Can you say this drug is a DOG!

Discussion in 'Ortho-McNeil' started by Anonymous, Sep 13, 2011 at 6:32 AM.

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  1. Anonymous

    Anonymous Guest

    Even if FDA approves Xarelto, Pradaxa could still gain
    September 9, 2011 — 12:11pm ET | By Tracy Staton


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    Boehringer Ingelheim may well have started celebrating earlier this week when the FDA gave a black eye to Bayer ($BAYN) and Johnson & Johnson's ($JNJ) potential competitor to its anticoagulant Pradaxa. And no wonder: The FDA review, in advance of yesterday's advisory committee meeting, raked Xarelto over the coals and questioned data on both its safety and efficacy in preventing stroke in atrial fibrillation patients. And as the first in a wave of warfarin-alternative drugs to hit the market--but perhaps not the best, given recent data on Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) version, Eliquis--Pradaxa can use all the alone time it can get.

    But BI has no doubt stopped the party--or at least taken it down a few notches. The FDA's expert panel voted 9-2 to recommend approval for Xarelto in spite of their reservations about the Rocket-AF trial. The panelists took issue with the trial's warfarin arm, for instance, saying patients on the old-standard blood thinner might not have been managed well enough, which in turn would have exaggerated Xarelto's comparative effect. Some panelists questioned Xarelto's proposed dosing. Others want the companies to generate more data on the safety of switching Xarelto patients to warfarin, if necessary. And the entire panel voted against allowing Xarelto to be marketed as superior to warfarin.

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    Now, the FDA doesn't have to follow its advisory committee's advice, although it usually does. And even if the agency decides to approve Xarelto, it could heed the advice of some panelists--and its own reviewers--who said the drug might be best used as a second- or even third-line treatment. "The recommendation for approval is potentially a Pyrrhic victory," Barclays Capital analyst Mark Purcell wrote in a note to clients (as quoted by Bloomberg). "The FDA may very well opt for a label that restricts Xarelto to a small part of the market."

    If that's the case, then BI's Pradaxa would maintain its solo advantage, at least for awhile. The company said 300,000 people have been prescribed the drug so far. And in the long term, even if Xarelto gets the FDA nod, Pradaxa may keep a bigger share than it otherwise might; Morningstar is now predicting Xarelto would get only 10% of the warfarin-alternative market, rather than the 15% previously expected. Meanwhile, Bayer said it could meet its $2.8 billion peak-sales target without the U.S. atrial fibrillation market if necessary because it expects such strong sales outside the country. J&J has marketing rights in the U.S., with a 30% royalty to Bayer.



    Read more: Even if FDA approves Xarelto, Pradaxa could still gain - FiercePharma http://www.fiercepharma.com/story/even-if-fda-approves-xarelto-pradaxa-could-still-gain/2011-09-09#ixzz1XpLztcdF
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  2. Anonymous

    Anonymous Guest

    It will be a second or third line drug guaranteed.
     
  3. Anonymous

    Anonymous Guest

    Which is still worth between $1-2 billion. Why so bitchy and negative, is it that time for you?
     
  4. Anonymous

    Anonymous Guest

    Dude....it will be third.....third......everything in front is better than this dog....if they didnt work this piece of shit will not!! Spin this dog how ever you will like but it will never fly!!!!
     
  5. Anonymous

    Anonymous Guest

    It won't be fun out there and everyone will be begging for scripts. Not sure how you came up with that high number. If it is third line, the estimations are way lower. Not trying to be negative, but they ere banking this to be a first line drug...which it won't be. Welcome to commodity world.
     
  6. Anonymous

    Anonymous Guest

    Afib market alone thought to be $12-17 billion depending on where you look, analysts are saying Eliquis with 50-60% share, Pradaxa 20-30%, Xarelto, even with a poor label, 10-20%. The market is so large the dollars are there. Not my opinion, just what others have been saying.
     
  7. Anonymous

    Anonymous Guest

    Who wants the third best drug?
     
  8. Anonymous

    Anonymous Guest

    You're right. Let's just all give up now without knowing what the label will be and what the marketing plan is. I'm with you Eeyore, let's just give up without trying at all. Viva la France!
     
  9. Anonymous

    Anonymous Guest

    Once a day is worth 25% or more of the market........guaranteed!!!
     
  10. Anonymous

    Anonymous Guest

    It's a drug that is cursed...and has been that way for years now
     
  11. Anonymous

    Anonymous Guest

    You're right! I surrender! Viva la France!
     
  12. Anonymous

    Anonymous Guest

    Woof woof
     
  13. Anonymous

    Anonymous Guest

    Bowsie Wowsie
     
  14. Anonymous

    Anonymous Guest

    Grrrrrrrrr. Arf arf
     
  15. Anonymous

    Anonymous Guest

    It was just on CNN that Public Citizen just wrote a letter to FDA last week begging the FDA not to say yes to Xarelto because its's not safe for prevention of stroke. Something to do with rebound effects and study design being bad.

    Great. Now what?
     
  16. Anonymous

    Anonymous Guest

    from Cafepharma Janssen--
    http://www.citizen.org/documents/1974.pdf
     
  17. Anonymous

    Anonymous Guest

    "Xarelto is going to be a game changer!"

    -multiple sr. leaders at OMP circa 2009.
     
  18. Anonymous

    Anonymous Guest

    I don't really give a damn what you clowns think will or won't happen once all these drugs are approved and market share reports reveal the final truth.

    I do, however, laugh my ass off at your citing reports on this class of drugs written by people who have no clue how to read clinical trial publications. It's not the first time I've seen idiots (including people with MD or PharmD on their business cards) exhibit utter cluelessness when it comes to understanding how to (not) compare the apples and oranges of clinical trials.

    Those who make such comparisons today reveal a scary level of stupid.
     
  19. Anonymous

    Anonymous Guest

    Thanks. I guess your business card which reads 'Executive Sales Representative' gives you all the credibility needed as you rip into the data from the front seat of your company car parked in a lot somewhere in Omaha, Nebraska.

    Theres a lot more than the data when it comes to these drugs getting approved these days, or haven't you noticed the political and legal environment?