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INCY:
Not too surprised. I think there are two pieces of "uncertainty" hanging around the company:
1) The (imo) false uncertainty that after one year of treatment, the drug is no different than the standard of care in treating MF patients. This is the worry that was kicked off by the NEJM letter.
2) The (imo) real uncertainty centers around sales expectations and the size of the addressable market. Analysts are usually able to say "well, drug X sells this much in indication Y" and make extrapolations for new drugs for indication Y. For MF, they really have no reference point whatsoever.
OT:
Holy brutal name Batman.
OT:
For a variety of reasons, I stand to increase my charitable donations in the upcoming year. Since there are a variety of deserving organizations that I'm likely not aware of, I'm hoping to crowd-source some good ideas. If you know of a worthwhile small and/or local charity, please send me a PM so that I can check them out.
Please, no pointers to American Heart, American Cancer, etc...
Thanks
INCY:
The "survival issue" was just a lazy piece of retrospective database analysis.
I wish. I'd take that immediately.
ONXX:
OT:
Re: INCY
Friedman is a bit of a blowhard, but nonetheless here is my quick transcript of his comments regarding the recent letter in the NEJM:
""there are some pretty squirrely letters in the nejm … we know the data in that "screed" and the fda knows it. We've analyzed that data upside and down… we will show you all the data and you'll see it supports ruxolitinib. Won't talk about it in the middle of the NDA review. Top line points: it shows that if you don't keep your patients on the drug, their symptoms will come back and spleens begin to grow again. We'll show you how many came off when and it'll be an eye-opening result. Secondly, if you don't give enough drug, you won't get a maximally effective response. Thirdly, if you did not keep your patients on drug for a decent length of time, and then you used them as subjects for a survival curve, the results are fairly meaningless. Lastly, wrt the 5 sick patients who were hospitalized when they stopped drug, you can find several of them in the appendix to the nejm paper (where they were also authors)… we took those cases very seriously when we designed phase 3 and looked closely at possibility of a withdrawal syndrome. We found not a whiff of evidence for withdrawal syndrome in the phase 3 trials. "
fwiw... obviously he's going to defend his drug.
It's an absorbance reading, so it'll be milli.
Carfilzomib:
I don't disagree that there is a risk here and am accordingly prepared. The one small fact that gives me comfort is that the FDA is very familiar with accelerated approval in myeloma. Their strategy in this indication has worked really well for them in the past, so I think there is an intangible that works in ONXX's favour.
At the same time, I have to shake my head at Weber's biggest red flag: The Trial Also Enrolled Patients Who Were Intolerant of Velcade, But Did Not Truly Fail.
Well, technically yes, if you can't tolerate Velcade, did not take it, and moved onto carfilzomib, you're not Velcade refractory. But is this really relevant? As far as I'm concerned, patients refractory to Velcade are just as eligible, clinically, for carfilzomib as patients who can't take / tolerate Velcade.
Dumb point by Weber.
ONXX / Bayer:
Looks like ONXX didn't get completely cut out of the fluoro-sorafenib prospects. A Bloomberg article says "Bayer will pay Onyx a 20 percent royalty on worldwide sales of regorafenib for use in oncology; Bayer also will pay Onyx $160 million for the Japanese royalty rights for Nexavar, a liver-cancer treatment, according to the filing."
So as part of the settlement, it looks like the Nexavar agreement was tweaked a bit.
Onyx Pharmaceuticals and Bayer HealthCare Restructure Global Oncology Partnership
Settlement in Litigation Reached
San Francisco, CA, USA, October 12, 2011 – Today Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) and Bayer HealthCare restructured their partnership for the global development and marketing of Nexavar® (sorafenib) tablets and entered into a new agreement related to regorafenib, a late-stage oncology compound.
Under the terms of the agreements, regorafenib is a Bayer compound, and Bayer will have the final decision-making authority for global development and commercialization. Onyx will receive a royalty on any future global net sales of regorafenib in oncology. In addition, Bayer will contract the Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the United States.
The status of Nexavar under the revised Collaboration Agreement remains largely unchanged. Onyx and Bayer are free to use their respective Nexavar sales forces to promote regorafenib and additional products outside of the collaboration in the future. Bayer will purchase Onyx’s royalty rights for sales of the product in Japan in exchange for a one-time payment to Onyx. Bayer will have no obligation to pay Nexavar royalties to Onyx on Japanese sales after December 31, 2011. Further, in the event of a change of control or acquisition of Onyx, the current profit-sharing, co-development and U.S. co-promotion of Nexavar will be preserved.
