Aa
How do we put pressure on Gilead/Bristol??
That's my question because this just makes me sick!
http://hepatitiscresearchandnewsupdates.blogspot.com/2012/04/gilead-bristol-put-profits-ahead-of.html
http://hepatitiscresearchandnewsupdates.blogspot.com/2012/04/gilead-bristol-put-profits-ahead-of.html
He was inaccurate regarding the dosage of one pill of each drug. The dosing with everyone in my study of BMS 790052 and 7977 was two pills of each once a day. Not really important though.
I've asked this on a few posts and haven;t gotten an answer - maybe b/c there isn;t one. How LONG? Are we looking at 2yrs, 5yrs or 10yrs for an interferoin free tx? Best guesses guys?
mythoughts, I think it would be hard for anyone to answer your question. If we were just talking about testing, approvals and distribution perhaps you could say 2-5 years in the USA. That is based on time required to complete trials and approvals. But the primary driver for drug companies is profit. Period.
Trials and regulatory approvals are just hurdles for drug companies to jump over before they can start selling their products widely. Such things push up the cost of getting to market and delay the final profit-making phase in the lifecycle of the product. The high costs drive out smaller players who can then only profit by successfully marketing themselves and selling their company or product to a pharmaceutical giant. Pharmasett's story.
The problem is that Interferon will have been a good earner and companies currently profiting from it won't really want it to be discontinued. Gilead will try to package and sell GS7977 _with_ Interferon if it will grab market share, form a valuable alliance with another company, and/or be more profitable than combining it with a safe well tolerated drug. Those companies who are now profiting from Interferon will be pretty keen to address that problem in some manner. The trials with Interferon, Ribavirin and 7977 in various combinations were never about finding the best cure for patients. It looks like there is enough momentum for an Interferon-free treatment but I won’t relax on that one until I see that drug take the very last gasp.
Gilead is now starting to flood the media with news about GS 7977 bathed in glory from a combo trial with Bristol Myers Squibb's Daclatasvir which they may never have had any intention of taking to phase three. If that is true, let's hope it really backfires on them. Maybe some other company will come up with a better combination before they can pair GS 7977 if the game of brinkmanship goes on too long.
How can we put pressure on Gilead and BMS? Individual patients obviously aren’t at all important. We can’t prescribe treatments, and they are so expensive that we generally don’t pay the whole cost for them either. The only consumer power we have is to refuse treatment, not always a viable option although patient reluctance to take Interferon has had an effect. Governments might be motivated to respond to potential productivity increases and improved tax revenue when we patients are cured effectively. But that requires forward thinking beyond one election cycle. Insurance companies might care about keeping their customers happy and avoiding payouts for repeated failed treatments and disability perhaps? Twitter? Facebook? Popular TV shows?
Thank you very, very, much to Adam Feuerstein for speaking out.
Trials and regulatory approvals are just hurdles for drug companies to jump over before they can start selling their products widely. Such things push up the cost of getting to market and delay the final profit-making phase in the lifecycle of the product. The high costs drive out smaller players who can then only profit by successfully marketing themselves and selling their company or product to a pharmaceutical giant. Pharmasett's story.
The problem is that Interferon will have been a good earner and companies currently profiting from it won't really want it to be discontinued. Gilead will try to package and sell GS7977 _with_ Interferon if it will grab market share, form a valuable alliance with another company, and/or be more profitable than combining it with a safe well tolerated drug. Those companies who are now profiting from Interferon will be pretty keen to address that problem in some manner. The trials with Interferon, Ribavirin and 7977 in various combinations were never about finding the best cure for patients. It looks like there is enough momentum for an Interferon-free treatment but I won’t relax on that one until I see that drug take the very last gasp.
Gilead is now starting to flood the media with news about GS 7977 bathed in glory from a combo trial with Bristol Myers Squibb's Daclatasvir which they may never have had any intention of taking to phase three. If that is true, let's hope it really backfires on them. Maybe some other company will come up with a better combination before they can pair GS 7977 if the game of brinkmanship goes on too long.
How can we put pressure on Gilead and BMS? Individual patients obviously aren’t at all important. We can’t prescribe treatments, and they are so expensive that we generally don’t pay the whole cost for them either. The only consumer power we have is to refuse treatment, not always a viable option although patient reluctance to take Interferon has had an effect. Governments might be motivated to respond to potential productivity increases and improved tax revenue when we patients are cured effectively. But that requires forward thinking beyond one election cycle. Insurance companies might care about keeping their customers happy and avoiding payouts for repeated failed treatments and disability perhaps? Twitter? Facebook? Popular TV shows?
Thank you very, very, much to Adam Feuerstein for speaking out.
Odin!!!!
you have absolutely hit it on the nail!!! FACEBOOK....If it can cause governments to be overthrown in other countries and tell the world about KONY. Why can't we "share" with the whole world what Gilead is trying to do? This decision DOES affect the whole world, not just here in America.
