» Sponsored ads

» Sponsored ads

» Sponsored ads


Go Back   Cafepharma Message Boards > Lost Civilizations > Ortho-McNeil
Register Members List Calendar Search Today's Posts Mark Forums Read

Ortho-McNeil Anonymous company board for Ortho-McNeil

Reply

 
Bookmark and Share Thread Tools Rating: Thread Rating: 34 votes, 4.97 average. Display Modes
  #1  
Old 06-23-2011, 03:06 PM
Anonymous
 
Posts: n/a
Default Xarelto vs Eliquis - Pfizer/BMS win....

When several drugmakers are developing similar new drugs, there's always a lot of talk about which one will reach the market first. In the case of clot-busting drugs to compete with the old standby warfarin, Boehringer Ingelheim won that race with Pradaxa. Since then, it's been a race for second-to-market status between Pfizer and Bristol-Myers Squibb's candidate apixaban--branded as Eliquis--and Bayer's Xarelto, approved in Europe but waiting for the FDA nod.

But now, new data on the Pfizer/BMS drug is throwing the contest into disarray. Pradaxa's first-to-market score may just be a token prize. That's because Eliquis, the yet-to-be-approved drug, aced a late-stage trial, performing far beyond analysts' expectations. The drug was more effective at preventing strokes than warfarin--and safer, too. That means Eliquis patients were less likely to develop bleeding problems than those using the older drug.

As Forbes notes, Eliquis had been considered the third-ranking drug in the warfarin-replacement crowd. Now, it might just find itself in first place. Boehringer's Pradaxa did perform better than warfarin, but the study wasn't totally blind, so the FDA didn't allow the company to claim superiority for its product. If the FDA allows Pfizer and BMS to slap a superiority note on Eliquis, their drug could gain a major edge. "At first blush, it's a home run for apixaban. It looks better than the other two drugs," Barclays Capital analyst Tony Butler told Reuters.

Meanwhile, the data on Bayer's Xarelto shows the drug is equivalent to--not better than--warfarin on safety and efficacy, Forbes notes. But it's a once-a-day drug. So, it might have a dosing advantage; but then again, the lack of superiority could give the edge to Eliquis. Investors were worried enough that Bayer's stock fell by as much as 5 percent.

But we'll only know more once the new study's details are unveiled at an upcoming conference. The early data is just headline info, not nitty-gritty stuff.
Reply With Quote
  #2  
Old 06-23-2011, 04:26 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

--------------"YIKES"---------------------
Reply With Quote
  #3  
Old 06-23-2011, 04:35 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Apixaban will compete against Boehringer Ingelheim GmbH’s Pradaxa, approved last year, in the contest to replace the half- century-old drug warfarin, a sensitive medicine that requires regular laboratory tests to ensure patients get the proper dose. Xarelto, another rival from Bayer AG of Leverkusen, Germany, and New Brunswick, New Jersey-based Johnson & Johnson (JNJ), is awaiting U.S. approval.
“Since apixaban looks very likely to be the only blood thinner with superior efficacy and safety, we think it could take as much as 50 percent” of the market for atrial fibrillation, Schoenebaum wrote. “At peak that represents worldwide sales of $3.5 billion” in the heart condition alone, and increase from a $1.4 billion estimate before yesterday’s data, he wrote.
Reply With Quote
  #4  
Old 06-23-2011, 04:59 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Apixaban will compete against Boehringer Ingelheim GmbH’s Pradaxa, approved last year, in the contest to replace the half- century-old drug warfarin, a sensitive medicine that requires regular laboratory tests to ensure patients get the proper dose. Xarelto, another rival from Bayer AG of Leverkusen, Germany, and New Brunswick, New Jersey-based Johnson & Johnson (JNJ), is awaiting U.S. approval.
“Since apixaban looks very likely to be the only blood thinner with superior efficacy and safety, we think it could take as much as 50 percent” of the market for atrial fibrillation, Schoenebaum wrote. “At peak that represents worldwide sales of $3.5 billion” in the heart condition alone, and increase from a $1.4 billion estimate before yesterday’s data, he wrote.
---------------------------------

moles are implanted to make those statements to get action on the stock market.
means zip.
xarelto and eliquis will battle for runner up, pradaxa will remain king.
Reply With Quote
  #5  
Old 06-23-2011, 08:50 PM
Anonymous
 
Posts: n/a
Party Re: Xarelto vs Eliquis - Pfizer/BMS win....

You guys are so fucked

Most hospitals will choose less expensive alternatives. Patient care is #10 in importance when making real formulary decisions.

All insurance plans will make it 3rd tier with coumadin failure before they cover it. Good luck. Days of J&J pharma are over....and I'm so happpppppppppyyyyyy.
Reply With Quote
  #6  
Old 06-23-2011, 11:40 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
You guys are so fucked

Most hospitals will choose less expensive alternatives. Patient care is #10 in importance when making real formulary decisions.

