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Pharmasset's stellar data on combo hep C treatment Read more: Analysts jolted by Pharmasset's stellar data on combo hep C treatment - FierceBiotech http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-
Analysts jolted by Pharmasset's stellar data on combo hep C treatment
March 9, 2011 — 9:12am ET | By John Carroll
n one of the worst kept secrets of the year, new data shows that Pharmasset's combo oral approach to hepatitis C triggered the complete elimination of the virus in 15 of 16 patients after only 14 days of treatment. And the startling results, which were supposed to be kept under wraps in a blanket embargo lowered by the European Association for the Study of the Liver, spurred a quick spike in Pharmasset shares as word of the outcome spread swiftly among investors.
As Adam Feuerstein at TheStreet notes, this is the best such early-stage data released on an oral drug for hepatitis C. And the PSI-938 and PSI-7977 one-two punch eliminates the need for interferon, which is linked to a number of side effects among patients. That's the kind of news investors like to hear about early on, and the data--which is easily available online--spurred an increase of more than 32 percent in Pharmasset shares ($VRUS) over the first two days of the week.
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Quoting analysts at BMO Capital Markets, Bloomberg notes that Pharmasset's data indicates it may be on track to eventually gain an approval for a new hepatitis C therapy that will be able to compete with Vertex, which is widely expected to gain approval for telaprevir in the spring. Jason Zhang says that a combination of telaprevir and VX-222 didn't generate data that was good enough to follow up in additional patient studies, leaving Vertex open to a later challenge if Pharmasset can duplicate these early results in larger trials.
"The hepatitis C treatment landscape subsequent to the initial phase of telaprevir dominance is tilting away from Vertex to companies such as Pharmasset that have potent combinations," Zhang wrote. Vertex shares slid about five percent.
"We believe the full data of a 14-day combination of PSI-7977 / PSI-938 to be presented at the upcoming EASL could show proof of principle for a nuc-nuc combination and position Pharmasset as one of the front runners in the race to develop an interferon-free regimen, which is considered a Holy Grail in hepatitis C treatment," noted Leerink Swann analyst Howard Liang.
Read more: Analysts jolted by Pharmasset's stellar data on combo hep C treatment - FierceBiotech http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-09#ixzz1G7qrJyRm
http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-09
March 9, 2011 — 9:12am ET | By John Carroll
n one of the worst kept secrets of the year, new data shows that Pharmasset's combo oral approach to hepatitis C triggered the complete elimination of the virus in 15 of 16 patients after only 14 days of treatment. And the startling results, which were supposed to be kept under wraps in a blanket embargo lowered by the European Association for the Study of the Liver, spurred a quick spike in Pharmasset shares as word of the outcome spread swiftly among investors.
As Adam Feuerstein at TheStreet notes, this is the best such early-stage data released on an oral drug for hepatitis C. And the PSI-938 and PSI-7977 one-two punch eliminates the need for interferon, which is linked to a number of side effects among patients. That's the kind of news investors like to hear about early on, and the data--which is easily available online--spurred an increase of more than 32 percent in Pharmasset shares ($VRUS) over the first two days of the week.
Sign up for our FREE newsletter for more news like this sent to your inbox!
Quoting analysts at BMO Capital Markets, Bloomberg notes that Pharmasset's data indicates it may be on track to eventually gain an approval for a new hepatitis C therapy that will be able to compete with Vertex, which is widely expected to gain approval for telaprevir in the spring. Jason Zhang says that a combination of telaprevir and VX-222 didn't generate data that was good enough to follow up in additional patient studies, leaving Vertex open to a later challenge if Pharmasset can duplicate these early results in larger trials.
"The hepatitis C treatment landscape subsequent to the initial phase of telaprevir dominance is tilting away from Vertex to companies such as Pharmasset that have potent combinations," Zhang wrote. Vertex shares slid about five percent.
