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How pharmaceutical industry financial modelers think about rare diseases

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Re: How pharmaceutical industry financial modelers think about rare diseases

#131

Post by s1artibartfast »

refurb wrote: post #105
vibrio wrote: post #97

Earlier quoted context omitted.

I guess the concern is that paying a company not to challenge the patent(and start the 6 month clock if the patent is lost) is anti-competitive and collusive.

I can see how that could be the perception. However, if the generic company is certain they could successfully challenge the patent, they'd never enter into such an agreement because there is a far higher payoff to move forward with the patent challenge. It's the gray area cases that end up in pay for delay deals. The ones that neither party is sure they will win. So they cut their loses and negotiate middle ground w…

That depends entirely on how much they are paid to delay. A successful pay to delay settlement can be more profitable for the generic than entering the market. That is to say, it is more profitable to share revenue from a monopoly than race to the bottom.

A classic example is GSK and TEVA with Lamictal. GSK priced the original drug at $465/dose with $1.5 billion in sales. Teva's Generic was $14/dose. TEVA happily agreed to be paid by GSK because if TEVA had won in court, entered the market, and captured 100%, they would only bring in 50 million a year

https://www.fiercepharma.com/regulatory/more-scotus-fallout-...

Re: How pharmaceutical industry financial modelers think about rare diseases

#132

Post by fgonzag »

elliekelly wrote: post #126
cbhl wrote: post #40

Looking at these numbers, I wonder whether the FDA process is a bit too conservative with respect to safety. There were the articles yesterday about diabetics yesterday creating closed-loop feedback systems out of old insecure parts, because a FDA-certified alternative is decades out. I've heard also of folks joining studies for newer-and-better IUDs that are approved by European regulators, but need to be re-certifi…

Your comment reminded me of the (ridiculous but sadly necessary) "Sunscreen Innovation Act" passed a few years ago.[1] U.S. financial regulators often "vet" their equivalent foreign agencies and whitelist those whose processes are sufficiently analogous and in some cases allow US entities to rely upon the work done in those whitelisted jurisdictions. I've always wondered why the FDA can't work out a similar system. I…

I agree, safety is very important but so is actually getting the drugs to people at prices they can afford. Perfect drugs are still useless if no one can buy them.

An international certification, recognized by all the major countries, could work very well

Re: How pharmaceutical industry financial modelers think about rare diseases

#133

Post by phkahler »

Balgair wrote: post #92
dralley wrote: post #81

Earlier quoted context omitted.

>For example they switched him to a ketogenic diet back when this was just starting to show results for cancer I'm curious as to how this would have an impact. Is there any research demonstrating that keto slows the development of cancer? Or hypotheses on why that would be the case?

Though it's incredibly dependent on the type of cancer, it's history, it's environment, and it's genome, it is related to the metabolic pathway that you shut off. This is known as the Warberg Effect [0]. Essentially, for some reason, some cancers will start eating only via glycolysis and not via oxidative phosphorylation. Glycolysis requires glucose (sugars, like carbohydrates), so if you just stop eating foods that…

But if you've been handed a death sentence, why NOT try a keto diet? That's a rhetorical question btw of course the is no reason not to try it.

Re: How pharmaceutical industry financial modelers think about rare diseases

#134

Post by jonlucc »

modzu wrote: post #123
jonlucc wrote: post #66

Earlier quoted context omitted.

I still don't understand why it's bad for society? It seems like this is a common point that implies something, but I can't figure out what that thing is.

well in the context of developing drugs that cure disease (esp rare ones), pharma says its so expensive to do, it costs billions to develop a drug. but if in fact it "costs" billions to "market" a drug then is that the same thing? i dont have a strong opinion on this

I'm not super familiar with the numbers, but I believe the "billions to develop" number is a development number, if a little juiced. I think they take the total amount of R&D spend and divide it by the number of drug launches for a given period of time. So it's a good idea of how much money you have to spend to get a new launch, but it is higher than the cost of a single project, the majority of which are terminated before launch (many well before clinical trials).

After you spend a couple billion per launch to make a new drug, then you spend another couple billion on marketing. Again, I could be mistaken, but I'm pretty sure that's the position of pharma.

Re: How pharmaceutical industry financial modelers think about rare diseases

#136

Post by Balgair »

phkahler wrote: post #133
Balgair wrote: post #92

Earlier quoted context omitted.

Though it's incredibly dependent on the type of cancer, it's history, it's environment, and it's genome, it is related to the metabolic pathway that you shut off. This is known as the Warberg Effect [0]. Essentially, for some reason, some cancers will start eating only via glycolysis and not via oxidative phosphorylation. Glycolysis requires glucose (sugars, like carbohydrates), so if you just stop eating foods that…

But if you've been handed a death sentence, why NOT try a keto diet? That's a rhetorical question btw of course the is no reason not to try it.

