy at any dose. Final results were reported in three posters at AASLD 2010 (Abstracts 815, 806, 1861).
In August 2010, we initiated a phase 2b dose-finding trial with PSI-7977 for 12 weeks in combination with SOC. The trial is expected to enroll approximately 125 treatment naïve, genotype 1 HCV-infected patients who will receive either 200mg QD, 400mg QD or placebo in combination with SOC for 12 weeks, followed by 12 weeks or 36 weeks of SOC alone. A fourth arm has completed enrollment of 25 treatment naïve, genotypes 2 or 3 HCV infected patients who will receive 400mg QD PSI-7977 in combination with SOC for 12 weeks only. We anticipate reporting preliminary safety results from this genotype 2/3 arm in the first quarter 2011 and SVR12 in the second quarter 2011.
In August 2010, Pharmasset received fast track designation from the US Food and Drug Administration (FDA) for PSI-7977 for the treatment of chronic hepatitis C (HCV) infection.
We are planning to initiate a Phase 2b study of PSI-7977 in combination with ribavirin administered with and without pegylated interferon in early December 2010. The study is expected to enroll approximately 40 treatment-naïve patients with HCV genotypes 2 or 3 and is designed to assess SVR with limited durations of pegylated interferon.
PSI-938
In April 2010, Pharmasset initiated a phase 1 single ascending dose trial with PSI-938, a purine nucleotide analog for HCV. In July 2010, we reported that single doses of PSI-938 ranging from 100mg to 800mg, and subsequently 1600mg, were generally safe and well tolerated and that a 7 day, multiple ascending dose trial had been initiated.
In October 2010, we reported positive preliminary antiviral data with PSI-938 demonstrating a median decline in HCV RNA of between 3.94 log10 to 4.64 log10 from baseline at all doses tested (100mg QD, 200mg QD, 300mg QD, 100mg BID). For the 16 subjects who received PSI-938 200mg QD or 300mg QD for 7 days, more than half (9 of 16) of the subjects on PSI-938 monotherapy achieved HCV RNA below the limit of detection (15 IU/mL) and 11 out of 16 patients achieved HCV RNA below the limit of quantification (43 IU/mL).
We are screening patients for Part 2 of a phase 1 study that includes the first combinations of a purine (PSI-938) and a pyrimidine (PSI-7977) nucleotide analog for the treatment of HCV. The cohorts within Part 2 are expected to evaluate PSI-938 QD, in the absence of interferon, as monotherapy and in combination with PSI-7977 QD. The primary objective of Part 2 of this study is to assess the safety, tolerability and pharmacokinetics of PSI-938 alone and in combination with PSI-7977 in the clinically-relevant setting of combination therapy for 14 days. The secondary objective of Part 2 of this study is to evaluate the short-term change in HCV RNA. Preliminary results are expected in the first quarter of 2011. Approximately forty patients are expected to be randomized into the study.
PSI-661
In October 2009, we nominated PSI-661, a purine nucleotide analog, for preclinical development. Our current plan is to submit an IND application, or its foreign equivalent, during the first quarter of 2011. We also plan to initiate a Phase 1 SAD study to assess the safety, tolerability, and pharmacokinetics of PSI-661 during the second quarter of 2011.
Financial Results
For the fiscal year ended September 30, 2010 Pharmasset reported revenues of $1.0 million, compared with revenues of $13.3 million for fiscal year 2009. The receipt of a $10.0 million milestone from Roche for the initiation of the phase 2b study with RG7128 led to higher reported revenues in fiscal year 2009.
Total costs and expenses for the fiscal year ended September 30, 2010 were $64.7 million compared to $65.9 million for the same period in 2009. The decrease in operating expenses for the fiscal year ended September 30, 2010 was primarily the result of discontinuing our clevudine program in April 2009. This reduction was mostly offset by increases in development costs for PSI-7977, PSI-938 and PSI-661.
