KRYSTEXXA Worst Drug Launch Ever!

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The point is that the immunogenicity of the drug limits the ability to sell and market Krystexxa. It is a high risk therapy and so will be a last choice for patients after other options have been exhausted. The risk (or reality) of anaphylaxis after the patient has been give several doses of uricase further limits the market, once the patient has an antibody to the drug a prudent physician will seek other therapies.

Not only do patients develop antibodies against uricase they also develop antibodies against the PEG. That means they will have problems with other pegylated drugs. Dosing a patient with Krystexxa is a lawsuit waiting to happen.

The FDA does not "read" the package insert, they read the filing that contains the CMC data and results from the clinical trials. The onus is on the company marketing the drug to ensure that the drug is appropriately labeled, the FDA will approve or disallow that label.

To say that "infusion reactions are 60% rarer" is to simply parrot the corporate BS you have been told to try and sell this turd. That is like saying "only one out of six russian roulette players will blow his brains out"....the one who loses is still dead.

Krystexxa is a bad drug because of the risk profile, the limited market and the poor managment of the company.
 






Anonymous said:
Not only do patients develop antibodies against uricase they also develop antibodies against the PEG. That means they will have problems with other pegylated drugs. Dosing a patient with Krystexxa is a lawsuit waiting to happen.
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Where did you learn that patients develop antibodies against the uricase in pegloticase? All of the study results show that most of the antibodies are against the PEG. Have you heard of there being neutralizing antibodies against the uricase in Krystexxa?

Maybe you are thinking of Oncaspar, where there are neutralizing antibodies, as well as anti-PEG antibodies -- not so with Krystexxa.
 






Try reading the full prescribing information FOR kRYSTEXXA........

"Immunogenicity

Anti-pegloticase antibodies developed in 92% of patients treated with Krystexxa every 2 weeks, and 28% for placebo. Anti-PEG antibodies were also detected in 42% of patients treated with Krystexxa. High anti-pegloticase antibody titer was associated with a failure to maintain pegloticase-induced normalization of uric acid. The impact of anti-PEG antibodies on patients' responses to other PEG-containing therapeutics is unknown."

Better yet read the clinical trial results......there were several deaths. Not related to the drug (wink wink)
 






Anonymous said:
Try reading the full prescribing information FOR kRYSTEXXA........

"Immunogenicity

Anti-pegloticase antibodies developed in 92% of patients treated with Krystexxa every 2 weeks, and 28% for placebo. Anti-PEG antibodies were also detected in 42% of patients treated with Krystexxa. High anti-pegloticase antibody titer was associated with a failure to maintain pegloticase-induced normalization of uric acid. The impact of anti-PEG antibodies on patients' responses to other PEG-containing therapeutics is unknown."

Better yet read the clinical trial results......there were several deaths. Not related to the drug (wink wink)
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Thank you for confirming that you do not work for Savient.
 
























Anonymous said:
Amen, Brother -- and the positive opinion from EMA's CHMP is the work of the devil.
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If you're counting on Europe, a far more price-sensitive market than the US, for the massive success of K, you're dreaming. Do you really think that in a system where people wait 6 months for an MRI they are going to embrace a $6000/month therapy for gout? Take another hit and pass it to the left.

RCG is not life-threatening, so the theory that we'll just keep cranking up the price like other ultra-orphan drugs do won't hold water either.

Fast burn rate, ignorant leadership and an inability to evolve...sounds like a winner.
 












Animated version of a small biotech company, starring:

Fat Weasel...marketing spinmaster

Back Hoe ..... head of HR

Top Heavy ..... HR sidekick

Sidekick ....... right hand to the CEO

Napolean ........ CEO

Scorpion ...... compliance officer
 












Anonymous said:
How long can it last? Burn rate is 10X sales......even if Europe doubles sales we are still upside down.
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Not much longer now. Chapter 11 is going to be soon, but what they will reorganize is a mystery to me. Sales don't cover expenses. Even is they lay off 70% of the people we are still upside down on the balance sheet. No one will buy this turkey. Thanks Lou, take the $$ and run.
 












Seeing stock now under $1 again puts a sad perspective on the recent run under $1 to 2+. That little stock price run was like when Titanic starting going under, and the stern snapped off, falling rightside up for a few moments, providing false sense of safety before starting final plunge to the depths.

K is a good drug for the people it works in. The huge error , among many, was launching it without having the reimbursement structure already in place. No way hcp's were gonna take that kind of $ risk.

LF is just one of the several CEO's that have played musical chairs here. Management has turned over here several times. Epic fails for all of them.
 


















Yes. The worst launch I've been involved with. But I've worked with some drugs that were never even launched!

Krystexxa works for some folk (40%) with a severe, dibilitating disease. Problem is the market doesn't support the current structure of the company.

For all you reps out there, the drug will be bought (in a fire sale) and promoted/sold through third parties. Savient will reduce to a rump of 12-15 people. The good news though, is that the people with RCG will have another option.
 
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