"We believe the full data of a 14-day combination of PSI-7977 / PSI-938 to be presented at the upcoming EASL could show proof of principle for a nuc-nuc combination and position Pharmasset as one of the front runners in the race to develop an interferon-free regimen, which is considered a Holy Grail in hepatitis C treatment," noted Leerink Swann analyst Howard Liang.
Read more: Analysts jolted by Pharmasset's stellar data on combo hep C treatment - FierceBiotech http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-09#ixzz1G7qrJyRm
http://www.fiercebiotech.com/story/analysts-jolted-pharmassets-stellar-data-combo-hep-c-treatment/2011-03-09
I agree with all those cautioning against over-excitement on the basis of this single, early, partial result set.
However, I got all hyped about PSI-7977 during my trial, as I started to look at ALL the results out and about re this drug, and added what I was observing around me.
This particular piece is only exciting, when put alongside all the other results 7977 is getting, and any conclusions that might be drawn from the decisions and timelines that Pharmasset seem to be perusing.
And from that analysis, I think PSI-7977 is worthy of a bit of special attention, and a lot of optimism.
However, I got all hyped about PSI-7977 during my trial, as I started to look at ALL the results out and about re this drug, and added what I was observing around me.
This particular piece is only exciting, when put alongside all the other results 7977 is getting, and any conclusions that might be drawn from the decisions and timelines that Pharmasset seem to be perusing.
And from that analysis, I think PSI-7977 is worthy of a bit of special attention, and a lot of optimism.
I feel that this is jumping the gun. While the 14 day results are very good, the study size is too small to be anything more than an indicator of what the final study might show. "Complete eradication of the virus" is misleading and no one will know that until 6 more months have passed and they are SVR. We have no data on side effects, breakthrough or anything else yet. Not to mention that they have many years to go before the product gets on the market.
In fact, the number of HCV infected people will drop dramatically by the time this drug is on the market. The 2 protease inhibitors about to get approval will cure a huge percentage of infected people within 3 years and the number of new infections has dropped significantly.
This is clearly great news, but we have a long way to go on this one. Betcha the announcement was a great buying opportunity for VRTX.
I sold most of mine when it went north of 50, but I might buy some back.
In fact, the number of HCV infected people will drop dramatically by the time this drug is on the market. The 2 protease inhibitors about to get approval will cure a huge percentage of infected people within 3 years and the number of new infections has dropped significantly.
This is clearly great news, but we have a long way to go on this one. Betcha the announcement was a great buying opportunity for VRTX.
I sold most of mine when it went north of 50, but I might buy some back.
Getting a 2 week response is a far cry from;
1) knowing how long you would have to treat after clearance
2) whether the stuff is safe enough to take for 12 or 24 weeks w/ or w/o SOC.
3) whether these people may break through at 3 to 7 weeks and end up requiring SOC.
My guess is this stuff is 4 years out, maybe more. Hint; Vertex started their phase 3 trials in 2008, 2.5 years ago and may be approved at about the 3 year mark after starting Phase 3.
best,
Willy
1) knowing how long you would have to treat after clearance
2) whether the stuff is safe enough to take for 12 or 24 weeks w/ or w/o SOC.
3) whether these people may break through at 3 to 7 weeks and end up requiring SOC.
My guess is this stuff is 4 years out, maybe more. Hint; Vertex started their phase 3 trials in 2008, 2.5 years ago and may be approved at about the 3 year mark after starting Phase 3.
best,
Willy
I personally think it will be a long time until Riba and IFN are out of the mix. Relapse rates just seem too great without them when doing the shorter treatment times.
I'm convinced that this virus is just DAMN hard to kill. You can blow away 10 trillion of them in 3 days with brand new drugs, and if you have 1000 left your just as surely going to relapse as if you had 3 trillion left.
Not trying to be negative, just tempered and realistic. All progress requires some setbacks and a learning curve.
I'm convinced that this virus is just DAMN hard to kill. You can blow away 10 trillion of them in 3 days with brand new drugs, and if you have 1000 left your just as surely going to relapse as if you had 3 trillion left.
