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Gilead's remdesivir wins orphan drug status for coronavirus

Mar. 23, 2020 4:34 PM ETGilead Sciences, Inc. (GILD) StockGILDBy: Stephen Alpher, SA News Editor159 Comments
  • As expected , the FDA designates Gilead Sciences' (NASDAQ:GILD) remdesivir an Orphan Drug for the treatment of COVID-19. Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved.
  • Remdesivir (GS-5734), a nucleotide prodrug that blocks a key enzyme needed for viral replication, is also being developed for Ebola virus disease.
  • Shares up 2% after hours
  • FDA link

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Comments (159)

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Ptcamd77 profile picture
Is this stock a buy?
It is rumored to be getting FDA Approval within the next month to treat COvid19 patients with their drug Remdesivir. It is in Stage 3 trials here and abroad. If FDA approves it, that means it is a cure for CoVid19. The stock will skyrocket 🚀!
autofocus111 profile picture
Why was the drug given 'orphan' status? Did GILD just take advantage of a loophole, or was it because they don't expect to profit?

>>>The 1983 Orphan Drug Act gives special inducements to pharmaceutical companies to make products that treat rare diseases. In addition to the seven-year period of market exclusivity, “orphan” status can give companies grants and tax credits of 25 percent of the clinical drug testing cost. The law is reserved for drugs that treat illnesses that affect fewer than 200,000 people in the U.S. But a loophole allows drugs that treat more common illnesses to be classified as orphans if the designation is given before the disease reaches that threshold. As of press time, there were more than 40,000 confirmed cases of Covid-19 in the U.S, and some 366,000 worldwide....The special orphan designation, which can also be granted to drugs when there is little reasonable expectation that a company will recoup its research costs, was given to remdesivir despite hefty support by the government for the development of the drug.

antivirals have 2-3 years of studies done before it can be considered "Safe" by the FDA. At the rate people are dropping dead this info can't take that long. Orphan drugs are essentially drugs that the FDA can't guarantee its safeness but can guarantee its effectiveness. The half govt payment is used to continue the research into the long term side effects of these drugs
Also the intercept was wrong. GILD applied for orphan status in January 2020. At the time the majority of cases were in China. It had yet to spread. The only US cases came from 1) people traveling back to china and 2) people coming home from cruise ships. Both were way under 200k. But being as the intercept is a liberal rag is knowingly withheld this information
autofocus111 profile picture
Well I guess I have my answer.

>>>Gilead Sciences (GILD -3.1%) has submitted a request to the FDA to rescind Orphan Drug status for antiviral remdesivir for COVID-19, a designation granted by the agency only two days ago.

pat45 profile picture
GILD has reached the people limit for test... FDA says no more till results..not GILD!....bad news for people that hydrochlorquine did not work hope it is tested more..hope GILD results this week and more available for use
where did you read this? My understanding is GILD can give out by they have to be taking details as to who is given it, how bad they are, outcomes etc. Not sure if they're charging for it.
Humble Eagles profile picture
Here is a story about a very healthy (before) 25 year old who has been put in a medically induced coma and they are desperately trying to get Remdesivir. Scary. They need to figure this out--yesterday. We don't have time for the usual process imo. This time is different.

pat45 profile picture
call the FDA or CDC...need government to give OK not GILD...they have reached limit for test set by FDA...pray results this week and that they continue positive so more can be treated, and treated earlier rather than deathbed!
Humble Eagles profile picture
pat, why did GILD say they were overwhelmed with requests and they were cutting off the drug for compassionate use? Why didn't they say that the FDA directed us to cut it off?
@Humble Eagles under compassionate use they couldn't use the result of the drug. Say you have 1 person in critical condition vs 1 person in moderate with tube but not critical. All of the data were anecdotal which is not used for FDA approval. By switching it to clinical they essentially enroll more people into their trial and can use the data to fast forward the trial.

but thanks to the brilliant FDA, companies don't like giving out compassionate use because 1) insurance normally don't pay for it and 2) it still leaves them open to liability even if the patient waives it (multiple way like intentionally giving people dangerous drugs or people weren't in their right state of mind to sign the contract (coercion))

In other news. China is about to approve remdesivir and GILD will make their drug in China. Whereas the lazy bums at the FDA suck each other off while praising each other for their hard work and increasing their raises. Who cares if Zantac, FDA approved, caused cancer and death. At least it was "Safe" according to these numbnuts

"American biotech firm Gilead Sciences may make Remdesivir, an experimental Covid-19 drug, using original equipment manufacturers in China if the treatment passes clinical trials, according to China Securities Journal.

