This page has been archived and commenting is disabled.

AbbVie Stock Plunges After FDA Warns Of "Serious Liver Injury Risk" From Company's Hep C Treatments

Tyler Durden's picture




 

It has been a horrible quarter for biotechs, and for AbbVie it just got worse.

Moments ago specialty pharma drug company AbbVie which had a market cap of over $80 billion plunged over 10% after the FDA unexpectedly issued a warning of "serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie."

Specifically the FDA, which approved Technivie for use in combination with ribavirin for the treatment of hepatitis C virus (HCV) genotype 4 infections in patients without scarring and poor liver function (cirrhosis), said that "hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels.

It adds that "patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines. Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.

The immediate result is that ABBV shares are tumbling...

... while those of its biggest Hep C competitor Gilead Sciences, are spiking by 6%.

And just like that, the day of another happy camper in hedge fund hotel stocks, Glenview - which is long 17.9 million shares of ABBV - was ruined.

 

- advertisements -

Comment viewing options

Select your preferred way to display the comments and click "Save settings" to activate your changes.
Thu, 10/22/2015 - 15:29 | 6699596 Dr. Engali
Dr. Engali's picture

"As a result, we are requiring the manufacturer to add new information about this safety risk to the drug labels."

 

Here, now put this little tiny message on your bottles so nobody can see it and slip it into your 30 second list of side effects in the commercials so that nobody can hear it.

Thu, 10/22/2015 - 15:31 | 6699631 NYPoke
NYPoke's picture

Notice: Small Pharam is getting hammered by the governement at same time as Small Insurance.  No Drugs For You.

 

The Big Boys are sending smaller competition out to swim with the fishes.

Thu, 10/22/2015 - 15:42 | 6699689 NoDebt
NoDebt's picture

Knock, knock.  Who's there?  Liver.  Liver who?  Liver failure.

Thu, 10/22/2015 - 15:49 | 6699722 Boris Alatovkrap
Boris Alatovkrap's picture

Boris is recommending Khortytsa alternative for treatment. Of course, there is still great risk to detrimental of liver, but at least there is innebriative benefit!

Thu, 10/22/2015 - 16:09 | 6699817 Manthong
Manthong's picture

Acid Reflux?

Here, try our new elixir, it’s pure, triple distilled H2SO4..

Thu, 10/22/2015 - 16:11 | 6699829 chumbawamba
chumbawamba's picture

Management: How is our cure coming along, Scientist?

Scientist: Well, we've managed to find a poison that will kill the disease, the problem is we haven't figured out a way to inject the poison into the patient without killing the patient.

Management: Details...marketing will take care of that.  Looks like we got ourselves a product.  Let's ship!

I am Chumbawamba.

Thu, 10/22/2015 - 16:33 | 6699954 El Viejo
El Viejo's picture

Formula for Bio Pharm success:

Get guinea pigs to invest in your company.

Thu, 10/22/2015 - 17:59 | 6700341 knukles
knukles's picture

The irony of all ironies! 
A Hep-C drug that damages the liver.
Can't make this shit up.

Thu, 10/22/2015 - 16:10 | 6699826 Latina Lover
Latina Lover's picture

My favorite  poison is Nemiroff with Honey and Hot Peppers, and to heck with my liver!  Who wants to live forever?

Thu, 10/22/2015 - 16:24 | 6699906 Boris Alatovkrap
Boris Alatovkrap's picture

More vodka is reduce toxicity overdose of Di-Hydrogen Monoxide.

Thu, 10/22/2015 - 18:36 | 6700500 Scooby Dooby Doo
Scooby Dooby Doo's picture

Bunch of drunks on this thread!

Thu, 10/22/2015 - 15:36 | 6699656 Vampyroteuthis ...
Vampyroteuthis infernalis's picture

Another biofraud bites the dust. 

