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  #51  
Old 08-29-2011, 04:38 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

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Originally Posted by Anonymous View Post
Best read this before predicting who has the best product.
http://www.nejm.org/doi/full/10.1056...featured_home&
NO KIDDING!

Look out, warfarin-alternative market. Eliquis may be the last to hit, but it may hit the hardest. Some much-anticipated data came out at the European Society of Cardiology conference over the weekend, showing the Pfizer/Bristol-Myers Squibb drug beat standard warfarin therapy at reducing stroke or systemic embolism in patients with atrial fibrillation--with less risk of bleeding to boot. Plus, the risk of death from any cause was cut by 11%, a statistically significant result that's sure to make it into Eliquis' marketing campaigns.

So, with this data from the Aristotle trial, Pfizer ($PFE) and BMS ($BMY) can tout their drug as the only new-generation anticoagulant to surpass warfarin in both efficacy and safety. And it's the first to show a statistically significant reduction in deaths, Forbes notes. Boehringer Ingelheim's Pradaxa proved better than warfarin at stroke-prevention, but the bleeding risk was about the same. And Xarelto from Bayer and Johnson & Johnson ($JNJ) basically matched the older drug at both. Pradaxa is FDA- and EMA-approved for stroke prevention, while Xarelto has a clot-prevention indication, and the partners expect to hear on its stroke-prevention app soon.

Pfizer and BMS will certainly roll out a major marketing push, assuming Eliquis gets FDA approval to launch. But this data has experts talking up the drug already, even before the companies have asked the FDA for the indication. "It's a remarkable achievement," said Dr. Valentin Fuster, a past president of American and world heart associations, who was not involved with the trial, told the New York Times. "This is one of the most significant advances in cardiovascular medicine in the last [5] years, no question." And as the study leader tells Reuters, "It gives a lot of confidence when you see a drug that reduces mortality. That's another feather in the cap."

Analysts are also hailing Eliquis, predicting it will easily take the lead position in this anticoagulant market, which is expected to top $10 billion. Leerink Swann's Seamus Fernandez figures Eliquis will top the new class of drugs with $4.2 billion in sales by 2017. Tony Butler of Barclays pegs peak sales at more than $5 billion, the Wall Street Journal reports. Mark Schoenebaum of ISI Group predicts Eliquis will get 60% of the market.
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  #52  
Old 08-29-2011, 09:06 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Best read this before predicting who has the best product.
http://www.nejm.org/doi/full/10.1056...featured_home&
omg & we are about to hire pod contract reps everywhere to make up the diff
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  #53  
Old 08-29-2011, 11:22 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Best read this before predicting who has the best product.
http://www.nejm.org/doi/full/10.1056...featured_home&
Take a look at the patient populations. That's why you can't compare clinical trials to each other. DUH. A less severely acute patient population is going to look better vs any drug than a patient population with a higher level of acuity. Study design is also important. Hello?
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  #54  
Old 08-30-2011, 05:39 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Take a look at the patient populations. That's why you can't compare clinical trials to each other. DUH. A less severely acute patient population is going to look better vs any drug than a patient population with a higher level of acuity. Study design is also important. Hello?
QD vs BID anyone?
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  #55  
Old 08-30-2011, 11:43 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Quote:
Originally Posted by Anonymous View Post
Take a look at the patient populations. That's why you can't compare clinical trials to each other. DUH. A less severely acute patient population is going to look better vs any drug than a patient population with a higher level of acuity. Study design is also important. Hello?
Study design is our prob
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  #56  
Old 09-02-2011, 11:42 AM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

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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.
I totally agree with your comments. This market will be so over saturated with options and everything will come down to price. If patients do fine on warfarin, they will stay on it. People have no idea what pharmacy's power is now like...they will always choose the least expensive options no matter what they say...pharmacists are sleaze. This will not be a fun job.
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  #57  
Old 09-06-2011, 11:50 AM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

FDA Reviewers Say J&J, Bayer Blood Thinner Should Be Rejected
9/06/2011: 10:01AM

Staff scientists at the Food and Drug Administration recommend that the agency reject Xarelto, a new blood thinner being developed by Bayer and Johnson & Johnson. The review is a huge blow to the drug giants. Analysts largely expected that Xarelto would generate peak sales of $1 billion or more.

The reviewers also hinge their argument on a piece of FDA policy stating that “It is essential that a new therapy must be as effective as alternatives that are already approved for marketing when the disease to be treated is life-threatening or capable of causing irreversible morbidity (e.g. stroke or heart attack).” They argue that the fair comparison is not just warfarin, but warfarin used skillfully by doctors, and that Xarelto misses this bar. They also compare Xarelto unfavorably with the study that got Pradaxa approved as a treatment for atrial fibrillation.

