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I'm on it.
Would you like a foot massage as well?
I think this may help
http://www1.easl.eu/easl2011/program/Posters/
The yahoo poster is correct.
http://www1.easl.eu/easl2011/program/Posters/Abstract8.htm
It seems that nothing is going right for JNJ these days
In Europe, Firazyr only sold $15M worth in 2010 but this should help sales:
European Commission Approves Self-Administration Label for FIRAZYR(R) (icatibant) for the Symptomatic Treatment of Acute Hereditary Angioedema Attacks
http://www.prnewswire.com/news-releases/european-commission-approves-self-administration-label-for-firazyrr-icatibant-for-the-symptomatic-treatment-of-acute-hereditary-angioedema-attacks-117306118.html
Some good news for PDLI - it settled a few patent litigation and its '216B Patent was upheld.
http://phx.corporate-ir.net/phoenix.zhtml?c=100463&p=irol-news&nyo=0
FRX/Daxas
First, Forest was smart to propose a narrow label indication, that's how the modest efficacy issue was precluded. Second, there's a need for a treatment other than corticosteroids with their pneumonia risk, that reduces exacerbations in severe COPD patients.Btw, Advair in COPD wasn't approved smoothly, FDA issued an approvable letter after the panel raised questions on efficacy vs SE of steroid especially in older patients.
Forest/Nycomed - Daxas approved by the FDA in severe COPD
http://www.bloomberg.com/news/2011-03-01/forest-nycomed-win-fda-approval-for-daliresp-lung-medicine-1-.html
I never thought this U.S. patent No. 5,908,838, which expires in 2018, and relates to the use of the Solodyn unique dissolution rate is very strong as it was rejected and then reexamined but I guess it is very hard to circumvent the claims and get a bioequivalent drug.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/PTO/search-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=5908838.PN.&OS=PN/5908838&RS=PN/5908838
I'd say 30-45 days.
Israeli regulator will not approve before an FDA approval but there's a chance the EMEA will (we should know by the end of March 2011). Don't know about ANVISA (the Brazilian agency) policy, so no handle on this.
how MRX has protected the Solodyn franchise from genericization
The link below can serve as our Scientific Meeting Calendar and only needs to be updated by the month:
http://www.eurekalert.org/calendar.php?month=3&type=meet
Ikaria will start pivotal trial with IK-5001 (a.k.a. BL-1040 from BioLineRx) in mid 2011.
http://www.clinicaltrials.gov/ct2/show/NCT01226563?term=IK-5001&rank=1
No need to listen since you did
Thanks.
Did you listen to the latest CC? I believe this was mentioned:
... Congratulations, Jonah, on the settlement. I just wanted to ask about the remaining doses. I believe Lupin has first to file on the 55 milligram and I believe you've reached settlements with Ranbaxy on the 80 milligram and Novartis on the 105 milligram, but that's never been fully disclosed, I guess to the same extent that you've just released on the Teva settlement...
PLX delay
gives Genzyme time to get their Manufacturing in order and get their oral product that much closer to the market
Solodyn has four that I know of:
Teva holds first-to-file exclusivity on the 65 and 115mg doses, Lupin on the 55mg dose, Ranbaxy on the 80mg dose, and Novartis/Sandoz on the 105mg dose.
Cerezyme will probably lose market share in cost-sensitive regions. I still expect it to keep at least 70% longer term in two-drug market, and at least 50% in three-drug market.
I think most (perhaps all) ERT's in general have some degree of antibody formation.
I wouldn't dismiss Shire's drug already. Genzyme resumed full supply of Cerezyme market and yet about 1,000 patients were on Shire's Vpriv by end of 2010 and Shire stated in its last CC that they see a very low rate of switchbacks to Cerezyme. Bear in mind that Shire is at nearly max current manufacturing capacity for Vpriv, reimbursement takes time and Vpriv's home infusions problem was just resolved lately.
One patient developed non-neutralizing IgG antibodies to taliglucerase at the end of the study
Yes, lower is better.
Assuming a six month (Class II) review, launch will be delayed to early 2012. We'll know more on the timeline after PLX will meet with the FDA to discuss the CRL.
Schizophrenia gene?
http://www.nih.gov/news/health/feb2011/nimh-23.htm
The site www.ncbi.nlm.nih.gov IP Address 130.14.29.110 is unpingable but it loads just fine for me with the usual chrome speed.
VRTX/VX-770 in CF
I'd say data are stellar for G551D mutation carriers, and there's still hope for the F508del mutation carriers that the VX-809/VX-770 combo therapy will work with acceptable safety profile.
After all you're not as lazy as some people say
On a serious note, I'm aware of the fear physicians and patients might have because uplyso is produced in plant cells. Reminds me of a discussion we had on Roy's board a while ago regarding the fear from GM plants.
On the Brazil label issue I think there's a draft version of the label not a final one. If we look at the clinical data, PLX' drug had lower antibody and similar hypersensitivity rates compared to Cerezyme, so there's no reason that I can see for a different label.
Shire booked sales of $59M for Vpriv (velaglucerase for Gaucher) in Q410. Shire also sees very low switch-back to Cerezyme.
Kamada is going to start a phase I/II safety and preliminary efficacy clinical trial of its IV Alpha-1 Antitrypsin (AAT) in type 1 diabetes. A couple of more recent basic research works in the area:
http://www.ncbi.nlm.nih.gov/pubmed/21099312
http://www.ncbi.nlm.nih.gov/pubmed/20692406
Baxter's Aralast is being tested by the NIAID for that indication: (looks like the trial is still in its first part (safety))
http://clinicaltrials.gov/ct2/show/NCT01183468
There is one commercial company trying to pursue the area:
http://www.omnibiopharma.com/development
Sorry if that isn't clear but the phrase "Teva's generic is different from Lupin's." is definitely the analyst quoting the CFO not something the analyst interpreted.
Yes, but that's the translation.
This part:
He knows about the "rumors".
Teva normally do not discuss its API suppliers or product sources.
About 40% of this generic product comes from out source.
He knows ItalFarmaco and its drug marketed in India by Lupin.
Teva's generic is different from Lupin's.
For reasons unclear to me our moderator thinks I have offended you with my reply as he feels it was ridiculing your post. I honestly have no idea what makes him see it this way, but if he is correct, do know it wasn't my intention and my apology to you.
I'm sure there was no webcast. Suppose there's no transcript either (not certain about that but I'm pretty sure there are analysts notes from the meeting). Still, it's not like it the CFO was whispering to the analyst ear in some dark alley. Do you really believe he would dare laying in an analysts meeting, knowing "it's not a 'public forum' according to a definition that’s germane to investors", and the only evidences is a hearsay? Seems very unlikely to me. While you have the word of an anonymous source, who told you in private. I have the CFO answer given to an analyst who emailed me. I think I'll stick with the latter.
Sorry but what your source says, that Teva’s Lovenox has a different name—it’s not called Lupenox—and it has different packaging and nothing else about Teva’s Lovenox is different from Lupenox, that sounds like nonsensical to me. Time will tell.
PS I do believe the analyst met the CFO in public when the Lupenox question was asked.
PDSV/ALIM Iluvien
It's not like efficacy is their only problem. Safety issues - high rate of cataract and IOP are also (not surprisingly) there.
Merck ended its alliance with Galapagos. Merck will make a final payment of €12 million and Galapagos will look for another partner.
http://www.reuters.com/article/2011/02/04/galapagos-idINLDE71304Q20110204