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So far Brilinta had a lackluster launch too.
ABT’s all-oral HCV combo(s)
The components will likely include ABT-450 (a PI), ABT-267 (an NS5A inhibitor), and one of the non-nukes (ABT-072 or ABT-333).
AMGN/T-vec aka oncovex
Results are from phase III in metastatic melanoma are now expected in 2013 (not 2012 as before).
XNPT/XP23829 potential clinical differentiation from BG-12
Judging from XNPT home page, they hope for the whole package i.e superior dosing, efficacy and better tolerability but I think QD dosing is probably the more real one, but even so I believe BIIB may also be working on a sustained release and pro-drug formulations. So my guess is QD is nice but may not be enough in the long run.
On BG-12 SE from that last PR: "The incidence of these events [flushing and GI events] decreased substantially in the BG-12 groups after the first month." and I think patients also acclimate to these effects over time. Competing on price like Peter said is the last option and not a bad one when no other generic available and you have a strong partner to do the marketing.
Clearly, the media-relations staffs of NVS’ two licensors for NVA237 [Vectura and Sosei] collaborated on this PR effort :- )
Yes, I've read it before (the exact quote is also in the Reuter link I've posted :) )
The fourth phase III study evaluating Novartis inhaled COPD therapy QVA149, meets its primary endpoint:
http://www.reuters.com/article/2012/04/24/idUS51335+24-Apr-2012+RNS20120424
BIIB/BG-12
Detailed CONFIRM Data Presented at 2012 American Academy of Neurology Annual Meeting
http://www.biogenidec.com/PRESS_RELEASE_DETAILS.aspx?ID=5981&ReqId=1686377
One more question on PYMX: in the PR it says " The study was conducted at 21 sites in Canada, Russia and Ukraine." I was wondering about the proportion but in http://clinicaltrials.gov/ct2/show/NCT01211470?term=PolyMedix&rank=1 only Canada is mentioned. I assume the PR is more accurate on the trial's locations, but do you know the proportion between Canada and the other two?
A study comparing 454 GS Junior (Roche), MiSeq (Illumina) and Ion Torrent PGM (Life Technologies):
Performance comparison of benchtop high-throughput sequencing platforms
Nicholas J Loman et al., NATURE BIOTECHNOLOGY, Published online 22 April 2012
http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.2198.html
No one is talking about Roche’s all-oral HCV program either...
http://www.rochehcvcongress.com/uploads/EASL2012_PO1412_Gane.pdf
PYMX
Still the market is disappointed from the data, i don't see why.
Thanks, Peter. Do you know the MRSA cases did in all treatments?
PYMX
I don't see any p value, efficacy results were not stat-sig?
I agree. The case seems rare and less likely to occur with a potent drug like 7977 in the combo.
There should be a poster(s).
The patients in the IFN/ribavirin-ineligible arm may have had worse overall health, on average, than the patients in the null-responder arm, which could have influenced the SVR rate to some degree.
Another interesting difference I've come across while looking at past data from daclatasvir trials: the cobmo daclatasvir/BMS-650032 produced an SVR24 of 91% in GT1b nulls and only 64% in ineligible/intolerant patients. One would expect the nulls arm to achieve a lower SVR not to mention the fact that there were 5 times more patients with IL28B CC genotype in the other arm.
http://www.natap.org/2012/EASL/EASL_27.htm
GILD appears to be keeping the phase-2 data on GS-5885 (the NS5A inhibitor) under wraps
Edit to the previous post
The 91% SVR4 in the AI444-040 study is combined from 3 combos of 7977, daclatasvir and Riba, but the GT2/3 patient with viral relapse and aonther with viral breakthrough were in the 7-day lead-in dose of GS-7977, then DCV + GS-7977 for 23 weeks.
Another interesting difference, although a minor one (100% vs 91%), is between SVR4 achieved with the combo 7977/Riba (ELECTRON study) and 7977/daclatasvir (AI444-040 study http://www.reuters.com/article/2012/04/19/idUS85346+19-Apr-2012+BW20120419 ), in GT2/3 patients. Could be attributed again to IL28 status or to a better synergy with Riba (I had thought that a more potent combo i.e the latter, would have achieved a higher SVR). Anyway, too soon to conclude too little data and probably not so important as GILD already in phase III 7977/Riba combo in GT 2/3 which looks like the better combo.
SVR36 data have rarely been reported
ABT HCV combo
SVR36 in the PILOT study is down to 82% from SVR24 that was 91%
http://www.abbott.com/news-media/press-releases/abbott-presents-positive-results-from-phase-2-pilot-study-of-an-interferonfree-combination-regime.htm
I'm not aware of anything in the clinic yet. I think Procognia (the Israeli company we've mentioned years ago as a possible competitor to MNTA) was also looking into this but from the diagnostic aspect.
From pcrutch's post #msg-74579648 seems you were right on GILD going with their in-house NS5A candidate and not willing to partner.
The expression of genes controlling branching of O-glycans were found to be associated with the progression of various types of cancer. Here are just a few papers:
http://www.ncbi.nlm.nih.gov/pubmed/11280791
http://www.ncbi.nlm.nih.gov/pubmed/19267921
http://www.ncbi.nlm.nih.gov/pubmed/20017138
I think you didn't find publications on this cause you searched for CGNT1.
Yes, that's probably the reason.
Interesting the big difference in SVR4 between the two trials QUANTUM and ELECTRON.
Interesting and important finding from this work is the role of the GCNT1 gene in the cancerous process in breast cancer.
Hypertension is also a growing epidemic in China and so is dyslipidemia.
VSTM
Are you cautiously optimistic on VSTM?
Are Cancer Stem Cells Ready for Prime Time?
http://the-scientist.com/2012/04/01/are-cancer-stem-cells-ready-for-prime-time/
I was thinking that results from the CO-PILOT study bode well for VRTX' oral combo in the sense of both contain drugs with the same MoA (PI+non-nuke+Riba) and ABT-333 was dosed BID (ABT-072 was dosed QD in PILOT study). Of course both would be inferior to a QD combo with similar SVR.
Results from the CO-PILOT study also bode well for VRTX' oral combo (Incivek + VX-222 +Riba) although if memory serves SVR4 there were nowhere near those from CO-PILOT.
Common adverse events in ABT's cocktail in CO-PILOT study:
fatigue 42%
nausea 22%
headache 20%
(very similar in PILOT plus dry skin)
What's interesting about ABT is they are the dark horse in this contest. They are behind in development, with a somewhat sloppy combination, yet 90%+ SVR rates is a remarkable achievement even within this small study.
If GS-7977/Riba lacks acceptable potency in GT1/GT1A do you think GILD would partner with BMY or Tibotec as opposed to focusing only on an in-house combo?
This throws a monkey-wrench into the theory that a nucleotide-backbone is required for oral therapy.
Investor focus should be centered on who will be first to market in GT1 oral.
Right on both (me being a sensible person and the 0.01% formulation should supersede the 0.03% plus the shorter IP protection for the latter).