Multaq study stopped early

News that another Multaq study was stopped early due to cardiovascular problems. Another nail in the coffin for Multaq.

 

Couldn't happen to a nicer company. I hope Sanofi and its malignant leadership rot in hell. I rejoice their failures.

Sanofi Ends Heart Med Trial Over Heart Problems
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By Ed Silverman // July 7th, 2011 // 10:49 am

Call it a sad irony. Sanofi has discontinued a Phase IIIb trial in patients who were being treated with its Multaq heart med and suffer from permanent atrial fibrillation. Why? There was a significant increase in cardiovascular events. And so the study’s operations committee and a data monitoring committee recommended ending the trial, known as Pallas.

This is only the latest setback for Sanofi and its Multaq heart med, which is supposed to bolster flagging fortunes. Last month, French regulators reevaluated the effectiveness of the drug after two patients developed severe liver damage and decided Multaq is “insufficient,” which means French authorities could withdraw reimbursement (see this). Sanofi says the decision to end the trial was not related to kidney damage (read here).

And last year, a study in the Journal of the American College of Cardiology found the pill is only modestly effective and has no clear safety benefits (see this) and more recently, questions were raised about the study in The New England Journal of Medicine that led to FDA approval (look here).


Multaq, by the way, is currently approved in the European Union in adult clinically stable patients with a history of, or current non-permanent Afib to prevent recurrence or lower ventricular rate. In the US, the pill is approved to reduce the risk of cardiovascular hospitalization in patients with persistent Afib or atrial flutter.

In explaining the decision, Sanofi says the patient population in the study was different from the population for which Multaq is approved. In the Pallas population, 70 percent of the 3,149 patients enrolled had permanent AF for over two years; approximately 70 percent had NYHA heart failure Class I to III at baseline. In contrast, in the study supporting the current indication, no patients enrolled had permanent AF and less than 30 percent had NYHA heart failure Class I to III. Pallas patients were also older than patients in the other trial, called Athena.

The Pallas trial was a multinational, randomized, double-blind, parallel-group, placebo-controlled, multicenter Phase IIIb trial comparing efficacy of 400mg Multaq taken twice-daily to placebo in permanent AF patients. They were required to be 65 years and older with co-morbid conditions, such as systemic arterial embolism, myocardial infarction, documented coronary artery disease, prior stroke, symptomatic heart failure, or the combination of age above 75 years, hypertension and diabetes mellitus

 

Wow, another stake in the heart of Multaq...or "Ketek II", as it seems to be destined to become. Since upper management left the door open to more layoffs based on "business environment", will this be the sort of environment that would trigger another cut?

 

Yes, the CV business unit is dead. Why do you think Durzo high tailed it over to diabedes.

 

You really have to question why some Sr level person would approve a study like this. Clearly in a patient population we have been proven to not be effective in. What arrogance and hubris.

 

Diabedes? Diabedes? DIABETES, idiot!

 

Prediction on how the teleconference will go:
This is just for permanenet afib has nothing to do with our indication. Continue moving ahead and pretend like there is nothing wrong. No wonder they did not want us to talk about the recent change regarding pulmonary issues. Is this 3 strikes when will Multaq be out? Doctor I know it is the most expensive AAD in the market and yes remember when I told you you didn't have to worry about the lung or the liver? Oh and yes I know it doesn't work well at all but maybe if you try it in your dog it will. HF no don't use it in that patient type start early in the disease state, bs bs bs
Rah rah rah - now stay focused and sell away. Contact you RML if you have any questions.

 

Normally I'd laugh at all the losers that post here... but you are dead on in terms of the last post. It will be an interesting spin indeed in just about 15 minutes as I log on to the CC.

Hoping to last through the end of the year... now I'm just hoping to get to Vegas for that dog and pony show.

 

SPOT on.

 

Fuck you. I'm a fanatic speller.

 

Yes, for sure, you are.

 

Don't let them fool you. Multaq is heading to the grave yard. There is no way we can be effective selling a product that isn't effective, is EXPENSIVE, and has a safety profile that is now even worse than amiodarone. The reason for stopping Pallas, was that there was a 2.3 fold increase to the negative of ALL endpoints for the study. That's ALL... folks.. ( ha ha ..yeah it is....hmmm)
Then there was a 1.5 fold increase in CV hospitalization. Hmm Athena had less CV hospitalization? Boy and we thought we had some bad articles last year even before liver, CHF, pulmonary, dabi, ohhhh..and Coumadin.

The sad part is we have no pipeline! Nothing to be assigned to so I guess we will be history soon.

 

First, whoever signed off on this study to take place in a population where Multaq has already proved to be fatal -- was a COMPLETE r*****. It's almost as if they provided their own suicide to CV..sunk their own battle ship! Or maybe it's Obama's way to reduce the elderly population located on page 496 on the healthcare reform bill, don't know but I'm thinking Darwin Awards.

Second, it probably wouldn't be so bad if all we had to do was tell our doc's we work for a bunch of drunk, retarded, too much electroshock therapy mental patients disguised as our leaders but the press also has it plastered everywhere in this piece of news about the French government considering Multaq ineffective therefore potentially pulling reimbursement. !@#*!!!!!! Are you effin' kidding me? Well, I guess I can fulfill my dream retirement job as a Walmart greeter earlier than I had thought...

 

I hate selling this dog. How do you sell something that you wouldn't even take

 

You sell it because you KNOW every two weeks you get a good paycheck and benefits. Outside of that, say as little as possible if you get the chance to even speak to a doc.

 

You really can't help but laugh at the situation we in this compnay find ourselves in, we have now been a combined company since 2004 and we have now launched maybe 4 new products during this time and most have been real winners (not counting new indications for existing products.) Let's review Multaq (just about ready to go down the crapper), Jevtana (actually looks promising but small), Oforta (bet most of you have never even heard of this one) and Scuptra (could this product be more of a turd.) In the mean time over roughly the same time period we loose Lovenox, Ambien, Ambien CR, Avapro/Avalide, Taxotere, Eloxatin among others. All right I have to stop now this is far too depressing.

 

Look at our executives. They are the dumbest in the pharma world. Totally flat footed with their pants down around their ankles. What a bunch of preverts. Yes, PREVERTS!!!!

 

don't sell multaq but would'nt it come to reason that as pts with peroxysmal and persistant afib get older and have other co morbidities..... would it come to reason that at some point some of these pts will fall into perminent afib? with that said the negative data coming in on pts with perminent afib in Pallas would be concerning for doctors. Cause they know some of these pts will end up having Perminent afib..... to those who sell Multaq is this a true statement? thanks

 

First, jeepers, your grammar and spelling are horrible. Second, you make a great point. Many older patients, previously with multiple cardioversions and co-morbities are now a concern. They could easily slip into the Pallas type patient. Also, stay away from this drug if you have ever had heart failure. The best word that comes to mind for multaq is - "niche"

 

yes definetly a Niche' drug now... how much $ do you think top end sales will be?