Gilead ramps up remdesivir production ahead of approvals

• Gilead Sciences (NASDAQ:GILD) has been working with regulatory authorities to start additional expanded access programs for remdesivir, its investigational medicine for COVID-19, Chairman and CEO Daniel O'Day wrote on the company's website.
• Such programs allow hospitals or physicians to apply for emergency use of the treatment for multiple severely ill patients at a time.
• Even though the medicine isn't yet approved for use by any regulatory authorities, Gilead is taking the step of of expanding production to increase supply.
• "As a result we have reduced the end-to-end manufacturing timeline from approximately one year, to around six months," O'Day wrote.
• Its existing supply, including finished product and investigational medicine in final stages of production, amounts to 1.5M individual doses, which could equate to more than 140,000 treatment courses for patients.
• Gilead is providing all of its existing supply at no cost to treat patients with the most severe symptoms of COVID-19.
• Sets a goal of producing more than 500,000 treatment courses by October and more than 1M treatment courses by the end of the year.
• Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, has recommended that in order to be prepared for COVID-19 becoming a seasonal occurrence, drug manufacturers should take the risk to ramp up production of therapeutics before phase 2 trials begin.
• Previously: Gilead's remdesivir OK'd in Europe for compassionate use in COVID-19 (April 3)

Comments

[pat45]

Corona trials expanded, but data not until May....

[EliasMouawad]

@pat45 What is the source of your info ?

[birdman9989]

Couple recovers after being part of clinical trial

www.kiro7.com/...

[pat45]

they do not know if they received drug

[sininar]

I think with rapid diagnosis, it may well become standard of care to get this drug immediately for those over 50 years old. I don't think that means hospital admission. I do think it will eventually be millions of patients.

[mako69]

For all of you interested I found the best article I've seen on the trials and $GILD. It moved me from the middle to the side that Rem is going to get passed. While not perfect nor a cure, it most likely will be the first approved therapeutic for this crap virus. That's my opinion, so only take it as that.

I attached the article below for you so you can decide for yourselves. Peace

www.statnews.com/...

[edaskew]

I bet it will be marginally effective at best. Regeneron is going to have the winning therapy.

[Downtown10]

My money is on Cytodyn (CYDY) with Leronlimab being the go-to therapy

[combatcorpsmanVN]

Somewhere along the line in this fight against COVID-19 the medical community is going to have to begin human testing on the most promising therapies. Country cannot afford to use traditional methods of assuring maximum safety in drug development.

USA is on a war footing with this Virus and 'drastic' measures need to be tried by highly skilled, experience, public health and infectious disease experts. Normal time frames no longer applied when large numbers of people are infected and dying worldwide.

No perfect solution but we, as a Nation, better have some strong, effective medicines availabile if this Virus comes into a 2nd wave this Fall.

Anyone ignoring the Guidelines now should be jailed so they can get a sun tan when they're allowed to leave their cells. This type of conduct is reprehensible and should be handled not delicately.

The Governors of N. Carolina, Arkansas, and Georgia better wake up soon or their states are going to be creamed by those sun bathers returning with a great Tan as they proceed to their family home. This type of ignorance is going to be heart rendering for the ignorant who, in many cases, are intentional ignoring the warnings. And, these governors are brain dead in not recognizing the severity of this Virus and the adverse impact on the people of their States.

Ignorance isn't a defense after a Month of the carnage created worldwide by COVID-19.

[Joel2040]

I might note that all 3 of those Governors are Republicans and a little on the God Complex hard headed side of people.

[tranacria]

Market up 5% across the board today. This POS is dropping. I understand that the covid virus will not be a "gold mine" for it and that is fine as I'd rather there be a cure for humanity. But it can't even post one positive percentage point on its other drugs which are in the pipeline or the Allergan acquisition. As I have posted before this is a dog of a stock . I have over $ 50,000 invested and do not give a darn about the dividend. Wanted and needed capital appreciation. In the 5 years which I have held this trash it hit my cost average point only once, very briefly & recently ,and I missed it because I was in the lavatory. I chased the falling knife and got cut badly. I only want to break even but with this POS it'll take another 5 years plus. Stay out of this stock it is dead money. Needs an activist.

