As I understand it, the drug doesn't do anything by itself, but it helps Taxanes do better. In that case, the company's ability to price this drug and control the revenue may be limited.
I understand that a research report pegged the peak revenue at 130 million. That's not very much for a cancer therapy drug.
A company with promising cancer treatment entering phase III may command 250 million typically. But, that's because the potential reward is 10 times higher than this drug.
With the potential reward being 1/10th of the typical cancer therapy, why should this company be valued on similar basis?
Unless I'm missing something, the stock seems overvalued.
You're not an onco doctor, you don't know squat. This drug can be used with maybe six different CA's. Also, already has some data as a stand alone drug that was good. But no one in their right mind would miss a chance of beating CA by using only one med when two or three would do so much better. If I were shorty I'd think about the market in general beind down big and this stock up BIG when that happened. The sell-off on Tuesday looks more and more like profit taking. If that Sat CC hits the ball out of the park shorty will be vaporized. t
I think they hit the ball out of the park in December.
Meadian overall survival 27.5 mths versus 16.9 months....OGX reduced serum clusterin and OS appears superior with DOC/OGX
It's still early in understanding on how to most effectively use OGX-011. Much more to come.
Thanks for the info.
I'm still suspicious of data coming out of Phase II. Those trials are designed to test safety more than efficacy. Any result shown then is suspect. I can't remember how many times a drug looked so good in Phase II only to fail miserably in Phase III.
I guess that makes sense. Why would any company plunk down hundreds of millions of dollars required to do a Phase III on a not-so-good-looking drug?
Phase III's are designed to show efficacy, so results coming out of those are much more rigorously analyzed.
Variable analysis brought down p value to 0.04. That's suspicious as well. Efficacy data coming out of phase II are cosmetically enhanced by the statisticians, because it's not supposed to look at the efficacy anyway (from the FDA's point of view), but it helps biotechs raise capital...
DNDN on the other hand did Phase IIIs. Those get carefully designed to eliminate statistical shenanigans.
I mean, the analysts were very unimpressed with DNDN even with Phase III data showing survival advantage before IMPACT.
Survival is one of the endpoints. That did well enough in that area that the FDA last August after an interim analysis of the data agreed to grant a fast track designation for both survival and pain palliation (it does a good job relieving the horrible pain in this patient population). Last Nov/December Onco reported on the 30 month mark of the trial. The data to be presented this weekend takes us up thru April (36 months).
In pharmacology, adjuvants are drugs that have few or no pharmacological effects by themselves, but may increase the efficacy or potency of other drugs when given at the same time.
This is more in the class of a miracle.
Cancer therpaies and radiation are toxic for the body. One of the bodies self defense mechanism to the toxic attack on the body is to produce clusterin. Increased levels of clusterin protect the cancer cells from the toxic attack. The result is a cancer resistant to chemo & radiation via the overproduction of clusterin by the body.
OGX-011 inhibits the production of clusterin by up to 90%. The resulting lower level of clusterin opens the gates for chemo & radiation to again attack the cancer cells.
OGX-011 lowers clusterin production. It has no direct effect on cancerous cells.
"""""As I understand it, the drug doesn't do anything by itself, but it helps Taxanes do better. In that case, the company's ability to price this drug and control the revenue may be limited."""""
You are correct. Avastin, Erbitux and for the most part Tarceva are never used alone either.
Not bad company if you ask me.....
There is a difference between OGXI's drug and Avastin, Erbitux, etc. They do get used in combination, but most of the cancer drugs are used in combination because there is no cure. Everything gets thrown at the cancer at some point (except if the drugs are in the same class--chemos to chemos and mabs to mabs, etc.)
What is meant by 'adjuvant' is that it has no independent mechanism of action.
OGXI's drug helps to inhibit clusterin which makes Taxanes work better.
The definition of adjuvant is:
Adjuvants are pharmacological or immunological agents that modify the effect of other agents (e.g., drugs, vaccines) while having few if any direct effects when given by themselves
Avastin, Erbitux, Taxanes, Abiraterone, they all work on their own in the absence of other drugs. They are NOT adjuvants.
But, they get thrown at the cancer in combination, because not one of them is a cure.
Adjuvant is a different class by itself. It has no value on it's own. It's tied to Taxanes. It helps Taxanes work a little better. That's entirely different class of drugs...
The Cougar Biotech lead drug (acquired by J&J) also works in combinaation with taxotere. It showed no survivor benefit, but lowered the PSA and tumor size. Its for the same patient population (i.e. HRPC). A morgan stanley analyst pegged U.S. sales at over $500 million. That put Cougar at about 2x projected annual sales. That was about what J&J paid.
What is very appealing about Onco is their lead drug (OgX-011) is showing a substantial survior advantage. If that continues to hold up (final mature results to be presented May 30) then these guys will have some pricing leverage. And there is a huge need for a drug that can make taxotere more effective for hormone refractory prostate cancer patients. That is why I think the FDA has granted the drug fast track designation.
Also we have not talked about ROW and other indications (small cell lung cancer Phase II trial is looking strong on the survivor angle).
The second point is even if thinks the 130 million sales number is all they will get, given that Onco has so few outstanding shares, it is still undervalued.
It is not true Abiraterone is an adjuvant. It is a hormone therapy, and it has independent mechanism of action.
For OGXI, the median survival advantage was observed in a phase II setting with statistical significance. The median is a noisy data point. It's hard to tell what the final result will be.
And, the discussion of us vs. row, this sort of thing is already taken into account in valuing a company.
For example, DNDN has the US estimated peak revenue at 2 billion. ROW and other drugs in the pipeline are arguably more valuable than OGXI's, because DNDN has opened up a new line of treatment (immunotherapy is new). This means, their drug will be used in combination with other types of drugs (like chemo class).
DNDN is valued around 2 Billion which is equal to their estimated peak value. Currently, OGXI is valued around their estimated peak value as well.
But, DNDN has finished Phase III (in fact, it has three phase III studies). One of the finished Phase III is large (with 512), achieved statistical significance on survival advantage. The other two has only achieved stat. sig. on retrospective analysis--but still valuable considering the FDA likes to see two phase III that are meaningful.
OGXI on the other hand has just finished one phase II. Their final result on Phase III won't be out for a few years at least. And, who knows what the result will be? Even with good drugs, the trial design and expertise needed to get it through the FDA is very tough.
I believe only 11% make it through to the end.
So, given all those risks, why should OGXI be valued in a similar way as DNDN, given their differences in where they are in the drug development stage? Also, DNDN has opened up a new line of treatment with PC, whereas OGXI's drug is an adjuvant to Taxanes.
So, where is this being valued like this?
The peak revenue estimate was just in the U.S. and just for one indication. The global numbers for several indications will be much, much higher. Also, the company has more than one drug in the pipeline.