Repatha Outcomes to be delayed further

[anonymous]

Now I am hearing that the outcomes are not expected to be publicly known until second semester of next year. Inside source got preliminary data that isn't telling a story we were hoping for. Not completely over, but it will take some analytical prowess to scrub the data and tell us specific patient types and levels that can possibly benefit. There is potentially some bad news for patients with too low of cholesterol level. Also, it doesn't appear to follow a consistent trajectory once the ldl levels drop below 70. Once this level is reached there is less benefit per ldl point dropped, and the lower it drops the less benefit there seems to be. A law of diminishing returns appears to rear its ugly head. Potentially bigger benefit in patients on lower statin dose and higher baselines. May not show to be great for everyone but I am hoping we find specific patient types to target. Fingers crossed!

 

[anonymous]

Now I am hearing that the outcomes are not expected to be publicly known until second semester of next year. Inside source got preliminary data that isn't telling a story we were hoping for. Not completely over, but it will take some analytical prowess to scrub the data and tell us specific patient types and levels that can possibly benefit. There is potentially some bad news for patients with too low of cholesterol level. Also, it doesn't appear to follow a consistent trajectory once the ldl levels drop below 70. Once this level is reached there is less benefit per ldl point dropped, and the lower it drops the less benefit there seems to be. A law of diminishing returns appears to rear its ugly head. Potentially bigger benefit in patients on lower statin dose and higher baselines. May not show to be great for everyone but I am hoping we find specific patient types to target. Fingers crossed!

Translation to impact on Amgen and the field:

• More subtypes means a small patient population and less revenue potential
  • To the field, this means: 1) Less need for a large field force given the cost/benefit when the number of patients drops 2) More patient types to memorize and convince doctors they need to identify. This will be challenging as we all know doctors are lazy 3) More PA requirements to prove that you are targeting the right patients.
• The LDL benefit wasn't going to be a linear curve where once you hit "0" LDL, patients would live forever. LDL is only one piece of cardiovascular health and a patient's overall health. This drug isn't going to protect you from eating cheeseburgers all day. While there will be some clinical benefit, it may only be moderate. And the price to make it cost-effective may very well be below what Amgen wants to price at. Don't expect payer requirements to ease up and especially not until the price drops and for another 2 years when contracts get renegotiated. Payers will take their time when the ball is in their court.
• If a patient has a high baseline, they would likely go to a higher statin before PCSK9s. If the reason the statin is low is because of tolerability, then PCSK9s would be appropriate and that's not too much different from today. Got prove side-effects of statins first and have it documented.
• Keep in mind Sanofi/Regeneron will report first (Q4 2016) and depending on the data, there may be a strong class effect. I mean we are suing them because it's basically the same drug so I would expect similar results for Repatha.

All of this means is that the peak sales of Repatha may be more like Prolia, a $1.5B dollar drug WW but $1.5-2.0B in 2025 not 2019-2020 meaning it won't impact the biosimilar encroachment of Neulasta/Neupogen/etc. It may be a blockbuster by definition of over a $1B in sales but that won't be until 7+ years after launch. Remember Gileads HCV drug did $10B US it's first year.

With Kyprolis having reduced revenue expectations and a longer than expected ramp to the lower peak sales, it means Amgen will likely be desperate to buy Kite Pharma if it's the first to launch. Amgen is desperate to be a leader in oncology and missed the big play in immuno-oncology since the BiTe bi-specific platform is commercially limited. Amgen will likely have more layoffs, and on it's way to being merged with another desperate pharma company. Bob Bradway will have his deal and exit parachute while the community inTO dissolves.

 

[anonymous]

So the Lower is better isn't completely true and Praluent's ability to dose titrate will have an advantage once this is proven correct. great! Amgen is so dumb.

 

[anonymous]

Now I am hearing that the outcomes are not expected to be publicly known until second semester of next year. Inside source got preliminary data that isn't telling a story we were hoping for. Not completely over, but it will take some analytical prowess to scrub the data and tell us specific patient types and levels that can possibly benefit. There is potentially some bad news for patients with too low of cholesterol level. Also, it doesn't appear to follow a consistent trajectory once the ldl levels drop below 70. Once this level is reached there is less benefit per ldl point dropped, and the lower it drops the less benefit there seems to be. A law of diminishing returns appears to rear its ugly head. Potentially bigger benefit in patients on lower statin dose and higher baselines. May not show to be great for everyone but I am hoping we find specific patient types to target. Fingers crossed!

This shows you that their is an optimal level of LDL. Too much is bad but too little is as well. Like most human processes, it's about balance and Praluent scientist understood this. Amgen was hoping the lower the better and it backfired. It's about hitting a goal and the failure of these outcomes shows where that optimal level is and what benefit you can get. Health is about the balance of all aspects and is limited by the bottleneck attribute. Once LDL hits 70, it's optimized and a patient should focus on other aspects for a wellness inprovement.

 

[anonymous]

This shows you that their is an optimal level of LDL. Too much is bad but too little is as well. Like most human processes, it's about balance and Praluent scientist understood this. Amgen was hoping the lower the better and it backfired. It's about hitting a goal and the failure of these outcomes shows where that optimal level is and what benefit you can get. Health is about the balance of all aspects and is limited by the bottleneck attribute. Once LDL hits 70, it's optimized and a patient should focus on other aspects for a wellness inprovement.

Who at Amgen will be accountable and be fired for this blunder?

 

[anonymous]

I wish the praluent reps would get off our thread. So annoying.

 

[anonymous]

I wish the praluent reps would get off our thread. So annoying.

Still drinking Mike Tuller's koolaid. They will be just as fucked too. But that doesn't change our fate.

