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TOPIC: Gilead to Cease HCV R & D

Gilead to Cease HCV R & D 1 year 9 months ago #22574

  • mgalbrai
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Gilead's Q3 Bombshell: No More Hepatitis C R&D

hepatitiscnewdrugs.blogspot.com/2016/11/...-more-hepatitis.html

Not enough money in it for them anymore it appears...
m
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G 1a F-1
Started tx 10/23/15 (Meso sof & led) ALT 48 AST 28 v/l 1.6 mil
11/17/15 4 wk lab ALT 17 AST 16 <15
11/18/15 Started Harvoni
12/16/15 8 wk lab ALT: 15 AST: 13 V/l UND
1/14/16 Fin. Tx
7/07/16 UND SVR 24
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Gilead to Cease HCV R & D 1 year 9 months ago #22576

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So instead of lowering their price, they just moved on to other treatments for different illnesses and will continue to get huge profits from their HCV treatment protocols. The thought of rape, pillage and plunder to the consumer is heart breaking. I and others believe that could be the case and really they could give a rats ass about the people that can't afford it. It is simply legal murder for monetary gain with no laws broken, I find that repulsive and they should be held accountable as other pharma companies. But since that is a business decision, capital aggressive, it will never happen. I maybe off base but that's how it looks to me.
Contracted HCV 1980's
Geno Type 1a
F3 ( doc says once treated I'll be F2 maybe F1)
Meds shipped 6/17/2016 arrived early 7/2016

Viral count - 3,471,080

4 week quantitative bloods: August 17, 2016. I have been diagnosed as <15 (told undetected)

8 week quantitative bloods: September 14th. I have been diagnosed as <15 (told undetected)

11 week PCR RNA Qualitative bloods: September 26th 2016 - Undetected

December 19th 2016: Cured!
Viral count: zero!!!
2018 viral count: still zero!
Cured!
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Gilead to Cease HCV R & D 1 year 9 months ago #22580

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Great post Mike!

There is no need for them to innovate any further. I recently posted this link:

www.scmp.com/comment/insight-opinion/art...nd-china-must-resist

The drugs they have developed are very effective. They only make money in the first world countries. TPP & RCEP agreements will give them a monopoly. I don't know how it will play out, but the RCEP agreement may even pose an obstacle to REDEMPTION. If Gilead can sue the Generic manufacturers for allowing foreign distribution, you can bet there is going to be trouble. I hope I am wrong, but I urge anyone reading this to act now to get your medication.
Gt 1a, F0, VL 6.5 million, AST 59, ALT 62
Started Twinvir 1/15/16
6 wk. labs, VL UND, AST 27, ALT 20
EOT labs, VL UND, AST 23, ALT 19
SVR 16, VL UND, AST 28, ALT 17
SVR 24, VL UND, 10/8/16
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Gilead to Cease HCV R & D 1 year 9 months ago #22581

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I wonder if it will turn out to be (another) poor business decision?
I was taught that when investing, the smart money should be on a business that is passionate about and has a vision for the industry they are in. Looking at this latest strategy along with others they have implemented it seems to me that the Gilead board's passion and vision is often inwardly directed toward their own best chance.......perhaps the market feels the same way?



G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
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Gilead to Cease HCV R & D 1 year 9 months ago #22582

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The downward trend relates mostly to missing projected targets.

From memory they had 150,000 script this time last year for the quarter, but only 110,000 in the most recent quarter.
YMMV
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Gilead to Cease HCV R & D 1 year 9 months ago #22588

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Gaj wrote:
I wonder if it will turn out to be (another) poor business decision?

One cannot trust any news from Gilead. Granted, their profits are being curtailed, but they can still
compete w/ the other major players in the HCV field even w/ a price drop.

Something else is going on that we are not privy to. R & D, even on a limited basis, is probably still
going on, IMO.

