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DewDiligence

02/07/13 7:54 PM

#156658 RE: masterlongevity #156656

The salesforce that AMGN uses for (branded) Enbrel will clearly not be the salesforce used to detail the FoB's for Humira and Remicade!
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DewDiligence

10/29/13 4:21 PM

#168916 RE: masterlongevity #156656

AMGN starts two phase-3 trials of Humira FoB called APB 501:

RA; 500 patients; expected completion Apr 2015:
http://clinicaltrials.gov/ct2/show/NCT01970488

Psoriasis; 340 patients; expected completion Aug 2015:
http://clinicaltrials.gov/ct2/show/NCT01970488

ACT is a partner on this FoB program; AMGN is responsible for manufacturing and clinical trials, while ACT pays a portion of the development costs (#msg-70097496).
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DewDiligence

09/23/15 10:03 AM

#195231 RE: masterlongevity #156656

AMGN/AGN report positive phase-3 data for Avastin FoB:

http://finance.yahoo.com/news/amgen-allergan-announce-positive-top-130000816.html

The primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared to bevacizumab, showing clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. Secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).

AMGN and AGN are also collaborating on FoBs for Rituxan, Herceptin, and Erbitux (#msg-70097496). Although it was previously reported that AMGN and AGN were also collaborating on FoBs for Humira and Remicade (#msg-84340328), AMGN is now developing those programs on its own (#msg-110547164).