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And I assume it will go on for sometime.
Perhaps the decision is not so horrible if you add switching to Gilenya as an option.
You can see the 3 AD candidates in phase II but hard to find what they are
http://clinicaltrials.gov/ct2/show/NCT01137526?term=alzheimer+ABbotT&rank=1
http://clinicaltrials.gov/ct2/show/NCT01018875?term=alzheimer+ABbotT&rank=2
http://clinicaltrials.gov/ct2/show/NCT00948909?term=alzheimer+ABbotT&rank=6
ABT are working like the Mossad when it comes to their pipeline.
Laquinimod results from the ALLEGRO study
Reduction in the relapse rate was as expected relatively weak but on efficacy Teva will emphasize the strong reduction in disability progression (measured by the EDSS scale) as only Avonex (not even Gilenya) among first line agents showed a slightly higher rate.
Approval of the “import” route also known as a Class 3, requires a PK/PD study to prove bioequivalence and a single phase III confirmatory trial, both in Chinese patients. The problem usually isn't the trials but the inefficiencies of the SFDA with relatively long review process and then not many clinical sites. It's improving though.
BG-12 met the primary and secondary endpoints in phase III DEFINE trial
http://www.news-medical.net/news/20110411/Positive-top-line-results-from-Biogen-BG-12-Phase-3-trial-in-RRMS.aspx
ARISTOTLE study data should be available at the European Society of Cardiology Aug. 2011. ADOPT study is scheduled to be completed in May 2011 so data are not far away either. Bleeding risk could be better than Xarelto given lower peak blood levels and BID dosing limiting the peak-to-trough ratio.
The difference in duration of treatment makes it more difficult to assess the relative merits of the two drugs.
Teva already said that Laquinimod had a similar safety profile as placebo (very big relief considering its parent compound) in the trial and that reduction in disability progression and in relapse rate were both statsig. So big question is how efficacy compares to other first line drugs. Here are a couple of takes from Israeli analysts:
http://www.globes.co.il/serveen/globes/docview.asp?did=1000637053&fid=1725
Seems all expect reduction in relapse rate below 30%, which is relatively weak, but perhaps reduction in disability progression will be around 40%.
I cannot respond on behalf of Clark and Vin but me, I'm pleased you've found viral sex of interest intellectually :)
Hepatitis C has only a single RNA molecule for its genome
Not hybridization, recombination.
Re: Xarelto vs Lovenox in immobilized patients (MAGELLAN study)
Xarelto is probably dead in this indication
thus allowing a strain resistant to one drug but not the other to exist long enough under a dual treatment to cross breed with a strain with the inverse phenotype.
I don't have much to add to your comments on ACH-1625. It is certainly a PI to watch, especially as each of the competitors has its own quirks. Main worry as you noted is safety in longer and bigger trials but looks fine so far.
Longer for Israelis
Yes, I told people who asked me that it should be part of the treatment decision algorithm. Having an unfavorable genotype means you will most likely fail on SOC and better wait for telapravir.
Re: Using IL28B status to dictate treatment
I’m inclined to agree with ThomasS that giving Telaprevir to only the patients who fail to achieve RVR on SoC is likely to backfire in terms of economics (in addition to being bad medicine).
We both agree that 2nd gen nukes whether a purine or a pyrimidine nucleotide analog, are potent enough. I just don't refer to 1st and 2nd gen as two different classes of drugs.
Resistance analysis of the hepatitis C virus NS5A inhibitor BMS-790052 in an in vitro replicon system
http://www.ncbi.nlm.nih.gov/pubmed/20585111
I assume they (as jbog noted, most ex-US countries), will pay for the a new, expensive, treatment with xxx efficacy only if certain patients fail (or have a high risk of failing) the existing less expensive treatment with xx efficacy.
Still, TMC435 looks to me as the most promising 2nd gen PI.
On IL28B status
I read an opinion (cannot find the link but think it was someone like Jules Levin, who attended EASL), that in price sensitive countries, naïve CC genotype patients will get peg-INF+Riba and the PI will be added only if patients don't achieve RVR.
In particular I found it interesting that starting with one drug, and then adding the second later results in a better end-of-treatment response then just doing combo the entire time.
I think VRUS's first generation nuke RG7128 unlike the latest-generation HCV nukes is also not potent enough.
VRUS Nuclear Study 14 Day Data:
http://www.natap.org/2011/EASL/EASL_07.htm
"No viral breakthrough was observed during therapy"
IL28B POLYMORPHISM PREDICTS VIROLOGIC RESPONSE IN PATIENTS WITH HEPATITIS C GENOTYPE 1 TREATED WITH BOCEPREVIR COMBINATION THERAPY
http://www.natap.org/2011/EASL/EASL_24.htm
but we haven't talked about the significance of having achieved what looks like a cure in 50% or so of patients without interferon
We've talked about the hight viral breakthrough in group A (BMS-790052 + BMS-650032) of that trial and AE were also kind of hight although generally not so much in group A (except for ALT elevations).
http://www.natap.org/2011/EASL/EASL_28.htm
Boehringer/BI 201335
Interim data from phase 2b SILEN-C1. Efficacy ok but AE seems so-so (I mean when you're the 2nd gen you want to be better than the 1st).
http://www.natap.org/2011/EASL/EASL_20.htm
I would like to know the reason for the high relapse rate first (IL28 genotype, mutation etc).
Data of the genotype 2/3 arm from PROTON trial of PSI-7977 QD with PEG/RBV suggest that these patients could be cured after 12 weeks only
http://www.natap.org/2011/EASL/EASL_22.htm
EASL - first SVR data for mericitabine (a.k.a RG7128 ) interim analysis from the Jump-C phase 2b study. Note the high relapse rate
http://www.natap.org/2011/EASL/EASL_30.htm
On top of what you've mentioned, I also have confidence in management and their experience in bringing ERTs to the market. They need to enroll patients carefully as too severe ones will have advanced skeletal defects and will probably not improve on 6MWT during the trial. I don't see any reason why GALNS should have different injection site reactions than other ERTs.
I don't think PLX will spoil the nice statistics for ERT's to enter Phase 3, and will be approved :)
BMRN/BMN 110 in Morquio A Syndrome
FWIW, I'm quite optimistic for GALNS phase III trial to be successful.
Mr. Kedar and others say they often recommend investing in companies that already have products on the market,
However, accelerated approval landscape in oncology has changed a little bit especially with Avastin situation in MBC
ONXX/ASPIRE trial could support the use of carfilzomib in earlier line of treatment.
ONXX/carfilzomib European FOCUS Study
Previously, Estimated Study Completion Date was February 2012. Now, time to market in EU will probably be delayed. Although, the study design now incorporates planned interim analyses on the primary endpoint, so perhaps a chance for an earlier end of trial.