Xarelto approved!

Hey, at least it made it to the market with no more delays. Now let's pray that the card. indication makes it as well so that we have a jumpstart over the BMS product coming next year. This is going to get very interesting, especially if another generic Lovenox makes it to market and lowers LMWH prices dramatically.

 

BMS product has better data so any headstart to the market is not going to matter.

 

I can't wait for the cardiology indication! Hopefully very soon!

 

OOPS!


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

 

Did you see the apixaban data this morning? Superior efficacy vs warfarin with reduction in bleeding and mortality. Xarelto may be dead in the water before it even gets started. Sure am glad I didn't make the switch to JNJ.

 

Ha! Apixaban may be dead in the water before it even gets started, the FDA has a habit of causing delays! Xarelto is on the market today which makes future indications just a tad bit easier. Let's check back in November to see if Xarelto is "dead in the water"

 

Why delay apixaban when there will already be an oral anti Xa on the market? First to market is who gets delayed, subsequent molecules get to market faster because that trail has already been blazed. Will be an interesting fight between the two especially with Pfizer leading the charge for second to market.

 

sooooooooooo happy I did not take this job!!! wish you'll all the luck!

 

Not looking too good for Xarelto!

Pfizer Inc. (PFE)’s and Bristol-Myers Squibb Co. (BMY)’s Eliquis will lead the market for stroke-preventing blood thinners after “best-in-class” clinical trial results that marry safety with effectiveness, analysts said.

The twice-daily pill had a 31 percent lower risk of major bleeding, a feared side effect of blood thinners, than the current standard treatment, warfarin, researchers said yesterday at the European Society of Cardiology’s conference in Paris. Patients on Eliquis had an 11 percent reduced risk of dying, the first time a warfarin replacement has saved lives in a study.

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.

“The bleeding profile is phenomenal and trumps everything else,” Mark Schoenebaum, a New York-based analyst for ISI, said in a telephone interview. “Clearly, this drug will be the leader in the market.”

Yesterday’s results may mean an additional $1.1 billion in peak sales for Eliquis, also known as apixaban, Leerink’s Seamus Fernandez said in a report to investors today. The Boston-based analyst now forecasts the drug will garner revenue of $4.2 billion by 2017, writing that it’s “best-in-class” for safety and reducing deaths.

Two Competitors

Pfizer rose 67 cents, or 3.7 percent, to $18.88 at 4 p.m. in New York Stock Exchange composite trading. Bristol-Myers climbed 57 cents, or 2 percent, to $29.29.

Pfizer and Bristol-Myers trailed two competitors in the race to bring a warfarin replacement to market. Boehringer Ingelheim GmbH’s Pradaxa was the first, approved last year in the U.S. Bayer AG (BAYN) and Johnson & Johnson (JNJ) also have a candidate, Xarelto, due for regulatory review in the U.S. next month.

Until the Paris conference, the two U.S. drugmakers had only compared Eliquis with aspirin. Now cardiologists have results of two large trials showing the drug is safe, a potentially compelling argument, said Lars Wallentin, a cardiologist at Uppsala Clinical Research Center in Sweden who worked on both Eliquis and Pradaxa.

“There is an edge to apixaban, I would admit,” Wallentin said in an interview at the conference.

Fewer Strokes

Irregular heartbeat, or atrial fibrillation, is the biggest part of the market for Eliquis and its competitors. Other smaller groups of patients, such as people who’ve had hip and knee surgery, could generate an additional $3 billion to $6 billion in sales a year, Fernandez said.

Eliquis also prevented 21 percent more strokes than warfarin in the Aristotle study presented yesterday. For every 1,000 patients treated during the trial, it prevented a stroke in six people, major bleeding in 15 people and death in eight people, investigators wrote in a New England Journal of Medicine article published to coincide with the presentation in Paris. Pfizer and Bristol-Myers funded the research, which followed 18,200 patients.