Thu, 10/22/2015 - 15:22 | 6699598 BandGap
BandGap's picture

Hep C destroys the liver and this drug accelerates it? WTF. If I was a shareholder I would demand an independent review of their clinical trials.

 

 

Thu, 10/22/2015 - 15:26 | 6699609 Bananamerican
Bananamerican's picture

I understand AbbVie is working on just such an independant clinical drug trial review as we speak!

Forward my Homeland!

Thu, 10/22/2015 - 15:22 | 6699601 MayIMommaDogFac...
MayIMommaDogFace2theBananaPatch's picture

Let us fix your liver with a drug that destroys your liver.  Wait -- what?!??

Thu, 10/22/2015 - 17:38 | 6700249 Agent P
Agent P's picture

no liver = no Hep C issues

Thu, 10/22/2015 - 15:34 | 6699605 JustObserving
JustObserving's picture

So many drugs currently on the market are so toxic that over 200,000 die a year from prescription medications in the US.

Statin drugs are a great example of toxic drugs as MIT scientist Raymond Francis explains:

Statin Drugs are Poison

https://www.youtube.com/watch?v=TZomZEPBdbM

There are about 784,000 iatrogenic deaths (deaths induced inadvertently by a physician or surgeon or by medical treatment or diagnostic procedures) a year in the US.  No one complains about those deaths

 

http://www.ourcivilisation.com/medicine/usamed/deaths.htm

Thu, 10/22/2015 - 15:26 | 6699613 yogibear
yogibear's picture

I could have concocted that in my Kitchen for a lot cheaper.

Didn't this drug go through trials?

Thu, 10/22/2015 - 15:27 | 6699619 Bananamerican
Bananamerican's picture

er....more of a kangaroo court

Thu, 10/22/2015 - 20:04 | 6700875 aVileRat
aVileRat's picture

As Miffled will attest, nearly all drug blinds are heavily skewed. If it fails Phase 2, they'll just keep goal seeking the testing sample pool until it passes. Which is why some drugs fly through phase 1 and languish in phase 3 hell, until magically they cure "something" (with 80% fatality rates). Then they patent that 1 chiral and market the crap out of it for 5 years, often hoping the first 'second line' side effects to not show up until at least 5 years after first treatment. 

Probably why Big Med pays 2x the more in donations then any other lobby on the Hill. And also likely behind why Big Biotech spends more than all other companies (even Coke) on adverts these days.

 

 

Fri, 10/23/2015 - 10:47 | 6702657 Amicus Curiae
Amicus Curiae's picture

I miss Miffed;-( I joined to try n tell her to stay as I loved her input. but it took a while to get membership through. been lurking for year+ I think.

that aside it REALLY pays to read trials n suss the placebos they use

because  too often the supposed sugar pill placebo is another variant of the same med

thereby they say

well the  placebo groups side effects were around the same as the trials one

therefore its no more dangerous.

I noted this especially in trials for nsaids the cartophen/vioxx sort in canines. they KILL many many recipients.

same as VIOXX did to humans only even faster in aged patients.

the recent Yervoy melanoma drug?

very few in the trial the side effects are horrendous and the extension of life..with little quality as little as a few weeks in most, yet Aus govt has approved n subsidised it recently.

queries to govt health promoters of its use here got ignored totally.

Thu, 10/22/2015 - 15:33 | 6699642 azengrcat
azengrcat's picture

AbbVie, how 'bout you bail out my ARWR position?

Thu, 10/22/2015 - 15:55 | 6699739 ljag
ljag's picture

I'm one of the lucky ones. Just found out I'm HepC free after taking HARVONI

Thu, 10/22/2015 - 16:12 | 6699833 Omega_Man
Omega_Man's picture

most drugs are bs

Thu, 10/22/2015 - 16:32 | 6699941 NuYawkFrankie
NuYawkFrankie's picture

"They hate us for our toxic pharmaceuticals...."

Do NOT follow this link or you will be banned from the site!