Sunday, August 28, 2011

$PFE/$BMY score big with ELIQUIS(apixaban)

Pfizer($PFE) and Bristol-Myers Squibb($BMY) scored a huge win for ELIQUIS(apixaban) in their Phase 3 ARISTOTLE trial. ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation), was a randomized, double-blind, multicenter, head-to-head trial, including 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. Now, the market had known that the drug had met the primary endpoint back in June, but with anticoagulant agents, the safety data is just as important. 

ELIQUIS will be 3rd to market out of the recently approved new anticoagulants Pradaxa(Boehringer Ingelheim) and Xaralto(Bayer/$JNJ). However, this clean safety data is a really big deal/success for $BMY and $PFE. So much so, that in my opinion, the data looks better than Pradaxa or Xaralto in Afib. They plan on submitting the NDA, EMA  end by year end. 

"ELIQUIS® (apixaban) was superior towarfarin for the reduction of stroke or systemic embolism with significantly less major bleeding in patients with atrial fibrillation in Phase 3 ARISTOTLE Trial. ARISTOTLE Demonstrated that ELIQUIS is the First Oral Anticoagulant to Significantly Reduce All-Cause Death. ELIQUIS, compared to standard of care warfarin, significantly reduced: risk of stroke or systemic embolism by 21 percent, risk of major bleeding by 31 percent, mortality by 11 percent."

Disclosure: Long $PFE Weekly calls and Sept $BMY calls

PFE/BMY ELIQUIS(apixaban) news wrap up with links to multiple articles 

NEJM article - Apixaban versus Warfarin in Patients with Atrial Fibrillation - http://bit.ly/q49394 

Forbes' Matthew Herper: Pfizer and Bristol Overtake Rivals In Multi-Billion Blood Thinner Market - http://onforb.es/rtunCn 

Forbes' - Pfizer and Bristol's ARISTOTLE Study Finds the Golden Mean of Anticoagulation - http://onforb.es/pguVe0 

Fierce Biotech - Pfizer, BMS unveil mega-blockbuster data on apixaban - http://bit.ly/q5pBaE 

Bloomberg - Pfizer, Bristol-Myers Experimental Blood Thinner Reduced Deaths in Study - http://bloom.bg/phjmdN 

"Pfizer and Bristol-Myers may now take 60 percent of the market for blood thinners to ward off strokes in people with an irregular heartbeat, according to analysts for ISI Group and Leerink Swann & Co. Leerink estimates sales of warfarin replacements will reach $7 billion to $9 billion a year."

From earlier, "Results of this caliber may mean that while the drug lags behind two rivals in the race to win approval in the U.S., it could still take up to half of the market, Christopher Schott, a New York-based analyst for JPMorgan Chase & Co., wrote in a note to investors before the data was public. Schott said a “best- case scenario” may add $1 billion in peak annual sales to the $2.8 billion he estimated Eliquis will generate by 2017.
[ in my view, the data would seem to fall under best-case scenario.

WSJ: Boost for New Stroke-Prevention Drug - http://on.wsj.com/qZ0L6T 

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