Novartis reports earnings, Afinitor data

Novartis AG (NYSE:NVS; SIX:NOVN) disclosed in its 2Q10 earnings that Afinitor everolimus plus Sandostatin LAR octreotide missed the primary endpoint of progression-free survival (PFS) vs. Sandostatin LAR alone in the Phase III RADIANT 2 trial to treat advanced carcinoid tumors (p=0.026). The predefined p-value was p=0.024. The pharma said an imbalance in baseline was observed between the two treatment arms and will be further investigated. The double-blind, international trial enrolled 429 patients. Additionally, Novartis said an sNDA for the oral mammalian target of rapamycin ( mTOR; FRAP; RAFT1) inhibitor received Priority Review from FDA to treat subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis (TS). An FDA decision is expected by year end.

Novartis markets everolimus as Certican to prevent transplant rejection in over 80 countries, as Zortress in the U.S. to prevent organ rejection of kidney transplants in adult patients at low to moderate immunologic risk, and a higher-dose formulation as Afinitor in the U.S. and EU to treat advanced kidney cancer. Novartis markets Sandostatin LAR. ...