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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
I think the old shelf expired two years from the date it became effective, which was somewhat later than the Jun 2008 filing date.
VRUS files $150,000,000 mixed shelf offering 8/30/2010.
http://files.shareholder.com/downloads/VRUS/1001246220x0xS1193125-10-200593/1301081/1193125-10-200593.pdf
Right now VRUS has $140,000,000 cash on hand so the good news is we know this isn't a funding issue. The stock is well off its 52 week high so it's obvious they aren't trying to take advantage of an over inflated price to sell stock. It's the third time VRUS has looked to raise money in the last 6 months.
Bull case: They are carrying the mixed shelf to defend against a hostile takeover. Perhaps initial discussions have already begun with an acquirer and they are further protecting shareholder (as well as their own) interests. Will we see a deal by the end of the year?
Bear case: Roche intends to drop the INFORM studies due to tox problems with ITMN-191 ,which is partnered with VRUS' RG7128 in a STAT-C combo. Is this VRUS' chance to raise more money before bad news hits?
Neutral case: VRUS is planning to take PSI-7977 into phase 3 testing unpartnered. Perhaps in combination with PSI-938 or PSI-661. Maybe CFO Kurt Leutzinger foresees fewer opportunities for VRUS to raise money going forward in this sick economy as he does today?
The reasoning (or lack of) behind this offering should draw some speculation. Carrying the mixed shelf can be looked at as added leverage in partnering talks for their second generation nukes. My feeling is this is a net positive for VRUS.
Full PR for PSI-7977 2B GT1,2,3
http://investor.pharmasset.com/releasedetail.cfm?ReleaseID=501896
6:52AM Pharmasset initiates Phase 2b clinical trial of PSI-7977 for Chronic Hepatitis C Genotypes 1, 2, and 3 (VRUS) 24.75 : Co initiates Phase 2b clinical trial of PSI-7977 for Chronic Hepatitis C Genotypes 1, 2, and 3. The trial will evaluate PSI-7977 200mg QD and 400mg QD in combination with pegylated interferon alfa 2a and ribavirin, the current standard of care (SOC) in patients with HCV genotype 1 who have not been treated previously.
Credit to poster ghmm on biotech values MB for picking up on this
http://clinicaltrials.gov/ct2/show/NCT01185860
Roche is recruiting for their phase 1 study of ITMN-191 boosted with Ritonavir. Many of us weren't sure if Roche would move forward with this study. This can be looked at as a good news/bad news story.
Good news: Roche hasn't given up on ITMN-191 due to tox problems. This bodes well for the INFORM study to which VRUS' RG7128 is partnered.
Bad news: Adding Ritonavir brings a fourth drug into the mixture which includes SOC. It's disappointing that ITMN-191 needs boosting and its future, and the continuation of the INFORM study, are still in question.
Article noting Pharmasset's ties to Duke University and UNC-Chapel Hill
http://triangle.bizjournals.com/triangle/stories/2010/08/23/story5.html#ixzz0xIPRGOM6
FYI—A link to the latest version of the “HCV: Most Likely to Succeed” compilation is always kept in the iBox at #board-1418.
HCV purine nukes from companies other than VRUS include IDIX’s IDX184 and INHX’s INX-189, both of which are structurally similar to VRUS’ PSI-938 (#msg-48567678).
All I'm able to find is valopicitabine which IDIX discontinued due to adverse events.
Does anyone know of another public company besides VRUS currently developing a purine nucleotide analog for HCV?
Question posed earlier today on the Biotech Values MB. This is in response to a statement made by DueDiligence concerning the INFORM study undertaken by Roche..
D.D.:
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For Roche, dropping the program where ITMN-191 was being added to the SoC ought to be a relatively easy decision. The all-oral INFORM-n program is tricky, however: under the terms of the ITMN-191 license, Roche has financial obligations to ITMN if Roche develops any HCV PI, even if ITMN had nothing to do with it. Thus, Roche may try to combine RG7128 (the nuke from VRUS) with an oral drug from a non-PI class, which incurs no obligations to ITMN.
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Now that VRUS has suggested a dual nuke combo might be all that's needed in a DAA I'm interested in hearing comments from those who feel that a guanine nuke (PSI-938/661) might/might not be Roche's substitute for ITMN-191. CEO Schaefer Price makes an interesting case for a two drug combo suggesting three drugs are needed in HIV therapy because of lifelong treatment but two complimentary nukes might be enough to eradicate the HCV virus. Does anyone feel the guanine program was started after consultation with Roche or did VRUS act independently? My feeling is we are looking at the next generation of SOC.
Anyone that is interested in learning more about VRUS is advised to check the biotech values message board moderated by DewDiligence. His thread HCV: Most Likely to Succeed is a must read for anyone investing in the HCV antiviral space. My hope is future discussion and/or questions concerning VRUS can be more specifically addressed by myself or others on this MB.
Hey Surf1944 are you long VRUS? How do you find the time to surf moderating 136 message boards.
7:02AM Pharmasset: PSI-7977 receives fast track designation from the FDA for the treatment of chronic hepatitis C infection (VRUS) 26.81 : Co has received fast track designation from the U.S. Food and Drug Administration for PSI-7977 for the treatment of chronic hepatitis C virus infection. PSI-7977 is an oral uridine nucleotide analog polymerase inhibitor of chronic hepatitis C. Co recently completed dosing in a 28 day Phase 2a trial to evaluate PSI-7977 in combination with Pegasys plus Copegus in treatment-naive patients chronically infected with chronic hepatitis C genotype 1. Co expects to initiate a 12-week Phase 2b study of PSI-7977 in the fourth quarter of 2010.
6:53AM Pharmasset initiates phase 1b multiple ascending dose clinical trial of PSI-938 in Patients with Chronic Hepatitis C (VRUS) 26.56 : Co announced that safety and pharmacokinetic data from the PSI-352938 ("PSI-938") single ascending dose study support progression to a multiple ascending dose trial with PSI-938, which has initiated dosing. PSI-938 is a guanine nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. This study is designed to assess the safety, tolerability and antiviral activity of PSI-938 monotherapy administered over 7 days in HCV-infected individuals.
Pharmasset to conduct public offering
Pharmasset to conduct public offering of 3.2 million shares
Companies:Pharmasset, Inc..On Tuesday May 11, 2010, 6:21 pm EDT
PRINCETON, N.J. (AP) -- Pharmasset Inc. has begun a public offering of 3.2 million shares of its common stock, the company said Tuesday.
The pharmaceutical company said it will grant underwriters an option to purchase up to 480,000 additional shares.
Pharmasset said it intends to use the net proceeds from the sale of the shares for general corporate purposes, including funding of clinical trials or acquisitions.
Shares of the company rose 82 cents to close at $29.20 Tuesday.
Pharmasset Reports Fiscal Second Quarter 2010 Financial Results
Press Release Source: Pharmasset, Inc. On Wednesday May 5, 2010, 5:27 pm EDT
PRINCETON, N.J., May 5 /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 quarter ended March 31, 2010.
