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Inverted dose response happened to Atrasentan
Their xenograft data was not impressive at all.
Can't possibly imagine CG arrogance and bulldogging would be well received.
this is mostly for the dive into TNBC. Although, I think they're a bit too late to be have an impact. MRK already has a study going and is an approved agent. Think Roche as well.
http://clinicaltrials.gov/ct2/show/NCT01848834?term=merck+tnbc&rank=1
You know the imagination of traders or Twitterati in biotech has no bounds
RGLS
The idea this is worth ~450M (17.33 - 6.77 x 43.34M OS) more today than 2 days ago seems absurd.
- 7-day data were only ~2.5 logs when you exclude the one rapid responder. Even at day 29, most had ~3 log reduction
- Running a trial in the US will be very challenging
- FDA has recently told Santaris they would need quite long follow up data ( 5 years )
- FDA unlikely to approve a drug based on RVR data and will still require 12 weeks. I don't see any reason for them to change their minds here especially with Harvoni and ABBV regimen coming.
http://files.shareholder.com/downloads/AMDA-14LKIJ/3566165809x0x787853/66089b1b-f1db-47f2-8972-355f0cbc8ae9/RG-101%20PoC%20Presentation%2010%2022%2014.pdf
I hear you. Just so sad to see these HFs with sub par performance using activism to effectively pump their position. Mildly pleased to see the SHPG arbs like Paulson get scorched.
LOL, they own next to nothing but want the company to split up? Such a joke the activist seen has become.
I suspect PD-L1 inhibitors stand a (reasonable) chance of accomplishing this in oncology and HBV.
14% is a ridiculously low discount rate given this management.
Completely agree here. I think the reduction in HBsAg in patients that seroconversion is more of a secondary observation. Something else is causing the 'cures', not the drop in HBsAg, I would guess something with cccDNA happens. Haven't completely worked it out yet.
I do think ARWR may have a delivery problem and have heard concerns of this from other buysiders who have talked with some real experts(not pretend ones like Dirk). 2nd gen LNP can achieve KD levels 5x higher and 1/8th the dose.
Please explain. Very little dose response and 1mg/kg ended up having better KD at day 85 than 2mg/kg. Hardly think market overreacted, especially after being touted by management.
We can infer neither 1mg/kg or 2mg was stat sig at day 85, 1mg/kg wasnt stat sig on the day 3 thru 43 timepoints.
ARWR also did little in terms of proof of concept preclinically.
This is so pathetic of them. Company misled investors in 1-on-1 meetings
Opus Point is the CEO's hedge fund.
Actelion data coming
Thinking about this some more, very odd they didnt present at AASLD 2013 / EASL 2014 and havent said much about the Indonesia study. If data were truly this good, Gilead or BMY wouldve bought them by now.
Very interesting and certainly a much stronger looking argument than what Arrowhead presented. This is vastly different in terms of log reduction, almost night and day. ARWR didnt even lower HBV DNA or HBsAg 1 log in the NHP !
Thanks for this.
Notice the endless wait until actually posting data.
I've never seen so many dumb comments.
One could use IMS to look up the sales and come up with a reasonable multiple
Yeah it seems like you are right. Since diff MoA
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000392.jsp&mid=WC0b01ac058061f019
Does ITMN EU approval preclude BI's Nintedanib from getting approved?
Amazing some investors think IDIX has $400m+ in value from the Sovaldi litigation especially after being dealt 2 blows from the USPTO. Be surprised if they ever get more than $50m out of this.
What do you make of the valuation discrepancy between ACHN and IDIX? I see no reason for IDIX to be a $800M mcap company, especially since the FDA still won't let their nukes tested in the US and they're going to be quite far behind all other HCV regimens.
While the relapse rate was interesting, why no effects on MRI or other endpoints of interest?
I agree it's difficult to compare across studies, but I still am having a hard time reconciling the data as better than current options. This comes from their(Merrimack) Phase 2 paper.
