) recently received positive news when the European Commission
(EC) approved its ophthalmology drug, Lucentis, for an additional
Lucentis is now approved to treat patients with visual
impairment due to choroidal neovascularization (CNV), secondary
to pathologic myopia (myopic CNV) in Europe.
We remind investors that EU approval was expected as the
Committee for Medicinal Products for Human Use (CHMP) had
rendered a positive opinion for the label expansion in May
The approval was based on encouraging data from a phase III
study, RADIANCE. It was observed in the study that Lucentis
provides superior improvement in visual acuity as compared to
Visudyne in patients affected with myopic CNV.
Moreover, the study also showed that Lucentis' safety profile
was consistent with other studies.
Lucentis is already approved for wet age-related macular
degeneration (AMD). It is also approved for the treatment of
visual impairment due to diabetic macular edema (DME) and macular
edema secondary to retinal vein occlusion (RVO).
We note that Novartis has a collaboration agreement with
) Genentech for Lucentis.
While Roche holds the commercial rights for Lucentis in the
US, Novartis holds the rights to develop and market Lucentis
outside the US.
We remind investors that Novartis also pays royalties to Roche
on net Lucentis sales outside the US.
Lucentis, one of the key drivers of revenue growth for
Novartis in 2012, generated sales of $2.4 billion, up 22%.
Label expansion for the additional indication will further
boost sales of the drug, which bodes well for both Novartis and
We note that
) Macugen is also approved to treat wet AMD.
Novartis currently carries a Zacks Rank #3 (Hold). Right now,
) looks attractive with a Zacks Rank #2 (Buy).
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