Financial Results
Revenues were $0.3 million during the quarter ended March 31, 2010 compared to $1.9 million for the quarter ended March 31, 2009 and include amortization of up-front and subsequent collaborative and license payments received from Roche. Revenues during the quarter ended March 31, 2009 also include $1.4 million of non-recurring research and development payments from Roche for activities related to holding the IND application for RG7128.
Net cash used in operating activities was $27.3 million for the six months ended March 31, 2010, as compared to $30.7 million for the six months ended March 31, 2009. Net cash used in operating activities for the three months ended March 31, 2010 was $12.8 million. Pharmasset had $61.0 million in cash and cash equivalents as of March 31, 2010.
Total operating expenses for the quarter ended March 31, 2010 were $15.7 million as compared to $16.6 million for the same period in 2009. The decrease in operating expenses for the quarter ended March 31, 2010 was primarily the result of discontinuing our clevudine program in April 2009, partially offset by increases in development costs for PSI-7977, PSI-938 and PSI-661.
Pharmasset reported a net loss of $16.1 million, or $0.54 per share, for the quarter ended March 31, 2010, as compared to a net loss of $15.5 million, or $0.59 per share, for the quarter ended March 31, 2009.
Recent Operational Highlights:
•On February 17, 2010, Pharmasset announced that its partner Roche completed enrollment of the RG7128 phase 2b study (PROPEL), enrolling approximately 400 treatment naïve patients with hepatitis C virus (HCV) genotypes 1 and 4. The PROPEL study is investigating a 12 week duration of RG7128 with the standard of care (SOC), followed by an additional 12 weeks of SOC. The last patient enrolled in this study is to receive his or her last dose of RG7128 or placebo in early May.
•Roche has also initiated a second phase 2b trial investigating 24 weeks of treatment with RG7128 and SOC. This trial has completed enrollment of approximately 180 treatment naïve patients with hepatitis C virus (HCV) genotypes 1 and 4.
•The PROPEL and 24 week studies have been amended so that patients that failed treatment with placebo and SOC will receive RG7128 1000mg BID for 24 weeks followed by 24 weeks of SOC, starting in 3Q10.
•On April 8, 2010, Pharmasset announced that it had initiated a phase 1 study with PSI-938 for the treatment of HCV.
•On April 15, 2010, Pharmasset presented follow-up data from the 28 day study with RG7128 in genotype 2 and 3 non-responder patients, demonstrating a 65% SVR. Of those patients that received 48 weeks of therapy 90% achieved an SVR. Further in vitro data was presented on the combination of PSI-7977 and PSI-938 at the European Association for the Study of the Liver (EASL) meeting in Vienna, Austria
•On May 4, 2010, Pharmasset announced efficacy and preliminary safety results from its 28-day Phase 2a study of PSI-7977 dosed once daily (QD) in combination with SOC in patients with HCV genotype 1 who have not been treated previously. On an intent-to-treat analysis, patients receiving PSI-7977 100mg QD, 200mg QD or 400mg QD in combination with SOC achieved RVR rates of 88%, 94% and 93%, respectively, compared to 21% in the placebo plus SOC arm. Preliminary safety and tolerability across all doses were comparable to placebo administered with SOC.
"Pharmasset had a very productive start to 2010." stated Schaefer Price, President and Chief Executive Officer, "as we recently reported positive Phase 2a results for our PSI-7977 program demonstrating high RVR rates in patients, consistent with RVR rates previously reported for RG7128. Safety results to date from both compounds are encouraging. During the quarter, we also advanced our first of two guanine nucleotide analogs, PSI-938, into the clinic. Based on the data from our compounds, we believe our nucleoside/tide analogs continue to differentiate themselves as a class of direct acting antivirals for the treatment of HCV and we look forward to reporting updates for our programs throughout the rest of 2010."
Calendar Year 2010 Anticipated Milestones:
•Roche expects to initiate a Phase 2b study of RG7128 in combination with SOC in patients with HCV genotypes 2 and 3 in the second half of 2010
•Pharmasset expects to present the PSI-7977 Phase 2a data at a scientific meeting later in 2010
•Pharmasset expects to initiate 12-week Phase 2b study of PSI-7977 in the fourth quarter of 2010
•Pharmasset expects to report top line Phase 1 antiviral data for PSI-938 in the third quarter of 2010
•Pharmasset expects to submit an IND or foreign regulatory equivalent for its second guanine nucleotide, PSI-661 (formerly PSI-879), in the fourth quarter of 2010
7:41AM Pharmasset stated that the development of RG7128 is on track, and that no safety or other concerns have delayed the program. (VRUS) 32.74 : VRUS, in response to certain inaccuracies in an article published by PharmaWire on May 3, 2010 about its development program for treatment of hepatitis C virus (HCV) in collaboration with Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd, stated today that the development of RG7128 is on track, and that no safety or other concerns have delayed the program.
7:06AM Pharmasset announces results of a 28-day phase 2a study with PSI-7977 for the treatment of chronic hepatitis C infection (VRUS) 32.74 : Co announced today the preliminary safety results from its 28 day phase 2a study with PSI-7977 dosed once daily combhined with Pegasys and Copegus. PSI-7977 demonstrated potent short term antiviral activity and was generally safe and well tolerated. All patients receiving active PSI-7977 demonstrated continuous and substantial declines in HCV RNA with no viral breakthrough during 28 days of therapy at any dose.
Pharmasset Announces Interim Data from an Ongoing 28-day Phase 2a Study with PSI-7977 for the Treatment of Chronic Hepatitis C Infection
Press Release Source: Pharmasset, Inc. On Thursday April 15, 2010, 4:41 am EDT
PRINCETON, N.J., April 15 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announced today interim efficacy and safety results from its ongoing 28-day phase 2a study with PSI-7977 dosed once daily in combination with Pegasys® (peginterferon alfa 2a) and Copegus® (ribavirin) in patients with hepatitis C virus (HCV) genotype 1 who have not been treated previously. PSI-7977 is Pharmasset's nucleotide analog for the treatment of HCV. The Company announced the interim results in conjunction with the European Association for the Study of Liver Congress that commenced in Vienna, Austria on April 14, 2010.
Interim Safety and Efficacy Data
The study is fully enrolled with 63 patients. Thirty-eight patients have completed 28 days of therapy, out of which, eight of ten patients receiving 100mg QD, nine of nine patients at 200mg QD doses, and ten of eleven patients receiving the 400 mg QD dose, have achieved a Rapid Virologic Response (RVR), defined as an undetectable HCV viral load (<15 IU/ml) as measured by Roche HCV TaqMan assay 28 days after the initiation of treatment.
Interim 28-day RVR efficacy data from the trial are summarized as follows:
Study Arm
Patients with Undetectable Viral Load (<15 IU/ml) at Day 28
100mg PSI-7977 QD + Pegasys + Copegus
8 of 10
200mg PSI-7977 QD + Pegasys + Copegus
9 of 9
400mg PSI-7977 QD + Pegasys + Copegus
10 of 11
Pegasys + Copegus
2 of 8
"To date, this drug candidate appears safe and well tolerated" stated M. Michelle Berrey, M.D., MPH, Chief Medical Officer of Pharmasset. This study is ongoing and Pharmasset anticipates reporting the complete data set for all dosing cohorts through day 28 later this quarter.