Pharmasset reported a net loss of $66.1 million, or $2.13 per share for the fiscal year ended September 30, 2010, as compared to a net loss of $55.6 million, or $2.10 per share for the same period in 2009.
"Pharmasset had a very productive year, advancing all of its HCV clinical programs," stated Schaefer Price, President and Chief Executive Officer. "During the year, we advanced PSI-7977 through a Phase 2a trial and into a Phase 2b study in genotype 1, 2 or 3 patients. At the same time, we also reported very exciting data with our first purine nucleotide, PSI-938, and look forward to advancing this candidate into a 'nuc-nuc' combination trial this month. In 2011, Roche plans to start a Phase 3 program with RG7128 and we are anticipating reporting data throughout the year from our PSI-7977 Phase 2b trial and our 'nuc-nuc' combination trial."
Calendar Year 2011 Anticipated Milestones:
Roche expects to initiate a phase 3 program with RG7128 in 2011
Pharmasset expects to report 12 week safety from its ongoing phase 2b trial with PSI-7977 in genotype 2/3 patients in the first quarter 2011; SVR 12 data in the second quarter 2011
Pharmasset expects to report the 12 week interim analysis from its PSI-7977 Phase 2b genotype 1 arms in the second quarter 2011
Pharmasset expects to initiate a 24 week Phase 2b trial with PSI-7977 in the second quarter 2011
Pharmasset expects to initiate Part 2 of a phase 1 study with PSI-938 alone and in combination with PSI-7977 in the fourth quarter 2010; report preliminary results during the first quarter 2011
Pharmasset expects to initiate a phase 2 study with PSI-7977 and PSI-938 in the second quarter 2011
Pharmasset expects to initiate an interferon sparing trial in genotype 2/3 patients with PSI-7977 in the fourth quarter 2010
Pharmasset plans to file an IND for PSI-661 in the first quarter 2011 and to initiate a phase 1 trial in the second quarter 2011
Roche expects to initiate a phase 2 study with RG7128 in genotype 2/3 patients in the first half 2011
This is very big news, IMO.
jk, of course :- )
Paul Lubetkin, general counsel, to leave Pharmasset effective November 15TH.
http://www.sec.gov/Archives/edgar/data/1301081/000119312510264124/d8k.htm
Pharmasset to Present at Two Upcoming Investor Conferences
PRINCETON, N.J., Nov. 9, 2010 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the Credit Suisse First Boston (CSFB) 2010 Healthcare Conference to be held November 10 to 12, 2010 at the Arizona Biltmore Hotel, Phoenix, AZ and the Lazard Healthcare Conference to be held November 16, 2010 at the St Regis Hotel, New York, NY. Schaefer Price, President and Chief Executive Officer, will provide an overview of the company at the CSFB conference on Wednesday, November 10, 2010 at 3:00 PM (MST) and at the Lazard conference on Tuesday, November 16, 2010 at 9:25 AM (ET).
Results from the phase 1b study of PSI-938 indicate 200mg/QD should be the optimum dose. Considering the recent run-up, and the dysfunctional economy, it's time to be cautious IMO. Bad news from Roche concerning INFORM is just as likely as a partnership with PSI-7977 at this point in time.
Pharmasset Reports Positive Preliminary Antiviral Data with PSI-938 for the Treatment of Hepatitis C
-- PSI-938 achieves a median 3.94 to 4.64 log10 reduction in HCV RNA after 7 days of monotherapy -- No early discontinuations or serious adverse events reported -- Initiating nucleotide combination trial later this quarter -- Conference call at 8:00 AM ET today
PRINCETON, N.J., Oct 28, 2010 /PRNewswire via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) reported positive preliminary results today from its phase I monotherapy trial of PSI-352938 ("PSI-938") for the treatment of chronic hepatitis C (HCV). PSI-938 is a guanosine nucleotide analog polymerase inhibitor in development for the treatment of chronic HCV infection.
