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The question is nonsensical. Beyond the milestone payments, Ariad receives tiered double digit royalties on sales of Ridaforolimus...period, end of discussion. If you have further questions on this matter, I suggest you review the company's filings regarding this matter:
"Merck will book global sales of ridaforolimus and pay ARIAD tiered double-digit royalties on global net sales of ridaforolimus. In addition to now receiving royalties on U.S. sales in lieu of a profit split, these global royalty rates are approximately one-third greater than the royalty rates that ARIAD would have received for ex-U.S. sales under the original collaboration agreement with Merck."
Phase IB Study of the mTOR Inhibitor Ridaforolimus With Capecitabine (Published September 20, 2010)
mTOR and ERK signaling was inhibited in proliferating endothelial cells and was more pronounced at the RD with the larger amount of ridaforolimus.
10 of 29 evaluable patients had stable disease for => 6 months
Conclusion Good tolerability, feasibility of prolonged treatment, antitumor activity, and favorable pharmacologic profile support further investigation of this combination.
http://jco.ascopubs.org/content/early/2010/09/17/JCO.2009.27.5867.abstract
BW,
I haven't been posting as much simply because my position is set and I'm waiting for the ponatinib trial to start, the rida final analysis, and an update on the endometrial trial.
fwiw, I like the ponatinib trial design. Since it's so unique, I would think the FDA had input. imho, it sure seems like the T315I mutation arm was structured in such a way as to allow the for quick approval if the results warrant while allowing the remaining patient groups to continue in the trial.
Last year Lundbeck received FDA approval of Sabril (vigabatrin)for the treatment of infantile spasms. It's still way too early to know but if CPP-115 turns out to have a better safety profile, which would you want your child to have? At some point I would think that Lundbeck would consider acquiring Catalyst in order to protect its own vigabatrin franchise.
CPP-115 Granted Orphan-Drug Designation
"Orphan-drug designation for the treatment of infantile spasms is an important milestone in the development of CPP-115," said Patrick McEnany, Catalyst's Chief Executive Officer. "Currently, there are limited choices available for treating this serious pediatric disease, all of which have significant side effects. We hope to offer providers and their patients a more effective and safer therapy than is currently available."
Catalyst is currently conducting a number of non-clinical safety and efficacy studies with CPP-115 to support various indications and expects to file an IND with respect to CPP-115 in the first half of 2011.
Sure, off the top of my head I can't think of another CML trial that separated pts into multiple cohorts based on disease phase and mutation status. Don't get me wrong, I like this design as it may reduce the risk in terms of gaining approval in one or more cohorts as opposed to the all or none that is more typical in registration trials. Furthermore, I found the use of different endpoints for each of the cohorts somewhat unique and in line with the idea that this lessens the trial risk. (btw, hats off to rkrw, biomaven et al who made the right call on the SPA not being necessary)
I don't know how the market will react but for me this announcement provides a solid road map to eventual approval.
ARIAD anticipates that it will be able to submit data from this single-arm trial with six months of follow-up response data.
ARIAD Announces Initiation of Ponatinib (AP24534) Pivotal Trial
Interesting trial design:
"The PACE trial is a global, single-arm clinical study of oral ponatinib in 320 patients with chronic phase, accelerated phase, or blast phase CML, as well as Ph+ ALL. Patients resistant or intolerant to dasatinib (Sprycel®) or nilotinib (Tasigna®), or with T315I mutation of BCR-ABL, will be enrolled in the trial. Patients will be grouped into one of six separate cohorts based on their phase of CML (i.e., chronic, accelerated or blast) and BCR-ABL mutation status (i.e., with or without the T315I mutation); Ph+ ALL patients will be grouped with blast phase CML. A total of 160 patients with chronic phase CML will be included. The primary endpoints are major cytogenetic response rate for chronic phase patients and major hematologic response rate for accelerated or blast phase CML patients and Ph+ ALL patients. Secondary endpoints in the trial include major molecular response rate, duration of response, progression-free survival, and overall survival."
ARIAD anticipates that it will be able to submit data from this single-arm trial with six months of follow-up response data.
http://finance.yahoo.com/news/ARIAD-Announces-Initiation-of-bw-1856153256.html?x=0&.v=1
I'm not expecting a partnership announcement this soon and a CC to just discuss the start of the 534 trial would be underwhelming so, I too, am hoping that we get an SPA tomorrow. Even though the CML approval path is well known, I'd think ariad would want the added security of identifying expectations in advance given the P2 is their pivotal, registration trial.
fyi, the FDA granted Gleevec a priority review and approved the drug after only a 2 ½-month review time which, I believe, set a record for the fastest approval to market of any cancer treatment.
fwiw, I also agree with rkrw. if the trial was targeting just pts with the T315I mutation then I think approval could come very quickly; however, the trial will likely enroll pts who have failed two prior tki's and as such will likely need to demonstrate that the response is durable.
Quiz Answer: Former US AstraZeneca CEO Lars Bildman?
hey surf, just noticed you moderated this board too. I've bought and sold CPRX a couple of times this year. I've been out of the stock since April but just got back in again. It's a low cap/low float stock which moves fast on news. You've got to be early and patient but so far the reward has been worth it...looking for upcoming CPP-115 news to confirm safety over vigabatrin and also start of CPP-109 trial to push stock higher.