 

[anonymous]

Amgen, Regeneron, and Sanofi reps will all suffer because all three teams had greedy incompetent management. The ride will be over for many. They will still needs reps but far less as this will be a niche drug. Sorry.

 

[anonymous]

Translation to impact on Amgen and the field:

• More subtypes means a small patient population and less revenue potential
  • To the field, this means: 1) Less need for a large field force given the cost/benefit when the number of patients drops 2) More patient types to memorize and convince doctors they need to identify. This will be challenging as we all know doctors are lazy 3) More PA requirements to prove that you are targeting the right patients.
• The LDL benefit wasn't going to be a linear curve where once you hit "0" LDL, patients would live forever. LDL is only one piece of cardiovascular health and a patient's overall health. This drug isn't going to protect you from eating cheeseburgers all day. While there will be some clinical benefit, it may only be moderate. And the price to make it cost-effective may very well be below what Amgen wants to price at. Don't expect payer requirements to ease up and especially not until the price drops and for another 2 years when contracts get renegotiated. Payers will take their time when the ball is in their court.
• If a patient has a high baseline, they would likely go to a higher statin before PCSK9s. If the reason the statin is low is because of tolerability, then PCSK9s would be appropriate and that's not too much different from today. Got prove side-effects of statins first and have it documented.
• Keep in mind Sanofi/Regeneron will report first (Q4 2016) and depending on the data, there may be a strong class effect. I mean we are suing them because it's basically the same drug so I would expect similar results for Repatha.

All of this means is that the peak sales of Repatha may be more like Prolia, a $1.5B dollar drug WW but $1.5-2.0B in 2025 not 2019-2020 meaning it won't impact the biosimilar encroachment of Neulasta/Neupogen/etc. It may be a blockbuster by definition of over a $1B in sales but that won't be until 7+ years after launch. Remember Gileads HCV drug did $10B US it's first year.

With Kyprolis having reduced revenue expectations and a longer than expected ramp to the lower peak sales, it means Amgen will likely be desperate to buy Kite Pharma if it's the first to launch. Amgen is desperate to be a leader in oncology and missed the big play in immuno-oncology since the BiTe bi-specific platform is commercially limited. Amgen will likely have more layoffs, and on it's way to being merged with another desperate pharma company. Bob Bradway will have his deal and exit parachute while the community inTO dissolves.

This poster speaks with great wisdom. This guy is not a field rep, rather someone who is the know. I would heed the warning. Consider this is final flare being shot from the one man raft floating helpless in middle of the Atlantic.

 

[anonymous]

Now it makes sense that a spokesperson for Amgen said that the potential sales of Repatha were being highly exaggerated by managed care companies. They probably do know the results and how limited in scope the "appropriate patient type" will be. Hopefully it won't be as restrictive as Corlanor PI. Might as well go hunting for wild rhinos in Jersey because they are just as rare as appropriate Corlanor patient. Might be time to polish the old resume. Not feeling the confidence on this one.

 

[anonymous]

Now it makes sense that a spokesperson for Amgen said that the potential sales of Repatha were being highly exaggerated by managed care companies. They probably do know the results and how limited in scope the "appropriate patient type" will be. Hopefully it won't be as restrictive as Corlanor PI. Might as well go hunting for wild rhinos in Jersey because they are just as rare as appropriate Corlanor patient. Might be time to polish the old resume. Not feeling the confidence on this one.

Best way to get access is to blame managed care for being too cautious....this will convince them to give Repatha full access. Don't bite the hand that feeds you.

 

[anonymous]

Now it makes sense that a spokesperson for Amgen said that the potential sales of Repatha were being highly exaggerated by managed care companies. They probably do know the results and how limited in scope the "appropriate patient type" will be. Hopefully it won't be as restrictive as Corlanor PI. Might as well go hunting for wild rhinos in Jersey because they are just as rare as appropriate Corlanor patient. Might be time to polish the old resume. Not feeling the confidence on this one.

Is Amgen calling all health plans liars who don't know how many potential patients they may have? I thought health plans when they pay for drugs and services that they know what the diagnosis and treatments are. I guess they just blindly write checks.

 

[anonymous]

Amgen will likely have more layoffs, and on it's way to being merged with another desperate pharma company. Bob Bradway will have his deal and exit parachute while the community in TO dissolves.

Amgen's office of the future and building consolidation serves two primary purposes.

1. It saves money and Amgen can use the sales of real estate for US cash, not the cash reserves we have that will be taxed when repatriated. It also helps our quarterly margin number for Wall Street reporting keeping our stock a float while revenue generation has been lower than expected.

2. Less buildings is in preparation for a sale of the company where Amgen will be the one shedding majority of the jobs. Think Wyeth losing more jobs than Pfizer when they merged. Both had huge cuts, but Wyeth suffered more.

Notice I didn't mention to be more collaborative. That's the excuse to justify the new office arrangement not the primary driver.

 

[anonymous]

Amgen's office of the future and building consolidation serves two primary purposes.

1. It saves money and Amgen can use the sales of real estate for US cash, not the cash reserves we have that will be taxed when repatriated. It also helps our quarterly margin number for Wall Street reporting keeping our stock a float while revenue generation has been lower than expected.

2. Less buildings is in preparation for a sale of the company where Amgen will be the one shedding majority of the jobs. Think Wyeth losing more jobs than Pfizer when they merged. Both had huge cuts, but Wyeth suffered more.

Notice I didn't mention to be more collaborative. That's the excuse to justify the new office arrangement not the primary driver.

Observe... Let's see if the 5th floor of Building 38 will be reconfigured as an "office of the future". Watch and wait to see if SVP and VP offices are consolidated to be "more collaborative". I think not.