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Wednesday, 01/19/2011 3:03:50 AM

Wednesday, January 19, 2011 3:03:50 AM

Post# of 80490
Barclays addresses the 3 week issue this morning:
We are reiterating our 1-Overweight rating on shares of ARIA following today's conference call to review positive SUCCEED data for ridaforolimus in sarcoma. With focus on clinical relevance of a 3-week PFS benefit we believe that investigator assessed PFS of ~8 weeks is more likely to reflect clinically relevant progression than central radiographic review and to track with both cancer related symptom progression and overall survival trends. We expect detail of data at ASCO in June to be better than the headline and would buyers on today's muted reaction.
ARIA hosted a conference call earlier today to review positive top-line results from the phase 3 SUCCEED study of ridaforolimus in patients with advanced Sarcoma. Results of the n=711 patient study suggested a statistically significant 28% reduction in risk of progression (p=0.0001) with median increase of 3.1 weeks vs placebo by central radiographic review. Of note, PFS by investigative site suggested a greater 52% benefit in PFS of 7.7 weeks.
With focus on clinical relevance of a 3.1 week PFS benefit we would note the approval of Tarceva for NSCLC maintenance therapy on ~1 month benefit and on ~2 week benefit in pancreatic CA. We expect significant focus on secondary endpoints of overall survival (OS) and cancer related symptoms and believe that clinician rated progression is likely more indicative of overall patient benefit on these metrics than that from centralized radiologists. Based on Sarcoma natural history we expect >50% of deaths to occur before ASCO and for sufficient detail to support regulatory filing in 2H11.

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