About the Phase 2a trial
The Phase 2a trial is completely enrolled with 63 chronic hepatitis C infected patients who have not been treated previously. The primary goal of the study is to determine the safety and tolerability of PSI-7977 in combination with pegylated interferon and ribavirin. The primary efficacy endpoint of the trial will be the proportion of patients who achieve an RVR. Patients will continue to be followed through a Sustained Virologic Response (SVR) endpoint. Patients were randomized to receive one of four treatments:
•16 subjects taking PSI-7977 100mg QD in combination with Pegasys® and Copegus® for four weeks, followed by 44 weeks of Pegasys® and Copegus®
•18 subjects taking PSI-7977 200mg QD in combination with Pegasys® and Copegus® for four weeks, followed by 44 weeks of Pegasys® and Copegus®
•15 subjects taking PSI-7977 400mg QD in combination with Pegasys® and Copegus® for four weeks, followed by 44 weeks of Pegasys® and Copegus®
•A control arm of 14 subjects taking only Pegasys® and Copegus®
http://finance.yahoo.com/news/Pharmasset-Announces-Interim-prnews-3133874973.html?x=0&.v=1
7:34AM Pharmasset discusses follow up data; nucleoside RG7128 in combination with SOC is effective in retreatment of HCV genotype 2/3 relapsers/nonresponders (VRUS) 27.94 : Co announces the oral presentation of new sustained virologic response (SVR) follow-up data in hepatitis C virus (HCV) genotype 2 and 3 non-responder patients treated for 28 days with RG7128 in combination with the standard of care (SOC), Pegasys and Copegus, and presentation of an in vitro combination study with PSI-7977 and PSI-938. Both presentations are at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria (April 14-18, 2010). Data from this trial suggest that the nucleoside RG7128 in combination with SOC is effective in retreatment of HCV genotype 2/3 relapsers/nonresponders and may provide an attractive option for treatment of prior non-responders and treatment-naive patients with HCV genotype 2/3. Larger studies are required to confirm these findings, determine the optimal duration of RG7128 therapy, and evaluate utility in treatment-naive genotype 2/3 patients. On April 17, Dr Veronique Zennou, a Pharmasset scientist, will present a poster entitled "Combination of two complementary nucleotide analogues PSI-7977 and PSI-938 effectively clears wild type and NS5B S282T HCV replicons - comparison with combinations of other antiviral compounds" (Poster 1034). The data indicate that in vitro combinations of two nucleotides targeting NS5b effectively suppress resistant replicons with no emergence of resistance. The poster will include comparative data on combinations of other direct acting antivirals (DAA) targeting different HCV proteins.
Pharmasset Initiates First Time in Human Study of PSI-938 for the Treatment of Hepatitis C
Press Release Source: Pharmasset, Inc. On Thursday April 8, 2010, 7:30 am EDT
PRINCETON, N.J., April 8 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq:VRUS - News) announced today that dosing has initiated in a phase 1, single ascending dose (SAD) study in healthy volunteers with PSI-938, a third generation purine nucleotide analog polymerase inhibitor of hepatitis C virus (HCV). Pharmasset recently filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA).
"PSI-938 is our first purine nucleotide analog to move into clinical development," stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "As PSI-938's resistance profile is different from other nucleoside/tides in development for HCV and it has a different metabolic pathway from pyrimidine analogs, such as RG7128 and PSI-7977, we believe PSI-938 could be potentially combined with other nucleosides in development to deliver a pan-genotype regimen. We look forward to reporting the first antiviral data with PSI-938 in the third quarter of 2010."
Purine and Pyrimidine Analogs
Purine nucleoside/tide analogs have many of the benefits of pyrimidine nucleoside/tide analogs, such as RG7128 and PSI-7977, in that they have demonstrated in vitro activity across multiple HCV genotypes, have a higher barrier to resistance than other classes of HCV small molecules in development, and have a lower risk of drug interactions when combined with other direct acting antivirals targeting HCV. In addition, Pharmasset's purine analogs retain activity against the S282T mutation associated with in vitro resistance in other nucleoside/tide analogs in development, and are metabolized to the active triphosphate form through a different phosphorylation pathway than the pyrimidine analogs. Given these characteristics, Pharmasset's purine and pyrimidine analogs have the potential to be combined as part of a future treatment regimen.
4:16PM Pharmasset announces complete enrollment of RG7128 Phase 2b clinical study (VRUS) 22.97 +0.17 : The co announces the complete enrollment by Roche of the 12 week RG7128 Phase 2b study (PROPEL) of approximately 400 treatment-naive patients with hepatitis C virus (HCV) genotypes 1 and 4. The study remains blinded to Roche and Pharmasset. Roche has initiated a 24 week Phase 2b study with RG7128 in combination with pegylated interferon and ribavirin in treatment-na?ve patients with HCV genotypes 1 and 4 in order to evaluate the safety and efficacy of RG7128 in combination with standard of care for longer durations. The data from this study could provide the flexibility for combining RG7128 with direct acting antivirals currently in development with varying durations of therapy. This study is currently enrolling at sites in the US and Canada and is expected to complete enrollment in the second quarter. In addition, Roche is planning to initiate a Phase 2b study of RG7128 in combination with pegylated interferon and ribavirin in patients with HCV genotypes 2 and 3 later in 2010... Roche has also announced that it will not conduct the previously planned 28 day INFORM-2 study, designed to evaluate the combination of RG7128 with RG7227, InterMune's (ITMN) HCV protease inhibitor, with and without pegylated interferon and ribavirin
4:16PM Pharmasset reports 1Q10 results (VRUS) 22.68 +0.40 : Pharmasset reports 1Q10 earnings of ($0.49) vs ($0.43) First Call consensus; revs $0.3 mln vs $1.77 mln First Call consensus. "Pharmasset continues to make solid progress across all of its clinical programs." stated Schaefer Price, President and Chief Executive Officer. "2010 is shaping up to be an important year for the company with phase 2a data from our proprietary PSI-7977 program and phase 1 data with our first purine analog, PSI-938, coming in the third quarter. We believe nucleoside/tide analogs have the potential to become the backbone of treatment regimens, not only for genotype 1, but also across a broad range of HCV genotypes. We look forward to reporting data from all our programs throughout 2010."
Pharmasset Announces Proposed Public Offering of Common Stock
Press Release Source: Pharmasset, Inc. On Wednesday January 27, 2010, 4:49 pm EST
PRINCETON, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that it has commenced an underwritten public offering, subject to market and other conditions, of $30,000,000 of its common stock pursuant to effective shelf registration statements. Pharmasset intends to grant to the underwriters a 30-day option to purchase up to an additional $4,000,000 of common stock. Leerink Swann LLC is acting as sole book-running manager for the offering.
Pharmasset intends to use the net proceeds from the sale of the shares for general corporate purposes, which include, but are not limited to, the funding of clinical trials, the funding of in-licensing agreements for product candidates, 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 pursuant to registration statements previously filed with and subsequently declared effective by the Securities and Exchange Commission. The transaction is subject to customary closing conditions.
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 by calling Leerink Swann, toll free, at 1-800-808-7525, Ext. 4814.
