Will Brilinta Be Approved Next Week or Not?

[Anonymous]

Big week next for AZ! Will it get approved? Will it be delayed or will it be rejected?

 

[Anonymous]

Big week next for AZ! Will it get approved? Will it be delayed or will it be rejected?

Regardless, it has been a scam from the beginning to keep us calm right up until the time they drop the ax on most of us. Even if it is approved, it might help save hospital and CVAS for a while but not the rest. Do you really think it will make up for a continued closing of access to offices and the loss of Seroquel and Crestor to generic pressure? This is just an example of soothing music to keep us working until they cut us all loose. Look at Novartis, Abbott, Lilly, GSK, Schering, ..... the examples are endless that this industry is dying a rapid death. Even the Kool Aid drinking DSMs and RSDs don't believe the bullshit stories any longer.

 

[Anonymous]

Who knows? AZ's track record is terrible. The FDA has already decided. Maybe they will announce it early next week. With all the patent loses, $4 co-pay for Lipitor, lawsuits, falling profits, a sales org that's doing all they can to leave the industry, you have a perfect storm brewing. A Brilinta delay would speed things up.

 

[Anonymous]

Bloomberg
Analyst: FDA decision poses risk for AstraZeneca
Dec 9, 2010 11:03 AM ET
By The Associated Press

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INDIANAPOLIS (AP) — An upcoming U.S. regulatory decision on AstraZeneca's blood thinner drug carries substantial risk for the British drugmaker that may be underestimated, according to a Jefferies International Ltd. analyst.

THE OPINION: The Food and Drug Administration is expected to complete its review of Brilinta by Dec. 16, and analyst Jeffrey Holford said in a research note he sees a high risk of a delay in the regulatory body's decision or an "uncommercial labeling" for the drug.

In September, an FDA advisory committee voted 7 to 1 to recommend the approval of Brilinta in patients with acute coronary syndrome, or blocked arteries. An international study conducted by AstraZeneca showed that patients taking Brilinta versus Plavix were less likely to experience various heart-related problems. But U.S. patients studied were more likely to report heart problems while taking the drug.

The drug has received European approval, but that should not reassure investors, Holford said. He noted that the FDA will be focused on the U.S. population, and committee members have said more studies in the United States are needed to confirm the drug's effectiveness.

"We see a number of significant issues that we do not believe the FDA has enough comfort on to issue a strong label for the product, if at all," Holford wrote, adding that he believes his firm is "anti-consensus" on the approvability of a strong label.

Holford also noted that AstraZeneca faces substantial exposure to generic competition over the next six years.

THE STOCK: Down 42 cents to $47.71 in Thursday morning trading, while broader trading indexes were up slightly.

 

[Anonymous]

Also, The drug, which has been approved by European regulators, could bring in about $2 billion by 2016. But while proving generally more effective in studies than Plavix -- another blood thinner, and the world's second-best selling drug -- Brilinta did not appear to offer an equal benefit in U.S. patients. That has some analysts cautioning that its approval is not a sure thing.

"We see a number of significant issues that we do not believe the FDA has enough comfort on to issue a strong label for the product, if at all," Jefferies analyst Jeffrey Holford wrote in a Dec. 9 note.


I would place a bet on it's getting approved, let alone a decent label where we can actually promote it. Enjoy this Christmas my friends, for certainly next year your bucket of coal will be a quite bit lighter. That is unless you are David Brennan of course!

 

[Anonymous]

FDA advisory panel voted 7-1 in favor of approval. The FDA usually follows the advice of their panel. If not, bigger trouble at AZ!

 

[Anonymous]

Regardless, it has been a scam from the beginning to keep us calm right up until the time they drop the ax on most of us. Even if it is approved, it might help save hospital and CVAS for a while but not the rest. Do you really think it will make up for a continued closing of access to offices and the loss of Seroquel and Crestor to generic pressure? This is just an example of soothing music to keep us working until they cut us all loose. Look at Novartis, Abbott, Lilly, GSK, Schering, ..... the examples are endless that this industry is dying a rapid death. Even the Kool Aid drinking DSMs and RSDs don't believe the bullshit stories any longer.

Well said. Even the best case predictions don't make up for the loss of Nexium, Seroquel, and Crestor which will tank under generic pressure when Lipitor is added to the mix. You won't find Crestor on any formularies at 1st or 2nd tier.
You would have to be blind, deaf and dumb to think that Brilinta is going to save us.

 

[Anonymous]

Well said. Even the best case predictions don't make up for the loss of Nexium, Seroquel, and Crestor which will tank under generic pressure when Lipitor is added to the mix. You won't find Crestor on any formularies at 1st or 2nd tier.
You would have to be blind, deaf and dumb to think that Brilinta is going to save us.

You must be blind, deaf, and dumb to still be working for AZ.

If the writing on the wall has not motivated you to pursue other employment, you are a fool.

 

[Anonymous]

The labeling will all but prevent an effective marketing campaign. On the other hand, a delay for "additional data" would be the last straw for AZ. Did I mention that Brennan increased his pension payout by 50% over the last 2 years?

