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I think that LLY's BACE inhibitor is already in phase II and so it leads the way:
http://clinicaltrials.gov/show/NCT01561430
Everyone (including me) viewed solanezumab (which binds to the mid domain of A-beta, not to the N-terminus) as safer but less effective than bapineuzumab, but then there was no efficacy signal with bapi... so who knows which mAb will be the winner. I give my vote to the IgG4 one - crenezumab.
Indeed, "Lilly is further behind the rest of the field in planning or thinking on early AD or Prodromal AD or asymptomatic" but they intend starting phase II with their BACE inhibitor, probably in pre-AD patients with MCI. So it will be their first move in this early stage territory, screening patients by PIB-PET imaging.
If there's no clear correlation between biomarkers data and improved cognitive endpoints, sola is dead.
If there is a correlation, another clinical trial would be required, likely in prospectively defined mild AD or prodromal AD (in case the effect is too small in mild, I think they should test in earlier stage AD patient population than those enrolled in the EXPEDITION trials - say MMSE scores of 24-30 and high biomarkers, also cause seems to me the FDA is getting more receptive to accept biomarkers as efficacy endpoint), so they have a better shot to demonstrate sufficient disease modifying efficacy.
On "solanezumab is not dead yet" issue
Agree on both your points - there is a small signal, probably not clinically significant but could be disease modifying.
I'm thinking: if the effect correlates with the biomarkers, it would be worth trying another trial perhaps in prodromal AD patients and negotiate with the FDA on using these biomarkers along with cognitive measure as efficacy endpoints.
Ok, you win.
(how come you get all the hot women in your camp?)
Not all bad, FRX is up nicely :)
Peter and myself are in your camp #msg-78897276 #msg-78916470
INCY's CCO Andrews Resigns
http://www.streetinsider.com/Management+Changes/Incyte+Corp.+(INCY)+CCO+Andrews+Resigns/7693805.html
I think we've mentioned before that the meaning of this biosimilar product for Teva is just that it's their first BLA application in the US. Other branded generic versions of G-CSF, which have been launched in the EU also have had very limited commercial success (like you said, they aren't interchangeable plus Amgen gave them a fight reducing prices).
Teva’s Neopogen biosimilar=Tbo-filgrastim approved:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317392.htm
Already in the market in EU (Tevagrastim), will not enter the US market before November 2013 (settlement with Amgen).
Anticoagulation guidelines should be updated soon (probably early next year), the novel anticoagulants will be reflected and their use should be boosted.
http://www.nice.org.uk/usingguidance/commissioningguides/anticoagulationtherapyservice/anticoagulationtherapyservice.jsp
http://www.escardio.org/about/press/press-releases/esc12-munich/Pages/atrial-fibrillation-guidelines.aspx
Just to make something clear: the 7,817 patients with STEMI mentioned in the quote are the major pre-specified subgroup from the ATLAS ACS 2-TIMI 51 study, and similar to the primary analysis of that study (#msg-68953169), Xarelto reduced recurrent CV events in this sub group, but there were also stat-sig more bleeding (major but not fetal), with Xarelto than the placebo.
In DEFINE study anacetrapib also increased HDL-C by 138%, if HDL is active it might compensate, but if the benefit of anacetrapib on reduction in CV events is solely derived from LDL-C reduction, then this of course bearish.
Solanezumab
Similar observation from Eliquis ARISTOTLE trial, see Abstract: 4045
Events after discontinuation of randomized treatment at the end of the ARISTOTLE trial
http://spo.escardio.org/SessionDetails.aspx?eevtid=54&sessId=9505&subSessId=0&searchQuery=%2fdefault.aspx%3feevtid%3d54%26days%3d%26topics%3d%26types%3d%26rooms%3d%26freetext%3dApixaban%2b%26sort%3d1%26page%3d1%26showResults%3dTrue%26nbPerPage%3d20%26scroll%3D534#.UDfkdNbiaJk
European Society of Cardiology (ESC) abstracts are out.
This is the search page:
http://spo.escardio.org/
Seems that AGN is no longer a potential suitor for Ophthotech as they have the dual anti-VEGF-A/PDGF-B DARPin (MP0260) that we amusingly predicted in #msg-76614988. REGN might not need Ophthotech as they are also working on their own anti-PDGF:
Apropos to NVS:
Novartis yanks imatinib PAH NDA; FDA wants more data, cancels AdCom
http://www.pharmalot.com/news/topic/Novartis/
Appeals Court Rules for Myriad on Gene Patents
http://online.wsj.com/article/SB10000872396390443324404577593251249665074.html?ru=yahoo&mod=yahoo_hs
ACOR:
Semi OT on phase II failures potential (perhaps I've posed that two years ago. If so, please del. Btw, FOLD is mentioned).
When failure should be the option
By Gregory A Petsko
http://www.biomedcentral.com/1741-7007/8/61
I'm a bit less bearish than I used to be a couple of years ago as noted here #msg-70875050.
Yes, although I don't know the size of the 'new' indication's market, not going for screening is a huge comedown commercially. I will keep them on my watch list to see the data and will make a decision after that.
GIVN falls 17% today, due to another lackluster earnings report and a neative announcement on PillCam COLON 2 regulatory path:
One more point is that in the failed phase 3 carriers trial, only the lower 0.5mg/kg dose was used, while both the 0.5 and the 1mg/kg were used in the non-carriers trial, so perhaps a bit better chance for the drug to show efficacy. Would like to see the biomarkers data and the mild subgroup, maybe there was a trend there.
Do you think the FDA will allow them to compare only the mild subgroups from all arms to placebo? that may be a big enough sample to show stat-sig.
TEVA - 2Q12 US Copaxone sales reported today by Teva were $701M up from $617M and in today's call the Dr. Levin said it is still growing in unit terms.
I'm in a relatively silent mode cause of a long summer vacation, and yes on PSTI.
MRK/odanacatib
Cool and breathtaking - The Pyrenees.