Pharmasset Initiates Phase 2a Trial with PSI-7977, a Chirally Pure Isomer of PSI-7851
Press Release Source: Pharmasset, Inc. On Thursday January 21, 2010, 7:00 am EST
PRINCETON, N.J., Jan. 21 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS) today announces the initiation of a 28-day Phase 2a study with PSI-7977, a chirally pure isomer form of PSI-7851, a nucleotide analog polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV). The trial will evaluate various doses of PSI-7977 in combination with Pegasys (peginterferon alfa 2a) and Copegus (ribavirin) in patients with HCV genotype 1 who have not been treated previously.
"We recently reported encouraging clinical results with PSI-7851," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We now believe there are a number of advantages in moving forward with a chirally pure isomer of PSI-7851, PSI-7977, including improvements in manufacturing. We look forward to reporting interim data from the Phase 2a trial in the third quarter of 2010, and hope to rapidly progress PSI-7977 into longer-term studies to demonstrate the safety and efficacy of the nucleosides/tides in all HCV genotypes."
About PSI-7977
PSI-7851 is a mixture of two molecules of identical chemical composition, PSI-7976 and PSI-7977, which only differ in the stereo-orientation of one of the atoms. Once inside a liver cell, both molecules are rapidly converted to the same active triphosphate. Given the greater improvements in manufacturing and better in vitro potency, PSI-7977 was selected for further clinical development. A superior formulation in the form of a tablet has been developed and has recently been evaluated in a Phase 1 study in healthy volunteers. The 28 day Phase 2a trial using the improved manufacturing process and tablet formulation has now been initiated and interim results from this study are anticipated in the third quarter of 2010.
About the Phase 2a trial
The Phase 2a trial is expected to enroll about 60 patients with chronic hepatitis C infection who have not been treated previously. The primary goal of the study is to determine the safety and tolerability of PSI-7977 in combination with pegylated interferon and ribavirin. The primary efficacy endpoint of the trial will be the proportion of patients who achieve a rapid virologic response (RVR), defined as undetectable levels of HCV (measured by TaqMan assay) four weeks after the initiation of treatment. Patients will continue to be followed through a Sustained Virologic Response (SVR) endpoint. Patients will be randomized to receive one of four treatments:
PSI-7977 100mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus
PSI-7977 200mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus
PSI-7977 400mg QD in combination with Pegasys and Copegus for four weeks, followed by 44 weeks of Pegasys and Copegus
A control arm with Pegasys and Copegus
Pharmasset Reports Fiscal Year End 2009 Financial Results
Press Release
Source: Pharmasset, Inc.
On 4:30 pm EST, Wednesday November 25, 2009
PRINCETON, N.J., Nov. 25 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported financial results for the fiscal year ended September 30, 2009. At September 30, 2009 Pharmasset held $58.4 million in cash, cash equivalents and short term investments.
Pipeline Update and 2009 Highlights
RG7128
Phase 2b Trial
In late November 2009, an independent Data Monitoring Committee (DMC) reviewed the safety and efficacy data from the first approximately 100 patients in cohort 1 and concluded that based on these data the remaining approximately 300 patients can be safely enrolled in the phase 2b study. The DMC reviewed any potential drug discontinuations, incidence and details of adverse events, and selected laboratory assessments. No safety events in the DMC review were considered significantly different from those expected from HCV patients taking peginterferon and ribavirin treatment. The DMC did not recommend modification of dose or duration of any RG7128 dosing regimens. Enrollment of these patients pre-screened for this cohort in the fourth quarter of 2009 has begun and is expected to be complete by the end of the first quarter of 2010.
This phase 2b trial is anticipated to enroll approximately 400 treatment-naive, genotype-1 or genotype-4 HCV-infected patients. The five arm trial, initiated in April 2009, is evaluating the dose and duration of RG7128 in combination with peginterferon plus ribavirin. The primary efficacy endpoint of the trial is the proportion of patients that achieve a sustained virologic response (SVR).
In the first quarter 2010, Roche plans to initiate longer duration, phase 2b studies with RG7128 in combination with peginterferon and ribavirin. An additional study in patients infected with HCV genotypes 2 and 3 is being planned to initiate later in 2010.
INFORM-1 Trial
In November 2008, Roche initiated the INFORM-1 trial, a ground-breaking study to investigate the activity of a combination of two oral antiviral molecules in the absence of interferon and ribavirin. The study investigated the combination of Pharmasset's RG7128 with InterMune's RG7227, an HCV protease inhibitor.
In April 2009, Pharmasset, Roche and InterMune reported interim results from this study at the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. These interim results demonstrated for the first time that the combination of an oral protease inhibitor and an oral nucleoside polymerase inhibitor resulted in significant HCV viral load reduction in patients with HCV over 13 days of dosing of the combination of RG7227 and RG7128 (without peginterferon or ribavirin). No treatment-related serious adverse events, no dose reductions and no discontinuations were reported during the study. Pharmacokinetic analysis confirmed that there were no drug-drug interactions between the compounds.
Roche expects to initiate a Phase 2 program of multiple INFORM studies during the first calendar quarter of 2010. Roche expects these INFORM-2 studies to investigate rapid virologic response (RVR) achieved by twice-daily dosing of RG7128 and RG7227 alone, in combination with peginterferon, in combination with ribavirin, or in combination with both peginterferon and ribavirin. Roche expects to initiate longer term studies evaluating SVR during the first half of 2010.
PSI-7851
PSI-7851 is a pro-drug of a pyrimidine nucleotide analog polymerase inhibitor and is currently in development for the treatment of chronic HCV infection. During March 2009, we initiated a Phase 1 study for PSI-7851. A single ascending dose study was conducted that assessed the safety, tolerability and pharmacokinetics of PSI-7851 in healthy subjects at doses ranging from 25mg to 800mg. PSI-7851 was found to be generally safe and well tolerated and, therefore, was advanced into a multiple ascending dose trial.
In June 2009, we initiated a phase 1 multiple ascending dose (MAD) study in HCV-infected patients. Subjects were enrolled at two U.S. centers and randomized to PSI-7851 (8 per cohort) or placebo (2 per cohort). Final results from the MAD study were presented in a late breaker poster at AASLD on November 2, 2009. In the MAD study, PSI-7851 was generally safe and well tolerated across all cohorts with no discontinuations, no serious adverse events, and no dose-related trends in adverse events or laboratory abnormalities. Further, PSI-7851 demonstrated dose-dependent potent antiviral activity with a maximum mean HCV RNA decrease of 1.95 log10 IU/mL in patients receiving 50mg QD, 100mg QD, 200mg QD and 400mg QD administered for 3 days.
PSI-938 and PSI-879
During 2009, we nominated two development candidates from our purine nucleotide analog polymerase inhibitor program for the treatment of chronic HCV. In June 2009, we nominated PSI-938 for further pre-clinical development required for an application with the FDA or equivalent foreign regulatory agency to begin clinical studies. Our plan is to submit an IND, or its foreign equivalent, during the first calendar quarter of 2010.
In September 2009, we nominated a second purine nucleotide analog, PSI-879, for pre-clinical development. PSI-879 differs from PSI-938 in the prodrug technology that it employs. We anticipate filing an IND, or its foreign equivalent, for PSI-879 in the fourth quarter of 2010.