PSI-938 Phase 1 Multiple Ascending Dose Study Overview
In August 2010, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-938 administered once daily (QD) or twice daily (BID) for 7 days. The trial was conducted at two US centers as a blinded, randomized, and placebo-controlled study in 40 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-938 administered over 7 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized within each cohort to receive either PSI-938 (8 patients per cohort) or placebo (2 patients per cohort). Four dose cohorts of PSI-938 (100 mg QD, 200 mg QD, 300 mg QD and 100 mg BID) have been completed.
PSI-938 Antiviral Activity Summary
Preliminary Antiviral Response Observed Following PSI-938
Administered as Monotherapy for 7 Days
Dose n Median Change in Range Number of Subjects with
HCV RNA at Day 8 HCV RNA
(log10 IU/mL) (log10 IU/mL) <LOD <LOQ
100 mg QD 8 -4.31 -2.66 to -5.12 1 3
200 mg QD 8 -4.64 -3.49 to -5.35 5 7
300 mg QD 8 -3.94 -3.43 to -5.29 4 4
100 mg BID 8 -4.59 -3.94 to -5.08 2 3
Placebo 8 -0.05 +0.17 to -0.29 0 0
------- --- ----- -------------- --- ---
LOD = limit of detection (<15 IU/mL)
LOQ = limit of quantification (<43 IU/mL)
PSI-938 demonstrated potent antiviral activity with a mean HCV RNA change from baseline of 4.31 log10 IU/mL, 4.64 log10 IU/mL, 3.94 log10 IU/mL and 4.59 log10 IU/mL in patients receiving 100 mg QD, 200 mg QD, 300 mg QD and 100 mg BID for seven days, respectively. HCV RNA declined consistently throughout the 7-day dosing period, with no viral breakthrough. For the 16 subjects who received PSI-938 200 mg QD or 300 mg QD for 7 days, more than half (9 of 16) of the subjects on PSI-938 monotherapy achieved HCV RNA below the limit of detection (15 IU/mL) and 11 out of 16 patients achieved HCV RNA below the limit of quantification (43 IU/mL).
PSI-938 Pharmacokinetic and Safety Summary
Pharmacokinetics parameters were similar between healthy subjects in the single ascending dose study and HCV infected patients in the seven-day multiple ascending dose study. PSI-938 at all doses provided good systemic exposure and continue to support once-daily administration.
PSI-938 was generally safe and well tolerated across all doses studied to date with no serious adverse events and no discontinuations. There were no dose-related trends in adverse events through the dose escalations, no grade 4 treatment emergent laboratory changes, and no trends in clinical laboratory abnormalities.
PSI-938 SAD and preclinical data
The Phase 1a single ascending dose study conducted earlier this year assessed single doses of PSI-938 ranging from 100 mg to 1600 mg or matching placebo in healthy male and female volunteers. No dose-limiting toxicity was identified. Safety and pharmacokinetic data supported progression of PSI-938 to the 7-day monotherapy trial. Full data from the SAD trial will be presented at the upcoming AASLD Annual Liver Meeting in Boston, MA, October 29-November 3, 2010 (poster #1890).
Preclinically, both PSI-938 and Pharmasset's other guanosine analog, PSI-661, which is in late preclinical development, have demonstrated similar potency against wild-type HCV or HCV with the S282T mutation, which can be selected by RG7128 and PSI-7977 in vitro. Although the S282T has not been detected in treatment-naive individuals with HCV, nor selected in clinical trials with any of Pharmasset's nucleoside/tide analogs, the potential for interferon-sparing regimens may increase the focus on antivirals with complementary resistance profiles.
"We are very encouraged by the preliminary efficacy and safety data with PSI-938, our purine nucleotide analog for HCV," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "These data provide the first confirmatory evidence that a nucleoside/tide analog can exhibit substantial early antiviral activity in monotherapy as has been observed with compounds in other DAA classes. Unlike other classes of DAAs to date, our nucleotide analogs also provide a higher barrier to resistance and clinically-validated antiviral activity across a broad range of HCV genotypes, characteristics not yet demonstrated with other classes of DAA. We continue to believe that nucleoside/tide analogs will become the backbone of HCV therapy. In addition, similar to HIV, the combination of two complementary nucleoside/tide analogs could provide a differentiated therapy for HCV patients in the future."
