- 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
Gilead's remdesivir wins orphan drug status for coronavirus
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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.theintercept.com/...
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.seekingalpha.com/...
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
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.www.foxnews.com/...
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!
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?
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
exactly. i mean, how much money do you think flu vaccine manufacturers make?
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
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
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/...
this will give GILD both financial aid to get it to patients and also a 7 year exclusive license so nobody steals it
Yes. And exclusivity" means no competition or patent issues. GILD has always worked good with the FDA.
how can Gilead prevent that its intellectual property will be stolen by th Chinese ?
seekingalpha.com/...Bad link? Shouldn't have been posted?
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?
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.
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
Not really, they say availability under the new program will have the same timing as the slower emergency drug access
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!!
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?
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.
Then why did they halt emergency drug access?
To force this move by the FDA>Think of it like a chess game. Brilliant move on there part !
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.
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.