Roche Starts Trials on Lampalizumab for Geographic Atrophy
Roche (RHHBY) announced that it has initiated two phase III studies on ophthalmology candidate, lampalizumab.
Lampalizumab is being evaluated for the treatment of geographic atrophy (:GA). The two identical phase III trials, Chroma (GX29176) and Spectri (GX29185), will evaluate the safety and efficacy of lampalizumab and its potential to slow the progression of GA.
Both studies will compare the effect of lampalizumab administered every four or six weeks by intravitreal injection to sham injections. The primary endpoint of the studies is to demonstrate a reduction in the rate of GA disease progression while secondary endpoints will assess the impact of lampalizumab treatment on the patients’ visual function.
We remind investors that the primary endpoint of the phase II study, MAHALO, showed a 20% reduction in GA lesion in patients treated monthly with lampalizumab as compared to sham injections at month 18. In addition, data from a sub-population of GA patients receiving monthly lampalizumab who were positive for the complement factor I (CFI) biomarker showed a 44% decrease in the rate of disease progression at 18 months. Hence, Roche plans to further evaluate this exploratory biomarker analysis in its phase III trials.
We note that Roche already has Lucentis in its ophthalmology product portfolio for the treatment of wet age-related macular degeneration (AMD). While the company has rights to Lucentis in the U.S., Novartis (NVS) markets the drug in the rest of the world.
Lucentis is also approved to treat macular edema following retinal vein occlusion (:RVO) and diabetic macular edema (:DME). The drug has generated sales of CHF 828 million in the first half of 2014, up 6% year over year.
The successful development and commercialization of lampalizumab will strengthen Roche’s ophthalmology franchise. We are encouraged by the company’s efforts to expand its portfolio beyond oncology.
Roche, a large cap pharma, currently carries a Zacks Rank #3 (Hold). Some better ranked stocks in the health care sector include Allergan (AGN) and Gilead Sciences (GILD). Both carry a Zacks Rank #1 (Strong Buy).
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