Eiger doesn't want to treat Enterovirus or ME/CFS, and lose orphan status

[sometexan84]

I found out why Eiger Biopharmaceuticals, creator of Pegylated Interferon Lambda, will not return any of my messages. They do NOT want to lose their Orphan Drug status.

There's great potential for this drug in treating Enterovirus B infections in ME/CFS.

And it's not just me who thinks this...

Maureen Hanson (of the recent The Enterovirus Theory of Disease Etiology in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Critical Review), appears to be in favor of a Peginterferon trial for ME/CFS, as she was helping me locate relevant contacts for such a trial.

Jane Zhou (of the recent Human Intestinal Organoids Recapitulate Enteric Infections of Enterovirus and Coronavirus) said "enteroviruses are very sensitive to IFN lamda. it will definitely be an excellent drug for treating enterovirus infections" when I asked about Peginterferon Lambda.

However, since this drug has "orphan" status, Eiger gets many many benefits and perks. And if they were to use it to treat ME/CFS, they'd lose this orphan status.

Orphan drugs treat rare diseases that have less than 200,000 in the U.S. They use PEG-IFN-lambda to treat Hep D virus, which has only 100,000 in U.S.

With Orphan status, they get the following....

• tax incentives
• exclusivity (special patent and marketing rights protections)
• government subsidies for clinical research
• can jack up the price for massive profit (orphan drug companies don’t have to disclose their pricing strategies)
• regulatory shortcuts (less FDA regulatory requirements and oversight)

They have more than enough money to fund a trial of this drug for Enterovirus, not just in ME/CFS, but other chronic conditions. But if they did, they'd lose their orphan status, and all of these fantastic benefits and profit.

 

[Rufous McKinney]

appalling

 

[Hip]

I wonder if it might be worth writing to the FDA, to hear what they have to say?

 

[bensmith]

: (

 

[sometexan84]

I wonder if it might be worth writing to the FDA, to hear what they have to say?

I guess it couldn't hurt anything

 

[Martin aka paused||M.E.]

I found out why Eiger Biopharmaceuticals, creator of Pegylated Interferon Lambda, will not return any of my messages. They do NOT want to lose their Orphan Drug status.

There's great potential for this drug in treating Enterovirus B infections in ME/CFS.

And it's not just me who thinks this...

Maureen Hanson (of the recent The Enterovirus Theory of Disease Etiology in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Critical Review), appears to be in favor of a Peginterferon trial for ME/CFS, as she was helping me locate relevant contacts for such a trial.

Jane Zhou (of the recent Human Intestinal Organoids Recapitulate Enteric Infections of Enterovirus and Coronavirus) said "enteroviruses are very sensitive to IFN lamda. it will definitely be an excellent drug for treating enterovirus infections" when I asked about Peginterferon Lambda.

However, since this drug has "orphan" status, Eiger gets many many benefits and perks. And if they were to use it to treat ME/CFS, they'd lose this orphan status.

Orphan drugs treat rare diseases that have less than 200,000 in the U.S. They use PEG-IFN-lambda to treat Hep D virus, which has only 100,000 in U.S.

With Orphan status, they get the following....

• tax incentives
• exclusivity (special patent and marketing rights protections)
• government subsidies for clinical research
• can jack up the price for massive profit (orphan drug companies don’t have to disclose their pricing strategies)
• regulatory shortcuts (less FDA regulatory requirements and oversight)

They have more than enough money to fund a trial of this drug for Enterovirus, not just in ME/CFS, but other chronic conditions. But if they did, they'd lose their orphan status, and all of these fantastic benefits and profit.

But they'd get a blockbuster instead if studies turn out to be positive...

 

[marcjf]

The orphan drug policy seems to do way more harm than good.
Would it be possible for others forms of IFN-lambda to also help, since PEG-IFN-lambda may be unavailable?
In that case, why won't other countries run a similar trial?

Also, has anyone else bumped into this one, for example: https://rupharma.com/ingaron-interferon-gamma/ ?

 

[BrightCandle]

They have potentially millions of customers if it works, it doesn't seem sensible to not test it and see if by chance it actually does have a massive audience rather than the tiny one they anticipate. They have a shot at something that will treat 10s of millions, it simply can't be more profitable to not pursue that possibility.

 

[mitoMAN]

No one is interested to bring out a medication for me/CFS sadly.
Funding a clinical trial seems impossible (by manufacturers).
I never fully understood why.
I mean most insurances don't even accept that diagnosis.
The lacking biomarker surely doesn't help

 

[junkcrap50]

Man that sucks. Hoped they’d find it. It doesn’t stop other researchers from using it does it? Have you heard from or tried Dr. Chia?

 

[sometexan84]

Man that sucks. Hoped they’d find it. It doesn’t stop other researchers from using it does it? Have you heard from or tried Dr. Chia?

I've tried, so have others w/ more sway than me. Dr. Chia does not want to correspond for some reason.

 

[sometexan84]

But they'd get a blockbuster instead if studies turn out to be positive...

They have potentially millions of customers if it works, it doesn't seem sensible to not test it and see if by chance it actually does have a massive audience rather than the tiny one they anticipate. They have a shot at something that will treat 10s of millions, it simply can't be more profitable to not pursue that possibility.