“These new agreements strengthen the collaboration and provide Onyx the opportunity to participate significantly in the market potential of regorafenib,” said N. Anthony Coles, M.D., President and Chief Executive Officer of Onyx Pharmaceuticals. “Together we are taking our collaboration to the next level by more effectively structuring our future working relationship. Onyx and Bayer are committed to benefitting patients worldwide and ensuring that the potential of both Nexavar and regorafenib is fully realized.”
"These agreements set the stage for the next chapter in our successful partnership,” said Dr. Joerg Reinhardt, Chairman of the Bayer HealthCare Executive Committee. “Innovation is central to Bayer's mission 'Science for a Better Life,' and our ongoing collaboration with Onyx demonstrates the priority we place on working with partners to identify, develop and commercialize new medicines to meet unmet or under-served medical needs."
These agreements also settle and dismiss all claims related to the complaint filed by Onyx against Bayer Corporation and Bayer A.G. in the U.S. District Court (Case No. CV09-2145 MHP).
DNDN:
If the tidbit about them considering an acquisition is true, then what does that say about their "platform"?
Whatever happened to Neuvenge? Why haven't they been able to move any new antigen into the clinic?
I clearly have a bias here, but actions speak louder than words. I really think they lucked out with Provenge, and they know that it doesn't work they way they advertise it to work... and hence they're not exactly desperate to follow up on the platform.
That's my take. From a perpetual DNDN-bear.
OT:
I don't want to clutter the thread with too much rambling about apple, but I do think you're being a bit obtuse in regards to this topic.
Yes, you may have a Rio MP3 player, and Sony may still make an MP3 player, but really? iPod is now synonymous with MP3 player... people don't ask if you have an MP3 player, they ask if you have an iPod. And if it was mostly marketing, then Apple would have been sunk 6 months after releasing the first iPod* because, as you state, neither was it first on the market, nor was it cheap in any way was extremely expensive ($400).
I think you're confusing the establishment of a market with real innovation and exploitation of the market.
Re the iPad: "provides nothing new and actually does a lot less than what they can do on their phone and laptop."
This encapsulates what Jobs understood about technology and what tech nerds (I'm one) didn't at first. People don't care if a product *can* do more or less than another; people care if the product does the things they want while doing it well. Jobs took the hardware discussion away from processors and ram to an all-in-one consideration of form and function. There is a reason why the tablet competitors still trail the iPad... the majority of customers don't care if the tablet has a better or worse processor, but rather they care if the UI is smooth, intuitive, consistent, functional.
And yes, you may have had a smartphone starting 10 years ago (and perhaps earlier). But take the latest smartphone offering from that manufacturer who made your first smartphone and compare it to the iPhone 4S today. Which one wins?
* This does happen. See RIM and the Playbook for one example.
RIP Jobs.
If i remember correctly it was an antisense against PKC.
edit: sorry, now i read that it was answered... I just replied without reading ahead.
OT:
Looks like Steve Jobs' health has taken a turn for the much worse... he just resigned as CEO.
Seriously, you guys need jobs or hobbies or something.
From never-ending job postings to circular arguments about the stock price, this board has become pretty much impossible to read.
RNAi
If you want to invest in this field, your best bet is to buy one of the companies like Invitrogen / Life Sciences as they serve the academic community for these reagents.
Otherwise, it doesn't look like this stuff is going to be successful clinically. Companies are moving away from these technologies.
OT:
OT:
OT:
Why should the Fed care to game the market??? How does that actually help the economy?
Here's my way-out-there suggestion of last last last resort: The Fed should just buy up to $250,000 of anyone's outstanding mortgage and refinance it at the prevailing interest rate offered to banks (ie. near zero).
If this recession is being caused by reduced demand due to balance sheet hardship for families, this will definitely increase demand.
I realize it's grossly unfair to those of us without mortgages, but I think that if you really want to do something to help the US economy, this is it. Trying to magically entice companies to invest when there is no demand is obviously not the way to go. For a change, help out the little guy and see what happens.
OT:
Yes, I read that. However, the following isn't very informative for me:
5-10% Stocks (nongolds).
15-20% Commodities: via futures, commodity stocks &/or physical assets.
Which stocks and commodity stocks are you talking about? It's a big market.
OT:
ML got specific with what he did.
If you have a suggestion, then I think we'd all appreciate it if you got specific.
OT:
Sold some JPM Aug 34 puts and have been picking up small lots of some bios.
The bravery or stupidity of this move will be revealed later