According to your post you claim to know "how it works." Well, despite your belief to the contrary, no institutional client is going to call up a MM and try to jam through a 1.3mm share trade at the close for the simple reason that they know they wouldn't get very good execution. No, in reality, the MM would be given an order so the seller could get the best execution/price. Furthermore, even if someone was stupid enough to do what you are suggesting the MM would have immediately hedged their position with options...which didn't happen yesterday.
Do you understand this? I hope this wasn't too much for you, but, this is how it works.....
A MM took a $4.5 mm position, out of the blue, in August, in a volatile market, without backing up the price. So, that's what you think actually happened. Give me break.
So what. Year to date ARIA +46.25%, BTK +13.7%. Do the math.
Be realistic, if a MM was stuffed with 1.3mm shares in a tough market, with little liquidity, then don't you think they would have backed up the price just a tad.
We've simply been range trading for weeks - bouncing off the 50 DMA support (3.17)waiting for news on the 534 trial and/or partnership and the rida results. geesh.
Wedbush says Medicare decision positive for ventricular device makers
In a note to investors, Wedbush analysts Dr. Duane Nash and Akiva Felt wrote that weakness in providers of left ventricular assist devices - including Thoratec (THOR), HeartWare (HTWR), and WorldHeart (WHRT) - could create an attractive entry point for investors.
Wedbush notes that the CMS said last night it is not expanding left ventricular assist device, or LVAD, reimbursement to include to Class IIIB patients. However, the firm points out CMS did make positive changes to the objective criteria. Wedbush recommends using any weakness in shares of Thoratec (THOR), HeartWare (HTWR), and World Heart (WHTR) following the news as buying opportunities.
To some it may be a legitimate concern, in my mind its not. In fact, with gleevec going off patent in 2014/15, and sprycel/tasigna potentially moving to first line, a strong case can be made that AP534 doesn't need first line approval to be a success. But just to answer your question, if AP534 is shown to achieve similar/greater CCyR then current treatments but with the advantage of less resistance/progression (due to mutations) then, yes, I think AP534 will eventually be approved as a first line treatment option. In fact for high risk pts (eg those with the T315I mutation) I can easily see a scenario where pts start with 534.
You asked
The correct answer can be found in the 10k.
"The Labrador Claims together make up an aggregate area of 33,482 acres."
"The Labrador Claims cover an area with approximate dimensions of 20 kilometers east-west (12.5 miles) and 10 kilometers north-south (6.25 miles)."
Nice to see Mass General install it's first LVAD. Mass General is the 5th site to come online and the 11th implant done so far this year.
Given the timing of the first and second interim results, the trial endpoint should be reached in Q4. At that point it's up to the IDC to compile the data and make their findings available to MRK/ARIA but I do think year end is in the ballpark.
lax, fwiw, I'm looking for the AP534 trial to start in Q3 and the rida results in Q4.
In one post you claimed the trial was going to cost 30 to 40 million then in another you said it was going to cost 20 to 30 million. So which is it?
Personally, based on the 26k per patient cost reported in the “Clinical Operations: Accelerating Trials, Allocating Resources and Measuring Performance” study, I think you are way off base in either case.
Your assessment that Ariad "would need to raise cash" by year end is incorrect. In it's most recent CC the company said it expects a year end cash position of $44-46mm. So while they may indeed raise additional funding (most likely through a AP534 partnership), the situation is not nearly as dire as you portend.
You have also insisted that the company has to raise cash in order to fund the upcoming AP534 trial. Imo, you are again incorrect. In a recent post on this board, you stated "A pivotal 534 study is going to cost $30 - 40 million." Is this more hyperbole on your part or do you have some facts to support your claim?
I'm wondering how many patients you think will be in the upcoming trial? To spend $30-$40mm you'd be talking about a 1,500 patient, multi-arm, head to head trial and I just don't think that's what we are looking at. My expectation is that the trial will be in the 400 patient range and cost around $26k per patient or somewhere in the $10mm range which, despite your "feelings" to the contrary, is hardly sufficient to warrant your continued insistence the company is about do a surprise financing.
Oh, so you think he put down $3mm for "window dressing". What are you basing this on...more "feelings"?
I haven't been worried about dilution since Harvey plunked down $3mm of his own $'s a year ago to buy stock, lol.
I'd agree if I knew A) how much of the current headcount is being essentially paid for by Merck during this transition period and B) how many of those positions will transition to AP534 once it's up and running. Other than manufacturing, I'd be surprised if there is as much redundancy as one may think.
Nice find, thx. fyi, vorinostat and temsirolimus were shown to be far more effective in combination than as single agents in both in vitro and in vivo models of RCC.
http://clincancerres.aacrjournals.org/content/16/1/141.abstract
World Heart doubles the number of sites participating in the Levacor ventricular assist device (VAD) Bridge-to-Transplant (BTT) clinical study. FDA has now approved 20 sites in the U.S.