Termination of Clevudine Registration Trials
On April 20, 2009, following consultations with our independent Data Safety Monitoring Board and the FDA, we voluntarily terminated our phase 3 studies of clevudine after we became aware of a number of spontaneous Serious Adverse Event reports and Events of Special Interest in patients receiving clevudine as prescribed therapy for HBV in South Korea, where the drug is marketed by Bukwang under the trade name Levovir, and in Hong Kong, where clinical studies were being conducted under the sponsorship of Bukwang. Given the number and severity of cases observed in South Korea and Hong Kong, we determined it was in the best interest of patients to voluntarily terminate our registration studies. All patients have now completed the follow-up period and we anticipate concluding activities by the end of the quarter ending December 31, 2009.
"Pharmasset has had a tremendous year on all fronts," said Schaefer Price, Pharmasset's President and CEO. "In collaboration with Roche, we are advancing our first in class nucleoside analog, RG7128, through a phase 2b trial and also exploring the paradigm-changing model of an all oral (interferon sparing) regimen for HCV. We reported best in class results with our second generation nucleotide analog inhibitor, PSI-7851 and anticipate starting phase 2a trials in the first quarter 2010. We believe nucleosides/tides will have an advantage in the marketplace when used with the current standard of care, due to their high RVR rates, pan-genotype activity and high barrier to resistance. In the future, as we move towards oral combinations, we believe our nucleoside/tides have the potential to be used in combination with one another and with other classes of direct acting antivirals."
Financial Results
For the fiscal year ended September 30, 2009 Pharmasset reported revenues of $13.3 million, compared with revenues of $1.9 million for the fiscal year 2008. 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 the fiscal year 2009.
Total costs and expenses for the fiscal year ended September 30, 2009 were $65.9 million, of which $26.7 million was associated with clevudine. This compares to $56.3 million for the same period in 2008, of which $26.5 million was related to clevudine. The increased operating expenses for fiscal year 2009 were primarily the result of an increase in preclinical and clinical trial expenses for PSI-7851 for the treatment of chronic HCV infection.
Pharmasset reported a net loss attributable to common stockholders of $55.6 million, or $2.10 per share, as compared to a net loss attributable to common stockholders of $54.7 million, or $2.51 per share for the same period in 2008.
Calendar Year 2010 Anticipated Milestones
-- Roche anticipates completion of enrollment for Cohort 2 in the RG7128 phase 2b trial by the end of first quarter of 2010
-- We expect to initiate phase 2a trial with PSI-7851 in the first quarter of 2010 with interim data in the third quarter 2010
-- Roche expects to initiate INFORM-2 in first quarter 2010
-- We expect to file an IND for PSI-938 in first quarter of 2010
-- Roche expects to initiate longer duration, phase 2b studies with RG7128 in combination with pegylated interferon and ribavirin in first half of 2010
-- Roche expects to initiate longer duration INFORM studies to investigate SVR in the first half of 2010
-- We expect to initiate phase 1 trial with PSI-938 in first quarter of 2010 with interim data in the third quarter 2010
-- Roche expects to initiate a phase 2 study in genotype 2 and 3 HCV patients with RG7128 in the second half of 2010
-- We expect to file an IND for PSI-879 in fourth quarter of 2010
Pharmasset Nominates PSI-879 as a New Nucleotide Analog Inhibitor of Hepatitis C for Preclinical Development
- IND or foreign regulatory equivalent submission anticipated in fourth quarter of 2010
Press Release
Source: Pharmasset, Inc.
On 7:00 am EDT, Tuesday October 6, 2009
Companies:Pharmasset, Inc.
PRINCETON, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announced today the nomination of PSI-352879 (PSI-879) as a second development candidate from two series of purine analogs for the treatment of chronic hepatitis C virus (HCV) infection. PSI-879 is a proprietary nucleotide analog polymerase inhibitor of HCV that is being advanced into studies required for submission of an Investigational New Drug (IND) application with the FDA or equivalent foreign regulatory application.
"PSI-879 employs a different prodrug technology than our lead purine nucleotide, PSI-938. We plan to submit an IND for PSI-938 in the first quarter of 2010" stated Michael Otto, PhD, Pharmasset's Chief Scientific Officer. "We now are in a position to have two opportunities to develop a purine and pyrimidine nucleoside/tide combination. We believe in addition to being used in combination, our nucleoside/tide analogs also have the potential to be combined with other classes of direct acting antivirals for HCV."
Preclinical data demonstrate that purine nucleotide analogs have many of the benefits of pyrimidine nucleoside/tide analogs, such as RG7128 and PSI-7851, by demonstrating in vitro activity across multiple genotypes, a higher barrier to resistance than other classes of HCV small molecules in development, and the potential to be combined with other direct acting antivirals targeting HCV. In addition, these purine analogs are also active against the S282T resistant variant selected in vitro by the pyrimidine analogs and are metabolized to the active triphosphate form through a different phosphorylation pathway than the pyrimidines. Given these characteristics, purine and pyrimidine analogs have the potential to be combined as part of a future treatment regimen.
Pharmasset VRUS Robert W. Baird upgraded from Neutral to Outperform $16 to $30
Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C
- PSI-7851 achieves a 1 log(10) reduction in HCV RNA after 3 days of monotherapy - No discontinuations or serious adverse events reported - Conference call at 8:00 AM ET today
Press Release
Source: Pharmasset, Inc.
On Friday July 31, 2009, 7:00 am EDT
Companies:Pharmasset, Inc.
PRINCETON, N.J., July 31 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) reported today positive preliminary results from its phase I clinical trial of PSI-7851 for the treatment of hepatitis C (HCV). PSI-7851 is a second generation nucleotide polymerase inhibitor of HCV.
PSI-7851 Phase 1 Multiple Ascending Dose Study Overview
In June 2009, Pharmasset initiated a phase 1 multiple ascending dose study with PSI-7851. The trial was conducted at two US centers, as a blinded, randomized, and placebo-controlled study, in 30 patients chronically infected with HCV genotype 1. The primary objective was to assess the safety, tolerability, and pharmacokinetics of PSI-7851 after once-daily (QD) dosing for 3 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA. Patients were randomized to receive either PSI-7851 (8 patients per cohort) or placebo (2 patients per cohort). Three dose cohorts of PSI-7851 (50mg QD, 100mg QD, 200mg QD) were evaluated.
PSI-7851 Antiviral Activity Summary
Preliminary Antiviral Response Observed Following PSI-7851 Administered as
Monotherapy for 3 Days
--------------------------------------------------------------------------
Dose N Mean Change in HCV RNA at Day 3
(Log(10))
--------------------------------------------------------------------------
50mg QD 8 -0.49
100mg QD 8 -0.61
200mg QD 8 -1.01
Placebo 6 -0.03
--------------------------------------------------------------------------
PSI-7851 demonstrated potent antiviral activity with a mean HCV RNA decrease of -0.49 log(10) IU/mL, -0.61 log(10) IU/mL and -1.01 log(10) IU/mL in patients receiving 50mg QD, 100mg QD, and 200mg QD, respectively.
