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The P1 was started in May 2008 so that would be my guess.
One thing that I hope the analysts pick up on is that current second line therapies have a median response rate of only 1 to 2 years. I strongly suspect that ponatinibs median response rate is going to be much closer to the current first-line drugs e.g 5+ years. Consequently, I think the analysts are significantly underestimating ponatinibs commercial opportunity.
Given the excellent P2 results, I expected MRK to move ahead with a stand-alone trial and then run combo trials after approval.
My guess is that we'll see the 113 IND filed around the time of the Amsterdam conference. What's even more exciting is that Berger confirmed the trial would use biomarkers to screen/enroll only those pts with ALK mutations. This would be like running a Ponatinib trial with only T3151 pts...and we know how great that would turn out.
At the current burn rate, the company should have around $80mm in cash at year end ($10mm from the warrants and $25mm from the rida NDA milestone). They aren't under a lot of pressure to do a round any time soon, imo.
I just wished MRK the would get the friggin endometrial P3 started...rida clearly showed sufficient efficacy to warrant it.
Yup, otherwise you might find yourself stuck on the sidelines waiting for a $6 pps with Kramer.
Imo, most of the recent run-up was due to the reduced uncertainty associated with whether Merck intends to file the NDA. First, Merck stopped the endometrial trial early, second, the SUCCEED trial met its primary end point,and third, Ariad exercised its co-promote option. I'm looking for the cohort data to remove any remaining uncertainty.
Yea, and you also told us the 5.25 gap was going to fill. Oh, and right before the recent 40% gain, weren't you posting that the stock wasn't going to move for months? Oh well, I guess
1 out of 3 ain't bad, lol.
The short answer is we don't know, however, the issue was discussed when the data was released back in January. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58929877&txt2find=PFS
At this point, imo, the OS data and cohort analysis will impact the pps far more than the overall pfs.
yosarian, several companies are running FGFR inhibitor trials including Novartis and AstraZeneca. The FGFR pathway has show to be active in a number of cancer types, including breast cancer, melanomas, pancreatic, prostate, ovarian, gastric and colorectal cancers.See http://www.nature.com/onc/journal/v23/n20/full/1207331a.html
More recently, FGFR has shown to be a possible target for lung cancer ( See http://pharmastrategyblog.com/2010/12/fgfr-as-a-target-in-lung-cancer.html/ )
In the short run, I don't see the FGFR news having much of an impact on Ariad's share price, however, I do think it serves to confirm the value of Ariad's pipeline/drug discovery capabilities in general and the value of ponatinib, in particularly. The fact that Ariad continues to own 100% of ponatinib only makes Ariad that much more attractive to any potential partner/acquirer down the road.
...Don
you know you are having a good week when up .30 is just ho hum
At current shares outstanding, $15 equates to around a $2 billion market cap. Based on the projected revenues for rida and ponatinib, I think that's in the ballpark of a fair "going concern" valuation. Obviously in a buy-out scenario the valuation could potentially be much higher.
imo, at current levels, ARIA still offers the most upside (on a risk-adjusted basis). fwiw, back of the envelope - here are the targets I've had for over a year:
$6 to $8 pre-Rida filing
$8 to $10 post-filing
$12 upon rida approval.
add $3 for ponatinib at NDA and $8 at approval.
2011 target is right around $12.
2012 target is $18 to $20 with the ALK inhibitor the wildcard.
The interim results were so strong in the endometrial trial (ridaforolimus, 3.6 months vs standard of care, 1.9 months) that Merck stopped the trial back in Oct. I'm somewhat surprised they haven't already started the P3 but this announcement will just make for more fun this Summer.
Credit duly noted...it's nice when the board is ahead of the PR curve.
So true. Anyone who is waiting for the gap to fill or listened to the tripe about being range bound for months is missing the boat. I'm expecting news every 4 to 6 weeks from now until the end of the year...and beyond.
Next up:
AACR presentation (April)
ASCO Abstracts (May)
ASCO presentation (June)
RIDA NDA (Summer)
Milestone payments (Summer)
AP113 P1 trial start (Summer/Fall)
Ponatinib First look/Full enrollment - ASH (Fall/Winter)
New Rida trials???
Ponatinib partnering???
Rida Approval???
Ponatinib NDA???
Per BTH - Phase 3 endometrial study to begin and initiation of further Phase 2 / 3 combination trials.