“The answer is crystal clear: patients will do better on this drug,” lead investigator Christopher Granger, of the Duke Clinical Research Institute in Durham, North Carolina, said in an interview at the conference. Lower cost is the only reason for patients to continue taking warfarin, he said.

Blood Tests

Doctors had been eager for a replacement for warfarin because patients need regular blood tests to ensure they’re getting a safe, effective dose of the older drug.

Eliquis was especially impressive because there was evidence it beat warfarin even in patients who were getting the optimal dose, Harvard University cardiologist Elliott Antman said in an interview. Antman is leading studies of another potential competitor, Daiichi Sankyo Co.’s edoxaban.

If a patient is stable on warfarin and doesn’t mind a monthly doctor’s visit for a blood test, there may be no reason to switch to a new, more expensive medicine, Ralph Brindis, senior adviser for cardiovascular disease at Northern California Kaiser Permanente, said in an interview. Warfarin, a generic drug, costs $4 a month, plus about $20 for blood tests, according to a January presentation by the University of Utah Health Care Thrombosis Service.

Atrial fibrillation occurs when the upper chambers of the heart quiver rather than contract, allowing blood to pool and form clots. More than 2.5 million Americans suffer from it, and 11,000 die every year.

Pradaxa, Xarelto

Pradaxa and Xarelto didn’t significantly extend patients’ lives in studies, though both showed a trend toward being able to do so, Jessica Mega, a cardiologist at Brigham and Women’s Hospital in Boston, wrote in an editorial published alongside the results in the journal. Yet all three appear to be better on some measure than warfarin, Mega wrote.

Boehringer’s Pradaxa has the most to lose from good Eliquis results, Larry Biegelsen, a New York-based analyst for Wells Fargo Securities, wrote in a note to clients before the study was published. Bayer’s Xarelto was studied in a more high-risk group of patients than Eliquis or Pradaxa and could maintain a market niche because it’s a once-daily pill, Biegelsen said.

Warfarin is also once-daily. Both Eliquis and Pradaxa must be taken twice each day.

Pfizer and Bristol-Myers plan to submit Eliquis for U.S. and European regulatory approval by year-end.

Bristol-Myers and Pfizer “are two of the best cardiovascular marketers out there,” Leerink’s Fernandez said. “Put this together with the data, and you have a clear winner.”

 

All of pharma is going to suck once the Sunshine Laws come in, but now I'm really glad I didn't get this position which would have kept me longer in pharma. Time to get out of this shitty industry.

 

How about all the doctor's that see their name down for pragrams that they never were a part of as we all know we all put extra names down to justify the cost? There should be a lot of nervous Reps. right now..

 

what's the insurance coverage like btwn the products

 

Afib approval........DENIRD!!""

all over cardiobrief.
announed an hour ago

 

A complete response letter was issued. But, yes it is denied until additional data is given. It doesn't look good though.

It doesn't really matter because Eliquis will dominate this market.

 

The FDA is finally doing it's job....not intimidated by big J&J & Bayer combo frauds!!!

J&J thinks they can fool the FDA easily everytime......not this time!!!

You need to employ some credible & experienced people in your regulatory department!!!!

 

It ain't over until the fat lady sings on Thursday!

 

"HATER"!!!!!!!

 

I lucked out when I applied for this job and was 2nd in line for the offer. I'm going to take this as a learning experience and never jump ship until the product is approved and on the market. Feel sorry for all those who left a crappy situation but jumped into this fire. Even if Xarelto is approved it would be a niche product with other oral anticoagulants dominating the market.

 

This is par for the course at J&J. Ultram ER, Nucynta, Aciphex, Invega. All never really met the potential of what they could have been. The hype on these products is unbelievable and then they fizzle like firecracker dud. J&J's best at talking up a pipeline than they are at actually executing it. Remember Xarelto is a "game changer" - yeah right

 

And the fat lady sang today...9 yes, 2 no, 1 abstain. Expect approval for afib with a modest indication.