Estimated 1 million ME/CFS in U.S. And they say 90% undiagnosed... so that's 100,000 in the U.S. Might not be a blockbuster to them, and still would increase their target from 200,000 to 300,000, above the orphan drug threshold.

 

[sometexan84]

I wonder if it might be worth writing to the FDA, to hear what they have to say?

the FDA's response to me...

I am sorry, but due to confidentiality laws, we cannot provide information related to drug applications that may have been submitted. All information on an unapproved application or investigational application is confidential and belongs to the manufacturer/sponsor of the application. You will have to contact the sponsor of the product for more information.

 

[sometexan84]

Odd/interesting finding...

After some sleuthing, I found that Stanford's Jeffrey Glenn, M.D. was granted $14.3 million by NIAID to develop broad spectrum antiviral drugs for enteroviruses and potentially SARS-CoV-2.

This is the Oct. 2020 article, announcing the grant, and basically saying he's now got all this money to find treatment for Enterovirus, and maybe also coronavirus.

But what's really strange, is that Dr. Jeffrey Glenn it turns out, is actually the founder of Eiger Biopharmaceuticals.

So, if he's in control of Eiger's Peginterferon Lambda, and obtained a huge grant to treat Enterovirus, it makes zero sense that there's no trial, or plans for this treatment. Not even a whisper out there regarding this.

This dude is smart, and knows (and clearly has interest in) enteroviruses. So it's not like he hasn't put two and two together. He HAS to know Lambda's potential to treat enterovirus.

Also sucky, I guess at some point this grant to develop antivirals for Enteroviruses, turned into a grant to develop antivirals for Covid-19.

https://reporter.nih.gov/search/vjzyOsWdA0OKiXD8lwTskw/project-details/10269648

Idk, maybe he actually did have plans to use Lambda for enterovirus initially... before Covid blew up, and by the time he got the grant money approved, he changed focus to SARS-CoV-2 instead.

And then, for whatever reason, decided to steer clear of Enterovirus. Could be Orphan drug related. It just all seems very fishy to me.

 

[Hip]

After some sleuthing, I found that Stanford's Jeffrey Glenn, M.D. was granted $14.3 million by NIAID to develop broad spectrum antiviral drugs for enteroviruses and potentially SARS-CoV-2.

Interesting news. Unfortunately it normally takes 15 years before new drugs hit the market, even if research starts now. Although the FDA has said that any drug which has the potential to treat ME/CFS they will place it on its fast-track program, which greatly speeds up the whole process.

 

[YippeeKi YOW !!]

They have more than enough money to fund a trial of this drug for Enterovirus, not just in ME/CFS, but other chronic conditions. But if they did, they'd lose their orphan status, and all of these fantastic benefits and profit.

I'm just .... what's the word ..... stunned .....wait, no, that's not it ..... shocked ..... nuh-uh ...... unsurprized. Yeah, that's the one ...

I wonder if it might be worth writing to the FDA, to hear what they have to say?

You're kidding, right? The FDA wont talk to Congress, the odds of their responding to a private citizen are right up there with being struck by lightening right after you find out you've won lotto and grown a second head ....

 

[junkcrap50]

Would writing to any of the ME advocacy groups (like MEaction and others) help to do anything? Spread the word or raise awareness? Get more attention or public knowledge about it. Maybe they have better or other contacts? Or they could get someone in Europe interested about it?

 

[sometexan84]

Interesting news. Unfortunately it normally takes 15 years before new drugs hit the market, even if research starts now. Although the FDA has said that any drug which has the potential to treat ME/CFS they will place it on its fast-track program, which greatly speeds up the whole process.

Another interesting fact about this Jeffrey Glenn, he is actually a member of the FDA Antiviral Drugs Advisory Committee. Now, when I googled this, this committee is either now defunct, changed names or something else.

BUT, he has, or at least DID have sway w/ the FDA. Which seems like should not be allowed, as the founder of a pharma company.

 

[YippeeKi YOW !!]

Which seems like should not be allowed, as the founder of a pharma company.

And again, the odds of Pharma and the FDA being in bed together present as pretty close to absolute.

Consider the number of dangerous, even deadly, drugs that the FDA has not only approved, but kept on the market looooong after their damages had been proven, and hundreds of people had died.

I'm too deeply fatigued and brain dead to make a cogent argument or do a decent rant, but truly, the FDA and BigPharm were def a marriage made in ..... well, wherever it smells heavily of sulfur and deals are signed in blood ..... usually someone elses's.

 

[Martin aka paused||M.E.]

And again, the odds of Pharma and the FDA being in bed together present as pretty close to absolute.

Consider the number of dangerous, even deadly, drugs that the FDA has not only approved, but kept on the market looooong after their damages had been proven, and hundreds of people had died.

I'm too deeply fatigued and brain dead to make a cogent argument or do a decent rant, but truly, the FDA and BigPharm were def a marriage made in ..... well, wherever it smells heavily of sulfur and deals are signed in blood ..... usually someone elses's.

It's the same everywhere