PSI-938 and PSI-7977 Combination Study
In this quarter, Pharmasset plans to initiate a short-term study to assess the combination of PSI-938 and PSI-7977. The trial will be conducted in the US, as a blinded, randomized, placebo-controlled study in approximately 50 patients chronically infected with HCV genotype 1. The primary objective will be to assess the safety, tolerability, and pharmacokinetics of PSI-938 and PSI-7977 alone and in combination. Preliminary results are expected in the first half of 2011.
AASLD 2010 webcast
Pharmasset to Webcast an Investor Event from the AASLD Meeting
PRINCETON, N.J., Oct 27, 2010 /PRNewswire via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) today announced that it will webcast an investor event from the American Association for the Study of Liver Diseases (AASLD) on Sunday, October 31, 2010 starting at 7:00pm ET. During this webcast, management will review Pharmasset's progress on the programs that are the subject of presentations at AASLD.
To 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).
RG7128
Abstract 81
"High rates of early viral response, promising safety profile and lack of resistance related breakthrough in HCV GT 1/4 patients treated with RG7128 plus PegIFN alfa-2a (40KD)/RBV: Planned Week 12 interim analysis from the PROPEL study" will be presented in the HCV Clinical Trials session on Sunday October 31st at 5:15pm ET. Authors of the study are Jensen, D. M. et al.
Abstract 799
"No evidence of drug resistance or baseline S282T resistance mutation among GT1 and GT4 HCV infected patients on nucleoside polymerase inhibitor RG7128 and Peg-IFN/RBV combination treatment for up to 12 weeks: Interim analysis from the PROPEL study" will be presented in a poster session on Sunday October 31st. Authors of the study are Le Pogam, S. et al.
PSI-7977
Abstract 806
"High Rapid Virologic Response (RVR) with PSI-7977 Daily Dosing plus PEG-IFN/RBV in a 28-day Phase 2a Trial" will be presented in a poster session on Sunday October 31st. Authors of the study are Lawitz, E. et al.
Abstract 1861
"Clinical synergy of an Anti-HCV Nucleotide Analog with SOC: Viral Kinetics of PSI-7977 with SOC" will be presented in a poster session on Tuesday November 2nd. Authors of the study are Lawitz E, et al.
Abstract 815
"IL28B SNP Geographical Distribution and Antiviral Responses in a 28-day Phase 2a Trial of PSI-7977 Daily Dosing plus PEG-IFN/RBV" will be presented in a poster session on Sunday October 31st. Authors of the study are McHutchison, J.G. et al.
PSI-938
Abstract 1890
"Pharmacokinetics, Safety, and Tolerability of PSI-938, a Novel Nucleotide Polymerase Inhibitor for HCV, Following Single Ascending Oral Doses in Healthy Subjects" will be presented in a poster session on Tuesday November 2nd. Authors of the study are Symonds, W. et al.
Just a correction to MSN Moneycentral's company description of Pharmasset which is listed on the top of the IHUB VRUS homepage.
What are you doing conversing with yourself over here? I just commented on your post. Regards, Dew
InterMune Sells Danoprevir Rights to Roche for $175 Million
-- Conference Call and Webcast Today at 4:30 p.m. EDT --
BRISBANE, Calif., Oct 06, 2010 /PRNewswire via COMTEX/ --
As of today we can officially lay to rest ITMN-191 (only in name) and refer to this drug as RG7227 or by it's generic name danoprevir. Roche is the savviest of drug companies and I have a hard time believing they paid $175 million dollars just to break free of their contractual obligation with ITMN, so they can use another PI with first generation nuke RG7128. That $175 million could go towards licencing PSI-7977 and starting from scratch with a DAA consisting of a second generation nuke with QD dosing. My feeling now is Roche is completely committed to INFORM (RG7227/RG7128) and you will see them moving aggressively forward with lower doses of 7227 to avoid toxicity. Nobody has better insight into the capabilities of this drug in combination with RG7128. Roche and Pharmasset have a very good chance of being the first companies to market with a DAA for HCV.
