Switzerland-based pharmaceutical company, Novartis AG ( NVS ) recently announced that positive data on Lucentis was presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). The data presented at the meeting highlights the benefit of individualized treatment and the drug's long-term efficacy and safety profile in patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
In the RESTORE extension study, 240 patients suffering from DME received individualized treatment with Lucentis. Results demonstrated that to maintain mean visual acuity gained in the core study, an average of 3.7 injections and 2.7 injections were required in the 2 nd and 3 rd years, respectively. We note that in the core RESTORE study, patients showed vision gains with an average of 7 injections for a one-year period.
In a separate study, 316 wet AMD patients received individualized treatment with Lucentis, as needed, according to a disease-activity-guided monitoring and treatment algorithm. At the end of 3 years, vision gains similar to pivotal phase III trials MARINA and ANCHOR were observed. Results showed that an average of 16 injections was required during 3 years, which was less than the regimen used in pivotal phase III studies.
Lucentis is currently approved for wet AMD, visual impairment due to DME and visual impairment due to macular edema following retinal vein occlusion (RVO). The drug was developed by Novartis in partnership with Roche Holdings ( RHHBY ). Roche holds the U.S. marketing rights of the drug. In the first quarter of 2012, Novartis recorded Lucentis sales of $567 million, up 30% year over year in local currency.
Though we are pleased with Novartis' wide range of products and its efforts to diversify further, we prefer to remain on the sidelines in the long term. We remain concerned about the patent expirations of key drugs like Femara and Diovan. Thus, we have a Neutral recommendation on Novartis. The company carries a Zacks #4 Rank ("Sell" rating) in the short run.