All insurance plans will make it 3rd tier with coumadin failure before they cover it. Good luck. Days of J&J pharma are over....and I'm so happpppppppppyyyyyy.
How could you be so happpppppppppppyyyyy after your posting ?????????
[[[--You can't build happiness on other people's unhappiness.--]]]
Reply With Quote
  #7  
Old 06-24-2011, 12:45 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

your a genious.. now what does a coumadine failure look like? think about it
Reply With Quote
  #8  
Old 06-24-2011, 09:53 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
You guys are so fucked

Most hospitals will choose less expensive alternatives. Patient care is #10 in importance when making real formulary decisions.

All insurance plans will make it 3rd tier with coumadin failure before they cover it. Good luck. Days of J&J pharma are over....and I'm so happpppppppppyyyyyy.
Only true if there is no superiority data of one drug against another. The game changes on superior data, then evidence based protocols take into effect. If the guidelines support superiority of one drug over another then that drug will assume first line positioning. Its becomes very difficult, actually can put a hospital in a legal liability position, to deny a superior drug for patient care. Especially a medicine that is considered life sustaining. CMS has implemented quality of care as one of the priorities for core measures. You don't spend much time in the hospital environment making the statement you just made.
Reply With Quote
  #9  
Old 06-24-2011, 05:11 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
---------------------------------

moles are implanted to make those statements to get action on the stock market.
means zip.
xarelto and eliquis will battle for runner up, pradaxa will remain king.
This poster is too stupid to chew gum. Rarely is the first product in a stale market the ultimate winner. Usually it's the second or third that hit market.

One problem for all this: Medicare will dominate the payment for anticoagulants.

That said, the Federal Gov't is running 1.5 trillion $ deficits, the economy is rolling over into decline, the stock market's tail wind of money "printing" by the central bank is over and, given its effect on gasoline prices (spiked higher) not to be redone. The national debt is rising at an exponential rate (I know, few of you understand mathematics.)

Medicare, Medicaid, and Social Security already consume almost all tax receipts, plus you have a trillion dollars of war being "fought" each year with no end in sight.

If you people think Medicare is going to be business as usual in coming years, I have a bridge or some Florida swamp land to sell you.

The days of honey and joy are OVER. I enjoyed the $100K-plus and the company car while it lasted, but I could see the future and saved a lot of that. Those of you who bought the McMansion and think this gig has legs are truly fools, and you know what they say about a fool and his money....
Reply With Quote
  #10  
Old 06-25-2011, 12:57 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

MOST do not get it. They believe/think the future will be buisness as usual. You an I know it will not. Best of luck 'head north'.

Quote:
Originally Posted by Anonymous View Post
This poster is too stupid to chew gum. Rarely is the first product in a stale market the ultimate winner. Usually it's the second or third that hit market.

One problem for all this: Medicare will dominate the payment for anticoagulants.

That said, the Federal Gov't is running 1.5 trillion $ deficits, the economy is rolling over into decline, the stock market's tail wind of money "printing" by the central bank is over and, given its effect on gasoline prices (spiked higher) not to be redone. The national debt is rising at an exponential rate (I know, few of you understand mathematics.)

Medicare, Medicaid, and Social Security already consume almost all tax receipts, plus you have a trillion dollars of war being "fought" each year with no end in sight.

If you people think Medicare is going to be business as usual in coming years, I have a bridge or some Florida swamp land to sell you.

The days of honey and joy are OVER. I enjoyed the $100K-plus and the company car while it lasted, but I could see the future and saved a lot of that. Those of you who bought the McMansion and think this gig has legs are truly fools, and you know what they say about a fool and his money....
Reply With Quote
  #11  
Old 06-25-2011, 07:28 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Only true if there is no superiority data of one drug against another. The game changes on superior data, then evidence based protocols take into effect. If the guidelines support superiority of one drug over another then that drug will assume first line positioning. Its becomes very difficult, actually can put a hospital in a legal liability position, to deny a superior drug for patient care. Especially a medicine that is considered life sustaining. CMS has implemented quality of care as one of the priorities for core measures. You don't spend much time in the hospital environment making the statement you just made.
The thing you have to keep in mind is:
1. Everyone must compare to coumadin to just line up for the race.
2. One study does not make the final call.
Do you remember apixaban had a study D/C'd due to excessive bleeds?
CV docs will take that into factor.
3. The real decisions will be made once we begin head to head vs. the other Xa's- Riva vs. apix et al. That is when where the war will be decided. Those studies are still years away from announcement.

It was the same way w/ the statin's. It was Mevacor/Zocor vs. Pravachol. There was h to h studies then the big survival study in 4S. That gave Z the big advantage. Then, the monster Lipitor came alone and Cleaned EVERYONE's clock.