InterMune, Inc. (Nasdaq: ITMN) today announced that it has sold worldwide development and commercialization rights to danoprevir (also known as RG7227 or ITMN-191) to Hoffman-La Roche Inc. and F. Hoffman-La Roche Ltd. for $175 million in cash. In connection with this transaction, the collaboration agreement that InterMune and Roche entered into in October 2006 has been terminated. In addition, the companies are actively exploring ways to continue their ongoing work together on other HCV research programs. InterMune noted that as a result of this transaction, the company will make no further investment in danoprevir and that, including net proceeds from the transaction, it currently expects to have a cash balance of approximately $290 million at the end of 2010.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "After conducting a careful review of our strategy and financial position, we have decided to divest our rights to danoprevir to Roche. This transaction provides a very substantial non-dilutive cash infusion that allows us to continue to independently and aggressively pursue the registration and commercialization of pirfenidone in the US and EU, and eliminates our obligation to make significant ongoing investments related to the further development and commercialization of danoprevir. We are now in a very strong financial position that provides us with the resources and flexibility to maximize the value of pirfenidone, our largest and nearest-term value creation opportunity."
One of the most promising DAA combinations in development was taken to the woodshed today upon BMY's 12 week abstract release of their NS5A inhibitor+PI without SOC in null responders. BMY's acquisition of ZGEN can now be justified accounting for their DAA's dependence on SOC and/or a third class of drug to prevent potential viral breakthrough. The case for investing in VRUS and the nuke class is getting stronger each day.
BMS-790052 is a potent NS5A inhibitor with broad genotypic coverage while BMS-650032 is a potent HCV NS3 protease inhibitor with coverage of HCV genotypes (GT) 1a and 1b. Clinical studies combining these compounds alone and with pegIFN/RBV are underway in HCV infected null responders to determine their safety and efficacy. Methods: AI447011 is a randomized, open label, Phase 2a study comparing the antiviral activity and safety of BMS-790052 (60 mg QD) and BMS-650032 (600 mg BID) alone (Group A) or with pegIFN/RBV (Group B) for 24 weeks in HCV GT 1 null responders. The primary aim was to determine the proportion of subjects achieving undetectable HCV RNA (<10 IU/mL) at Weeks 2 and 4 of therapy and 24 weeks post-treatment. A Week 12 interim analysis was performed. Results: Twenty-one patients (11 Group A, 10 Group B) were randomized in a sentinel cohort. Median age was 55 years, 13 were male, and 16 were white. Virologic responses are presented in Table 1. 6 (54.5%) Group A subjects experienced viral breakthrough while all subjects in Group B maintained viral suppression. Viral breakthrough occurred exclusively in individuals infected with GT 1a occurring as early as Week 3 and as late as Week 12. The two GT 1b subjects in Group A remained HCV RNA undetectable. The 6 subjects with breakthrough had pegIFN/RBV added to their regimen. HCV RNA fell to UD in 2 subjects and to < 25 IU/mL in another 2 subjects while the other 2 had = 1.5 log decreases in HCV RNA. No deaths, SAEs, or discontinuations due to AEs were recorded during the analysis period. Diarrhea was the most common AE and was mainly mild to moderate in severity. Conclusions: Treatment with BMS-790052 and BMS-650032 with or without PegIFN/RBV demonstrated similar RVR rates in HCV infected GT 1 null responders. 6/11 subjects receiving 2 direct antiviral agents alone experienced viral breakthrough by Week 12 while a four-drug combination maintained viral suppression in all subjects. Should this activity predict SVR, these results will have significant implications for future combination HCV antiviral therapy.