Not trying to be negative, just tempered and realistic. All progress requires some setbacks and a learning curve.
That seems to be great great news, my only issue is availability, specifically -time to availabilty. There are many of us with little time to wait so news like that can be bitter sweet-"here it is, but you cant have it"
Sorry just a bit disillusioned with pharma/trials situation.
Sorry just a bit disillusioned with pharma/trials situation.
NYgirl: " the dream everyone has waited for seems to be coming to fruition sooner than we anticipated."
And that ain't Roseanne Barr naked, folks.
And that ain't Roseanne Barr naked, folks.
Apparently there is a little fight about the so called news embargo. Easl apparently has some things available on line. provided here is a graph form the above trial.
My only other commentary...... is that IF..... IF..... a breakthrough were to occur due to resistance, there is a good chance that it would occur outside of the 14 day TX. We don't know what happened or what would happen a week after these results were given.
It is still exceptional, but if lets say you started seeing breakthroughs after 3 weeks..... then you may be back to augmenting/treating with interferon and RBV, unless you find another DAA to add to the mix.
Or so I wonder..... willy
=============================================
http://www1.easl.eu/easl2011/program/Posters/Abstract8.htm
(2 graphs with commentary)
My only other commentary...... is that IF..... IF..... a breakthrough were to occur due to resistance, there is a good chance that it would occur outside of the 14 day TX. We don't know what happened or what would happen a week after these results were given.
It is still exceptional, but if lets say you started seeing breakthroughs after 3 weeks..... then you may be back to augmenting/treating with interferon and RBV, unless you find another DAA to add to the mix.
Or so I wonder..... willy
=============================================
http://www1.easl.eu/easl2011/program/Posters/Abstract8.htm
(2 graphs with commentary)
I'm just assuming the same old holding pattern.
Wishing it was only 2 weeks. : ) The problem is after you wait 2 years there is always something else coming in 2 more years. : )
The clock is ticking though.....
willy
Wishing it was only 2 weeks. : ) The problem is after you wait 2 years there is always something else coming in 2 more years. : )
The clock is ticking though.....
willy
Good point willy, i shouldn't just skim through something....... Hope all is well
cando
cando
I believe that this is what they call "preliminary data".
It does not mean that the trial lasted and completed after 14 days.
willy
It does not mean that the trial lasted and completed after 14 days.
willy
I had not realized all treatment stopped after 14 days. The releases don't seem to say that explicitly. Do people know that is the case?
If so, and time shows the virus doesn't break through, this would be truly AMAZING, an answer to a lot of prayers.
BTB
If so, and time shows the virus doesn't break through, this would be truly AMAZING, an answer to a lot of prayers.
BTB
Time will tell but right now it looks very promising. 14 days of tx? Wouldn't that be a dream come true.
Word of caution though Mike, posting this at the vertex stockholders club. Might want to watch your back...:)
Word of caution though Mike, posting this at the vertex stockholders club. Might want to watch your back...:)
either it's the riba or I'm getting older and crankier but it seems I've seen this movie before. Wasn't it at EASL09 that Roche/Pharmasset presented results of an amazing two DAA/no-ifn combo (INFORM-1) that knocked the virus out of the ball park:
http://www.hivandhepatitis.com/2009icr/easl/docs/042809_a.html
A promising polymerase inhibitor (R7128) coupled with a protease inhibitor (ITM-191). The future looked bright. Fast forward to 2011. Phase IIb trials of r7128 are moving forward at a snail's pace and no one. anywhere, has tried coupling it with one of the two mature protease inhibitors pending approval in about two months.
New technology is great, and as dointime noted a while back, Pharmasset seem to have the smartest kids on the block, but I'm starting to think Mike716 wasn't off the mark after all - maybe it's not in big pharma's stockholders' interest to cure too many of us too quickly.
http://www.hivandhepatitis.com/2009icr/easl/docs/042809_a.html
A promising polymerase inhibitor (R7128) coupled with a protease inhibitor (ITM-191). The future looked bright. Fast forward to 2011. Phase IIb trials of r7128 are moving forward at a snail's pace and no one. anywhere, has tried coupling it with one of the two mature protease inhibitors pending approval in about two months.
