Will Brilinta Be Approved Next Week or Not?

[Anonymous]

What do the last 30 to 40 posts have to do with the approval of Brillinta? Brillinta WILL get approved.......just not in the US............

Interesting that you don't understand that...

Brillinta is a me too product. If approved it will be priced in the stratosphere. There will be no price competition due to the new entry in the market, it'll just ramp up the noise and expand the market.

That's the opposite of how it's supposed to work, on several fronts. The first point is that in a free market, more choice drives prices down -- in pharma, more product choices has no impact on price. The second perversion is that pharma R & D is supposed to bring new therapies to market. What it actually delivers is only me too products, combination, isomer, and XL versions of existing therapies.

 

[Anonymous]

What do the last 30 to 40 posts have to do with the approval of Brillinta? Brillinta WILL get approved.......just not in the US............

Would agree. It has been delayed twice and given the weakness of the latest response the chance could be less than 50/50.

 

[Anonymous]

Interesting that you don't understand that...

Brillinta is a me too product. If approved it will be priced in the stratosphere. There will be no price competition due to the new entry in the market, it'll just ramp up the noise and expand the market.

That's the opposite of how it's supposed to work, on several fronts. The first point is that in a free market, more choice drives prices down -- in pharma, more product choices has no impact on price. The second perversion is that pharma R & D is supposed to bring new therapies to market. What it actually delivers is only me too products, combination, isomer, and XL versions of existing therapies.

I am just so tired of reading your high school rants. Let me make this very simple for you. Go to this link and read it, then go to the citations and read them. Then take a economics class for Christ sake. In about a month, come back here and apologize to all of us.

http://en.wikipedia.org/wiki/Oligopoly

 

[Anonymous]

I am just so tired of reading your high school rants. Let me make this very simple for you. Go to this link and read it, then go to the citations and read them. Then take a economics class for Christ sake. In about a month, come back here and apologize to all of us.

http://en.wikipedia.org/wiki/Oligopoly

I could post many links for you to read, but the single best one is this one:

http://www.amazon.com/Truth-About-Drug-Companies-Deceive/dp/0375508465

Pharmalot has plenty about the corruption going on, you might click over there. Not a week goes by without another major "settlement" announced between the government regulatory agencies and a big pharma company. One I read about concerned a company using a blood product that wasn't heat treated to kill HIV, because there was $400,000 worth of "old" supply on hand. Some of the patients taking the old batch got AIDS. It was preventable, and the company knew the risk. But hey, the company decided to save $400 large! So what if a few people got sick, and the US healthcare system will have to dole out far more than that taking care of these people. And a really gigantic big fat "so what" about the people who caught AIDS because of the pharma company, right (I think it was Bayer)? They probably say "Patient Health First!" too.

We're not discussing an oligopoly, we're discussing a government protected corrupt industry that preys off the sick and elderly, at the expense of the taxpayers. The CIA agreements that every major Rx company is currently operating under does nothing to stop the fraud and abuse, so the next step is government regulation a la the electric utilities. If the people in the country knew what was going on, it would happen.

And talk about high school! Wikipedia? Come on.

 

[Anonymous]

I will take it you didn't bother reading it like the poster suggested. You just got owned and you are to stupid to see it.

 

[Anonymous]

It will be approved, but will it matter? At the very least the market opportunity will be significantly less, generic plavix and oral anticoagulants coming to market, rivaroxaban, apixaban likely to take a significant slice of the pie.

 

[Anonymous]

I will take it you didn't bother reading it like the poster suggested. You just got owned and you are to stupid to see it.

You're a minion, unable or unwilling to think for yourself.