Also, you can't factor out the Medicare section. It ain't business as usual and $$$ by 3rd party payors could still really screw us.
Reply With Quote
  #12  
Old 06-25-2011, 11:31 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

[quote=Anonymous;3992840]The thing you have to keep in mind is:
1. Everyone must compare to coumadin to just line up for the race.
2. One study does not make the final call.
Do you remember apixaban had a study D/C'd due to excessive bleeds?
CV docs will take that into factor.
3. The real decisions will be made once we begin head to head vs. the other Xa's- Riva vs. apix et al. That is when where the war will be decided. Those studies are still years away from announcement.

It was the same way w/ the statin's. It was Mevacor/Zocor vs. Pravachol. There was h to h studies then the big survival study in 4S. That gave Z the big advantage. Then, the monster Lipitor came alone and Cleaned EVERYONE's clock.

Also, you can't factor out the Medicare section. It ain't business as usual and $$$ by 3rd party payors could still really screw us.[/QU



Excellent points!!!
Reply With Quote
  #13  
Old 06-25-2011, 01:29 PM
Anonymous
 
Posts: n/a
Rant Pradaxa > Xarelto > Eliquis = who will win?

Clinical studies are not real life. Average drug has 40% compliance thus a twice a day (BID) drug vs. once a day drug (QD) the QD drug will perform better. There will never be head to head studies, but BID dosed drug with average compliance will result in sub therapeutic levels and be less effective. Eliquis has a long way to go and yet unknown analysis have to be completed. Only time will tell who will be the leader 12-31-2012!
Reply With Quote
  #14  
Old 06-25-2011, 02:04 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
The thing you have to keep in mind is:
1. Everyone must compare to coumadin to just line up for the race.
2. One study does not make the final call.
Do you remember apixaban had a study D/C'd due to excessive bleeds?
CV docs will take that into factor.
3. The real decisions will be made once we begin head to head vs. the other Xa's- Riva vs. apix et al. That is when where the war will be decided. Those studies are still years away from announcement.

It was the same way w/ the statin's. It was Mevacor/Zocor vs. Pravachol. There was h to h studies then the big survival study in 4S. That gave Z the big advantage. Then, the monster Lipitor came alone and Cleaned EVERYONE's clock.

Also, you can't factor out the Medicare section. It ain't business as usual and $$$ by 3rd party payors could still really screw us.
FYI. Your number 2. Do you remember apixaban had a study D/C'd due to excessive bleed? You obviously don't know that Xarelto also had a study problem due to excessive bleeds. Hum, I wonder if it has to do with the class that both drugs are in? Hum, if you had read the results of both data, heavily reported, you would know what the class has to do with excessive bleeds. I am guessing you are not going to be selling Xarelto, because not knowing impt. info. about this class of drugs that was widely reported would make you not very qualified to sell this product. You should read the data about apixaban first before you make comments. Happens all the time. They're everywhere.
Reply With Quote
  #15  
Old 06-25-2011, 02:08 PM
Anonymous
 
Posts: n/a
Default Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
Clinical studies are not real life. Average drug has 40% compliance thus a twice a day (BID) drug vs. once a day drug (QD) the QD drug will perform better. There will never be head to head studies, but BID dosed drug with average compliance will result in sub therapeutic levels and be less effective. Eliquis has a long way to go and yet unknown analysis have to be completed. Only time will tell who will be the leader 12-31-2012!
Never have seen the data you are referring to regarding QD vs. BID adherence in 15+ years. Or does making things up apply as clinical data these days to some in the pharma industry. Cite your sources. Then determine what it means to have superior data vs. comparable data for these new drugs. You should be able to determine alot after that.
Reply With Quote
  #16  
Old 06-25-2011, 08:55 PM
Anonymous
 
Posts: n/a
Default Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
Never have seen the data you are referring to regarding QD vs. BID adherence in 15+ years. Or does making things up apply as clinical data these days to some in the pharma industry. Cite your sources. Then determine what it means to have superior data vs. comparable data for these new drugs. You should be able to determine alot after that.
http://eurheartj.oxfordjournals.org/...l_A/8.full.pdf

Here is a link to one of many studies validating poor compliance to drug regimins - this one is 30% non-complaince
Reply With Quote
  #17  
Old 06-25-2011, 11:55 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
FYI. Your number 2. Do you remember apixaban had a study D/C'd due to excessive bleed? You obviously don't know that Xarelto also had a study problem due to excessive bleeds. Hum, I wonder if it has to do with the class that both drugs are in? Hum, if you had read the results of both data, heavily reported, you would know what the class has to do with excessive bleeds. I am guessing you are not going to be selling Xarelto, because not knowing impt. info. about this class of drugs that was widely reported would make you not very qualified to sell this product. You should read the data about apixaban first before you make comments. Happens all the time. They're everywhere.
Yer a real genius! All anticoagulants increase the risk of a bleed ...a class effect right?

Guess that's what they say in the black boxes
Reply With Quote
  #18  
Old 06-26-2011, 01:55 AM
Anonymous
 
Posts: n/a
Arrow Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
Never have seen the data you are referring to regarding QD vs. BID adherence in 15+ years. Or does making things up apply as clinical data these days to some in the pharma industry. Cite your sources. Then determine what it means to have superior data vs. comparable data for these new drugs. You should be able to determine alot after that.
keep in mind that Dabig is QD for VTE in Europe. Riva could likely come out to be bid for aFib.
Reply With Quote
  #19  
Old 06-26-2011, 11:21 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Yer a real genius! All anticoagulants increase the risk of a bleed ...a class effect right?