Each cancer is unique to the organism. Not all cancers are death sentences. Nearly every sunburn you or I have had has been cancerous to some degree; the inflammation and reddening are your body fighting those cancers (among many other issues). Some cancers can be benign, some can be handled quite easily, some can be treated in other ways. Again, each is unique.

The data on Ketogenic diets and cancer are showing a lot of promise, but you should follow the advice of you oncologist/s. They have dedicated some portion of their lives to helping you out with your cancer. You do not want to end up in a situation where you have convinced yourself that kale is better than chemo. Again, each cancer is unique though.

Re: How pharmaceutical industry financial modelers think about rare diseases

#137

Post by cperciva »

Balgair wrote: post #92
dralley wrote: post #81

Earlier quoted context omitted.

>For example they switched him to a ketogenic diet back when this was just starting to show results for cancer I'm curious as to how this would have an impact. Is there any research demonstrating that keto slows the development of cancer? Or hypotheses on why that would be the case?

Though it's incredibly dependent on the type of cancer, it's history, it's environment, and it's genome, it is related to the metabolic pathway that you shut off. This is known as the Warberg Effect [0]. Essentially, for some reason, some cancers will start eating only via glycolysis and not via oxidative phosphorylation. Glycolysis requires glucose (sugars, like carbohydrates), so if you just stop eating foods that…

Cancer isn't something like measles, each one is super specific to the organism and evolves over time.

My preferred phrasing of this is "Cancer is a symptom, not a disease".

Re: How pharmaceutical industry financial modelers think about rare diseases

#138

Post by refurb »

elliekelly wrote: post #126
cbhl wrote: post #40

Looking at these numbers, I wonder whether the FDA process is a bit too conservative with respect to safety. There were the articles yesterday about diabetics yesterday creating closed-loop feedback systems out of old insecure parts, because a FDA-certified alternative is decades out. I've heard also of folks joining studies for newer-and-better IUDs that are approved by European regulators, but need to be re-certifi…

Your comment reminded me of the (ridiculous but sadly necessary) "Sunscreen Innovation Act" passed a few years ago.[1] U.S. financial regulators often "vet" their equivalent foreign agencies and whitelist those whose processes are sufficiently analogous and in some cases allow US entities to rely upon the work done in those whitelisted jurisdictions. I've always wondered why the FDA can't work out a similar system. I…

I've always wondered why the FDA can't work out a similar system. If the EU has approved a drug and done all of the studies and asked all of the questions surely we don't need to do all of the same studies and ask all of the same questions just so we can approve the drug a decade later.

The reason is thalidomide. The US was one of the few countries that chose not to approve it despite other countries doing so. Saved a lot of US children from birth defects.

Re: How pharmaceutical industry financial modelers think about rare diseases

#139

Post by refurb »

s1artibartfast wrote: post #131
refurb wrote: post #105

Earlier quoted context omitted.

I can see how that could be the perception. However, if the generic company is certain they could successfully challenge the patent, they'd never enter into such an agreement because there is a far higher payoff to move forward with the patent challenge. It's the gray area cases that end up in pay for delay deals. The ones that neither party is sure they will win. So they cut their loses and negotiate middle ground w…

That depends entirely on how much they are paid to delay. A successful pay to delay settlement can be more profitable for the generic than entering the market. That is to say, it is more profitable to share revenue from a monopoly than race to the bottom. A classic example is GSK and TEVA with Lamictal. GSK priced the original drug at $465/dose with $1.5 billion in sales. Teva's Generic was $14/dose. TEVA happily agr…

Do you have another source? The one you shared is light on details.

I'm not sure why TEVA would price at $14/dose at launch - most exclusive generics price at ~95% of the branded therapy, then drop once other generic entries happen. If the TEVA generic were to capture 50% of the market over 6 months, that's $600M+ in revenue, not $50M.

Re: How pharmaceutical industry financial modelers think about rare diseases

#140

Post by iandanforth »

DoreenMichele wrote: post #127
iandanforth wrote: post #67

This is a well researched, informative and infuriating article. Within the system I cannot think of a better or more determined approach to this problem, but as this is HN I need to lay out a few points. As we mint more billionaires they are going to do an end-run around the FDA. If I were a billionaire there is no way in hell I'd wait for a standard drug trial to progress on an FDA timeline. Eventually one or more o…

Ordinary joes are already finding loopholes in the medical system, such as this article from yesterday about the popularity of old insulin pumps with an exploitable security flaw: https://news.ycombinator.com/item?id=19781118 Eventually one or more of the ultra wealthy is going to survive a disease that government sanctioned healthcare says is incurable. I knew a woman who used chelation to resolve issues in a child…

You may be right but now I want to hear your story!
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