 

[Anonymous]

Listen you little, "life is unfair and corporate greed is ruining the rain forest and I bleed from a wound in between my legs once a month in spite of the fact that I'm a man", man. What you've done on here is make yourself look like an idiot. You claim to be a capitalist, but your against big business (big pharma). You claim to want "innovation" but you want to suck all the profit and incentive out of achieving said innovation. You claim to want products that "really help" but you want it done for free, or at the very least done by the good grace of some scientists heart. Listen here, moron, the same system that is still in place today has produced drugs over the years that have improved everything from ED to neural function. From the tip of your toes to your hair follicle, there was an R&D process that was driven mainly by dollar signs. If you don't understand that, along with a companies desire to maximize utility and profit, then clearly you didn't go to college, or at least paid no attention. You really think Pfizer stumbled upon Viagra and said, "hey, this can really help people! we should price it modestly for no reason other than to be good, upstanding, altruistic human beings! Yeah, lets do it!".... There will NEVER be a day when that is the case, and that drug, Viagra, was the result of developing aa drug that would have made an "incremental difference" in a previous therapy. Look at the reverberations and the improvements made to peoples health. I guess I shot that "thesis" to shi*.

Oh, and one more thing. HEALTH CARE AND A GOOD QUALITY OF LIFE IS NOT AN ENTITLEMENT YOU D-LEANING WUSS. If you can't afford the "astronomical" costs of medication, then don't take them. Don't purchase them. Don't be a consumer in this twisted, wicked world of pharma. Oh, but in your mind and in your world everyone deserves the good life. Everyone deserves to live to be 90 ... it's a basic right! and, oh yeah, we don't wanna have to pay for anything. The cheaper the better. But will ya still try? will ya still try to make medicine? Your entire thought process is just completely irrational. I don't see how you could have a job with a company with that type of mentality. It's not Pharmas fault if they are maximizing profits. Its the logical and only way. Have a talk with your lefty president. He wants to make this country socialist too I'm sure he'll be on board.

 

[Anonymous]

You're a minion, unable or unwilling to think for yourself.

I learned to think for myself during my PhD. I learned all the business models during my MBA. But Dude, I learned to walk all over people like you in grade school. Why you ask? Because I could, hahahhahahahahah!

 

[Anonymous]

OK, back on to personal attacks. Your untenable position is being exposed so the boil over from you is an attack against me. Is that the way you respond to everyone who outwits you -- to claim they're not a man? Is that a manly response, tough guy?

I am a far right wing conservative. I believe in free market competition. If it existed in pharmaceuticals, there would be some actual innovation. There has been none in decades.

It's interesting you mention Viagara. Viagara was STUMBLED upon. It was an experimental blood pressure medicine, and the subjects reported a side effect and presto. Then, the leaches swooped in, changed a methyl group, and patented Cialis, Levitra, and maybe other branded products, invented "ED" as a medical condition. Everybody charges astronomical prices for their product -- none of the companies compete on price. The corrupt industry normalized the treatment as a medical condition (it's not), bombarded us with ads at dinnertime, prompting our 6 year olds to ask "Dad, what's erectile disfunction" and convinced state medical programs to reimburse for this at best recreational product. At sky high prices.

I don't think life is unfair, I think the way pharmaceuticals are distributed and paid for is extremely corrupted and need to be redone. Either the government needs to get all the way in and socialize it, or the government needs to get out and allow free market forces to drive down prices and drive up innovation. As it stands, we get high prices and zero innovation.

And the one thing we do agree on is that health is not an entitlement. The first questions our solons need to answer is "Do Americans have a RIGHT to healthcare?" I believe the answer is no. You, though, promote your "only $30.00 copay" and pass on the rest to the taxpayers -- me.

Other major companies all have R & D departments, and they either produce innovative products or they go out of business. Pharma is corrupt. Their R & D function produces zilch. They're still selling patented versions of pennicillin and insulin, the two products that were the first covered by the Food and Drug Act, the signing of which started the ball rolling on the corrupt industry that you are a pawn of. The people in charge are lining the pockets of our lawmakers, and repackaging old products, hoping to keep the game going for themselves as long as they can.

 

[Anonymous]

OK, back on to personal attacks. Your untenable position is being exposed so the boil over from you is an attack against me. Is that the way you respond to everyone who outwits you -- to claim they're not a man? Is that a manly response, tough guy?

I am a far right wing conservative. I believe in free market competition. If it existed in pharmaceuticals, there would be some actual innovation. There has been none in decades.