"Results from one of the largest studies conducted to date for the second-line treatment of APC (CONKO-003) randomised 165 patients to receive a weekly regimen called OFF or 5-FU/folinic acid alone (Pelzer et al, 2008). Patients receiving the oxaliplatin-containing combination demonstrated significantly improved outcomes in terms of both progression-free survival (13 vs 9 weeks, P=0.012) and overall survival (26 vs 13 weeks, P=0.014), leading to the adoption of this regimen (or slight variations thereof) as a de facto standard of care in the salvage setting."
http://www.ejcancer.com/article/S0959-8049(11)00260-7/abstract
When the Abraxane data came out, I thought it was disappointing. I thought the MACK data didn't seem all that different from other trials run in salvage setting.
Irinotecan plus bolus/infusional 5-Fluorouracil and leucovorin in patients with pretreated advanced pancreatic carcinoma: a multicenter experience of the Gruppo Oncologico Italia Meridionale.
http://www.ncbi.nlm.nih.gov/pubmed/20142727
A retrospective survey was carried out including 40 patients with stage III or IV gemcitabine-refractory pancreatic carcinoma. Patients received standard FOLFIRI regimen biweekly until progression or unacceptable toxicity. Response evaluation criteria in solid tumors and National Cancer Institute common toxicity criteria were employed respectively for response and toxicity assessment.
RESULTS:
Six partial responses (15%) and 14 stabilizations of disease (35%) were recorded for a tumor growth control rate of 50%. The median time to progression was 3.7 (range, 1-6.5 months), and median overall survival was 6 months (range, 2-8.2 months). A stabilization of performance status and a subjective improvement of cancer-related symptoms were recorded in 21 patients (52.5%). No correlation has been found between length of time to progression during first-line chemotherapy and length of that reported in the second-line setting or objective response. Grade 3-4 diarrhea and mucositis was observed in 15% and 10% of cases, respectively.
Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer.
http://www.ncbi.nlm.nih.gov/pubmed/18839175
Between March 2004 to February 2007, 33 patients were registered and treated with irinotecan monotherapy. The patients' median age was 59 years (range 36-70) and two had an ECOG performance status of 2. A total of 167 chemotherapy cycles were delivered (median, 4; range 2-12). In an intent-to-treat analysis, three (9%) confirmed partial response and 13 patients with stable disease were observed for a disease control rate of 48%. The median progression-free and overall survivals were 2.0 months (95% CI, 0.7-3.3) and 6.6 months (95% CI, 5.8-7.4), respectively. Toxic effects were mainly gastrointestinal (nausea in 64% of patients, diarrhea in 36%), Toxicity profiles were generally predictable and manageable, and there was no treatment-related death.
CONCLUSIONS:
Second-line chemotherapy with single-agent irinotecan is marginally effective and well tolerated regimen for gemcitabine-pretreated patients with advanced pancreatic cancer.
Management made a comment about whether the FDA still viewed the Ph3 trials as confirmatory given the change in endpoints.
Operator
And our next question comes from the line of Thomas Wei with Jefferies. Please go ahead.
Thomas A. Wei
Analyst, Jefferies LLC
Thanks. Just on the ECHELON-1 and -2 changes, should I be thinking of it becoming something likea landmark PFS analysis? Is that what you're thinking of, like switching the endpoint to a responder analysis, that the proportion that get to one year – what the one year PFS rate is or the three-year PFSrate is, kind of similar to what you did with the AETHERA trial?
And then my second question on AETHERA was just a reminder again of, there were a lot ofconcerns that had been raised at the FDA panel on the design of AETHERA, which led them to saythat it could not be the confirmatory study for approval. Can you just remind us what those concernswere and how we should think about that as the AETHERA data approaches here? Thanks.
Clay B. Siegall
Chairman, President & Chief Executive Officer, Seattle Genetics, Inc.
