How do we put pressure on Gilead/Bristol??

[UKgirl55]

That's my question because this just makes me sick!

http://hepatitiscresearchandnewsupdates.blogspot.com/2012/04/gilead-bristol-put-profits-ahead-of.html

[Willy50]

It bears printing so that people can read this more easily.
Adam has for years provided some of the best information about the newest wave of HCV drugs since I've been reading him in 2006.
Adam also made a few waves with the EASL information embargo this year as well.  Always worth a read.  ~willy


http://hepatitiscresearchandnewsupdates.blogspot.com/2012/04/gilead-bristol-put-profits-ahead-of.html

87756315

By Adam Feuerstein 04/19/12 - 10:24 AM EDT

BARCELONA (TheStreet) -- The most effective new therapy for hepatitis C -- two pills that could cure nearly every patient treated -- may never see the light of day because the developers of these new medicines, Bristol-Myers Squibb(BMY_) and Gilead Sciences(GILD_), seem unable to work together.

Apparently, profits are more important than best patient care.

The new Hep C therapy at issue here combines Bristol's daclatasvir with Gilead's GS-7977. Each is a single pill administered once a day. The results from this new therapy are nothing short of spectacular -- an early cure rate of 100% for genotype 1 patients and 91% of genotype 2/3 patients, according to data from a mid-stage study announced Thursday at the European Association for the Study of Liver Disease (EASL) meeting.

A 100% cure rate for genotype 1 patients! Obviously, results can't get better than that.

You'd think there'd be a rush to move the combination regimen of daclatasvir and GS-7977 into a larger, confirmatory phase III trial, but you'd be mistaken. Amazingly, this most promising new treatment for hepatitis C patients may actually be discontinued because Bristol and Gilead can't work together.

Good luck understanding why Bristol and Gilead can't come together to help Hep C patients. The companies can't even agree on the fact that the two companies are not agreeing.

"Given the strong SVR4 [early cure] data from the combo trial of daclatasvir (DCV) + GS-7977, and in the interest of advancing the science and for the benefit of patients, we were interested in a Phase III collaboration. Unfortunately Gilead was not interested," said Bristol spokeswoman Cristi Barnett.

Gilead spokeswoman Amy Flood responded, "That's not the case. There are a number of new data sets at EASL and we need to evaluate and understand all of them. We're going to do that, and look at the best option or options for proceeding as quickly as possible to advance the best all-oral regimen."

Gilead may have $11 billion worth of reasons for not wanting to hook up with Bristol, as in the money spent by the company to acquire Pharmasset this year and gain control of GS-7977. Gilead spent outrageously to buy Pharmasset in an attempt to dominate the future of Hep C treatment in much the same way it already dominates the HIV market.

Gilead needs to justify that $11 billion and deliver profits and returns to its shareholders. Collaborating with Bristol would more than likely dilute Gilead's Hep C profits, which helps explain why Gilead isn't exactly thrilled to push ahead with the daclatasvir GS-7977 combination.

Instead, Gilead would prefer to combine GS-7977 with GS-5885, another drug it owns 100% that belongs to the same NS5A inhibitor class as daclatasvir. But a lot of work remains to be done on GS-5885; it may not be as safe or as effective as daclatasvir. It could also take longer for this all-Gilead combination to reach the market, which means Hep C patients in need of treatment will suffer.

Bristol is in a similar situation. Without access to GS-7977, the company is likely to move ahead with a combination of daclatasvir and INX-189, which belongs to the same nucleoside, or "nuc" class of drugs as GS-7977. Bristol acquired INX-189 when it bought Inhibitex for $2 billion earlier this year.

Bristol still has a lot of work to do with the daclatasvir-INX-189 combination before it can move into phase III studies, which also potentially means Hep C patients will be waiting longer.

Idenix Pharmaceuticals(IDIX_) is also working on a regimen combining an NS5A inhibitor with a nuc, but those clinical studies are well behind Bristol and Gilead.

Regardless of who's to blame in this Bristol-Gilead spat, Hep C patients in need of convenient and potent new cures are being hurt. It remains to be seen if leading Hep C doctors, patient advocacy groups or medical societies like EASL will object and pressure the companies to move daclatasvir and GS-7977 into phase III studies as soon as possible.

Drug companies always say patients come before profits, but that feels like nothing more than an empty slogan today.

