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The starting point was the debate about Vyvanse. That led to the Emend case, which is another prodrug. Then I found another case in which the FDA reversed its decision - Vitrase, and Veramyst just popped while I was reading, regardless of today's news.
I was in a hurry so I feel I wasn't clear at all about Vyvanse. My point is that even in Vyvanse' case, in which Actavis sued the FDA for classifying Vyvanse as an NME (Actavis claimed that Vyvanse' main compound is an already approved amphetamine and therefore should not be considered an NME). The FDA insisted and the case made it to the U.S. District Court that upheld Vyvanse' NME status and thus, 5-years exclusivity. There are cases like Vitrase and Emend, where the FDA has reversed its previous decision and granted the NME status. Sometimes the issue is so controversial that it takes the FDA years after the NDA approval to decide on the NME status and Veramyst is a case in point. So, I think Roy is correct saying it's not automatic #msg-68778881.
Wonder how much longer MRX can keep sales at this level unless they lower their prices.
If memory serves, Shire's Vyvanse NDA was clasified as NCE by the FDA and got the 5 years Hatch-Waxman exclusivity.
On efficacy - tofacitinib and Humira were numerically similar for all outcomes:
http://acr.confex.com/acr/2011/webprogram/Paper19572.html
We should have known after VRUS announced the initiation of a Phase 3 program for PSI-7977 with ribavirin #msg-68544233
VRUS/PSI-7977 ELECTRON study
How did the monotherapy arm do?
Indeed the GSK/IPXL drug had a higher hurdle in that trial for the reason you've mentioned. Moreover, the XP21279 phase 1b trial was an open label study. In its phase II trial IPX066 reduced subjects’ “off” time during waking hours by 2 hours compared to Sinemet (3.8 hours of “off” time for IPX066 vs. 5.8 hours for Sinemet, P<0.0001):
http://www.businesswire.com/news/home/20090921005658/en/Impax-Pharmaceuticals-Reports-Positive-Results-Phase-II
IPX066 first phase III study was vs. placebo, so not that important. This is the PR for the second phase III trial vs. the standard immediate-release carbidopa/levodopa:
http://www.gsk.com/media/pressreleases/2011/2011_pressrelease_10040.htm
Bear in mind that Stalevo (combo of levadopa/carbidopa and entacapone) goes generic in less than a year so cost will play a part in adapting any of these future drugs.
Offhand, I'd say Orencia is the one with weaker efficacy among the three but with the better safety profile and delivery. Also, Rituxan is not approved in biologic-naïve patients while Orencia is and Acterma might be. The latter two are approved in juvenile idiopathic arthritis and Rituxan is not.
Let me rephrase: in all likelihood, Actemra will never have more than an inconsequential third-place ranking in the third-line setting.
Yes, and it makes sense as it was approved few years later.
Even if Acterma' label is broadened to naïve patients, as monotherapy or in combo with DMARDs (it is only approved in anti-TNF failures currently), it would need to prove superior to anti-TNF in a head-to-head trial before it can compete with anti-TNFs. Accumulating efficacy and safety data like those presented at ACR, will likely help it in taking share from Orencia.
Apropos to XP21279 the prodrug of L-dopa in Parkinson's, this is a recent PR related to GSK/IPXL competitive product - IPX066, regarding its second phase III trial, which I haven't seen mentioned here :
http://www.gsk.com/media/pressreleases/2011/2011-pressrelease-580727.htm
$3.7M of quarterly sales after almost one year on the market is, pathetic.
A newspaper here reports it's Lipitor (a deal with Ranbaxy).
I'm way out of my depth here but under the 35 U.S.C. 271 (g)(1) saying "it is materially changed by subsequent processes", I think Teva (or others) can use the methods in part of the manufacturing process say from step A to C of the manufacturing process, in EU where there's no patent protection and then take the product which is not yet the final one and continue from there differently even in the US, the final product may be considered 'materially changed' and may not infringe on the US patent of the analyzing method. This is of course all mute until Teva or others will get an FDA approval, if they will. What I find interesting is why was that EU patent I've found withdrawn. Perhaps because generic Lovenox needs to go through clinical trials in EU.