Humble Eagles profile picture
Many of us don't really understand this process. GILD pulled the drug from compassionate use while people are dying to get the drug--literally. I strongly suspect they already know the safety and efficacy. Can anybody explain why they pulled it and what is going on? TIA
24 Mar. 2020
This is not making a lot of sense to me and maybe someone explained it below but why is this $GILD not responding to any positive news or even a market really?
SharkLady profile picture
how much money do you think this will bring in?
maybe not so much today but think of this..if this drug works as advertised then EVERY country on earth will have to have a ready stockpile .Also it works on not just COVID19 but other coronoviruses. It could be a whole new franchise for the company
If FDA Approved, it could soar pretty quickly. It depends how bad the virus 🦠 /economy is, I guess. If I had to guess, I see it going over $100 when news of FDA approval is announced.
Gilead has a cure for this plague, what's it worth? Ehh...not much.
SharkLady profile picture
exactly. i mean, how much money do you think flu vaccine manufacturers make?
Probably not much, but if they have a uniquely good cure, you'd think they could sell millions of doses at $500 a pop. Even with this treatment the virus will eventually spread to most people.

Plus it's great PR. No one will criticize them if this is the real deal.
pat45 profile picture
Data should be out this week or next, but several leaked patient stories have been very good. This could be a turn around in corona story...but want shots to be formulated for home use
wwmeinc profile picture
Dosing will be interesting to know...with the increase in patient enrollment they should have some quick data in knowing what works best/quickest by early next wk if all goes well. glta
At best they'd have it outpatient. But for the ones in hospital at least it'd shorten their stay to a few days instead of weeks.
wwmeinc profile picture
Shorten their stay...? How about it saved their lives....Stay well and glta.
CaptainSolo profile picture
Orphan status is reserved for drugs that treat conditions that are thought to have limited potential for profitability without government sponsorship or assistance. Companies that sponsor a drug eligible for orphan status gain access to incentives designed to aid development, such as tax credits for clinical testing and a seven-year exclusivity window on production. www.foxbusiness.com/...
pat45 profile picture
this will give GILD both financial aid to get it to patients and also a 7 year exclusive license so nobody steals it
CaptainSolo profile picture
Yes. And exclusivity" means no competition or patent issues. GILD has always worked good with the FDA.
marsuculix profile picture
how can Gilead prevent that its intellectual property will be stolen by th Chinese ?
Where was it published that remdisivir received orphan status???
Oil Can profile picture

Bad link? Shouldn't have been posted?
Oil Can profile picture
Did anyone else notice that SA posted another article/news bulletin - something to the effect that "FDA approves Remdesivir for COVID-19; shares up +2% after hours" - but now the link appears to be missing? I'm assuming the SA editors misread the status of the drug also?
Yes, this was puzzling last night.
It was a misleading link... it has not passed through the final approval stages as yet.
Where are this drug's parents!?!??
Vlae Kershner profile picture
They can't leave their homes.
This drug is a 50/50 proposition sad and total irresponsible stories fda only approved a pathway to approval not approval shame on u carnival barkers
who says it's 50/50?
edaskew profile picture
Just about anyone who has a habit of looking at studies for various drugs under development. Remdesivir isn’t out of the woods yet; not by a long shot, regardless of how much we want it to be.
pat45 profile picture
If it looks like it works it will get very quick limited approval so insurance can pay...because WE NEED IT, FDA will not sit on thumbs and kill people...it has been thru safety trials...results far more promising than expensive cancer drugs
Coronavirus Patients in Limbo as Gilead Suspends Emergency Drug Access www.nytimes.com/...
Goomba69 profile picture
Not really, they say availability under the new program will have the same timing as the slower emergency drug access
biotech_gal profile picture
Yes exactly but the headlines certainly caught a lot of people's attention, didn't they?
pat45 profile picture
well I hardly call corona an orphan....but just want to get it approved, lots of production and to patients...please formulate shots for it that can be given at home!!
Balthazar-B profile picture
@pat45, wouldn't you rather vape it, or administer it via a butt patch?
birdman9989 profile picture
How long will it take to ramp up production to where we have adequate supply for the demand in the event it is a lifesaver?
abbdiver2 profile picture
They already did now millions of already produced doses will be shiped out to hospitals and European countries .China and South Korea are already using it.
birdman9989 profile picture
Then why did they halt emergency drug access?
abbdiver2 profile picture
To force this move by the FDA>Think of it like a chess game. Brilliant move on there part !
gametv profile picture
Of course they needed to get the 7 year exclusive before they would come out with positive results. Need to protect those future income streams.
johnfairplay profile picture
Yep, after all that's why they're in business.
I dont care about all the bickering. I am still wondering why it went down from 84.00 after Trump promoted it. When does it start making us Money? I Pray for all our sakes it treats covid-19. Sixty,bad ticker, chronic COPD and adult children still living at home.
johnfairplay profile picture
The stock's moved up and down 15 percent on zero news over the past 2 weeks. It's pretty ridiculous and shows you how nonsensical the price action has been.
Trump promoted Regeneron today.
The Orphan Drug designation means Gilead is protected from competition for, I believe, seven years, that is 7 years of exclusivity. it does not mean they can immediately vend it as a prescription cure. That would be another step.

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