It's interesting you mention Viagara. Viagara was STUMBLED upon. It was an experimental blood pressure medicine, and the subjects reported a side effect and presto. Then, the leaches swooped in, changed a methyl group, and patented Cialis, Levitra, and maybe other branded products, invented "ED" as a medical condition. Everybody charges astronomical prices for their product -- none of the companies compete on price. The corrupt industry normalized the treatment as a medical condition (it's not), bombarded us with ads at dinnertime, prompting our 6 year olds to ask "Dad, what's erectile disfunction" and convinced state medical programs to reimburse for this at best recreational product. At sky high prices.

I don't think life is unfair, I think the way pharmaceuticals are distributed and paid for is extremely corrupted and need to be redone. Either the government needs to get all the way in and socialize it, or the government needs to get out and allow free market forces to drive down prices and drive up innovation. As it stands, we get high prices and zero innovation.

And the one thing we do agree on is that health is not an entitlement. The first questions our solons need to answer is "Do Americans have a RIGHT to healthcare?" I believe the answer is no. You, though, promote your "only $30.00 copay" and pass on the rest to the taxpayers -- me.

Other major companies all have R & D departments, and they either produce innovative products or they go out of business. Pharma is corrupt. Their R & D function produces zilch. They're still selling patented versions of pennicillin and insulin, the two products that were the first covered by the Food and Drug Act, the signing of which started the ball rolling on the corrupt industry that you are a pawn of. The people in charge are lining the pockets of our lawmakers, and repackaging old products, hoping to keep the game going for themselves as long as they can.

You are self obsessed.

There seems to be more htan one person here calling bs on you.
If you're in the industry - you should get out, for your own peace of mind.

 

[Anonymous]

You are self obsessed.

There seems to be more htan one person here calling bs on you.
If you're in the industry - you should get out, for your own peace of mind.

Why is every retort only about the poster, any nobody's taking the industry's side arguing the issues raised? Can't the industry supporters do any better than that to defend what they're doing? Are the lies going to be THAT easy to expose -- are they so obvious that there's no defense at all -- like a smoking gun in the industry's hand?

 

[Anonymous]

Why is every retort only about the poster, any nobody's taking the industry's side arguing the issues raised? Can't the industry supporters do any better than that to defend what they're doing? Are the lies going to be THAT easy to expose -- are they so obvious that there's no defense at all -- like a smoking gun in the industry's hand?

If our industry is so bad go to canada or mexico for your drugs. take twice a day triamcinalone vs once a day budesonide. Take RHI 2 or three times a day vs once daily analog insulins. people here argue with emotion not logic. yes some shit are me too drugs but some are more convienent to take thus increasing compliance thus helping pts.

The industry gives MILLIONS of dollars of free drugs to help pts. Tell me the last time best buy gave away free tvs or blue rays - and by the way most people complaining about drug costs etc. have one of each. Let me know when Mickey Ds gave away free big macs - again those that complain are likely to be found here buying a few of each.

We are the only industry where people expect shit for free. they smoke, become obese and then its someone else's fault that they are the way they are so gimme my shit for free.

Thanks to many liberals profit is a bad word. A me too drug or not, if a company makes something they should get paid for it if there is a market and our job is to create the market.

Dont like whats going on fucking leave or do something about it. Create an industry, most likely using my tax dollars, to help fight drug prices. quit your current job and become a crusader - but do it without government grants. feed your family that way

 

[Anonymous]

If our industry is so bad go to canada or mexico for your drugs. take twice a day triamcinalone vs once a day budesonide. Take RHI 2 or three times a day vs once daily analog insulins. people here argue with emotion not logic. yes some shit are me too drugs but some are more convienent to take thus increasing compliance thus helping pts.

The industry gives MILLIONS of dollars of free drugs to help pts. Tell me the last time best buy gave away free tvs or blue rays - and by the way most people complaining about drug costs etc. have one of each. Let me know when Mickey Ds gave away free big macs - again those that complain are likely to be found here buying a few of each.

We are the only industry where people expect shit for free. they smoke, become obese and then its someone else's fault that they are the way they are so gimme my shit for free.

Thanks to many liberals profit is a bad word. A me too drug or not, if a company makes something they should get paid for it if there is a market and our job is to create the market.

Dont like whats going on fucking leave or do something about it. Create an industry, most likely using my tax dollars, to help fight drug prices. quit your current job and become a crusader - but do it without government grants. feed your family that way

Agreed.

