NVS' Lucentis Gets EU Backing - Analyst Blog

Novartis AG (NVS) recently announced that it has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for approving eye drug Lucentis for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO) in Europe.

The recommendation was based on data from the CRUISE and BRAVO phase III trials, which showed that Lucentis was more effective than current standard of care at 6 and 12 months of treatment. Lucentis improved vision and vision related quality of life in patients with visual impairment due to macular edema secondary to both branch-RVO (BRVO) and central-RVO (CRVO).

Lucentis is already approved in the US for the treatment of macular edema following RVO. Lucentis is currently marketed for treatment of wet age-related macular degeneration and visual impairment due to diabetic macular edema.

The drug was developed by Novartis in partnership with Roche Holdings (RHHBY).  Roche holds the US marketing rights of the drug.

RVO is caused by a blockage in a blood vessel in the retina which can lead to swelling of the macula. Macula is the central portion of the retina. This swelling of the macula, also called macular edema, is the most common cause of visual impairment in patients with RVO.

We believe that this new use of Lucentis will lead to increased sales.

Our Recommendation

Currently, we have a Neutral recommendation on Novartis, which is supported by a Zacks #3 Rank (short term “hold” rating). We are pleased with Novartis' wide range of products and its efforts to diversify further as is evident by the acquisition of a majority stake in Alcon (ACL). Novartis is looking to acquire the remaining stake in the eye-care company.  However, we prefer to remain on the sidelines due to the imminent patent cliff faced by Novartis.