MNTA needs only one blocking patent to prevent a generic Lovenox from launching
Vpriv sales up to $65M in Q311.
Randall Stanicky, an analyst at Canaccord Genuity:
some very positive catalysts into the year end
Do you know Dr. Ayalew Tefferi? I had a first hand experience in which I felt he was rushing ahead in a way I consider to be careless. I know it's just one case still, I guess that's why I wasn't surprised to see his name on that NEJM correspondence.
Full data on Sarilumab phase 2b MOBILITY trial in RA at ACR (abstract):
http://acr.confex.com/acr/2011/webprogram/Paper24502.html
Questioning malaria vaccine trial
http://www.nature.com/news/2011/111026/full/478439a.html
NVA237 (COPD) will require additional clinical data to support submission in the US and thus will be delayed. As a result of NVA237 delay in the US, QVA149 submission is also delayed in the US.
The SOM230 NDA submission was withdrawn:
In the US, the SOM230 application that had been submitted in June was withdrawn due to an issue related to chemistry, manufacturing and controls (CMC).
Serious AEs occurred in 4.9% of VX-509 and 2.4% of placebo subjects, with serious infection in 3.1% of VX-509 subjects and none in placebo.
Biogen is also trying to protect their avonex franchise with PEG-Avonex.
The burden of proof is on proving superiority. All they can say now if they are both superior to PBO. From a sales and marketing standpoint, that's a big difference.
All told, I do not expect the CONFIRM study to have much impact, if any, on Copaxone sales.
The fact that BG-12 was not statsig better than Copaxone in the CONFIRM study does not mean that BG-12 isn’t better.
So far, BG-12 safety profile is far better than Gilenya's. My bet is BG-12 will become the oral MS market leader, pending any unforeseen safety issues.
SubQ vs IV ERT delivery:
I was more curious if sub-q delivery would increase or reduce side effects (primarily site reactions).
ILMN reports a restructuring
Given the uncertainties associated with academic and government research funding and the global economic environment, the company is implementing a restructuring to better align the company’s organization and cost structure. As a result, the company expects to record a restructuring charge of approximately $15-17 million, the majority of which will be recorded during the fourth quarter of 2011
But my understanding is you must show both - merit of the case and irreparable harm, in order to get an injunction and if the launch of AG hurts the irreparable harm argument then the other argument cannot win.
ERT delivery
Like I've replied to jq, if Halo can deliver large volumes without causing frequent injections problem, I think sub-q ERT is doable. I guess the more important issue with ERT is protecting them from the impediments they are prone to in the blood and to improve half-lives, bioavailability and uptake by target tissues and cells. So studies were focused mostly on different carriers (with limited success though).
Yes, unlike Shire, PLX missed a great market opportunity with their ERT for Gaucher. The rest of the pipeline is still early (except for PRX-105 but I don't remember seeing any progress with it).
Yes, there's the local Israeli market for starters and other price sensitive countries where they can compete but altogether I would be surprised if they can take more than 15% share in time.
ERT are relatively large substances and not too stable at 37°C and at the neutral pH of the blood and proteases so they have short circulating half-lives and poor bioavailability. Obviously, that's why patients get large amounts of the enzyme. If vol isn't an issue, I don't see why sub-q delivery wouldn't work.
Yes, I have a reasonable amount of confidence that PLX's taliglucerase alfa gets approved on the re-submission. I am however less optimistic about the prospects of the drug in taking market share than I was before the delays.
Not that I have something against iBio's plant production system, quite the contrary, but once again (first time was when a paid promoter of iBio posted that the iBio has a more versatile technology than Protalix does), I would like to comment on a careless sentence:
PLX is 20 years in the past
ERT delivery
I'm not aware of any sub-q work with ERT, It will be very difficult to do as the volume is huge and so, if it requires more than say a daily injection in a physician's office then not viable commercially speaking. There are attempts to improve delivery/efficacy of ERT via encapsulation within liposomes or RBC, but didn't see any of these strategies moving to the clinic. Except for the intrathecal delivery for ERT that you've mentioned, PLX is working on oral ERT but very early in development. Genzyme and Amicus as we've discussed elsewhere, are working on oral small molecules, which are not ERT and I'm quite optimistic at least with one, but you know that too