Guess that's what they say in the black boxes
And Einstein, read the data on the new Factor Xa class. They increase the risk of bleeding on certain indications greater than other anticoagulants. Why don't you fu__-ers ever read the data.
Reply With Quote
  #20  
Old 06-26-2011, 11:26 AM
Anonymous
 
Posts: n/a
Default Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
http://eurheartj.oxfordjournals.org/...l_A/8.full.pdf

Here is a link to one of many studies validating poor compliance to drug regimins - this one is 30% non-complaince
This study does not distinguish the compliance differences between different medication dosing. It simply states that patients are up to 30% non compliant in taking medications varied against their disease state. Without comparason data between different dosing regimens you are not answering the question___Did you get the question????? Since you are stating that there will be a big difference in compliance of a QD vs. BID dose einstein, what does that look like? Also, when you decide to read your own study you cited, then you will have read that dosing compliance of a drug is in direct correlation to the significance of the disease state.
Reply With Quote
  #21  
Old 06-26-2011, 03:45 PM
Anonymous
 
Posts: n/a
Default Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
http://eurheartj.oxfordjournals.org/...l_A/8.full.pdf

Here is a link to one of many studies validating poor compliance to drug regimins - this one is 30% non-complaince
In your previous post #13, you said that patients have a 40% compliance, meaning they have a 60% non-compliance. Now you quote a study showing 30% with no comparasons. Those 2 numbers are a long way off. Which one do you prefer 30 or 60%, or should you just make up another number that makes you feel good.
Reply With Quote
  #22  
Old 06-26-2011, 08:34 PM
Anonymous
 
Posts: n/a
Default Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
In your previous post #13, you said that patients have a 40% compliance, meaning they have a 60% non-compliance. Now you quote a study showing 30% with no comparasons. Those 2 numbers are a long way off. Which one do you prefer 30 or 60%, or should you just make up another number that makes you feel good.
seriously, get a life dude
Reply With Quote
  #23  
Old 06-26-2011, 10:15 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
And Einstein, read the data on the new Factor Xa class. They increase the risk of bleeding on certain indications greater than other anticoagulants. Why don't you fu__-ers ever read the data.
Please enlighten us Dr.
Reply With Quote
  #24  
Old 06-26-2011, 10:20 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
And Einstein, read the data on the new Factor Xa class. They increase the risk of bleeding on certain indications greater than other anticoagulants. Why don't you fu__-ers ever read the data.
Don't you think you're being a bit abrasive to that person? Afterall the Xa's are so new, there isn't enough data out there to make such a clear cut declaration about Xa's causing more bleeding in certain indications, they are still in trials.

Oh, and before you jump on me, yes, I know, there are completed trials out there and they make no such declaration.
Reply With Quote
  #25  
Old 06-27-2011, 10:23 AM
Anonymous
 
Posts: n/a
Banghead Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Don't you think you're being a bit abrasive to that person? Afterall the Xa's are so new, there isn't enough data out there to make such a clear cut declaration about Xa's causing more bleeding in certain indications, they are still in trials.

Oh, and before you jump on me, yes, I know, there are completed trials out there and they make no such declaration.
If someone is going to sell a new drug they damn better be capable of knowing the differences between them. That used to be what a good sales rep. looks like. I know that most of the reps. in this business are basically clueless, and are only concerned with the vomit repeating of a detail piece. That should never be considered good enough, esp. since the reps. hired for the CV specialty positions are supposed to be some of the best. If J&J is not concerned about hiring people that can function intelligently they are going to have a hard time in this division since there will be at least 3 competitors in the market by 2012, and 4 by 2013. You can pretend all you want, but little nuances between classes will make a big difference in a soon to be crowded market. FYI, for those who bother to come to cafepharma should know that the data was reported heavily on this website. Yes, you heard me, completed trials about both Riva and Apixaban on this site. Laziness does not equal quality.
Reply With Quote
  #26  
Old 06-27-2011, 12:15 PM
Anonymous
 
Posts: n/a
Arms Re: Xarelto vs Eliquis - Pfizer/BMS win....