Director Elliot Hahn exercised and held 14666 shares at $3.87, 3333 shares at $3.00, and 6666 shares at $4.02. Michael Otto sold another another 5000 shares at $29.50. Hahn now holds 73,999 shares and Otto holds 16,689 shares. Quite interesting action.
FWIW- BMO starts VRUS with outperform rating and $41.00 price target.
Chief Scientific Officer Michael Otto exercised options and bought 7811 shares at $4.02 than sold 12,811 shares at $29.50. Otto is one of only two insiders to have sold stock in the last several years.
Pharmasset to Present at the JMP Healthcare Conference
PRINCETON, N.J., Sept. 24 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announces that management will present at the JMP Healthcare Conference to be held September 27-28, 2010 at the New York Palace Hotel, New York, NY. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the JMP conference on Tuesday, September 28, 2010 at 10:00 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 webcast 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.
Insider buy and hold
Director Elliot Hahn bought and held 30,000 shares today at prices ranging between $3.00-$6.75 through previously awarded option grants.
Pharmasset to Present at the UBS Global Life Sciences Conference
PRINCETON, N.J., Sept 17, 2010 /PRNewswire via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that management will present at the UBS Global Life Sciences Conference to be held September 20-22, 2010 at the Grand Hyatt, New York, NY. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the UBS conference on Monday, September 20, 2010 at 9:30 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 webcast 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.
Takeover speculation usually isn't worth the paper it's printed on. The idea of Roche buying VRUS is nothing new and some would suggest it's why VRUS trades at a premium to its clinical peers. Since Adam Feuerstein is in a speculative mood I will add my own thoughts. If Roche does make a bid for VRUS I would expect the offer to be at least twice the company's current valuation. The last thing Roche wants is to put VRUS in play and have Gilead Sciences come in with a better offer. GILD's dual nuke combo Truvada for HIV was approved in 2004 and has been incredibly profitable. Given GILD's list of management blunders the last few years this strategy for HCV could play right into their pocket if they buy VRUS. VRUS is in an enviable bargaining position.
thestreet.com...credit jbog at BV message board
Do you think the acquisition of Zymogenetics(ZGEN) by Bristol-Myers Squibb(BMY) signals more consolidation or takeout activity in the hepatitis C space? I know there are other partnerships out there already, but can we expect to see more deals?"
Great question. This was a rather busy week in Hep C land, with Bristol buying partner Zymogenetics for $885 million, or $9.75 a share (and at a whopping 84% premium, no less), Idenix Pharmaceuticals(IDIX) putting its two lead Hep C drugs on clinical hold (temporarily, it's hoped) and Vertex Pharmaceuticals(VRTX) releasing the final phase III clinical data supporting the strong efficacy of telaprevir in helping treatment-resistant patients achieve a cure.
Investors should think about the evolving Hep C drug market like a buddy system. Everyone, meaning every company developing a new Hep C drug, needs a buddy, a partner, a wing man. Partnering is essential because in five or 10 years, maybe sooner, doctors will be treating Hep C patients with various combinations of drugs -- i.e. drug cocktails -- in many of the same ways that doctors treat HIV patients today.
The current standard of care for treating Hep C is a 48-week, two-drug regimen consisting of long-acting interferon (either Roche's Pegasys or Merck's(MRK) PEG-Intron) plus the generic medicine ribavirin.
If Vertex and/or Merck are successful in getting their respective direct-acting antiviral drugs approved next year, a third drug will be added to the Hep C treatment cocktail. If that add-on drug is Vertex's telaprevir, for instance, newly-treated Hep C patients will take telaprevir plus interferon-ribavirin for 12 weeks, followed by another 12 weeks of interferon and ribavirin. Total treatment time, just 24 weeks or six months. Based on what we know today about telaprevir, cure rates of 75% will be achieved compared to about 40% today with standard of care alone.