Any ideas any tech savy people?? Just get the page up and running and point us to the LIKE button :-))
you have absolutely hit it on the nail!!! FACEBOOK....If it can cause governments to be overthrown in other countries and tell the world about KONY. Why can't we "share" with the whole world what Gilead is trying to do? This decision DOES affect the whole world, not just here in America.
Any ideas any tech savy people?? Just get the page up and running and point us to the LIKE button :-))
Patience folks: As I have said many times in the past , "Pharma's insatiable appetite for profit will eventually bring us more effective treatment ,however it is still many years away and so many variables and bumps in the road will be felt along the way.
This today:
findings accelerated momentum in an already fast-moving category, in which drugmakers are swooping up assets to pad HCV pipelines and experimenting with a variety of regimens and combinations. Last November Gilead agreed to pay almost $11 billion for biotech firm Pharmasset's GS-7977, and BMS in January said it was buying Inhibitex for about $2.5 billion and getting access to that firm's potential HCV drug, INX-189.
The direct-acting antivirals (DAAs) from BMS, Gilead and Abbott are showing the best efficacy and tolerability to date.
Not that there haven't been speed bumps along the way. In February, Gilead's ‘7977 had come under assault when data showed that six out of six subjects treated with the pipeline drug, who were prior null responders to other HCV therapy, had experienced a relapse of their disease.
Analysts had predicted that patients who are naïve to therapy would be easier to treat with a non-interferon regimen than null responders, and the Gilead/BMS data furthered this notion. Several analysts now believe daclatasvir, an NS5a inhibitor, and ‘7977, a nucleotide analog (or “Nuc” as the class is called), may form the best treatment “backbone” option across all genotypes.
“It appears that the ‘killer app' in HCV is probably an NS5A plus a nuc without ribavirin,” Schoenebaum declared.
The newer protease inhibitors—Vertex's Incivek and Merck's Victrelis, both launched in 2011—look like they will be vulnerable to the all-oral regimens, but not for a few years.
“These results obviously reinforce the expectation that DAA-only (IFN and RBV-sparing) regimens will likely quickly supplant current HCV treatments when they become available in the 2015/2016 timeframe,” wrote Deutsche Bank's Barbara Ryan in a note today.
In a Thursday dispatch to investors, Credit Suisse's Catherine Arnold said the data also “takes a little shine off” Abbott's HCV program, “but we still view it as a competitive presence.” The triple therapy combines the firm's protease inhibitor ABT-450 + non-nucleoside polymerase inhibitor ABT-333 + ribavirin.
While the Gilead/BMS combination sets the bar high for competitors, scientists are still debating where the best treatment synergy lies, and firms are awaiting more data before finalizing their commercial plans.
The Gilead/BMS combo “represents the most compelling all-oral, interferon-free data in the highly visible [HCV] marketplace,” noted Arnold. “Despite this strong data,” she added, “a partnership is unlikely in the near term as both companies wait for additional data sets related to their HCV assets to fully evaluate their options.”
Ryan cautioned that other factors—side effects, dosing convenience and, of course, cost—“will be important considerations in determining market share. In our opinion, it is premature to conclude who the ultimate winners and losers will be in the ‘new' HCV market on the basis of the data available to date.” Ryan doesn't think any one or two players will dominate the field. Null and non-responders could also be a factor in determining long-term HCV dominance.
Results from a cocktail joining Gilead's ‘7977 and ribavirin also surprised, hitting an SVR rate of 88%—far better than the 50% the Street had expected, according to Schoenebaum. Abbott's all-oral triple combo may be another good backbone option, while daclatasvir so far looks like a solid add-on option—one that has pan-genotype efficacy and excellent tolerability—and BMS is exploring multiple pairing options (including with its own Nuc, INX-189).
Other Nucs in development include Vertex's ALS-2200 and ALS-2158, and biotech firm Idenix's IDX184, which can be combined with its NS5A inhibitor, IDX719.
Source
This today:
findings accelerated momentum in an already fast-moving category, in which drugmakers are swooping up assets to pad HCV pipelines and experimenting with a variety of regimens and combinations. Last November Gilead agreed to pay almost $11 billion for biotech firm Pharmasset's GS-7977, and BMS in January said it was buying Inhibitex for about $2.5 billion and getting access to that firm's potential HCV drug, INX-189.
The direct-acting antivirals (DAAs) from BMS, Gilead and Abbott are showing the best efficacy and tolerability to date.
Not that there haven't been speed bumps along the way. In February, Gilead's ‘7977 had come under assault when data showed that six out of six subjects treated with the pipeline drug, who were prior null responders to other HCV therapy, had experienced a relapse of their disease.
Analysts had predicted that patients who are naïve to therapy would be easier to treat with a non-interferon regimen than null responders, and the Gilead/BMS data furthered this notion. Several analysts now believe daclatasvir, an NS5a inhibitor, and ‘7977, a nucleotide analog (or “Nuc” as the class is called), may form the best treatment “backbone” option across all genotypes.
“It appears that the ‘killer app' in HCV is probably an NS5A plus a nuc without ribavirin,” Schoenebaum declared.