Damn - this is funny sh_t! Predicting the future of yet unreleased drugs. Take a chill pill as there will be no clear winner for 2 more years. The person getting all worked up over data analysis is such a "TOOL". I feel sorry for that person as they will be on Cafe Pharma instead of watching fireworks with their family! But then again, that person is working at Home Depot as they previously lost their job with J&J.
Reply With Quote
  #27  
Old 06-27-2011, 06:07 PM
Dr. Phil
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
If someone is going to sell a new drug they damn better be capable of knowing the differences between them. That used to be what a good sales rep. looks like. I know that most of the reps. in this business are basically clueless, and are only concerned with the vomit repeating of a detail piece. That should never be considered good enough, esp. since the reps. hired for the CV specialty positions are supposed to be some of the best. If J&J is not concerned about hiring people that can function intelligently they are going to have a hard time in this division since there will be at least 3 competitors in the market by 2012, and 4 by 2013. You can pretend all you want, but little nuances between classes will make a big difference in a soon to be crowded market. FYI, for those who bother to come to cafepharma should know that the data was reported heavily on this website. Yes, you heard me, completed trials about both Riva and Apixaban on this site. Laziness does not equal quality.
It sounds like your taking this discussion a bit more serious than what it was intended based on my reading. Help me with this, isn't it outside of package insert to make a head to head or PI to PI claim? It is.
You really can't say much more than what is allowed or in the insert by the FDA. Of course you would expect to be knowledgeable of the other articles but for customer discussion, it is limited, right? It is.

Oh, and to claim what has been heavily reported/discussed at CP doesn't much make a good argument for could be used in a clinical argument. It's kinda like Wikipedia.
Reply With Quote
  #28  
Old 06-27-2011, 07:47 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Damn - this is funny sh_t! Predicting the future of yet unreleased drugs. Take a chill pill as there will be no clear winner for 2 more years. The person getting all worked up over data analysis is such a "TOOL". I feel sorry for that person as they will be on Cafe Pharma instead of watching fireworks with their family! But then again, that person is working at Home Depot as they previously lost their job with J&J.
Right, did you get this by calling 1-800-psychic. We should all be watching fireworks continue to help burn all those states in the south expriencing a severe drought. J&J does not expect much out of their workers.
Reply With Quote
  #29  
Old 06-27-2011, 07:52 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Dr. Phil View Post
It sounds like your taking this discussion a bit more serious than what it was intended based on my reading. Help me with this, isn't it outside of package insert to make a head to head or PI to PI claim? It is.
You really can't say much more than what is allowed or in the insert by the FDA. Of course you would expect to be knowledgeable of the other articles but for customer discussion, it is limited, right? It is.

Oh, and to claim what has been heavily reported/discussed at CP doesn't much make a good argument for could be used in a clinical argument. It's kinda like Wikipedia.
Would someone in the training dept. please inform this fool that when a product shows superiority in clinical trials over a comparator on primary endpoints, then you can most definitely and legally make superiority claims, esp. if it is adopted on guidelines as superior. This is info. from clinical trials, not PI's. Man you people are a piece of work.
Reply With Quote
  #30  
Old 06-27-2011, 07:54 PM
Anonymous
 
Posts: n/a
Lol Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Dr. Phil View Post
It sounds like your taking this discussion a bit more serious than what it was intended based on my reading. Help me with this, isn't it outside of package insert to make a head to head or PI to PI claim? It is.
You really can't say much more than what is allowed or in the insert by the FDA. Of course you would expect to be knowledgeable of the other articles but for customer discussion, it is limited, right? It is.

Oh, and to claim what has been heavily reported/discussed at CP doesn't much make a good argument for could be used in a clinical argument. It's kinda like Wikipedia.
Dufus, do you ever think to stop long enough to read the home page of cafepharma before you make a beeline to the company threads. Junior, you may learn something.
Reply With Quote
  #31  
Old 06-27-2011, 09:58 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Would someone in the training dept. please inform this fool that when a product shows superiority in clinical trials over a comparator on primary endpoints, then you can most definitely and legally make superiority claims, esp. if it is adopted on guidelines as superior. This is info. from clinical trials, not PI's. Man you people are a piece of work.
Have you seen the training dept lately? Maybe you better explain it to them first.
Reply With Quote
  #32  
Old 06-27-2011, 11:15 PM
Anonymous
 
Posts: n/a
Party Re: Xarelto vs Eliquis - Pfizer/BMS win....

How 'bout after any of these drugs are launched it will be cake to write. Orthos don't give a crap about a pill. They cut.

Can anyone say "Want do you want for lunch?"

Out! Signed, Ex-Primary Care Hospital rep wannabe
Reply With Quote
  #33  
Old 07-03-2011, 02:11 PM
Anonymous
 
Posts: n/a
Default Re: Pradaxa > Xarelto > Eliquis = who will win?