And also do not expect any support or accountability from generic houses. They'll be like builders. Packing up their bags and changing their names before they get sued.

Try tracking down a manufacturer in China or India and see how far you get. They add what ever they have in their pocket at the time and don't expect the same standards or quality of meds. The industry can drop some headcount, but don't think you can live with cheap drugs. There is no such thing.

 

[Anonymous]

If our industry is so bad go to canada or mexico for your drugs. take twice a day triamcinalone vs once a day budesonide. Take RHI 2 or three times a day vs once daily analog insulins. people here argue with emotion not logic. yes some shit are me too drugs but some are more convienent to take thus increasing compliance thus helping pts.

The industry gives MILLIONS of dollars of free drugs to help pts. Tell me the last time best buy gave away free tvs or blue rays - and by the way most people complaining about drug costs etc. have one of each. Let me know when Mickey Ds gave away free big macs - again those that complain are likely to be found here buying a few of each.

We are the only industry where people expect shit for free. they smoke, become obese and then its someone else's fault that they are the way they are so gimme my shit for free.

Thanks to many liberals profit is a bad word. A me too drug or not, if a company makes something they should get paid for it if there is a market and our job is to create the market.

Dont like whats going on fucking leave or do something about it. Create an industry, most likely using my tax dollars, to help fight drug prices. quit your current job and become a crusader - but do it without government grants. feed your family that way

You're doing better, only about 1/2 of that post was personal crap, the rest was an attempt to argue on substance. You're wrong, but you're still trying, which is better.

1) I am doing something about it, and I'm feeding my family too. There's no need for an entire industry to fight drug prices in the information age. I'm not leaving the country, I think foreign drug companies should be treated like foreigners, not people like me. The foreign drug companies and every foreign company should have to pay a fee to access our markets. It'd be a start at tackling the national debt.

2) Profit is not a bad word. Usury is, in the sense you mean. Banks should make a profit -- interest -- on their loans. Companies that create new things should make as much as the free market will bear. An example is the Snuggie -- the person that came up with that made millions! The people who make blankets, though, should not be entitled to 3,000% markups due to protection by phony government patents they extend through trickery and thus people either have to be cold or pony up the dough, unless they have a special buying program like "insurance" which covers their blankets.

(I know that analogy is over your head, so I'm ready for a lambast on #2)

3) Pharma is not the only industry where people expect things for free. There are "buy one get one free" deals out there ALL OVER THE PLACE. Many free market companies use tactics like that. Many free market companies give away promotional samples and free trial offers. You're just so caught up in the fantasy land of big pharma that you don't notice. (Or you're stupid as shit. Or both.)

4) Budesonide QD is available in Canada, for far less than it is in the USA. It's generic, remember? My arguments are based entirely on logic, it is your tactic to be emotional, because your side of the argument is the loser's.

 

[Anonymous]

Here's the third hit on Google for a search for industries that give away free stuff:

http://hubpages.com/hub/100-Companies-That-Give-Away-Free-Stuff

My credit card company gives away free MONEY for using their card. My stock company paid me to move my account there. Buy some cars and they'll pay your gas for a year free.


Plenty of free market competition companies give away things for free if you use their products. Only the entitlement crew within an industry that is protected from free market competition doesn't see it. Kind of like the elite Obama crowd, who don't understand that debts must be paid off, and money must be earned, not simply printed, or borrowed.

 

[Anonymous]

My cell phone company gave me a free cell phone.

Now watch the guy call the poster "emotional," or out of his mind, now that the point he tried to make has been unequivocally proven FALSE.

 

[Anonymous]

You're doing better, only about 1/2 of that post was personal crap, the rest was an attempt to argue on substance. You're wrong, but you're still trying, which is better.

1) I am doing something about it, and I'm feeding my family too. There's no need for an entire industry to fight drug prices in the information age. I'm not leaving the country, I think foreign drug companies should be treated like foreigners, not people like me. The foreign drug companies and every foreign company should have to pay a fee to access our markets. It'd be a start at tackling the national debt.