 

[Anonymous]

The labeling will all but prevent an effective marketing campaign. On the other hand, a delay for "additional data" would be the last straw for AZ. Did I mention that Brennan increased his pension payout by 50% over the last 2 years?

It really does not matter if it is approved. Plavix will be generic in 1 yr or so..First quarter of 2012. Next year their reps will use the fda suggested guidelines for DES regarding keeping patients a drug for a year, and sell that fact to physicians. Why start a patient on a drug that in a year or less the patient could be getting a generic version and it is not 2 pills a day. On top of that, what if a patient goes out of town on friday and forgets his AZ drug, come monday will the patient still be around?

Having sold in the cath lab, the main thing Plavix reps will also have going for them, is that this drug is not actually reversable, as was advertised. It still has a 2-3 day period a wait recommended before CABG. Also in the US, there is truly no benefit unless in CABG patients.

Finally, previously was a seminar that had several leading Cardiologist, and the question came, and they said are you crazy...."when asked if marketing the fact that brillianta is somewhat reversable is a advantage. They brought up good points. When you give the cocktail of drugs that is used when a patient is headed for stent, you are anticoagulating the patients body which is already sick,, then you want to reverse it to anticoagulate it again. The key is to only use when you know there will not be a need for Cabg, thus Effient may offer a benefit especially in the diabetes patient.

There really is not market for this drug, unless the physician is sold on being able to preload with this drug because it minimzes risk for patient to have to cabg with drug on board. Good idea, but when you factor in no clinical beneifts for patient unless cabg patient...and vs generic...This drug simply will not be a big seller. Plavix will maintain its marker share.

 

[Anonymous]

It really does not matter if it is approved. Plavix will be generic in 1 yr or so..First quarter of 2012. Next year their reps will use the fda suggested guidelines for DES regarding keeping patients a drug for a year, and sell that fact to physicians. Why start a patient on a drug that in a year or less the patient could be getting a generic version and it is not 2 pills a day. On top of that, what if a patient goes out of town on friday and forgets his AZ drug, come monday will the patient still be around?

Having sold in the cath lab, the main thing Plavix reps will also have going for them, is that this drug is not actually reversable, as was advertised. It still has a 2-3 day period a wait recommended before CABG. Also in the US, there is truly no benefit unless in CABG patients.

Finally, previously was a seminar that had several leading Cardiologist, and the question came, and they said are you crazy...."when asked if marketing the fact that brillianta is somewhat reversable is a advantage. They brought up good points. When you give the cocktail of drugs that is used when a patient is headed for stent, you are anticoagulating the patients body which is already sick,, then you want to reverse it to anticoagulate it again. The key is to only use when you know there will not be a need for Cabg, thus Effient may offer a benefit especially in the diabetes patient.

There really is not market for this drug, unless the physician is sold on being able to preload with this drug because it minimzes risk for patient to have to cabg with drug on board. Good idea, but when you factor in no clinical beneifts for patient unless cabg patient...and vs generic...This drug simply will not be a big seller. Plavix will maintain its marker share.

"Having sold in the cath lab...blah, blah, blah." Hey Troll, your sensitivities toward Lilly and BMS reps, while noble, belong on their board. We do not need your pseudo high brow opinion and could care less what else you have to offer. It will be crushing to see so many MCR and MCL go in 2011. The last thing needed is a BMS scientist with cath experience spouting off their perceived wisdom.

 

[Anonymous]

It really does not matter if it is approved. Plavix will be generic in 1 yr or so..First quarter of 2012. Next year their reps will use the fda suggested guidelines for DES regarding keeping patients a drug for a year, and sell that fact to physicians. Why start a patient on a drug that in a year or less the patient could be getting a generic version and it is not 2 pills a day. On top of that, what if a patient goes out of town on friday and forgets his AZ drug, come monday will the patient still be around?

Having sold in the cath lab, the main thing Plavix reps will also have going for them, is that this drug is not actually reversable, as was advertised. It still has a 2-3 day period a wait recommended before CABG. Also in the US, there is truly no benefit unless in CABG patients.

Finally, previously was a seminar that had several leading Cardiologist, and the question came, and they said are you crazy...."when asked if marketing the fact that brillianta is somewhat reversable is a advantage. They brought up good points. When you give the cocktail of drugs that is used when a patient is headed for stent, you are anticoagulating the patients body which is already sick,, then you want to reverse it to anticoagulate it again. The key is to only use when you know there will not be a need for Cabg, thus Effient may offer a benefit especially in the diabetes patient.

There really is not market for this drug, unless the physician is sold on being able to preload with this drug because it minimzes risk for patient to have to cabg with drug on board. Good idea, but when you factor in no clinical beneifts for patient unless cabg patient...and vs generic...This drug simply will not be a big seller. Plavix will maintain its marker share.

so many things wrong with this post.

FOr one - who cares about generics in a year, when the indication will be for 6 months treatment? This will be for acs.

Not all the other things. There is a niche and a need. Something to work with.