[Finding Your Retirement]

need to be sold to china. at least the chinese will approve the damn drug unlike the lazy FDA

[allday1234]

@tranacria
You have a stock that has not performed in 5 years! yet you still own it and it is the stocks fault because you still own it.
It appears as if you have no exit plan or even a plan for that matter. Holding a non performing stock is your problem and not the stock.

[EliasMouawad]

Boris Johnson is in a critical condition. Give him Remdesivir !

[John CM]

theintercept.com/...
Gilead will not make billions from this coronavirus pandemic. There are laws that prevents it from manufacturing the drug for a few bucks and selling it for 100.
"The law, known as Section 1498, gives the government the right to override a patent at any time as long as the company receives “reasonable compensation.” Essentially functioning as a kind of eminent domain for patented products, the provision breaks the monopoly and permits low-cost competition. And if drugs such as Gilead’s antiviral remdesivir and other potential treatments and vaccines for the coronavirus are priced out of reach, it could give the government critical leverage to negotiate lower prices. Through the Defense Production Act, the government could even start producing lifesaving treatments itself."

Wait... the things get even more interesting.
www.bloomberg.com/...
"Chinese Firm Makes Gilead Drug in Virus Fight, Raising IP Fears"

It is called "compulsory licensing" which is allowed by the WTO rules.
www.twn.my/...
Law360 (March 19, 2020, 3:52 PM EDT) — Israel is allowing generic versions of AbbVie Inc.’s HIV drug Kaletra to be imported to treat coronavirus patients, even though the drug is still patent protected in the country, according to Thursday media reports.

So, there is a Chinese company, and soon more other companies, that will create a generic version of remdesivir. Then, the states will negotiate, i.e. pay Gilead what they find reasonable (maybe 2x - 4x the manufacturing costs, not 50x) for this "compulsory license". Israel already does it. Canada does it.
www.statnews.com/...

Assuming $5 to manufacture, Gilead will probably get something like $20 / person / licensing fee. If we look at today's stats about severe ill, we have 50 000 cases (5%). Not all will get Gilead's generic version. Some will get plasma before the 14 day of sickness, some will get other drugs.
So, let's assume 30 000 patients per year for remdesivir. Times $20, that is less than $1 mil.
Assuming I was too aggressive in price cuts, make it $5 millions. Like I said before.... a drop in a bucket.

[John CM]

And one more interesting survey:
"The survey also found that 83% of global physicians anticipate a second global outbreak, including 90% of U.S. doctors but only 50% of physicians in China."

There is a huge gap between the US doctors and those in China. Why is that? The Chinese doctors went already through a third crisis, after SARS and MERS. They know that if they have enough tests (and there will be enough tests in a few months), the disease control groups can effectively test, track and isolate immediately those infected.
As soon as few cases will be found in a region, then testing will be done in large scale, temperature will be taken everywhere, masks will be wear in public, transportation will be tracked..... so, this is how SARS and MERS were prevented to occur a second time. Because the doctors were prepared and tools were in place. The current situation is caused by poor public health management in the West which will not happen a second time.

[Finding Your Retirement]

i hope you're not serious it takes 5 bucks to make this drug. this is not grinding down some roots and packing it into a pill for people to swallow. 99% of the material used to make this drug is thrown away. this is a highly specialize drug to make that requires ton of material with low payout. The intercept is ran by a bunch of liberals who have no idea how to make medicine or understand how this drug is even made. The only thing they know is FREE FREE FREE

[John CM]

It is actually very well documented and it made the news in case of Truvada. This drug for Ebola cannot be more difficult.

www.ncbi.nlm.nih.gov/...
thehill.com/...

"For example, the target price for tenofovir alafenamide (TAF)/3TC/dolutegravir (DTG) has been set at $60 per person-year "
Look at all tenofovir prices (Truvada). The UK price is about $3200 per person/year. Thus $300 / month with a daily pill. Thus 10$ / pill. In the poorest countries, this price is 20x lower. So, there you go, you have the manufacturing price anywhere between $10 and $1. I'm fairly confident it is about $4-$6.

The US pays 3x more than UK. You can conclude whatever you want. I think UK negotiated a price closer to the manufacturing cost. But UK is a well developed country, not a poor one, so it should pay full price. I'm convinced that UK's price has 50% gross margin. Hence the $5-$6 cost / pill.