--Written by Adam Feuerstein in Boston."
=========================

[katla]

This is outrageous imho. I won't say what I really think because experience taught me that pharma bashing on hcv forums is almost as popular as mentioning alcohol.

[willbb]

Drug companies always say patients come before profits,
-----------------------------------
I find that interesting..
Will

[UKgirl55]

Oh please Katla....Let it loose because it's probably exactly what I want to say...Hmm??? Making you the Fall guy wouldn't be fair of me would it :-)

Outrageous is right!!!

[UKgirl55]

Thanks Will.

[Willy50]

If you disagree, just say so.  : )

To some extent this notion has been covered some time earlier by "willing", one of the sharper members of this board.

Willing has mentioned the idea of combining "best in class" type drugs to provide a cure.

However, the economic model here is that someone with deep pockets bought one one of the lead compounds and perhaps (too early to say what will shake out) it is going to be held back from other combinations of compounds in order to maximize profits for Gilead.  After all, they are under stockholder scrutiny for shelling out 11 billion for the drug.  The money must be regained and profits made.

What Mr Feuerstein writes is that the stage is being set for profits to come before the most efficacious possible treatment.  I don't think Gilead is going to *pull a Jonas Salk* on this one....... not after dropping 11 billion.

If there is a bright light, it is that there are other companies, other compounds coming.  No doubt Gilead is crunching numbers and weighing options how to maximize profits.  Gilead might be able to make serious bank in partnering with other companies; make the money while they can before another juggernaut compound comes from another company to unseat the king.  
These drugs and therapies after all, have a shelf life.

Lets not forget, that is true for members of the HCV infected community as well.  Many people will need the most efficacious treatment and soon.  A weaker treatment combination or a longer delay will mean death for some of us.

willy

[orphanedhawk]

Sigh !

I recall reading about  similar items AIDs years ago.
French researchers and Americans would not share information.

This situation is far from new, whether it is pharmas refusing to deal with each other for profits or scientists refusing to work with each other because of wanting to be the 'first' one to discover a cure.
( I read a book about the bubonic plague which dealt with this issue)

The only thing that seems to work is a massive publicity campaign but with hepC still being the silent epidemic, I don't know what can be done.

[candyce1953]

A petition perhaps.?
I really wanted to do that phase 3 trial

[rivll]

Too bad we can't picket their offices...
This is really a question, not a presumption so don't anyone bite my head off, please. Have null and partial responders been tested with 7977 and Riba? Has anyone said whether that pair (7977& Riba) is comparable to 7977 and BMS?

[Willy50]

Folks, 7977 is probably a best in class compound, but it is not the only one, nor is it one of the only combination that can work.  

There is a lot to figure out; what works on which genotype or sub-genotype (1a vrs 1b, for instance),

What is required to provide a high cure rate for TT genetic markers; ie, you may not need the "best in class" for CC's

What combination may work best for non or null responders, versus past relapsers.  Current triple therapy may cure about 90% of relapsers.

What treatment may be the best for people near decompensation?  Perhaps several compounds with riba will be effective in curing many advanced liver disease patients.

GS-7977 is NOT the only game in town.  There will be other compounds and other treatment strategies.  If they restrict it's use, either with it's partnering or in it's pricing there will be another similar treatment which will exploit it's exclusivity.  Right now the Abbott treatment seems to have more drugs, but it has comparable efficacy and the same 12 week treatment time, and no interferon.  Vertex also has a 3 drug treatment (VX-222, Incivek and RBV) that is efficacious.  There are other drug companies, other effective compounds.

It's still early.  There will be more trial presentations and more analysis.  the entire scientific community will better understand how to treat us effectively.  Think of antibiotics; one may not need to use the strongest out there to cure an ailment.  Most of us will be fine regardless of what Gilead does.  Their decision on how they will use that lead compound will certainly impact some of us though, perhaps.

willy

[Willy50]

This is one thing that will provide pressure on Gilead; other collaborations with very strong compounds;

http://www.natap.org/2012/HCV/041812_01.htm

HUDDINGE, Sweden, Apr 18, 2012 (BUSINESS WIRE) -- Regulatory News: -- Expanded clinical study program evaluating a combination of TMC435 and daclatasvir (BMS-790052)
(visit the link for the complete article)
===================================

It's a little off topic but a good read and germane to this discussion.  My point is that with all the compounds out there other alliances will probably be made.

