Roche's lampalizumab flops in Phase III GA study

Roche’s (ROG: SIX) shares took a 2% negative hit on Friday, when the Swiss pharma giant revealed that its first Phase III clinical trial, dubbed Spectri, assessing lampalizumab for the treatment of geographic atrophy (GA) due to age-related macular degeneration (AMD) failed to meet its primary endpoint.

Spectri is the first of two phase III studies evaluating the safety and efficacy of lampalizumab. The negative outcome is a setback for Roche, which has been counting on the monoclonal antibody to be one of its growth drivers as it faces generic competition for some of its biggest-selling cancer drugs.

According to average estimates collected by Reuters, Lampalizumab had been forecast by analysts to hit $1.5 billion in annual sales by 2023, if it wins regulatory approval. Now, some analysts who had been counting on even more are already writing it off, even before the second trial, according to a Reuters report. “There appears little scope for a positive outcome given the identical design of both trials,” said Deutsche Bank’s Tim Race, who had estimated peak annual sales exceeding 2 billion Swiss francs ($2.08 billion).