Hot off the press "the pill wins the PCSK9 battle"

It's over Regeneron & Amgen
You are doomed
If you don't believe me, google it up !

 

Summary


The real winner might just be Esperion after it gets its oral product approved eventually.

The stock soared after this announcement.
curtains for Regeneron !

 

Well this is obvious. When pfizers pill is approved, the injectables are completely done. No patient will choose an injectable over a pill. I didn't know this existed until I started asking advice from some of my cardiologists and they advised me not to take the Regeneron job and all they talked about is on the pill. No one wants to deal with reimbursement issues with the injectables. This is not the job you want to take. Sorry, but it is true.

 

Exactly, I learned about the oral shortly after researching the class and after I said I would fly to Dallas. Let's just say, that I was not motivated to get this job and of course I didnt. Just look at the MS class of drugs, no one wants to inject once the orals were approved.

 

I have sold injectables vs pills in other therapeutic areas. Drs will turn their heads to better efficacy or safety data of an injectable for the convenience of a pill. It's easier on them and their staff and most importantly the patients. This gig at Regeneron has a short life. Better make it a stellar launch, folks !

 

Chill. Esperion's oral is years away and provides about a 25% additional decrease in LDL. Good stuff, but not earth shattering.

 

Complete bullshit. Just look at Otezla. Shitty launch and can't take down the many injectables it competes with. Just proves you weren't the right salesperson for the job.

 

BS - OTEZLA DATA SUCKS

 

When will the first oral PCSK9 inhibitor be approved?

 

the orals that have entered the rheumatology market have barely made a dent. you have to have superior efficacy to shake up a market regardless of any perceived delivery system advantage.

 

You're out of your mind and you are seriously trying to fool yourself. Pure logic dictates that if the Orals weren't going to dominate the market than the pharmaceutical powerhouses working on them wouldnt. Speaking from several years of injectable experience, the Orals will take the majority of the market in this case. No question. Both Regeneron and Amgen will only enjoy a brief time in this market.

 

Shit, all you have to do is start talking to the physicians. They are waiting for the pill and will completely favor the pill.

 

True statement about the RHU market. I was in it for years. One BIG difference: The biologics market in RHU started as Self-injectables and Infusable products; Enbrel, Remicade, Humira, etc. They created a "standard of care" and now what is a long standing "habit" of going to a TNF inhibitor soon after MTX alone. Self injection and infusion became the established path to remission The BIG difference here is that the cholesterol market has been a pill or "small molecule" market for years and years and years. PILLS are the standard of care. PCSK9 inhibition is for sure a major breakthrough mechanism, but I too, am struggling with trying to envision a market with an asymptomatic disease where you are going to ask a patient to self inject QOW or even Weekly (in some patients). The SI PCSK9 inibitors will see disappointing uptake and only be used in real pill non responders. When a decent pill gets approved, the market will embrace the PCSK9 promise a lot more.

 

That is very well said.

 

Thanks for that! I signed up but am beginning to think I jumped the gun. I know people who take statins for cholesterol (who doesn't) and the feedback is consistent, they are not very compliant with taking it every day. I originally thought that an every other week injection made sense but am having second thoughts now. Too late to turn back now that I am in the new show and I hope you and I are both wrong. We'll see.

 

Well said. It's true that everything in cardiology is PO. It may be very difficult to change that paradigm to get patients to go to an injectable.

 

Thanks for the kind words. One other factor: the self injectable paradigm does not create a revenue opportunity for the docs. Unlike some "subq" or IM drugs, the office can not administer this and make a profit on its delivery. That doesn't help for 2 reasons: The first was already mention: no financial incentive. The second: when an office gives an injection they can easily monitor compliance; the patient either showed up and got it or they didn't. With self-injectables, the office can not monitor that (at least not effectively) So it becomes a double edged sword: on one hand they only have to inject QOW; on the other if they miss a dose and don't dose again until the next 2 weeks they have missed a month's therapy. If I'm a cardiologist, I'm trying to think through that. Miss a day? They miss a day's therapy and can take it the next day. Miss a QOW? will they do it the next day? day after that? two weeks later? Who knows. Only one thing is for sure in my experience with these self injectables and that, ironically, is uncertainty. No one knows how this will play out. If this was a symptomatic disease, I would be seeing it differently. I know that both companies will have ALL KINDS of patient education and retention and compliance support programs. You need look no further than the Enbrel and Humira experience for that. Once those patients got through the symptomatic period (usually 3 months) the compliance rates dropped significantly, even with all the patient ed and retention support. I'm droning sorry. Take care

 

Even the statins (PO) do not have good compliance rates.

 

Exactly! The statins are PO and are like taking blood pressure meds. You are treating a condition that has no symptoms and where the med can make you actually feel worse. Most people are not compliant (meaning they take it EVERY day) A QOW injection will either improve or worsen this. We wont know until the drugs are out there. Based on current patient behavior in other self injectable, asymptomatic diseases (RA, PSA, Psoriasis, again, once the patients are asymptomatic after 3 months) the history is that they take it at about a 75% rate. The patient education strategy will be nearly identical: "Continue to take your Enbrel,Humira etc. once the symptoms go away b/c your disease is not cured only suspended". In the PCSK9 area it will be "Lowering your cholesterol has all these related cardio vascular benefits and outcomes and you need to take this as prescribed, even though you don't feel bad. We'll soon see