Per biotech_researcher - "the release of information on new indications for all three of their compounds. Today, we just had the release for the pan-FGFR inhibitor for Pona, which is one. '113 will have one beyond NSCLC, and Rida will have another
ASCO - abstracts for randomized P3 trials for which preliminary data was not available by Feb 2 have until April 1
take a look at the chart. FOR OVER 2 YEARS NOW EVERY TIME THE STOCK HAS DIPPED BELOW THE 50 DMA HAS BEEN A BUYING OPPORTUNITY! Give the chicken little act a rest.
fwiw, I'm anticipating dilution of at least 15% to occur sometime in 2Q before I jump back in.
Thanks for the heads up on the pharma strategy post. I haven't been following this trial that closely but I'd be surprised if the combo is hitting the ZNF703 oncogene directly. Even if it's not, the results may indicate that the combination may prove to have broad potential in other indications. Either way, luminal b represents a significant opportunity - 25% of mBC with few viable treatment options.
That's my view as well. I originally invested in the ARIA after seeing the rida P2 data and the resulting change in the P3 trial design. At that time, my investment thesis was based on the view that rida would prove to work exceptionally well in some indications. I think the data is now proving that out. Most importantly, the sarcoma subtypes that rida appears to have the greatest efficacy in are the ones that also have the largest patient populations. So while 3 weeks PFS overall may not seem like a lot, I'm betting that the ASCO data will show a PFS that is much higher than that in STS. And, if that is true, MRK will, imo, file.(btw, based on lack of alternative treatments and the positioning of rida as a maintenance therapy, I don't think approval will be limited to just STS)
Merck's decision to file should be viewed in a larger context. The endo(single agent) and breast (combo) trials produced excellent results. Sarcoma is just the first step in what is arguably a much bigger opportunity for Merck.
fwiw, basically technical analysis is just one of several factors that I consider when deciding to ADD to a position that I already own based on the fundamentals. If I let the technicals decide when to sell a stock, I probably would have been long gone out of ARIA by now and would have missed out on the 300+ percent move this stock has had since I've owned it. I'll let the pipeline decide what the long-term value of ariad is...but I know one thing,for me, it's a market cap significant north of current levels.
Does anyone really think MRK isn't going to file an NDA this year? After the rida cohort data is released at ASCO, imo, there isn't a chance that they won't file. The drug works. MRK is expanding the number of trials. The NDA is already all but written...just waiting to fill in the OS data and we'll be good to go.
Everything else is just noise.
Perhaps dough would care to comment on this as well but my take is that Merck rarely PR's the start of new trials but I am hoping that rida will be mentioned in Merck's Feb 3rd CC. fwiw, I think one of the things holding back the pps is the uncertainty associated with the timing of Mercks filing of the rida NDA and their commitment to starting new p3 trials. Once that's cleared up, we should see additional upside.
BTH, I agree with your contention that the subset data is likely going to show significant benefit in a broad range of STS types but only marginal benefit in others, I also believe this was anticipated and, consequently, a review of pre-defined groupings was built into the trial from the very beginning. However, given the lack of alternative treatments and the positioning of rida as a maintenance therapy, I'd be very surprised if rida did not get approved based on the top-line results alone.
In the past, many drugs were approved on the basis of evidence of tumor shrinkage. However, the FDA now is looking for clear evidence of increased overall survival. With this increased importance on OS, the situation may only get worse in terms of time to market.
I may be mistaken but I seem to recall that historically roughly 1/2 of drugs that make it to P3 eventually get approved while only 75% of NDA's ultimately get approved. fyi, a list of Failed Phase III Cancer Trials in 2010 can be found here: http://knol.google.com/k/krishan-maggon/new-drug-approvals-fda-ema-2010/3fy5eowy8suq3/129#Failed_Phase_III_Cancer_Trials_in_2010
The FDA only approved 21 new drugs in 2010 compared to 25 in 2009 and 21 NME approved in 2008. With 2 drugs this close to the finish line and a market cap of less than $1 billion, the market is, imo, significantly mispricing the ARIA opportunity at current share levels.
It's hard to believe but according to a 2005 PhRMA report, on average, it takes 6.5 years to just bring a new drug from discovery to clinical trials and an additional 8.5 years to receive approval.