2) Profit is not a bad word. Usury is, in the sense you mean. Banks should make a profit -- interest -- on their loans. Companies that create new things should make as much as the free market will bear. An example is the Snuggie -- the person that came up with that made millions! The people who make blankets, though, should not be entitled to 3,000% markups due to protection by phony government patents they extend through trickery and thus people either have to be cold or pony up the dough, unless they have a special buying program like "insurance" which covers their blankets.

(I know that analogy is over your head, so I'm ready for a lambast on #2)

3) Pharma is not the only industry where people expect things for free. There are "buy one get one free" deals out there ALL OVER THE PLACE. Many free market companies use tactics like that. Many free market companies give away promotional samples and free trial offers. You're just so caught up in the fantasy land of big pharma that you don't notice. (Or you're stupid as shit. Or both.)

4) Budesonide QD is available in Canada, for far less than it is in the USA. It's generic, remember? My arguments are based entirely on logic, it is your tactic to be emotional, because your side of the argument is the loser's.

People don't argue with you because you are a long winded bore who is fixated on his own socialist views.

Who wants to engage with a fanatic who wiki's most stuff and has no commercial perspective.

Go work for a non-profit. Which by the way, still needs to make money.

You just bore me. Nothing more, nothing less.

And what has budesonide QD got to do with your arguement? That product went generic and respules has all but vanished from the market place - as non-patent products do. We still make it, as all companies do who's products age. Eventually it'll disappear. It's business. All businesses are the same.

 

[Anonymous]

If our industry is so bad go to canada or mexico for your drugs. take twice a day triamcinalone vs once a day budesonide.

You're the one who brought up Budesonide.

 

[Anonymous]

http://www.guardian.co.uk/business/marketforceslive/2011/feb/04/astrazeneca-brilinta-delay?

AstraZeneca slips as Brilinta faces six month wait for possible US approval

More developments with AstraZeneca's blood thinning treatment Brilinta, but not necessarily positive ones.

In December the US Food and Drug Administration asked for more information on Brilinta rather than giving it immediate approval, dashing Astra's hopes of an early launch. The company intends Brilinta as a new blockbuster to make up for expiring patents on some of its current bestsellers such as Nexium and Seroquel.

Now the FDA has said it will decide whether to approve Brilinta on July 20 - it could have gone for a two month or six month review and in the end plumped for the longer period. The problem is that although a US panel voted in the drug's favour last July, concerns were raised over its efficacy in relation to US patients.

This means more delay in launching the drug, although Astra repeated it was confident in its submission.

The news has sent Astra's shares down 16.5p to 2946.5p, with analysts mixed on the implications. Navid Malik at Matrix said:

[This] is not a good sign in our view. It is likely that if approved in the US, Brilinta may have its label restricted against high-dose aspirin, which will limit its commercial opportunity and there may be a requirement for a further clinical study post-approval.

We still have $2bn of peak sales for Brilinta in our model; however, with the extended review for Brilinta following re-submission post the FDA complete response letter, we have doubts about the perception that the issues the FDA is dealing with are straightforward. We believe that given the high-dose aspirin explanation for the lack of efficacy with Brilinta US patients, the FDA has a tough task: it has to decide whether to approve a drug which cannot be used with aspirin at high dose, which is standard of care and best practice. This would suggest that the FDA has some more serious issues to contend with than the market is discounting.

We retain our reduce rating and a target price of £28.06.

Seymour Pierce also has a reduce rating on the shares. Analyst Mike Mitchell said:

Any possibility of market entry in the first half of 2011 (admittedly, not widely expected) has been removed. While our current expectation is that approval will ultimately be successful, the episode is a continued reminder of the slow and challenging regulatory hurdles present within the industry. AstraZeneca remains, in our view, an inadequately diversified business, exposed to the broader headwinds of the pharmaceutical industry.

But Shore Capital keeps its buy recommendation, with analyst Brian White saying:

Following on from the December complete response letter and the January 21 resubmission regarding the Brilinta new drug application, the FDA has provided a new action date of July 20. While there was a possibility that this could have been a Class 1 resubmission [that is, a two month review], we always felt that this was unlikely given the protracted nature of the FDA review process so far. It is worth noting that our revised forecasts in our recent research note we assumed a 12 month delay from our original expectation of a December launch.