The goal of much of today's Hep C research is to eliminate interferon and/or ribavirin from the treatment regimen because the side effects of both drugs are nasty. The hope is that two- or three-drug combinations of new direct antivirals will be equally or more effective in eliminating the Hep C virus. Perhaps these antivirals could one day be combined into a single pill that patients would take once daily -- thus simplifying treatment vastly.
To reach this utopian state of Hep C treatment, experimental drugs -- mostly developed by separate companies -- need to be studied in combination. Roche is partnered with Pharmasset(VRUS) and InterMune(ITMN) for that purpose. Vertex is partnered with Johnson & Johnson(JNJ), although Vertex also bought a private company to gain control of another direct antiviral to combine with telaprevir.
Those small companies without partners today need to buddy up soon lest they miss out. Most prominently (for investors, at least), the list of "singles" includes Idenix, Achillion Pharmaceuticals(ACHN) and Anadys Pharmaceuticals(ANDS). (More on Idenix below.)
Pharmasset is an interesting case: The company has a deep stable of Hep C drug candidates and a strong partnership with Roche that many people believe will ultimately lead to Roche buying Pharmasset outright. That seems like a totally plausible scenario to me -- in fact, I'm a bit surprised it hasn't happened yet.
Getting to T.S.' last question, yes, I do think we will see more consolidation and deal making among the Hep C drug makers. Whether the Bristol-Zymogenetics deal is the start of a new wave or just the continuation of an ongoing trend probably doesn't matter a whole lot.
What is undeniable, however, is that the next year or so is going to bring unprecedented -- and positive -- change for Hep C patients. Two new Hep C drugs from Vertex and Merck are likely to be approved and the potential (or lack thereof) of a host of other drugs in earlier stages of testing will come into better focus.
Pharmasset to Present at Two Upcoming Investor Conferences
PRINCETON, N.J., Sept 10, 2010 /PRNewswire via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that management will present at the Morgan Stanley Global Healthcare Unplugged Conference being held September 13 to 14, 2010 at the Grand Hyatt, New York, NY and the Robert W. Baird & Co Healthcare Conference being held September 15 to 16, 2010 at the St Regis, New York, NY. Schaefer Price, Pharmasset's President and Chief Executive Officer, will provide an overview of the company at the Morgan Stanley conference on Tuesday, September 14, 2010 at 8:35 AM (ET) and at the Robert W. Baird & Co conference on Wednesday, September 15, 2010 at 12:45 PM (ET).
To access simultaneous webcasts of Mr. Price's overviews 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 presentations 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 conferences. The investor presentations will be available for download in PDF format immediately following the presentations in the "Events & Presentations" section of the Investor Center on Pharmasset's website at http://investor.pharmasset.com/events.cfm.
About Pharmasset
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http://www.pharmasset.com/
http://finance.yahoo.com/q/ks?s=VRUS
http://moneycentral.msn.com/ownership?Holding=5%25+Ownership&Symbol=VRUS
Pharmasset, Inc., a clinical-stage pharmaceutical company, engages in the discovery, development, and commercialization of drugs to treat viral infections. It focuses on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). The company focuses on three product candidates: Clevudine, an oral pyrimidine nucleoside analog, for the treatment of HBV, which is entering the United States and European Phase III registration clinical trials, and is approved for HBV in South Korea and marketed by Bukwang Pharm. Co., Ltd. under the brand name Levovir; R7128, an oral pro-drug of PSI-6130 for the treatment of HCV, that is in a Phase 1 clinical trial through a strategic collaboration with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc.; and Racivir for the treatment of HIV in combination with other approved HIV drugs that is in a Phase 2 clinical trial. It also engages in the discovery and development of additional antiviral therapeutics using nucleoside chemistry. Pharmasset was founded in 1998 as Pharmasset, Ltd. and changed its name to Pharmasset, Inc. in 2004. The company is headquartered in Princeton, New Jersey.
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