Quote:
Originally Posted by Anonymous View Post
Clinical studies are not real life. Average drug has 40% compliance thus a twice a day (BID) drug vs. once a day drug (QD) the QD drug will perform better. There will never be head to head studies, but BID dosed drug with average compliance will result in sub therapeutic levels and be less effective. Eliquis has a long way to go and yet unknown analysis have to be completed. Only time will tell who will be the leader 12-31-2012!
With that rational neither Pradaxa or Eliquis should have performed better than QD warfarin with its long half life
Reply With Quote
  #34  
Old 07-03-2011, 08:46 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Xarelto belongs to class of drugs known as Factor Xa inhibitors. Pfizer and Bristol-Myers Squibb Co. have co-developed another Factor Xa, apixaban. Last week, they released limited results of a clinical trial that some analysts interpreted as suggesting that apixaban was superior to Xarelto, though the drugs weren't compared head-to-head.
Reply With Quote
  #35  
Old 07-03-2011, 09:53 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Xarelto belongs to class of drugs known as Factor Xa inhibitors. Pfizer and Bristol-Myers Squibb Co. have co-developed another Factor Xa, apixaban. Last week, they released limited results of a clinical trial that some analysts interpreted as suggesting that apixaban was superior to Xarelto, though the drugs weren't compared head-to-head.
A little late to the dance, aren't you. Look up 10+ previous posts, and you would have gotten this information.
Reply With Quote
  #36  
Old 07-05-2011, 11:45 AM
Anonymous
 
Posts: n/a
Arms Pradaxa vs. Xarelto vs. Eliquis = GAME ON

Let the games begin.
Xarelto will not hit full stride until December with SPAF. Only then will we know how good Xarelto really is.
Reply With Quote
  #37  
Old 07-05-2011, 03:44 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

The news is the latest in the blood-clot drug race. Pfizer and Bristol-Myers Squibb's Eliquis, the yet-to-be-approved drug, recently aced a late-stage trial, performing far beyond analysts' expectations. The drug was more effective at preventing strokes than the old standby warfarin--and safer, too. That means Eliquis patients were less likely to develop bleeding problems than those using the older drug. Xarelto is equivalent to--not better than--warfarin on safety and efficacy, as Forbes has noted. But it is a once-a-day drug.
Reply With Quote
  #38  
Old 07-05-2011, 09:50 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
When several drugmakers are developing similar new drugs, there's always a lot of talk about which one will reach the market first. In the case of clot-busting drugs to compete with the old standby warfarin, Boehringer Ingelheim won that race with Pradaxa. Since then, it's been a race for second-to-market status between Pfizer and Bristol-Myers Squibb's candidate apixaban--branded as Eliquis--and Bayer's Xarelto, approved in Europe but waiting for the FDA nod.

But now, new data on the Pfizer/BMS drug is throwing the contest into disarray. Pradaxa's first-to-market score may just be a token prize. That's because Eliquis, the yet-to-be-approved drug, aced a late-stage trial, performing far beyond analysts' expectations. The drug was more effective at preventing strokes than warfarin--and safer, too. That means Eliquis patients were less likely to develop bleeding problems than those using the older drug.

As Forbes notes, Eliquis had been considered the third-ranking drug in the warfarin-replacement crowd. Now, it might just find itself in first place. Boehringer's Pradaxa did perform better than warfarin, but the study wasn't totally blind, so the FDA didn't allow the company to claim superiority for its product. If the FDA allows Pfizer and BMS to slap a superiority note on Eliquis, their drug could gain a major edge. "At first blush, it's a home run for apixaban. It looks better than the other two drugs," Barclays Capital analyst Tony Butler told Reuters.

Meanwhile, the data on Bayer's Xarelto shows the drug is equivalent to--not better than--warfarin on safety and efficacy, Forbes notes. But it's a once-a-day drug. So, it might have a dosing advantage; but then again, the lack of superiority could give the edge to Eliquis. Investors were worried enough that Bayer's stock fell by as much as 5 percent.

But we'll only know more once the new study's details are unveiled at an upcoming conference. The early data is just headline info, not nitty-gritty stuff.
when the docs get comfortable with the new generation, QD will prevail over BID...no question...from a physicians point of view
Reply With Quote
  #39  
Old 07-11-2011, 08:15 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
when the docs get comfortable with the new generation, QD will prevail over BID...no question...from a physicians point of view
Wrong. Still no antidote. Longer washout time before elective surgery which is a nuisance. Same thing with emergency surgery. Endoxaban will be the only XA with an antidote out the bag.
Reply With Quote
  #40  
Old 07-25-2011, 11:50 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Wow, things can really change in a month can't they?


Anti-Clotting Drug May Cause Severe Bleeding With No Benefit - (Yahoo!Health via NewsPoints Desk)
(Ref: Yahoo!Health)
July 24th, 2011

http://www.firstwordpharma.com/node/891607
Reply With Quote
  #41  
Old 07-27-2011, 10:20 AM
Anonymous
 
Posts: n/a
Red face Re: Xarelto vs Eliquis - Pfizer/BMS win....

I would bet my bottom dollar that they screw this up big time! Have you looked at the managers! It makes me sick to see how unhealthy the majority are. Off label selling galore with no respect for anything but money. Very sad company I have to say
Reply With Quote
  #42  
Old 08-11-2011, 05:25 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Bayer's new anti-clotting drug may not be superior to the old standby, warfarin, a new journal article suggests. But it is certainly just as good. And as co-author Gregory Zoppo told Reuters, "Non-inferiority is not a bad thing."