Maybe they are on to some major R&D cancer cure or world peace.
contracted Gen 1a in the 70's, dx in 2007...ast 27 to 35...alt 43 to 96...vl 1.2 mil to 8.6 mil.
biopsy F-2 (2012)..pre tx results 1/23/16 ast 32, alt 46, vl 3.1 mil
tx started 2/11/16.... lab results 2/24/16 ast 18, alt 18, vl <15 IU/ml
28 days later.............lab results 3/9/16 ast 21, alt 21, vl UND
56 days later.............lab results 4/6/16 ast 20, alt 22, vl UND
139 days later...........lab results 6/29/16 ast 28, alt 30, vl UND...EOT
SVR24
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Gilead to Cease HCV R & D 1 year 9 months ago #22591

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Actually, it makes perfect business sense. They have a drug (Epclusa) that cures>95% of patients. Those that don't get cured, they have Epclusa + Voxilaprevir to pick up >97% of those. How many does that leave?
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.


Thank you Jesus.
Thank you Dr. James
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Gilead to Cease HCV R & D 1 year 9 months ago #22595

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So far I'm hearing:

- They overstated their opportunities quarter on quarter.
- They underestimated the competition (and may now be looking for new fields where there will also be competitors)
- They are prepared to sit on their laurels.

This in a potential market of 180 million customers of which only 1-2% has been met so far.

Are these really people I would want to invest and grow my hard earned with? ;)
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
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Gilead to Cease HCV R & D 1 year 9 months ago #22596

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Did you read my reply above? How many does that leave?
perhaps it is better to spend your resources on the next big thing. They are already kingpins of this disease.
And i'm not 'on Gilead's side' or anything. Just a sound business decision.
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.


Thank you Jesus.
Thank you Dr. James
Last Edit: 1 year 9 months ago by splitdog.
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Gilead to Cease HCV R & D 1 year 9 months ago #22597

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I did splitdog, see my comment about "sit on their laurels".
There are approx 175 million potential customers left and those success rates you quote are based on 12+ week treatments. From what I'm reading the competition are already developing medications that achieve those or better rates in considerably less time. If that eventuates and given the development times involved Gilead may well find it is yesterday's news in the HCV field with their only effective response then to slash pricing of their current options to target the 'economy' end of the market......luckily they have a lot of room to do that. :evil:


(I'm proposing this purely from an investment perspective but would also note that Gilead have not been an R&D innovator in this field anyway. So far they have have been astute purchasers (Sofosbuvir) or developed "me too" products (Ledipasvir and Velpatasvir). Not sure of the provenance of Voxilaprevir, that could be their own novel work?)
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
Last Edit: 1 year 9 months ago by Gaj.
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Gilead to Cease HCV R & D 1 year 9 months ago #22598

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You said, "Are these the people that I would invest my hard earned with"?
I would say, "Yes". Based on normal, sound business decisions. There could be any number of things going on. Maybe Merck is on to a new approach for a cancer drug. Now maybe Gilead wants to pursue that with great speed. Who knows? But no question they are on the backside of the bell curve already. Just sayin'.....
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.


Thank you Jesus.
Thank you Dr. James
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Gilead to Cease HCV R & D 1 year 9 months ago #22599

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Maybe Merck is on to a new approach for a cancer drug. Now maybe Gilead wants to pursue that with great speed.

So we are in agreement that they are not innovators? Nor a business run by people with passion and vision?

You are correct about the bell curve, my argument is that they are a one trick pony centred around a very astute purchase back in 2011. Sadly, they have then held the HCV patients of the world to ransom with that purchase of Sofosbuvir (which is a truly innovative drug).
G3a since '78 - Dx '12 - F4 (2xHCC)
24wk Tx - PEG/Riba/Dac 2013 relapsed
24wk Tx - Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx - 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 - 22/06/17 UND
SRV12 - 27/07/17 UND
SVR24 - 26/10/17 UND
:cheer: :cheer: :cheer:
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Gilead to Cease HCV R & D 1 year 9 months ago #22601

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Doesn't matter that they are not innovators. Or run by people with a passion. We're talking about business. And they have made a lot of money off of their decisions so far.
I love you Gaj. :)

And yes, it is despicable that they have made money THE WAY THEY HAVE. But the shareholders are happy.
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.


Thank you Jesus.
Thank you Dr. James
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Gilead to Cease HCV R & D 1 year 9 months ago #22604

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Hi Gaj & Splitdog,

reading your posts, I see things are a little bit mixed... Perhaps we should look on the mission a company has on the market.