PSI-7851 Pharmacokinetic and Safety Summary
Pharmacokinetics were similar between healthy subjects in the single ascending dose study and HCV infected patients in the multiple ascending dose study. PSI-7851 was generally safe and well tolerated across all cohorts with no discontinuations. There were no serious adverse events and no dose-related trends in adverse events or laboratory abnormalities.
"We are very encouraged by the preliminary efficacy and safety data with PSI-7851, our second generation nucleotide analog," said Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "The data from these first three cohorts demonstrate that we have achieved our goal of identifying a nucleotide analog with good efficacy that can be administered once daily at a low milligram dose. Given these characteristics and the potential benefits of nucleotide analogs over other classes of HCV direct acting antivirals, we continue to believe that PSI-7851 could become a key component of any future combination treatment regimen for HCV."
Conference Call and Webcast
Members of Pharmasset's management team will host a conference call today, Friday, July 31, 2009, at 8:00 a.m. ET to discuss the preliminary results of the multiple ascending dose trial with PSI-7851. Investors may listen to the webcast of the conference call live on the "Events & Presentations" section of Pharmasset's website, www.pharmasset.com. Alternatively, investors may listen to the call by dialing (888) 806-6208 from locations in the U.S. and (913) 312-0640 from outside the U.S. The webcast replay will be available for at least 72 hours following the call.
About PSI-7851
PSI-7851 is a uridine nucleotide analog currently in development for the treatment of chronic HCV infection. PSI-7851 has demonstrated potent in vitro anti-HCV activity with EC(90) values of 31 +/- 12 nM, which is approximately 15-fold more potent than Pharmasset's first generation nucleoside polymerase inhibitor, RG7128 (formerly known as R7128). In vitro studies of PSI-7851 have not shown evidence of any mitochondrial or other cellular toxicities that may be associated with some nucleoside analogs. Like RG7128, PSI-7851 has demonstrated pan genotype activity in vitro.
7:03AM Pharmasset nominates PSI-938 as a new nucleotide analog inhibitor of hepatitis C for preclinical development (VRUS) 11.22 : Co announces the nomination of PSI-352938 as a lead development candidate from two series of purine analogs for the treatment of chronic hepatitis C virus infection. PSI-938 is a proprietary nucleotide analog polymerase inhibitor of HCV that is being advanced into studies required for submission of an Investigational New Drug application with the FDA or equivalent foreign regulatory application.
Pharmasset Reports Preliminary Results of a 4-week Proof-of-Concept Combination Study of R7128 for the Treatment of Chronic Hepatitis C in Genotype 2 or 3 Non-Responders
Monday September 8, 7:00 am ET
- 90% of genotype 2 or 3 patients achieve undetectable HCV RNA levels following 4 weeks of treatment with R7128 1500mg BID with Pegasys(R) plus Copegus(R) -
- Safety and tolerability comparable to placebo administered with Pegasys plus Copegus -
PRINCETON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announces the preliminary results of the fourth cohort of a 4-week Phase 1 proof-of-concept clinical trial evaluating R7128 1500mg twice daily (BID) in combination with the standard of care (SOC), Pegasys® (pegylated interferon) plus Copegus® (ribavirin) in 20 patients chronically infected with hepatitis C virus (HCV) genotype 2 or 3 who had not achieved a Sustained Viral Response (SVR) with prior SOC therapy. R7128, a prodrug of PSI-6130, is a nucleoside analogue polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche.
In this study, preliminary results indicated that R7128 demonstrated significant short-term antiviral activity in patients who were previous non-responders or relapsers to treatment and was generally safe and well tolerated. Of the 25 patients enrolled, 20 patients received R7128 1500mg BID and 5 received placebo. Patients receiving R7128 1500mg BID with SOC for 4 weeks achieved a mean 5.0 log10 HCV RNA decline and 90% (18 of 20) achieved undetectable (<15 IU/ml) HCV RNA levels (RVR). Patients receiving placebo with SOC for 4 weeks achieved a mean 3.7 log10 HCV RNA decline and 60% (3 of 5) achieved an RVR. These viral load reductions for patients with genotype 2 or 3 are similar to those reported earlier for patients with genotype 1 treated with 1000mg BID and 1500mg BID and are consistent with the in vitro data demonstrating equal potency by R7128 against HCV genotypes 1, 2, 3 and 4.
The preliminary safety and tolerability of R7128 1500mg BID with SOC was comparable to placebo with SOC in Cohort 4.
Dr. Michelle Berrey, Pharmasset's Chief Medical Officer stated, "In this study, R7128, in combination with SOC, has demonstrated significant antiviral activity in genotype 2 or 3 patients who had failed prior interferon-based therapy. R7128, an HCV nucleoside polymerase inhibitor, may provide better antiviral activity in these patients where the protease inhibitors and non-nucleoside polymerase inhibitors have not yet shown success. Longer-term studies of R7128 with SOC are needed to provide additional information about its potential to improve SVR rates and possibly shorten the treatment duration for genotype 2 or 3 HCV patients."
"Patients with genotype 2 or 3 represent 20-30% of the worldwide chronically infected HCV population. Up to 40% of these patients, using SOC in first line therapy for 24 weeks, do not achieve an SVR, which represents an unmet medical need that R7128 has the potential to address," stated Patrick Higgins, Pharmasset's Executive Vice President of Sales and Marketing. "R7128 is the first small molecule to demonstrate significant antiviral activity in humans against a broad spectrum of HCV genotypes. If this early evidence of competitive advantage is sustained in future development, this potentially means that R7128 could become the preferred direct-acting antiviral to be added to the SOC because it is equally active across all of the most common genotypes and has a high barrier to drug resistance."
R7128 4-week Combination Study Overview
The 4-week Phase 1 combination clinical trial was a multiple center, observer-blinded, randomized and placebo-controlled study that was conducted in 81 treatment-naive patients chronically infected with HCV genotype 1 and 25 prior treatment non-responder patients chronically infected with HCV genotype 2 or 3. The primary objective was to assess the safety, tolerability, pharmacokinetics and antiviral activity of R7128 in the clinically-relevant setting of combination therapy for chronic HCV infection. Cohort 1 administered R7128 500mg BID, Cohort 2 administered R7128 1500mg BID, and Cohort 3 administered an intermediate dose of 1000mg BID, all given in combination with pegylated interferon and ribavirin for 28 days. All subjects then went on to receive a total of 48 weeks of the standard-of-care regimen. In Cohort 4, patients with HCV genotype 2 or 3 who did not achieve an SVR with previous interferon-based therapy were administered R7128 1500mg BID in combination with SOC for 4 weeks, and subsequently treated with an additional 20 weeks of SOC.
About R7128
R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule. R7128 has shown in vitro activity against all of the most common HCV genotypes (1, 2, 3 and 4).
Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 demonstrated significant, dose-dependent antiviral activity across four prior treatment-failure patient cohorts (n=40) receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in HCV RNA from baseline was demonstrated in the patient cohort that received 1500 mg twice-daily, the highest dose of R7128 administered in the study. These patients demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of the development of viral resistance in any dose cohort after 14 days of dosing.
