I have read that they have applied (again?).
By the way, PTX did not run the original trials. That honor went to Purdue Pharma, which solid Zohydro to PTX recently, I believe. Purdue also sells OxyContin, which makes it a LOT of money.
PTX is a highly leveraged sales organization, essentially. Conversely, Kempharm is a research company with very low cash burn and something close to 105m cash on the books right now. The price of the stock is priced for complete and utter failure.
Finally, Zohydro is ER, not IR (extended/immediate release). The committee really applied the wrong test to Apadaz. It's much harder to beat overall liking scores when you are comparing IR to IR.
Finally, the IR market, especially for hydrocodone/acetaminophen, is really big. Hydrocodone/tylenol is the biggest sub-market out of all the painkillers today.
So let's say very conservatively that the company gets 2% of the market and makes $.50 per pill in income. In 2015 there were 5.9 billion pills prescribed. Let's say in 2017 there will be only 5 billion.
.02 * 5,000,000,000 * $0.50 = $50m. So we are talking half the current market cap yearly, and that is just for this one indication. I think this is extremely, extremely conservative.
The other opioid combos, as well as the ADHD market, will probably be huge, as well.
Achieving 2% of the market is very easy when state governments (and then the FDA) start taking IR pills without any abuse deterrence off the market. They could get maybe 30% of the market (though, will likely get less revenue)
If they get 25% of the market at $0.30 profit per pill (keeping in min, current pills cost maybe $1 on average -- guessing here, they are all different doses):
.25 * 5b * $.3 = $375 million. In this scenario, the company from just this product is worth maybe $1.875B. I think if you add up all the products in development (especially if they start making serious money in 2017 with accelerated development due more $), it could be closer to a $3-5B.
pbulljuan, can you tell me what specifically you are talking about here? Congress stepping in -- when and how?
Zyhydro ER was actually approved in 2013 (Wikipedia says 2014). I think the reason it does not have the abuse-deterrence label is that the guidelines for that were written in 2015, and FDA decided not to give the label.
No, it is exactly the same in terms of everything you mentioned.
The two differentiating characteristics are abuse-deterrent characteristics:
1) It's very difficult to extract pure hydrocodone from this.
2) It has a lower and less rapid high if snorted, and snorting side-effects are bigger.
Why do you think there is any news today? Just trying to see if this thing has any angle.
Finances are horrible and it failed a long and expensive trial last year.
It may be that beloranib slightly increases the odds and there is a mechanism that the researchers did not account for, which can explain the ratios in the non-PWS population. However, there are other explanations for the ratios seen in beloranib trials. For example, in the obese (mostly) women trial in Australia a few years ago, a number of patients from placebo dropped out (why keep taking a drug [placebo] that has no effect?). It may be that their thrombosis rates were not accounted for after they dropped out.
Regarding the PWS population, if you look at the Altum article, I calculate some potential odds in play here. First of all, I think it is very possible that the thrombosis rate is much, much, much higher than currently thought. There are many reasons why this is so (see Altum article).
Second, it may be that the observed sometimes very significant weight loss is exacerbating reports of thrombosis (because PWS patients have a larger tolerance for pain, which may increase as they become more overweight) or causing caregivers to place their children in more risky situations than they would have otherwise, such as extended-duration car rides.
Third, it has been posited that the rate of cancer in PWS patients is higher than the general population, and therefore beloranib may have a slight but meaningful effect on those patients. Combine it with all the other factors and you can begin to see a much more likely scenario than one the market currently assigns.
PWS patients will almost certainly be taking blood thinners here in the second (European/US trial) but it wouldn't be an issue for general pop, given current very light effects vs. placebo.
This happens quite frequently. Negative information that is "priced in" causes a stock to crash when news is re-iterated and confirmed. It's a troubling trend.
3 of those who said they were against were actually supportive of baby steps... in my opinion, the more substantive consideration is that the committee agreed that the nasal route of abuse is relevant in hydrocodone/acetaminophen. There is no doubt in my mind that the drug will be labeled as having abuse-deterrent properties.
Actually on the CC they said it was exactly as expected, but who knows what the HFTs think?
It specifically says that it is related to "tumour-associated endothelial cells". These are abnormal cells found in cancer patients.
Hard to say. Hedge fund short guys with HFTs are in control here. They destroyed the price from high 15s and crashed it five times in a row. This was $10 on Friday pre-market, then got crushed.
Chast01, top-right. There's a link to Elsevier. It costs, but some have found a way around that. Cough cough sci-hub cough.