I struggle my head to find the proper English word for a person who wins a battle, collect the laurels, but is not winning the war (neither willing to fight that war).... So, Gilead through a smart acquisition some years ago bought the company who invented Sofosbuvir and now holds the patent which is a cash machine.

Having drug combinations (SOF+LED, SOF+VEL) that are effective against HCV means that G. has won a battle [HCV can be defeated]. BUT they did not won the war against HCV..... To really win this war against the hepatitis C virus, you need to have "soldiers" (patients, doctors, etc) equipped with efficient weapons (e.g. Sofosbuvir based treatments) deployed on ALL battlefields where the enemy is (all over the world where HCV patients exists).

But, if you look at Gilead's company description, you will see that winning the war against HCV is not their focus:

"Advancing Therapeutics, Improving Lives
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with life-threatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions.

Our portfolio of marketed products includes a number of category firsts, including complete treatment regimens for HIV infection available in a once-daily single pill and the first oral antiretroviral pill available to reduce the risk of acquiring HIV infection in certain high-risk adults.
Strength Through Partnership

Collaborations of all kinds – with partners in science, academia, business and local communities – are central to our work. Partnerships enhance our ability to develop innovative medicines and deliver them to people as efficiently as possible.

Growing Worldwide Reach
Gilead was founded in 1987 in Foster City, California. Since then, we have grown to become one of the world’s largest biopharmaceutical companies, with 8,000 employees across six continents.
"

So, in my English, this sounds like : I want to make "weapons" against life-threatening illnesses and let others fight the war (see "Strengh through partnerships"), especially that the drugs can be replicated. And because of the patent laws, one can add ".... when I made already enough money out of it".
And this is a purely business (or better say profit based) approach, which does not necessarily require neither imply passion or vision to see the sick patients all over the world being cured. Just inventing an effective medicine, being proud of this, making money, then moving to a next medicine which should produce further money, and so on...

By compare, the mission of Natco company is "Making specialty medicines accessible to all". Or Cipla's goal "to ensure that no patient shall be denied access to high quality & affordable medicine and support." and the list could continue.

By this compare one can better see the difference between Gilead and generic drugs manufacturers. We might even call it paradox. Also to be mentioned here is the questionable aspect related to the usage of public knowledge.And this is why we saw recently the Sofosbuvir patent challenge being made by Doctors of the World , I-Mak, etc. as the current settlements for protecting and stimulating R&D leads to such situations of paradox that in the end .... leaves people die.

P.S. I do agree that my view is excluding perhaps other relevant data about Gilead and that it may be biased, however not seeing the mass treatment of HCV patients being worldwide deployed ... well I believe my opinion stands.

Cheers,
RHF
In fiecare an HCV ucide peste 500000 oameni.Medicamentele generice pentru hepatita C functioneaza. Nu deveni statistica! Cauta pe Google “medicamente generice pentru hepatita C”.
HCV kills more than 500000 people every year. HCV generic drugs work. Don't become a statistic.
By sharing this Youtube video you might save someone’s life!
My TX: HEPCVIR-L[generic Harvoni]-India
SVR52 achieved
Last Edit: 1 year 9 months ago by rohcvfighter.
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Gilead to Cease HCV R & D 1 year 9 months ago #22607

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While I staunchly believe in intellectual property rights and patents, I myself circumvented the system to obtain 'Chinese knock-off' generic drugs to save my own life. So something needs to be done in the area of patents for 'life saving medicines' for sure. While Gilead deserves protection and compensation for their drug, something else also needs to be done for fairness of all. NO ONE should die because they can't access food or medicine.This debate could go on and on as everyone will have a different idea of what is just and appropriate. And I'm sure it will be different from Gilead's. ;)

Also, the battle may have been won against HCV but not the war. I agree. However, one could also view the battle as HCV and complete health of all maladies the war. No one knows unless you were in the boardroom. This is the era of specialization, and usually it's better to concentrate on what you do best and sub the other parts out.

That's my story, and I'm sticking to it! B)
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Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.


Thank you Jesus.
Thank you Dr. James
Last Edit: 1 year 9 months ago by splitdog.
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