Novartis (NVS) received positive news when its ophthalmology drug Lucentis was approved in Japan for a fourth indication – diabetic macular edema (:DME).
The approval was based on encouraging results from a phase III trial, REVEAL, which was designed to assess the efficacy and safety of Lucentis in patients with visual impairment due to DME in Asia.
The patients in the trial were treated with monthly injections of 0.5 mg Lucentis, 0.5 mg Lucentis along with laser treatment vis-à-vis laser therapy for two months. The treatment continued for twelve months until stable vision was not reached. The results of the trial (n=396) showed superior efficacy of Lucentis with rapid and sustained visual acuity gains compared to laser therapy.
We note that Lucentis is approved for four ocular indications in over 100 coutries: wet age-related macular degeneration (wet AMD), visual impairment due to DME, visual impairment due to macular edema secondary to retinal vein occlusion (:RVO), and visual impairment due to choroidal neovascularization secondary to pathologic myopia (myopic CNV).
We note that Novartis has a collaboration agreement with Roche’s (RHHBY) Genentech for Lucentis. While Roche holds the commercial rights for Lucentis in the U.S., Novartis holds the rights to develop and market Lucentis outside the U.S.
We remind investors that Novartis also pays royalties to Roche on net Lucentis sales outside the U.S.
Lucentis, one of the key drivers of revenue growth for Novartis in 2013, generated sales of $2.4 billion. However, sales in 2013 were up only 1% due to competition and one-time price adjustments on the back of reimbursement expansion for new indications.
Label expansion for Lucentis in additional geographies should boost sales of the drug.