New technology is great, and as dointime noted a while back, Pharmasset seem to have the smartest kids on the block, but I'm starting to think Mike716 wasn't off the mark after all - maybe it's not in big pharma's stockholders' interest to cure too many of us too quickly.
LOL I dont think any of us care about the title being long Michael - as long as the news is good and gives hope it's all gravy.
I'm always very cautious about this type of news so I don't get too optimistic.
It would be great though if this approach really proves itself. Things do seem to be moving fast and that is a nice change.
I was actually trying to shorten the title but I must have copied and pasted something I had no intention of posting.
Again, sorry about that.
Mike
It would be great though if this approach really proves itself. Things do seem to be moving fast and that is a nice change.
I was actually trying to shorten the title but I must have copied and pasted something I had no intention of posting.
Again, sorry about that.
Mike
That may be the longest thread title at MedHelp; too bad that it didn't also contain some commentary. : )
Yes, it looks like good news, better days ahead and maybe we will get some assessment about the timetable for approval. Vertex stock took a dive, but down from 50+ bucks a share; it was around 39 dollars 3 months ago.
Also keep in mind.....although it appears to be good; great really. We need to see where they settle for TX times and also await the long term safety toxicology reports. Remember some drug treatments have worked but have been removed from trials due to safety concerns.
It looks wonderful though, really good.
Willy
Yes, it looks like good news, better days ahead and maybe we will get some assessment about the timetable for approval. Vertex stock took a dive, but down from 50+ bucks a share; it was around 39 dollars 3 months ago.
Also keep in mind.....although it appears to be good; great really. We need to see where they settle for TX times and also await the long term safety toxicology reports. Remember some drug treatments have worked but have been removed from trials due to safety concerns.
It looks wonderful though, really good.
Willy
That's the best news especially for us that have underlining heath issues that would make doing soc even with the new drugs risky at best.
Yipee
Donna
Yipee
Donna
Interestingly about a month ago when I was talking with my Hepa about Tela and Boce coming out in the near future he mentioned PSI 7977 (I don"t recall him saying anything about the combo,however I may have missed that in the conversation) being something that he and his colleagues were very excited about.
The future looks bright.
WILL
I'm glad you posted it as I had not seen it earlier and it's pretty staggering news. Adios interferon the dream everyone has waited for seems to be coming to fruition sooner than we anticipated. No more of the "should I just take supplements and put my head in the sand because I'm afraid of interferon posts" will be needed!
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Somewhat dated article - since the company that holds the patent is no longer called "Chiron'.
http://hepcproject.typepad.com/hep_c_project/2004/06/chirons_hepatit.html
"Chiron holds over 100 patents related to the HCV genome, which won't expire until 2015. Any company that develops a new drug targeting hepatitis C (such as a protease inhibitor), or a diagnostic test to detect and measure HCV (viral load; test for screening the blood supply), needs to license Chiron's patents, typically by negotiating a licensing fee and royalties on product sales. Chiron typically charges each company millions of dollars in licensing fees during research and development alone, and makes millions more each year in royalties from HCV tests.
Chiron's enforcement of its patent rights has slowed the pace of HCV drug development considerably, as other companies struggled to reach reasonable terms for licensing -- with Chiron filing several lawsuits beginning in the late 1990s that effectively halted much of the research into HCV protease inhibitors. Nobody can say how close we'd be today to having an effective HCV protease inhibitor on the market, were it not for Chiron's use (or abuse) of its patent position. But it's arguable that Chiron's actions -- or, put differently, greed -- will result in thousands of needless deaths from HCV-related liver disease over the next several years.
Under the new arrangement, companies can license Chiron's HCV patents without paying any up-front costs. Companies only have to make payments to Chiron when they reach certain milestones in their research, and then pay royalties on any sales for approved products."