Nor is Xarelto, which has the generic name rivaroxaban, necessarily safer than warfarin, they say. “Nonetheless, if rivaroxaban is approved, patients taking it might be at greater risk of harm from stroke and/or bleeding than if they were treated with warfarin used skillfully,” they write. If doctors are in “great need” of a new pill to prevent strokes in atrial fibrillation patients, the reviewers say it might be reasonable to approve Xarelto as a second or third option. This is all very bad for J&J and Bayer.
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  #58  
Old 09-06-2011, 03:19 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Yikes!!!! Time to rearrange the deck chairs again!!!!
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  #59  
Old 09-06-2011, 08:11 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

Hey cardiovascular sales force. Have your resume updated?
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  #60  
Old 09-06-2011, 08:34 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

ANOTHER ARTICLE

A bad review from Food and Drug Administration staff bodes ill for a Johnson & Johnson blood thinner.

An FDA staff report released Tuesday recommends against approving Xarelto for preventing strokes in patients with a common irregular heart rhythm. The report says data from a late-stage study doesn't make clear whether Xarelto is as effective as widely used warfarin or how safe Xarelto is.

Xarelto was approved in July for reducing the risk of deadly blood clots in patients getting knee and hip replacements, a small subgroup of the potential patient pool.

Johnson & Johnson and partner Bayer Healthcare of Germany developed the drug.

Next, a panel of outside advisers to the FDA is to review research on the drug Thursday.
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  #61  
Old 09-06-2011, 08:57 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

I am in hospitals. My job is completely safe
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  #62  
Old 09-06-2011, 09:31 PM
Anonymous
 
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Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

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I am in hospitals.

My job is completely safe

You are kidding?
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  #63  
Old 09-08-2011, 07:16 AM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

A new anticlotting drug that had been seen as a blockbuster comes under scrutiny by a panel of outside advisers to the Food and Drug Administration Thursday, two days after a negative review by FDA staff.

Johnson & Johnson and partner Bayer Healthcare of Germany are seeking U.S. approval of Xarelto for preventing strokes in patients with a common irregular heart rhythm called atrial fibrillation.

The FDA approved the drug in July for a much smaller patient pool, patients getting knee and hip replacements, a group at heightened risk of dangerous blood clots. Even that approval followed a delay of roughly two years due to FDA concerns about internal bleeding risk.

A 388-page report by FDA staff reviewers, released Tuesday, recommended against approving Xarelto for use in patients with atrial fibrillation, in which the heart's upper chambers quiver ineffectively - temporarily or for years - reducing blood flow through the heart.

They wrote that results of a late-stage study of more than 14,000 patients, known by the acronym ROCKET, don't make clear how safe Xarelto is, or whether it's as effective as widely used warfarin. The reviewers stated that an additional study of Xarelto, known chemically as rivaroxaban, is needed, citing questions about potential stroke and bleeding risks, among other issues.

During Thursday's daylong meeting, the FDA's Cardiovascular and Renal Drugs Advisory Committee will discuss that data, hear presentations from Johnson & Johnson officials on the drug's effectiveness and safety, ask questions and take comments from the public. The panel then is to vote on whether to recommend that Xarelto be approved for atrial fibrillation patients, and the FDA's Division of Cardiovascular and Renal Drugs is to make a final decision on approval by early November.

Several analysts on Tuesday wrote that the staff review was more negative than they had expected, increasing the risk that the approval will be delayed. When approval comes, some wrote, the label or detailed package insert could be "less generous" than what the makers are seeking, such as not allowing a claim that Xarelto works better than warfarin.

Warfarin is inexpensive and has long been a mainstay of stroke prevention. However, it's very tricky to get the dose right in each patient, so frequent blood tests are required.

Given that about 2.2 million Americans and 4.5 million people in the European Union have atrial fibrillation, multiple drugmakers have been trying to develop alternatives to warfarin.

Bayer Healthcare already markets rivaroxaban in 110 countries around the world.

Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., was approved in the U.S. last month and in the 27 European Union countries on May 20.

Credit Suisse analyst Catherine Arnold wrote to investors Tuesday that she continues to expect Eliquis to dominate the category, with peak sales of $5.3 billion and two-thirds of market share by 2020.

Meanwhile, Citigroup Global Markets analyst Matthew Dodds forecasts that about 70 percent of Xarelto's U.S. sales would be for atrial fibrillation patients. Losing Xarelto for that use, or a significant delay, would hurt Johnson & Johnson but likely would only cut earnings per share by 5 cents in 2013, he wrote.
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  #64  
Old 09-09-2011, 01:00 PM
Anonymous
 
Posts: n/a
Default Re: Xarelto vs Eliquis - Pfizer/BMS win....

4:58– Lincoff asks if anyone thinks the transitioning study should be done pre-approval? Everyone seems ok with a post-marketing study.

4:55– Nissen wants to see the drug tested in a BID regimen. Papdemetriou wants a post-marketing study on transitioning.

4:54: Last question:

9. If rivaroxaban were to be approved for stroke prevention in patients with atrial fibrillation, …

9.1. … are there any constraints you would place on the population in whom it would be indicated?

9.2. … are there any issues you would want to resolve post- marketing?

4:53– I missed this earlier: Fleming was the abstention.

4:50– Kaul recommends R be given a third-line indication. Nissen says it can be used in rare situations. I don’t think anyone has supported a superiority claim. McGuire makes the point that it can’t be claimed to be as effective as warfarin but that it is effective. Most panelists seem to go with this idea.
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