The New England Journal of Medicine piece analyzed data from a comparative trial that had some folks scratching their heads: The trial concluded that Xarelto was 21% better at preventing stroke in atrial fibrillation patients than warfarin was. But that conclusion relied on an analysis that left out some patients who began the study. When those patients were included, the results put Xarelto more on par with warfarin.

After taking a close look, the authors concluded the following: "I think we can say safely that [Xarelto] is not inferior to warfarin," Zoppo told the news service. "I don't think we can say it is superior." The NEJM editorial also put forward two caveats: One, the fact that new clot preventers such as Xarelto don't have antidotes that will quickly reverse their effects if serious bleeding occurs. Two, warfarin wasn't used optimally in the Xarelto study.

Now, the question is how Xarelto--and its new rivals in the warfarin-alternative space, including Boehringer Ingelheim's Pradaxa--will fare against the older treatment. The newer drugs are much easier to take; warfarin is something of a dosing nightmare. That ease of use is "exciting," Zoppo said. But will everyone switch? "I think the answer is 'No.' Patients who are managed very well on warfarin should stay on it."

And then there's the whole Xarelto vs. new competitors question. Pradaxa has some superior-to-warfarin data, efficacy-wise. And the yet-to-be-approved blood thinner from Pfizer and Bristol-Myers Squibb, Equilis, went one better in a recent trial, showing an edge over warfarin in stroke prevention and bleeding risk.
Reply With Quote
  #43  
Old 08-12-2011, 12:31 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Bayer's new anti-clotting drug may not be superior to the old standby, warfarin, a new journal article suggests. But it is certainly just as good. And as co-author Gregory Zoppo told Reuters, "Non-inferiority is not a bad thing."

The New England Journal of Medicine piece analyzed data from a comparative trial that had some folks scratching their heads: The trial concluded that Xarelto was 21% better at preventing stroke in atrial fibrillation patients than warfarin was. But that conclusion relied on an analysis that left out some patients who began the study. When those patients were included, the results put Xarelto more on par with warfarin.

After taking a close look, the authors concluded the following: "I think we can say safely that [Xarelto] is not inferior to warfarin," Zoppo told the news service. "I don't think we can say it is superior." The NEJM editorial also put forward two caveats: One, the fact that new clot preventers such as Xarelto don't have antidotes that will quickly reverse their effects if serious bleeding occurs. Two, warfarin wasn't used optimally in the Xarelto study.

Now, the question is how Xarelto--and its new rivals in the warfarin-alternative space, including Boehringer Ingelheim's Pradaxa--will fare against the older treatment. The newer drugs are much easier to take; warfarin is something of a dosing nightmare. That ease of use is "exciting," Zoppo said. But will everyone switch? "I think the answer is 'No.' Patients who are managed very well on warfarin should stay on it."

And then there's the whole Xarelto vs. new competitors question. Pradaxa has some superior-to-warfarin data, efficacy-wise. And the yet-to-be-approved blood thinner from Pfizer and Bristol-Myers Squibb, Equilis, went one better in a recent trial, showing an edge over warfarin in stroke prevention and bleeding risk.
You can transfuse blood but you can't transfuse brain. When will you lab geeks figure out that? When a patient shows up in my ED, the last thing I am worried is about their anticoagulation. We can deal with that with FFP. More people die of strokes than bleeds.
Reply With Quote
  #44  
Old 08-14-2011, 11:07 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

GOOGLE this past week's Seeking Alpha article,

J&J, Bayer muddied the waters on Xar
Reply With Quote
  #45  
Old 08-14-2011, 09:38 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

What is the status of this drug and the filling of the positions to sell it?
Reply With Quote
  #46  
Old 08-16-2011, 10:47 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

This is a bunch of shit. JNJ pharma cannot launch a product. When was the last successful launch? Levaquin 1997 .......UMMMMMM Oh Ultram ER , Regranex, Doribax, Nucynta(WHo cares about spelling) Invega!

Blockbusters. At least that is what we were told.
Reply With Quote
  #47  
Old 08-17-2011, 05:54 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

The U.K.'s cost-effectiveness watchdog is carefully eyeing Boehringer Ingelheim's new clot-fighting drug. The National Institute for Health and Clinical Excellence says Pradaxa, a new alternative to the old bloodthinner warfarin, just isn't cost-effective--at least not using the data Boehringer has provided so far.

NICE asked the German company for more information about Pradaxa, especially the cost effectiveness compared with warfarin. The agency thought Boehringer had overestimated the costs of monitoring patients on warfarin, thus overstating the cost-effectiveness of its alternative. NICE also wants "a more plausible set of assumptions" about Pradaxa's use in clinical practice, including better models for the type of atrial fibrillation patients found in the U.K.

As InPharm reports, Pradaxa is estimated to cost £2.52 per day, or £919.80 per year ($1,520). Warfarin costs the NHS only £14.60 per year ($24). But the cost of warfarin alone doesn't cover everything; because of individual dosing differences, patients using warfarin have to be monitored. Boehringer has estimated that cost at £414.90, but NICE puts the average at £115.14.