The newer protease inhibitors—Vertex's Incivek and Merck's Victrelis, both launched in 2011—look like they will be vulnerable to the all-oral regimens, but not for a few years.
“These results obviously reinforce the expectation that DAA-only (IFN and RBV-sparing) regimens will likely quickly supplant current HCV treatments when they become available in the 2015/2016 timeframe,” wrote Deutsche Bank's Barbara Ryan in a note today.
In a Thursday dispatch to investors, Credit Suisse's Catherine Arnold said the data also “takes a little shine off” Abbott's HCV program, “but we still view it as a competitive presence.” The triple therapy combines the firm's protease inhibitor ABT-450 + non-nucleoside polymerase inhibitor ABT-333 + ribavirin.
While the Gilead/BMS combination sets the bar high for competitors, scientists are still debating where the best treatment synergy lies, and firms are awaiting more data before finalizing their commercial plans.
The Gilead/BMS combo “represents the most compelling all-oral, interferon-free data in the highly visible [HCV] marketplace,” noted Arnold. “Despite this strong data,” she added, “a partnership is unlikely in the near term as both companies wait for additional data sets related to their HCV assets to fully evaluate their options.”
Ryan cautioned that other factors—side effects, dosing convenience and, of course, cost—“will be important considerations in determining market share. In our opinion, it is premature to conclude who the ultimate winners and losers will be in the ‘new' HCV market on the basis of the data available to date.” Ryan doesn't think any one or two players will dominate the field. Null and non-responders could also be a factor in determining long-term HCV dominance.
Results from a cocktail joining Gilead's ‘7977 and ribavirin also surprised, hitting an SVR rate of 88%—far better than the 50% the Street had expected, according to Schoenebaum. Abbott's all-oral triple combo may be another good backbone option, while daclatasvir so far looks like a solid add-on option—one that has pan-genotype efficacy and excellent tolerability—and BMS is exploring multiple pairing options (including with its own Nuc, INX-189).
Other Nucs in development include Vertex's ALS-2200 and ALS-2158, and biotech firm Idenix's IDX184, which can be combined with its NS5A inhibitor, IDX719.
Source
Sometimes ""Pharma's insatiable appetite for profit" brings us Vioxx.
I think that Adams article shows that greed isn't always good.
The crazy prices that they are paying for some of these drug compounds just means that many people will not be able to afford the new treatments.
Who will be responsible for paying back the 11 billion dollars plus the "profit"? How much more will need to be earned? The article suggests that to maximize the profits the drug may not go further into collaboration with BMS meaning that the most effective form of treatment will be delayed in trials. Who does this benefit?
One of the models of action is that Gilead wants to partner 7977 with it's own compound, but that drug is not as far along in the approval process and even so..... may not be as effective as the BMS compound. Now...... how does one rationalize that this is good? Where exactly lies the benefit? : )
my opinion;
1) driving up the prices of HCV treatments; bad
2) delaying the most efficacious form of treatment in order to squeeze out more profit; bad.
3) The delay could cost some people their lives. There are people that you know on this board who have advanced liver disease, are null or non responders to SOC or even triple therapy. No effective treatment to date has worked. The partnership with the 2 companies with what may be best in class compounds in current trials could save their lives or provide other people with less pressing need to treat a more certain outcome of success.
A delay and or a combining with a less efficacious compound may serve the stockholder but it will not aid someone with HCV.
We know some members or loved ones of members for which it is now too late. We also may be aware of some members for which hope still exists. I would like to understand the equation of how many lives will be lost to liver failure by delaying the most effective form of treatments in order to maximize ones bottom line. How many lives lost, how many dollars earned?
willy
I think that Adams article shows that greed isn't always good.
The crazy prices that they are paying for some of these drug compounds just means that many people will not be able to afford the new treatments.
Who will be responsible for paying back the 11 billion dollars plus the "profit"? How much more will need to be earned? The article suggests that to maximize the profits the drug may not go further into collaboration with BMS meaning that the most effective form of treatment will be delayed in trials. Who does this benefit?
One of the models of action is that Gilead wants to partner 7977 with it's own compound, but that drug is not as far along in the approval process and even so..... may not be as effective as the BMS compound. Now...... how does one rationalize that this is good? Where exactly lies the benefit? : )
my opinion;
1) driving up the prices of HCV treatments; bad
2) delaying the most efficacious form of treatment in order to squeeze out more profit; bad.
3) The delay could cost some people their lives. There are people that you know on this board who have advanced liver disease, are null or non responders to SOC or even triple therapy. No effective treatment to date has worked. The partnership with the 2 companies with what may be best in class compounds in current trials could save their lives or provide other people with less pressing need to treat a more certain outcome of success.
A delay and or a combining with a less efficacious compound may serve the stockholder but it will not aid someone with HCV.
We know some members or loved ones of members for which it is now too late. We also may be aware of some members for which hope still exists. I would like to understand the equation of how many lives will be lost to liver failure by delaying the most effective form of treatments in order to maximize ones bottom line. How many lives lost, how many dollars earned?
willy
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