[DividendInvestor2018]

Great!

[Greenhorn Investor]

Go GILD

[CaptainSolo]

"David Ho, a Columbia University professor and infectious disease specialist, agrees that remdesivir is the most promising candidate (for coronavirus)."

www.theguardian.com/...

EMA Recommends Compassionate Use of Gilead's Remdesivir for COVID-19

Expect a high cure rate.

GILD had $5.7 billion dollar revenues in Q1 2020 - mostly from HIV ($4.5 B) and HCV ($600M).

GILD has over 90% of the entire HIV market based on sales and drugs.

GILD sold over $16 billion of HCV (Sovaldi/epclusa) meds in 2015 - and is the world leader in HCV sales which have plummeted because it was effectively a cure.

GILD has been manufacturing remdesivir since November 2019.

[CaptainSolo]

Remdesivir stops coronavirus replications in humans.

That is the same method solvaldi and epclusa halted the HCV epedimic.

It is still too early to know how effective it will be - and without relapses.

[dunnhaupt]

@TAS:
There is no cure at this time. An injectable vaccine can only be made from the blood of persons who have survived and thus developed immunity. That will take time, but it would protect us if the virus returns next year.

[madisonriver]

@dunnhaupt

You might want to read this regarding vaccine creation and production
www.bat.com/...

[John CM]

I don't think so. The procedure you mention is called convalescent plasma (or hyperimmune plasma) and is used to pass antibodies from one person to another. Those antibodies only lasts for several months, a year (like a flu vaccine). The vaccine aim to replicate the protein, not the antibody, protein that is found inside the virus in order to stimulate the immune system to create their own antibodies.

[TAS]

In WW2 we buit aircraft carriers in three months. Liberty ships in three weeks.The country is in a crisis. Get the damn meds out now, with the very ill having the option to take "non-approved" doses immediately. What the hell do they have to loose?

And EXEMPT the drug companies, hospitals and doctors from lawsuits....that will solve the biggest problem dead in its tracks.

[The Stock Stooge]

Whatever it takes. Gottlieb should be put in charge. We need to mobilize all resources now to ensure that we have tools for the Fall.

[richjoy403]

TAS -- Great idea! Why hasn't someone thought of that?

BTW, which meds (or ships) do you have in mind?

[cleveland saint]

saw this coming but didn't buy shares :/

[USER679580]

Scott Gottlieb, former FDA head, was on Face the Nations(CBS) today, he feels the FDA is not showing urgency to advance new COVID-19 treatments, he feels a treatment or two will save our economy from a complete shutdown. You would think he would use his influence to light a fire under this antiquated FDA, especially when we are heading to peak deaths

[John CM]

This actually works.
www.fda.gov/...
And these instructions in Europe
www.ecdc.europa.eu/...

[Late to the Party]

The fda is full of red tape covered by reddish tape covered by blood red tape. Most of the laws and regulations make no sense but must be dogmatically followed. This is how the government works. People talk a lot about the polio vaccine. That was during a different time with different rules. If it was now the vaccine would be done in 20 years. In other words. Remdesivir will be approved when the 5th generation of the coronavirus hits the us.

[laotzu225]

@John CM The FDA source says : "convalescent plasma has not yet been shown to be effective". Maybe it is but further testing is necessary.

[John CM]

I can't do the math over the long term financial benefits for GILD. But I think it will be a mere drop.
This is a contagious disease that can easily be detected and cured. It is not like AIDS where you have to be treated for the rest of your life. And most importantly, the state will want to track you and your contacts down immediately. As a result, at the next wave of this virus, the state will no longer downplay it like it did this time (Europe and US were badly hit by this mistake made by its political liders). The state will have masks ready, will have disinfectants to clean every public place as often as possible, they will require all of us to wear masks in public places..... Once this wave will go in a few months, the mankind will be ready for the next battle. And will not fight with such an expensive drug from Gilead, but rather soap, water, 3-ply masks, cheap disinfectants and tracking human movement. After a while , the vaccine will be developed.