 

[Anonymous]

so many things wrong with this post.

FOr one - who cares about generics in a year, when the indication will be for 6 months treatment? This will be for acs.

Not all the other things. There is a niche and a need. Something to work with.

Obviously your a hopeful AZ rep who just got trained and think that having physicians stop writing plavix will be a easy task. Think again. It will not happen.

Physicians can not wait until Plavix goes generic. Plavix reps will play this card until the last day. "why put a patient on twice daily drug" when you have been using Plavix once a day, and it works, and this same patient will be able to use the drug for a generic price in the future.

Also, to the person that clearly does not know how these drugs works. Only Bare metal stints will physicians focus on taking patients off the drug, in other cases if they can afford the drug, they usually leave them on their plavix. Maybe you should want to learn the field that your talking about.

Your drug will only get minimal play in the ER or poss cath lab. No physician in their right mind will consider using this drug in a outpatient setting which is where 99% of the revenue occurs. Twice daily kills you all. Done deal.

 

[Anonymous]

Even if this drug is approved it will remain a challenging market. The American Heart Association guidelines for Acute Coronary Syndrome/STEMI recommend clopidogrel (yes, it is specifically spelled out - clopidogrel) administration prior to PTCA or fibrinolytic therapy. The guidelines were just updated for 2011 and clopidogrel stays for two more years. Good luck.

 

[Anonymous]

Even if this drug is approved it will remain a challenging market. The American Heart Association guidelines for Acute Coronary Syndrome/STEMI recommend clopidogrel (yes, it is specifically spelled out - clopidogrel) administration prior to PTCA or fibrinolytic therapy. The guidelines were just updated for 2011 and clopidogrel stays for two more years. Good luck.

Stemi's are a small percentage of the total cath's and effient is far superior to plavix in the diabetes patient and stemi based on efficacy, onset of action and the fact no non responders in the loading phase and very very very few in the maintenence phase. Effient is recommended as well, this person left that out.

Now as for Brillinta, there just is no place for it. Hospitals reimbursement cuts and challenges with cost will make it impossible for them to use this first line on all patients. It will not happen. They will start to genetic test patients to see if allergic to plavix or are non responders. If they are then yes Brillinta and or Effient will be used. In the Er Brillinta will make the better choice due to 2-3 days reversing period vs 5-7 days for effient. So that will be the window. In the cath lab once the see the anatomy, Effient clearly is the best choice, since reversing or the 2-3 day period of reversing vs Effient's period is irrelevant now as they now can see if there will be a need for a possible Cabg.

Once they leave the hospital, Brillinta will never be used two reasons

cost vs a generic (keep in mind this is not the only drug these patients pay for, they generally take 15-25 other pills, so this co-pay difference will be huge on physicians minds. It already is. Just look at the period of time with Plavix went generic for a short while what happened).

Brillinta is 2 pills per day and the risk if the patient does not take the recommended dose is severe.

Also, it truly is not a benefit to the patient to re-anticoagulate their body 2 times, this is extremely dangerous increases stroke risk and dangers to cardiac system in general. So I would be very careful marketing to thought leaders about the reversability of this drug, it should be a last ditch thing that you point out just in case, and then contrast and compare the data and the impacts of increased bleeding the happens from a patient going to CABG.

This drug simply just like effient, simply came along too late. Plavix may not be the best option, but it is THE option that Cardiologist were trained with, are comfortable with, and do not have to think through. Plus it will be a cost saviings to hospitals and to patients in the 1st quarter of 2012.

Only advantage is that there will not be plavix reps out counter detailing once it goes generic.

 

[Anonymous]

Even if this drug is approved it will remain a challenging market. The American Heart Association guidelines for Acute Coronary Syndrome/STEMI recommend clopidogrel (yes, it is specifically spelled out - clopidogrel) administration prior to PTCA or fibrinolytic therapy. The guidelines were just updated for 2011 and clopidogrel stays for two more years. Good luck.

I have sold AZN at $52. A possible dividend buy below 40. Stock will likely test this level if not approved.
Drug will likely be approved but with a limited label. Single digit share expectations.
Most reps do not know what they are in for, the battle will be a losing one for them as hospitals already have determined how to limit use based on cost and guidelines. It is a niche drug and due to the restricted operating environment and poor marketing will struggle to find it's highest and best use.
This company is worth more and could operate better if divisions were spun off and new management put in place.

 

[Anonymous]

Not a rep I know is excited about this drug. AZ has no clue anymore of how to market anything. It will go down as another mediocre launch, but even it will be better than Vimovo launch. The Vimovo launch was beyond pathetic. it was sad.

 

[Anonymous]

Any word? I know today is the day AZ is suppose to hear..

 

[Anonymous]

Any word? I know today is the day AZ is suppose to hear..

It doesn't matter. No doctor will prescribe a twice daily drug, that is about to face generic competition, and does not show any benefit in us population.

 

[Anonymous]

It doesn't matter. No doctor will prescribe a twice daily drug, that is about to face generic competition, and does not show any benefit in us population.

Wait to find out....