Yes. First of all, you asked a question about the ECHELON-1, ECHELON-2 trials and what kind of potential changes. And I use that word potential, because this is with discussions with our partner,with regulatory people. So nothing can be written into anything that we are either contemplating now.But your comment, could it be a landmark analysis instead of a event-driven analysis, like such aswhat we did with AETHERA. That is one of the options. When we look at all the different options, thatcertainly is not one we're throwing off the table. But I don't want to guide you that that will be it yet.We're still in discussions and contemplating all of the information before any specifics will be made.But I do appreciate your comment and that that is certainly one of the multiple of things that couldhappen.
As far as AETHERA, you do remember correctly. There were some issues that the FDA brought up to not make it a confirmatory trial, that it would be something that they wanted in – they wanted for thesafety database for certain. So that's written in there, but as far as confirmatory, it was not. And I thinkthere was a lot of different discussions up and down on AETHERA. It's our assessment that whenwe complete this trial, if the data are good and that's what we certainly are hoping for. And if the dataare good, our intention is to submit this and we believe that if the data are strong that we submitted,that it would be a review decision by the agency.
Oh I wasn't trying to pigeon hole the buyers list, just going along with the story. Certainly think ITMN has to be on some buyers watch list - wonder if GILD or GSK is interested, seems to fit their wants and specialties.
I think ITMN has a dominant position over BI - clinically and quicker to market. Already on the market in the EU and should only be a 6 month review in the US. Guess it comes down to valuation and how to value the follow on compound.
Wonder if Actelion tries to make this move before or after the Upcoming PAH data.
Any insight on the DEA scheduling process? Wonder what would happen to the payouts if initially class 3 or 4, then changed to class 5 or unscheduled? A number of these cases
Wonder what effect NVS will have on them, Ph3 data in second half of this year on PKC412 in FLT3+ AML. Could present a challenge to AMBI trial enrollment and future sales competition.
http://clinicaltrials.gov/ct2/show/NCT00651261?term=Midostaurin&rank=14
Interesting info. Long road ahead for AMBI - NVS had to screen 3200 patients to get 700 randomized.
http://www.iom.edu/~/media/Files/Activity%20Files/Disease/NCPF/2013-FEB-11/Capdeville.pdf
Agree re CCX140, especially when company can't deliver a clear PR. Appeared placebo was better based on the wording
What did you make of their CCX168 Phase II Data in ANCA-Associated Renal Vasculitis? A little skeptical on this at first glance.
http://ir.chemocentryx.com/releasedetail.cfm?ReleaseID=811237
Have they disclosed how exactly they will deliver the modified virus into the ear? Seems like a very tricky surgery.
Don't remember what's been disclosed publicly about their preclinical animal models. Given it's taken this long to get to IND, can imagine some issues in the pudding.
Re RNA/SRPT
Fast forward to 3 months later. Has SRPT disclosed what was in the FDA meeting minutes?
I suspect the FDA gave Prosensa/GSK its view in late December or early January given GSK walked soon after.
When was RNA supposed to have re-met with regulators? Sounded like they were planning a followup after the Jan16th press release. Any thoughts on Drisa re-dosing? Curious if they have considered doing IV vs the current subq.
Re SRPT
Re ALNY
Understood. I was just providing some personal info that had been relayed to me by a few execs.
Yeah, funny how it was "ALNY getting a steal on MRK's assets" to "Big pharma dumps RNAi". Important to keep in mind sites like FierceBiotech rely heavily on pageviews
Agree on his points, don't think big pharma leaving is some harbinger of doom.
The continued arrogance of executives at Alnylam never fails to show. Spoke with an RNAi executive last year and he said they have a bad reputation, especially the BD, CEO and legal team.
Re SRPT
this is so true!
Personally, I am disgusted that they haven't made more of an effort to get Austin the drug via compassionate use. Certainly got a bunch of money with all the ATMs, web redesigns and stock options they give out.
DES?
Only posting since it was relevant to the market dynamics for Vascepa