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BG-12 launch - I just saw the standard review PR (http://www.biogenidec.com/press_release_details.aspx?ID=5981&ReqId=1694087). Was thinking there was still a small chance for priority review timeline.
Indeed and I expect the new CEO to continue in this path.
Another note is that Copaxone sales for Teva are now 18% down from 21% in 2011.
Yes, assuming no generics and no BG-12 launch mid upper bound should be met.
Novartis does not generally comment on the filing of an NDA for low profile drugs so we'll probably won't be able to find their answer but I don't think the withdrawal of NDA for SOM230 is related to the LAR formulation. The LAR formulation trial in Cushing's is few years behind and they still have ongoing trials with the S.C formulation so my guess is NVS will re-file with added data from those trials. Btw, they filed in the EU in late 2010 and approved in early 2012, isn't that a bit long?
Nitpick: Signifor was approved in the EU in Apr 2012 (not 2011).
KERX will burn less as they returned perifosine back to AEZS.
Suggest the late CYPB/BLRX deal on BL-1020 qualifies if you accept the royalties of 12 to 18 percent based on sales part.
http://www.biolinerx.com/default.asp?pageid=16&itemid=47
Typical or not, they certainly do not signal high confidence in the future share price.
The CEO also has some shares shares left (#msg-75254736)
I see no reason why subQ formulation of C1-INH would not work for prophylaxis but don't think it would work in acute treatment cause mean Cmax of C1-INH plasma activity is reached several minutes after IV and many hours after subQ administration.
If CSL Behring gets the subQ formulation before 2015, would it break VPHM's orphan drug marketing exclusivity?
Agree on jq's comments that Replagal's clinical data are problematic. I had thought that post approval data from 8 years of use in EU plus Replagal's treatment protocol approved by the FDA for compassionate use on top of GENZ's contamination issue/market shortage altogether, would have satisfied the FDA this time around.
And I wouldn't bet on that batting average
I also thought Replagal had a very high chance of approval this time. Nice to be wrong with a good company such as you
Btw, EMA granted Replagal approval under ‘Exceptional Circumstances’ as well.
I see that you've noticed they were both approved on the same day so no need for the link below
http://www.orpha.net/orphacom/cahiers/docs/GB/list_of_orphan_drugs_in_europe.pdf
In EU, Fabrazyme and Replagal applications were submitted on the same week for EMEA approval and were approved on the same day with co-exclusivity marketing authorisations. In the US, applications were submitted on the same month but the FDA approved Fabrazyme first and with approval came orphan drug marketing exclusivity that TKT since had to break.
There are several ways to break such exclusivity - if the new drug is better or safer or if there is a shortage and patients cannot get treatment, are few ways. Cerezyme shortage is not entirely over plus Shire has reached its capacity limit, so seems to me as a valid claim. I most certainly agree on the 2nd claim being a stronger one. Just hope PLX people read this
Just to be clear, although there are a couple of strategies to try and work around AMGN's Enbrel patent #8,063,182, I am quite certain Protalix won't be able to do so.
The very obvious claim would be that there's still a shortage of supply in EU.
How about another claim - Vpriv's orphan marketing exclusivity may not be relevant to Protalix' drug because it refers to 'the same drug or biologic' and Elelyso isn't a biosimilar nor biogeneric version to Shire's drug.
Are you working under cover for Amgen or what?
Think there's a very good chance of bypassing Vpriv EU exclusivity.
PRX102 for Fabry is very much straightforward and path is quicker therefor agree it is more important at this point.
I can think of a couple but I imagine Protalix thinks that since the claims covering Enbel’s composition in patent #8,063,182 are specific to production of the protein in CHO cells (see for example claim #8), they might work around the AMGN patent by producing it in plant cell.
Shire/Vpriv
The same facility in Lexington received a CRL from the FDA a week ago.
PLX
Just heard their CEO talk and he said they are awaiting EU approval for Elelyso despite of Shire's orphan exclusivity there (for background see #msg-72258978). Another note is they are planning to enter the clinic with PRX-106 (anti-TNF fusion protein) later this year, despite of Amgen's new patent related to Enbrel.
Suvorexant profile looks suitable for chronic use and I assume its side effect data are better due to its shorter t½ than that of the now discontinued almorexant from GSK/Actelion.
The suvorexant data were released as you expected:
http://www.journalsleep.org/Resources/Documents/2012abstractsupplement.pdf
I've searched the PDF for "suvorexant" and found 3 abs o641, 0656, 0670, on pages A217, A222, A226, respectively. SE data seems very good to me. There's also one abs on the backup compound MK-6096 (in phase II).
GPRO will be acquired by HOLX for $82.75 a share in cash (20% premium to Friday's close.).
http://finance.yahoo.com/news/gen-pro-soars-hologic-buyout-122654570.html
PKI first-quarter revenues rose 14% YOY
http://www.reuters.com/article/2012/04/26/perkinelmer-idUSL2E8FQI3N20120426?feedType=RSS&feedName=technologySector&rpc=43
This observation was known from the post-treatment phase of ROCKET-AF and is reflected in the new Xarelto label that includes a black box warning about discontinuation and explanations (in the guide) on the need to consult a doc before discontinuing the drug plus instructions on switching and transitioning:
http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100
Also note that the big difference Piccini et. al. talk about was at the end of the study when blinded transition to open label warfarin occurred, probably because patients were insufficiently converted to warfarin i.e without proper bridging of anticoagulation coverage during the transition to a therapeutic INR.
Plavix is going generic in the US next month, that will make things even harder for the “next” Plavix. Perhaps it will take a few more years and more data like from this big CV outcomes study AZN is conducting http://clinicaltrials.gov/ct2/show/NCT01225562 to make the “next” Plavix a huge-selling drug.
FURX IBS-d drug (mudelta) note
You should also look at the additional analyses, based on the new FDA’s 2010 guidance.
http://www.furiex.com/pipeline/mu-delta/