2Da, about 15%-20% of gleevec pts develop resistance of which the largest percentage is from the T315I mutation. Also, the current market for gleevec/tasigna/sprycel in just CML is probably closer to $3.5 billion (fyi, this does not factor in the pricing impact likely to occur once gleevec comes off patent).
In a 2nd line setting, the commercial opportunity for ponatinib is the 50% of pts who eventual become resistant to sprycel/tasigna. For arguments sake, if sprycel/tasigna are able to capture a third of the existing market and 50% of pts progress, the dollar value to ARIA is closer to $575 million. You can probably add another 250mm - 300mm for the approximately 10% of pts who have the T315I mutation and may get ponatinib in 1st line setting (of course some of this may be "double counted" in the 575mm). Additionally, you would have to reduce the sales to reflect any partnership terms.
So, I'd place the commercial CML opportunity closer to $750mm which still translates into a significant increase in pps from current levels and doesn't consider the significant opportunity ponatinib has beyond CML.
heck, I'm just looking forward to getting 113 into P1 trial.
Speaking of 113, I think ariad is using a "fast follower" strategy. imo, let Pfizer take on the expense of commercializing the market for ALK inhibitors. Based on the early data, it appears that many pts will still progress which will allow ariad to start generating revenue without having to initially run head to head trials against Pfizer just to get to market. Come to think of it, this is the same thing they are doing with 534. Start generating revenue right away in pts with resistance and wait to run the expensive 1st line head to head trials after your already approved in 2nd line.
Not sure about NSCLC - I don't see merck running a P3 as a single agent. Prostrate is much more likely...but the the completion date on the P2 isn't until Feb 2012 http://www.clinicaltrials.gov/ct2/show/NCT00777959?term=ariad&rank=20
sorry about that, here's a repost of the potential catalysts that are most likely to affect ARIA in 2011:
Ponatinib partnering in Asia and/or EU
Start of AP113 Phase 1 trial
New Phase 3 ridaforolimus trials (P3 endometrial-single agent? P2 breast in combination with Merck's IGFR1 inhibitor, dalotuzumab??)
ASCO - first detailed look at SUCCEED data
possible first look at ponatinib data at ASH?
Ponatinib full enrollment
Filing rida NDA
I think we'll know more after the next conf. call because that will give us the first good look at the burn rate since merck has taken over 100% of the costs associated with rida. My guess is that the savings on rida will be substantially offset by the costs associated with the ponatinib trial as it ramps up to more sites. I'm also assuming that AP113 will start phase 1 sometime in the 3Q and those costs need to be considered as well.
As of today, I'm fairly confident that the company will reach the $25mm filing milestone this year but whether they need additional funding beyond that depends to a large part on the timing of rida's approval and whether the company partners pona in both the EU and Asia (and the upfront $'s that may be structured into those deals). Basically, the more time that passes without a pona partnership, the higher the likliehood of another financing but, depending on the price, that may not be a bad thing.
My understanding is that a priority review is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Based on this, rida certainly seems to qualify but it's up to Merck to file the request. If granted, a priority review means that the time it takes the FDA to review the rida application is potentially reduced to 6 months from the 10 months for a standard review.
Mcbio, I can't recall MRK mentioning rida on their quarterly cc's. However, MRK has highlighted rida in their last two R&D days. It will be interesting to see if rida warrants a mention on Merck's Feb. 3 conf. call.
fyi, here's a link to Merck's research PR's http://www.merck.com/newsroom/news-release-archive/research-and-development/home.html
fwiw, I'm not reading anything into it one way or the other...I'm just glad they were able to issue a PR that the trial met it's endpoint
The hazard ratio was .69-.72. The p-value was .0001 so, no, I don't think that MRK thinks the results were marginal.
lol, just posted to you over there http://investorshub.advfn.com/boards/read_msg.aspx?message_id=58969024
It will be interesting to see if MRK mentions rida on their quarterly CC Thu, Feb 3, 2011, 8:00 am
As far as the timing of a potential pona partnership, I'm not sure if Berger said it wouldn't occur until after the rida "results or "filing". My assumption is that the rida milestone payments will in part drive the pona partnering.
I don't think it's unusual for Merck to wait to PR results until they are presenting them at an appropriate conference which, in this case, I assume will be ASCO. fwiw, MRK let ARIA PR the endometrial results as well.