In a 4-week Phase 1 combination study that was conducted in 81 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated significant short-term antiviral activity with safety and tolerability comparable to placebo with SOC. Results from the 500mg, 1500mg and 1000mg dose cohorts (cohorts 1, 2 and 3) in 81 treatment-naive patients chronically infected with HCV genotype 1 indicated:
Preliminary results with R7128 1000mg BID with SOC indicated patients achieved a mean 5.0 log10 IU/mL decrease in HCV RNA and 88% (22 of 25) patients achieved RVR.
Results with R7128 1500mg BID with SOC indicated patients achieved a mean 5.1 log10 IU/mL decrease in HCV RNA and 85% (17 of 20) patients achieved RVR
Results with R7128 500mg BID with SOC indicated patients achieved a mean 3.8 log10 IU/mL decrease in HCV RNA and 30% (6 of 20) patients achieved RVR.
Results with placebo with SOC indicated patients achieved a mean 2.9 log10 IU/mL decrease in HCV RNA and 18.75% (3 of 16) patients achieved RVR
Pharmasset Reports Financial Results for Quarter Ended June 30, 2008
Thursday August 14, 4:01 pm ET
PRINCETON, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported unaudited financial results for the third fiscal quarter ended June 30, 2008. Pharmasset reported a net loss attributable to common stockholders of $15.0 million, or a loss per share of $0.69 for the quarter ended June 30, 2008, as compared to a net loss attributable to common stockholders of $7.1 million, or a loss per share of $0.40 per share for the same period in 2007.
Revenues were $0.5 million during the quarters ended June 30, 2008 and 2007 and reflect amortization of up-front and subsequent collaborative and license payments received from Roche previously recorded as deferred revenue. Total costs and expenses for the quarter ended June 30, 2008 were $15.0 million, as compared to $7.1 million for the same period in 2007. The $7.9 million increase in total costs and expenses during the quarter ended June 30, 2008 was primarily due to a $5.8 million increase in Phase 3 clinical trial expenses to support registration of clevudine for the treatment of chronic hepatitis B virus (HBV) infection, a $1.0 million increase in compensation expense resulting from increased headcount, a $0.4 million increase in new drug discovery expenses, and a $0.7 million increase in marketing and other administrative expenses. Investment income decreased to $0.2 million during the quarter ended June 30, 2008 from $0.7 million in the quarter ended June 30, 2007, primarily on lower rates of return on invested balances. Interest expense increased to $0.7 million during the quarter ended June 30, 2008 from $0.0 million in the year-ago quarter. The increase was due to interest on the $20.0 million of debt incurred during October 2007 and March 2008.
As of June 30, 2008, Pharmasset had approximately $51.0 million of cash and cash equivalents and approximately $1.0 million of short-term investments.
"We have made solid progress across all aspects of our business in this last quarter. The ANRS sponsored study investigating clevudine in combination with Viread® in HBV is a very exciting study for us and reflects the potential movement of the marketplace toward combination therapy," stated Schaefer Price, Pharmasset's Chief Executive Officer. "In addition, we have made substantial progress in our HCV programs with the recent clinical data from R7128 and our nomination of PSI-7851 as a next-generation lead product candidate to be advanced into clinical development. This progress allows us to maintain a well-balanced and growing portfolio of hepatology product candidates", added Mr. Price. "We look forward to the unblinding of our R7128 genotype 2/3 patient data and hope to see data that is consistent with the antiviral activity we see in genotype 1 patients."
Highlights of the Quarter Ended June 30, 2008
-- Commenced dosing two additional cohorts of a 4-week Phase 1 study of
R7128 in combination with Pegasys® (peginterferon alfa-2a) plus
Copegus® (ribavirin) in both genotype 1 treatment-naive patients and
genotypes 2 and 3 treatment-experienced HCV patients.
-- Nominated PSI-7851 as a lead product candidate for the treatment of
HCV. PSI-7851 is a proprietary nucleotide analogue polymerase inhibitor
of HCV that is being advanced into Good Laboratory Practice (GLP)
toxicology studies.
-- Announced receipt of a Notice of Allowance from the United States
Patent and Trademark Office covering the anti-HCV drug PSI-6130 and its
active metabolites.
-- Joined the NASDAQ Biotechnology Index and the broad-market Russell 3000
Index.
Highlights since the Quarter Ended June 30, 2008
-- Announced preliminary safety and efficacy results of Cohort 3 of a 4-
week Phase 1 study of R7128 1000mg twice daily (BID) in combination
with Pegasys® plus Copegus® for the treatment of HCV, in which
patients achieved a mean 5.0 log10 IU/mL decrease in HCV RNA and 88%
(22 of 25) of patients achieved undetectable HCV RNA levels following
4 weeks of treatment with blinded safety and tolerability similar to
the safety profile observed with the standard of care alone (Pegasys®
and Copegus®).
-- Raised $24.2 million in net proceeds after deducting placement agent
fees and estimated offering expenses by selling 1,450,000 shares of
common stock to a select group of institutional investors in a
"registered direct" public offering. The net proceeds from this
offering will be used for general corporate purposes.
-- Announced initiation of a combination study of clevudine and Viread®
for HBV by the French National Agency for Research on AIDS and Viral
Hepatitis (ANRS).
Anticipated Highlights
-- Announcing preliminary results of a 4-week combination study of R7128
1500 mg BID with Pegasys® plus Copegus® in treatment-experienced
patients with HCV genotypes 2 and 3 by the end of the third calendar
quarter of 2008.
-- Completing HBV patient enrollment for clevudine Phase 3 registration
studies in the second calendar half of 2008.
-- Submitting the draft protocol and supporting documentation for our 12-
week Phase 2b combination study of R7128 with Pegasys® plus
Copegus® to the FDA during November 2008.
Pharmasset drug passes early-stage goal
Tuesday August 5, 8:55 am ET
Pharmasset hepatitis C drug candidate meets safety goals in early-stage study
PRINCETON, N.J. (AP) -- Pharmasset Inc. said Tuesday its hepatitis C treatment candidate met safety goals in part of an early-stage study.
The drug candidate, called R7128, was administered to patients over a four-week period in 1,000-milligram doses. The study involved 31 patients.
Safety results were similar to prior sections of the study involving 500-milligram and 1,500-milligram doses. The drug also showed signs of effectiveness, though the study is not designed for that level of testing.
Early-stage, or Phase I clinical trials, are often too small to accurately measure effectiveness and are primarily used to determine dosing levels for later studies and to test for safety. The company expects to have Phase II, or midstage, study results filed with the Food and Drug Administration this fall.
Hepatitis C is an infectious disease that affects a person's liver. It is spread by blood-to-blood contact and symptoms include inflammation and scarring of the liver.
Shares of Pharmasset closed at $22.01 Monday.
Pharmasset Announces $25.9 Million Registered Direct Offering of Common Stock
Tuesday July 15, 9:53 am ET
PRINCETON, N.J., July 15 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announced today that it has entered into definitive agreements dated July 14, 2008 with a select group of institutional investors to sell 1,450,000 shares of its common stock in a "registered direct" offering. The investors have agreed to purchase the shares at a purchase price of $17.85 per share resulting in gross proceeds of approximately $25.9 million to Pharmasset, before deducting placement agent fees and estimated offering expenses. Morgan Stanley & Co. Incorporated, Canaccord Adams Inc., Cowen and Company, LLC and Leerink Swann LLC served as placement agents for the offering and Morgan Stanley acted as lead manager.
