Memorandum

Novartis' Lucentis gains Japanese indication for diabetic macular edema – February 25, 2014

Novartis announced last week that its multibillion-dollar anti-VEGF therapy Lucentis (ranibizumab) has been approved by Japanese regulatory authorities for the treatment of diabetic macular edema (DME), matching company guidance from its 4Q13 update for approval in 1H14. The indication was granted following the positive results of the REVEAL trial, which tested the efficacy and safety of Lucentis in Asian populations (including Japanese patients). The study found that Lucentis 0.5 mg was superior to laser therapy and was well tolerated, results similar to those seen in studies with primarily Caucasian populations. DME is Lucentis' fourth indication in the Japanese market. Worldwide, Lucentis' performance has been somewhat sluggish in recent months due to competition from Bayer's Eylea - see our Novartis 4Q13 Report for more details.