Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
It's from clinicaltrials.gov - MRK doesn't announce this level of news.
Peter
>>rida
Combo with mk2206 makes a lot of sense - when you inhibit mTor, Akt gets upregulated and much of the impact of inhibiting mTor is lost. So combo with an Akt inhibitor could be very promising.
I don't understand the combo with Notch though, although this isn't something I've ever looked at. I think Notch and Mtor are basically on the same pathway.
Bottom line though is that this shows MRK is taking this drug very seriously and are doing a very thorough job. Good thing Aria isn't still on the hook for co-development costs.
Peter
It's not just that the PSA didn't go down along with tumor and bone responses, it's that it actually skyrocketed (typically doubled or more). In all other prostate treatments I am aware of (except for Dendreon's) PSA was tightly linked to improvement.
I have no idea what this means, but I'll take actual improvement in tumors, mets and pain over a biomarker any day.
These results are spectacular overall in my view.
Peter
Well Natrecor, which was inpatient only, did pretty well until safety issues emerged down the line. (They did explore outpatient use but I don't think they got very far).
The key issue here is need is very great and, as you pointed out, all alternatives that make the patient feel better also increase mortality. So in some sense the bar is quite low, although the FDA will be tough after their Natrecor experience.
I've never followed the company myself - just pointing out that there is a very large market out there if you can show even moderate efficacy and no adverse impact on mortality.
(Natrecor if I recall correctly was approved based on short-term improved EF and subjective reports of how patients felt).
Peter
>>I doubt that the incremental revenue will be material for a company of GSK’s size
But for one of LGND's size...
Peter
I haven't read the NEJM article yet - all I know is what is outlined here:
Anyone here have any views on the prospects for GSK's platelet booster Promacta?
GSK has it in two Phase III trials as an add-on to Pegasys/Pegintron + Ribavirin in HCV. Phase II data showed a substantial increase in number of patients completing therapy (claim is 65% vs 6%).
Peter
>>Gralise orphan designation
Although the market didn't like this news, I really think it is of very little practical significance. Orphan designation stops an imitator for 7 years, but Gralise would be very hard indeed to copy because of its unique PK characteristics. (Note that it is labeled as non-substitutable with Neurontin, which in this case is a good feature). So the chance of generic competition is remote in my opinion.
Peter
But note the local radiologists were also (in theory at least) blinded here.
Peter
>>ARIA site vs IRC
Someone who I respect hypothesized that the difference between the central and the local review was because some small peripheral sarcomas (e.g. nerve sheath) are tricky to measure radiographically, and consequently the expert centers, who have seen a much greater volume of scans, detect progression earlier. She said she was not at all surprised by the discrepancy, and did not believe it indicated bias.
If this is correct, it suggests that although there was subtle progression in the discrepant scans, it was likely not clinically meaningful progression.
Peter
Interesting that Nexium (number 2 last year) has dropped completely out of the top 10. Insurance company muscle finally having some impact (forcing switches to comparable generics).
Here's data for the top 100 for the last few years:
http://cbc.arizona.edu/njardarson/group/top-pharmaceuticals-poster
Peter
>>SABMiller
It's worth noting that in dogs, there is a single allele largely responsible for the dwarf breeds:
>23andme etc
I think everyone understands now that SNPs (and even sequencing) are only going to provide part of the puzzle. Copy number variation, methylation and other yet-to-be-determined epigenetic variations will all turn out to play a part. Let's see what emerges from the 1,000 genome project before we throw up our hands and give up. It may be that common SNPs don't provide that much information, but that "uncommon" SNPs will. Worst case would be that very rare mutations are the big driver - that people are tall (or short) for their own individual (but still inherited) genetic reasons.
It was hard to understand from that MIT review article exactly what these folks are saying. I assume it involves something along the lines of this extract from wikipedia:
I don't disagree with you on the issue of trials.
But I do take issue with the notion that Copaxone is easier to reverse engineer than Lovenox. Sure you can ensure you have the same distribution of molecular weights and the same basic molecular building blocks. But how would you know if say the polypetides with odd-numbered chain lengths had a different distribution of chirality than the polypetides with even-numbered chain lengths? (This is not meant as a realistic example, just an illustration of how a complex mixture of molecules could have some weird characteristic that you wouldn't necessarily know about and wouldn't even know to test for).
I'm no organic chemist, so I'm admittedly very much out of my depth here, and simply trying to apply some common sense to the problem.
Peter
IJ -
I'm saying I have no idea what the FDA will do. The absence of any test for efficacy will certainly make them uncomfortable. As I see it, they could resolve this discomfit in some different ways:
1. Make MNTA do some clinical trials - this would be unprecendented for a generic, so I really don't see this as likely. (Same logic as I use to support my belief that a non-substitutable t-enox is a non-starter).
2. Be extra-demanding on the characterization side - but this is hard given Copaxone is really a class of molecules rather than a specific molecule.
3. Turn MNTA down.
So bottom line I am on the pessimistic side here. But given the rewards for success, the expected value of even a 20% shot at approval is significant and may not be reflected in MNTA's current stock price.
Given I personally think a t-enox approval is likely, with timing still uncertain but my guess would be well within the next year, my current strategy is to stay on the sidelines and see if there will be a buying opportunity if that comes to pass and the market overreacts. Sure I might miss a nice move (e.g. if MNTA find a partner for a another project or Teva announces some major delay), but there are plenty of other fish in the biotech sea.
Peter
Because nobody knows exactly how Copaxone works, there is nothing that corresponds to the enox measurement of anticoagulant activity which was part of the FDA enox "sameness" criteria. Thus there is no preclinical test that could be done to show that M-Copax has the same effect as T-Copax.
When Teva got Copaxone approved, of course they had to run preclinical safety tests and then go through the normal clinical trial process. But the whole point of a generic is to avoid having to repeat those trials.
I really have no idea what the FDA thinking will be in the case of Copaxone. But enox is not a complete analogy - in my view Copaxone is harder. In one sense harder is good - means MNTA wouldn't be faced with an overhang from another prospective entrant; but of course harder is initially bad in terms of getting approval in the first place.
Peter
Michael Lewis, as always, is an excellent read:
http://www.vanityfair.com/business/features/2011/03/michael-lewis-ireland-201103?currentPage=all
Here's a choice quote:
Sounds to me like Teva expected approval.
The notion that Teva would give out information like this to potential customers as part of some sort of devious plot to hurt MNTA is verging on paranoid in my opinion.
Peter
The Ironwood drug seems very good indeed.
A few months ago after listening to one of their calls I emailed rkrw asking why the stock wasn't a screaming buy - only problem was the market cap my system was showing was low by a factor of two for some reason (still haven't figured out why).
So using the correct market cap, the stock seems fairly fully priced given its stage of development.
I did buy some FRX about 6 months ago, so I do have a small indirect stake.
Peter