The shares described above are being offered by Pharmasset pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission on June 26, 2008. The transaction is expected to close on or about July 21, 2008, subject to customary closing conditions. Pharmasset intends to use the net proceeds from the sale of the shares for general corporate purposes, which include, but are not limited to, the acquisition of assets or businesses that are complementary to its existing business, the funding of clinical trials and the funding of in-licensing agreements for product candidates, additional technologies or other forms of intellectual property.
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 at the SEC's website at http://www.sec.gov or by calling Morgan Stanley & Co. Incorporated, toll free, at 1-866-718-1649.
Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research on AIDS and Viral Hepatitis (ANRS)
Tuesday July 8, 7:00 am ET
96-week comparative study of Clevudine versus Viread(R) versus Clevudine+Viread(R) in 150 patients with chronic hepatitis B
PRINCETON, N.J., July 8 /PRNewswire-FirstCall/ -- The French National Agency for Research on AIDS and Viral Hepatitis (ANRS), with the support of Pharmasset, Inc. (Nasdaq: VRUS - News) and Gilead Sciences, Inc. (Nasdaq: GILD - News), has initiated the first head-to-head study of clevudine and Viread® (tenofovir disoproxil fumarate) administered separately, versus their combination, for the treatment of chronic hepatitis B virus (HBV) infection in non-cirrhotic patients. The study treatments include clevudine 30mg/day, tenofovir 300mg/day or the combination of both drugs administered to 150 treatment-naive hepatitis B e-antigen negative HBV-infected patients for 96 weeks. At that time, all therapy will be discontinued, and patients will be monitored for sustained virologic response (SVR) after being off of therapy for 24 weeks, the primary endpoint of the study.
Clevudine is an oral, once-daily pyrimidine nucleoside analog that has been evaluated in 18 clinical trials in more than 800 individuals. Phase 3 studies are currently being conducted in approximately 140 global clinical sites to support the registration of clevudine in the Americas and Europe. Pharmasset licensed clevudine for these territories from Bukwang Pharm. Co., Ltd, who has received South Korean regulatory approval and is currently marketing clevudine in South Korea under the brand name Levovir.
"Clevudine's unique mechanism of action as a non-chain terminating nucleoside analog HBV polymerase inhibitor may demonstrate additive antiviral benefit in combination with tenofovir's recently demonstrated antiviral potency in HBV," stated Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "We also plan to reproduce the results from earlier studies demonstrating clevudine's ability to provide a sustained virologic response in patients with eAg negative chronic HBV infection, as either monotherapy or in combination, offering infected individuals and their physicians an important new treatment option."
Ongoing Registration Studies for New Drug Application (NDA)
The ongoing clevudine Phase 3 registration program includes two 48-week clinical trials designed to demonstrate the superiority of clevudine 30mg over Hepsera® (adefovir dipivoxil) 10mg, each administered once-daily as monotherapy. Pharmasset plans to submit the 48-week data from these studies to the FDA as the basis for the clevudine marketing approval. Please see www.clinicaltrials.gov or e-mail clinicaltrials@pharmasset.com for more information about the clevudine registration studies.
Pharmasset Joins Russell 3000 Index
Tuesday July 1, 8:59 am ET
PRINCETON, N.J., July 1 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) joined the broad-market Russell 3000® Index when Russell Investments reconstituted its equity indexes on June 27.
Pharmasset's membership in the Russell 3000, which remains in place for one year, means automatic inclusion in the small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. Russell indexes are widely used by investment managers for index funds and as benchmarks for both passive and active investment strategies currently applied to $4.4 trillion in assets.
"We are pleased to be included in these indexes only one year after our stock became publicly traded," stated Kurt Leutzinger, Pharmasset's Chief Financial Officer. "We feel fortunate that our stock price has grown 117% since the IPO in an otherwise difficult market."
Pharmasset Receives Notice of Allowance
Thursday June 26, 7:00 am ET
-USPTO to grant patent covering the anti-HCV drug PSI-6130 and its active metabolites
PRINCETON, N.J., June 26 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) announced that the United States Patent and Trademark Office has issued a Notice of Allowance for patent application Serial No. 10/828,753 titled, "Modified Fluorinated Nucleoside Analogues," covering the composition of matter of a family of molecules invented at Pharmasset for the treatment of hepatitis C virus (HCV), including PSI-6130 and the active metabolite of PSI-7851. R7128, a prodrug of PSI-6130, a nucleoside analogue polymerase inhibitor of HCV, is being developed through Pharmasset's collaboration with Roche. PSI-7851 is a proprietary nucleotide analogue polymerase inhibitor of HCV that Pharmasset has nominated as a lead development candidate.
"We are pleased that the USPTO has recognized our intellectual property rights in our growing pipeline of HCV nucleoside polymerase inhibitors," stated Schaefer Price, Pharmasset's Chief Executive Officer. "The success that our in-house research team has had in discovering new HCV product candidates can now be translated into potentially significant commercial value."
About R7128
R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 demonstrated potent, dose-dependent antiviral activity across four prior treatment-failure patient cohorts (n=40) receiving 750 mg or 1500 mg administered either once-daily or twice-daily for 14 days as monotherapy. The greatest mean decrease in HCV RNA from baseline was demonstrated in the patient cohort that received 1500 mg twice-daily, the highest dose of R7128 administered in the study. These patients demonstrated a mean 2.7 log10 IU/mL (>99%) decrease in HCV RNA. There was no evidence of the development of viral resistance in any dose cohort after 14 days of dosing.
In a 4-week Phase 1 combination study that was conducted in 50 treatment-naive patients chronically infected with HCV genotype 1, R7128 demonstrated potent short-term antiviral activity and was generally safe and well tolerated. Eighty-five percent (85%) of patients receiving R7128 1500mg twice-daily (BID) with Pegasys plus Copegus for 4 weeks achieved undetectable HCV RNA levels with safety and tolerability comparable to placebo with Pegasys plus Copegus.
We have commenced dosing two additional cohorts of this 4-week Phase 1 study. Cohort 3 will continue dose-exploration with administration of R7128 1000mg twice-daily (BID) with Pegasys plus Copegus in treatment-naive patients with HCV genotype 1. Cohort 4 will evaluate R7128 1500mg BID with Pegasys plus Copegus in treatment-experienced patients with genotypes 2 or 3 who did not achieve a sustained virologic response (SVR) with previous interferon-based therapy.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Pharmasset Inc files for $100 mln debt, stock offer
Wed Jun 18, 2008 4:25pm EDT
June 18 (Reuters) - Pharmasset Inc (VRUS.O: Quote, Profile, Research, Stock Buzz) on Wednesday filed to periodically sell up to $100 million in common and preferred stock, debt securities, warrants and units.
The pharmaceutical company said in a filing with the U.S. Securities and Exchange Commission that it will use the proceeds from the offering for general corporate purposes.
Under a shelf registration, a company may sell securities in one or more separate offerings with the size, price and terms to be determined at the time of sale. (Reporting by Karey Wutkowski)
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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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