NICE did acknowledge that because it doesn't require monitoring, Pradaxa would be easier for patients to take. And the agency recognized the drug was superior to warfarin at reducing the risk of stroke, "an important development for patients with atrial fibrillation."
Reply With Quote
  #48  
Old 08-19-2011, 04:33 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

One anticipated risk of Boehringer Ingelheim's new blood thinner Pradaxa has led to an unexpected warning. Japanese regulators have asked the German company to notify doctors about potentially deadly bleeding in some Pradaxa patients, Reuters reports. Doctors need to be warned not only about the bleeding risks with the drug--marketed as Prazaxa in that country--but also that there's no antidote to counteract bleeding if it starts, the regulators said.

With warfarin, the old drug Pradaxa seeks to replace, bleeding can be quickly treated with vitamin K. Neither Pradaxa nor any of the others in a new class of warfarin alternatives has a similar antidote. This new generation of drugs includes Xarelto, marketed by Bayer and Johnson & Johnson ($JNJ); Eliquis, the Bristol-Myers Squibb ($BMY)/Pfizer ($PFE) med that's awaiting U.S. approval; and Daiichi Sankyo's Lixiana.

The lack of an antidote isn't a surprise. Nor is the bleeding risk with Pradaxa; it's clearly stated on the drug's label. The rate of serious bleeding with Pradaxa was 3.3% per year, Boehringer's fact sheet states, compared with 3.6% with warfarin; the rate of GI bleeding was higher with Pradaxa, however, at 1.6%, compared with 1.1% in warfarin patients. Most of the Japanese patients who developed problems had bleeding in their GI tracts. And just because the stats are listed doesn't mean that all doctors are up-to-date on the risks.

Japanese officials suggest that patients older than 70 may need a lower dose of Pradaxa. Currently, the 110-mg dose is recommended for patients 80 and older. Boehringer says it's cooperating with the government on the warning, Reuters says, and that it's in the company's best interest to have the medicine prescribed within the recommended guidelines
Reply With Quote
  #49  
Old 08-20-2011, 12:56 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
One anticipated risk of Boehringer Ingelheim's new blood thinner Pradaxa has led to an unexpected warning. Japanese regulators have asked the German company to notify doctors about potentially deadly bleeding in some Pradaxa patients, Reuters reports. Doctors need to be warned not only about the bleeding risks with the drug--marketed as Prazaxa in that country--but also that there's no antidote to counteract bleeding if it starts, the regulators said.

With warfarin, the old drug Pradaxa seeks to replace, bleeding can be quickly treated with vitamin K. Neither Pradaxa nor any of the others in a new class of warfarin alternatives has a similar antidote. This new generation of drugs includes Xarelto, marketed by Bayer and Johnson & Johnson ($JNJ); Eliquis, the Bristol-Myers Squibb ($BMY)/Pfizer ($PFE) med that's awaiting U.S. approval; and Daiichi Sankyo's Lixiana.

The lack of an antidote isn't a surprise. Nor is the bleeding risk with Pradaxa; it's clearly stated on the drug's label. The rate of serious bleeding with Pradaxa was 3.3% per year, Boehringer's fact sheet states, compared with 3.6% with warfarin; the rate of GI bleeding was higher with Pradaxa, however, at 1.6%, compared with 1.1% in warfarin patients. Most of the Japanese patients who developed problems had bleeding in their GI tracts. And just because the stats are listed doesn't mean that all doctors are up-to-date on the risks.

Japanese officials suggest that patients older than 70 may need a lower dose of Pradaxa. Currently, the 110-mg dose is recommended for patients 80 and older. Boehringer says it's cooperating with the government on the warning, Reuters says, and that it's in the company's best interest to have the medicine prescribed within the recommended guidelines
Is warfarin's antidote for bleeding, vitamin K quick?
Reply With Quote
  #50  
Old 08-29-2011, 01:15 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
The news is the latest in the blood-clot drug race. Pfizer and Bristol-Myers Squibb's Eliquis, the yet-to-be-approved drug, recently aced a late-stage trial, performing far beyond analysts' expectations. The drug was more effective at preventing strokes than the old standby warfarin--and safer, too. That means Eliquis patients were less likely to develop bleeding problems than those using the older drug. Xarelto is equivalent to--not better than--warfarin on safety and efficacy, as Forbes has noted. But it is a once-a-day drug.
Best read this before predicting who has the best product.
http://www.nejm.org/doi/full/10.1056...featured_home&
Reply With Quote
Reply




Thread Tools
Display Modes Rate This Thread
Rate This Thread:

Posting Rules
You may post new threads
You may post replies
You may not post attachments
You may not edit your posts

vB code is On
Smilies are On
[IMG] code is Off
HTML code is Off
Forum Jump


All times are GMT -4. The time now is 07:22 AM.


Powered by vBulletin® Version 3.6.11
Copyright ©2000 - 2014, Jelsoft Enterprises Ltd.