Here's another.  Vertex doesn't need to partner since it has a collaborator with nukes;

Vertex;
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=665491

Vertex to Begin Enrollment in a Phase 2 Study of its Most Advanced All-Oral Regimen

"In the coming weeks, Vertex will begin enrollment in a Phase 2b study evaluating combination regimens of INCIVEK, VX-222 and ribavirin. The study will evaluate total treatment durations as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C who are new to treatment and will not use response-guided treatment criteria. If successful, Vertex plans to submit a New Drug Application (NDA) to the FDA for its first all-oral regimen as early as the end of 2014.

Vertex recently announced interim data from the two all-oral treatment arms of the ongoing Phase 2a ZENITH study that is evaluating VX-222 in combination with INCIVEK and ribavirin in people with genotype 1a or 1b hepatitis C who were new to treatment. As previously announced, viral loads were undetectable ( < 25 IU/mL) for 83 percent (38/46) of patients with genotype 1 hepatitis C at week 12. Nine of the 11 patients eligible to stop all treatment at 12 weeks achieved SVR4 (undetectable hepatitis C virus four weeks after the end of all treatment).

The three-drug regimen was generally well tolerated. The majority of adverse events were reported as mild. There were no cases of moderate or severe rash and no discontinuations due to rash or anemia in the interferon-free study arms. There were two discontinuations due to adverse events in the genotype 1b arm of the study. Additional data from this study will be presented at the 14th International Symposium on Viral Hepatitis and Liver Disease in Shanghai, China, June 22 to 25, 2012.

Nucleotide Polymerase Inhibitor Data Expected in the Second Quarter

Vertex and its collaborator Alios BioPharma are conducting seven-day viral kinetic studies of two potent, pan-genotypic, structurally distinct nucleotide polymerase inhibitors, known as ALS-2200 and ALS-2158. The first data from these studies are expected in the second quarter of 2012. Based on data from these studies, Vertex plans to begin Phase 2 studies in the second half of 2012 to evaluate combination regimens of ALS-2200 or ALS-2158 with INCIVEK or VX-222 with or without ribavirin, as well as potential dual nucleotide regimens and other interferon-free combination regimens."
=========================

My feeling is the strength of other compounds and collaborations will provide more pressure than people can.  Gilead owns the compound; if they want they can sit on it. However, the desire to earn back some of the 11 billion may provide the desire to partner with other pharmas.  We will have to wait and see what tomorrow brings.

willy

[Willy50]

Here is another brief discussion of what Adam Feuerstein was writing about;

http://seekingalpha.com/article/510971-gilead-hepatitis-upside-may-be-limited?source=yahoo

[gonnabhepcfree]

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.

[mythoughts]

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?

[OdinLovesLife]

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.

[UKgirl55]

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 :-))

[willbb]

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

[Willy50]

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

[willbb]

Greed certainly is not always good . however unfortunately in big business(and there is not much bigger than Pharma) it will always be the main factor .

Best..
Will

[gonnabhepcfree]

My doctor told me on one of my visits that he see's an all oral regime with in the next five years and now they just have to figure out which combinations work the best with the least side effects. He also said he believes there will come a time where you will go to your primary Dr and get a prescription and won't need a specialist to treat.  Dr Hassanein was involved in the trials for interferon before riba.  I will be happy to see him on my next visit having reached SVR12 with the 7977 and bms combo.  He is in Barcelona but  I will find out anything I can on my next visit regarding the future of my combo.

[libzo2]

Just a comment:  Perhaps Wallstreet has tainted the process which has filtered down to many of our individual doctors for example when I went to my expert doctor and saw that he had a new certificate on his wall, it was not for a new medical avenue; it was for business science from Georgetown U.  I wondered if I had changed from a patient under the doctors oathe or an asset to his black line in some account book.  Maybe Pharms should be forced to swear the Hippocratic Oathe as well (as if that would make a difference).

I feel like the waters are full of sharks.

[katla]

This thread was such an interesting read and gives much to think about. I'm grateful to have this forum and I appreciate all you clever people who contributed. :-)

[UKgirl55]

Excellent Willy!

This forum sometimes comes up on Google. This is one thread I'd like to see out there!

[sheepdoggie]

A petition was begun to encourage Gilead to do the right thing.  Please sign it:
http://www.change.org/petitions/gilead-sciences-a-phase-iii-collaboration-for-the-treatment-of-hepatitis-c