[pro8]

We know very little about this disease but we're learning and you're making it sound like we got it nipped in the bud... please just STFU

[John CM]

YOU know very little. Actually the scientists know so much about it.
The Chinese know a whole lot about this virus. They developed a procedure to transplant plasma with antibodies to cure the critically ill patients. And they applied this procedure to keep the death count low. This procedure is now used in EU and US, being approved by FDA. The Chinese tried this procedure during the SARS outbreak several years ago.

Also many vaccines are at trial phase. Some scientists say WE KNOW EXACTLY.... just STFU yourself, or go reading some instead.

"Researchers from the University Of Pittsburgh School Of Medicine say they may have found a likely vaccine for coronavirus infection.
The Pitt Med researchers said they were able to act quickly because they already had conducted research on SARS and MERS, which are also similar coronaviruses. In a statement, the study’s co-senior author, Andrea Gambotto, MD, said the two viruses are related to SARS-CoV-2.

Dr. Gambotto said, their previous studies on the two viruses taught them that “a particular protein, called a spike protein, is important for inducing immunity against the virus.” He also said, “We knew exactly where to fight this new virus.”"

[mako69]

@John CM

If you want to start believing everything that comes out of China which is all censored and molded by the CCP by the time it gets to your eyes and ears, be my guest.

This is the same CCP that covered up the viral outbreak, then only a few weeks ago, accused the US Army of a bioweapons attack, causing said outbreak, while simultaneously saying that Covid-19 started in America and that China doesn't get the flu.

#facts

[wurner]

Tracking Illinois Covid Deaths, today number decreased. The recent 3 day trend as reported on the Illinois Covid Site is (day, followed by reported deaths) Fri 53, Sat 43, Sun 21. There was a report that Remdesivir was being used in Illinois, but the extent of use was not identified. Hope the downtrend continues no matter what is accounting for the decrease.

[DeejL]

The drug doesn’t have a significant cure rate to be considered a potent cure for this virus currently. Needs much larger scale testing and retesting before being given the approval. Let’s not create false hope that’ll make people lower their guard so early on.

[CaptainSolo]

Don't underestimate Gilead's salesforce...www.cbsnews.com/...

Gilead gets the most revenues in return for every dollar invested in reps and marketing.

20 Drug Companies Ranked by Sales and Marketing Efficiency*
Rank, Name, Yield, Trend
1. Gilead: 7.37 Up
2. Teva: 4.19 Down
3. Genentech: 4.15 Up
4. Sanofi: 3.64 Flat
5. Abbott: 3.46 Flat
6. Pfizer: 3.37 Flat
7. Amgen: 3.31 Down
8. Wyeth: 3.25 Flat
9. Merck: 3.24 Down
10. Lilly: 3.20 Flat

The reason Gilead is the easy leader is its drugs are lifesavers, and there is little competition for them in the marketplace. IMO

Gilead has 9000 employees and $5.79 Billion in revenues over the last three months!

[kenberthiaume]

it doesn't have a "significant cure rate"? how would you know?

[mako69]

@DeejL

Dude, it's not a cure.

[mako69]

Again, looks all good and well, but if this thing's worked that great, Remdesivir would already be deployed all over the world. I'm pretty sideways on the situation now.

Yeah they are getting ready to ramp up production, but what I've read is that they are setting up contracts with other producers and securing the rites to precursors. None of this means they have to actually follow through on it. It's not like they are making large equipment purchases and retooling entire production facilities, which would be a hard tell.

It's starting to look like maybe it can be used in a cocktail and things are so desperate that everyone is willing to just throw the kitchen sink at Covid-19 and will administer anything that doesn't kill the patient.

Also, the problem with the upcoming Chinese trials is..well it's administered by mainland Chinese drs overseen by the CCP. There is no telling if the information will be accurate or Luckined up.

[combatcorpsmanVN]

GILD's scientist are known to have advanced the help for AIDs patients for a number of years. I haven't heard much about a variety of Drug cocktails to fight this Virus. Perhaps there are too many unknowns to administer at this point in time.

I applaud GILD for its efforts in trying to help mitigate or eliminate the world wide suffering.

[kenberthiaume]

1m treatments by year end? a pittance. Hopefully they can license it?

[DeejL]

Those are 1 million doses, that will only help 140,000 people. The actual impact if way less.