Jefferies Comments On VIVUS Safety Analysis

According to Jefferies, VIVUS VVUS has determined that it is feasible to conduct a retrospective safety analysis (FORTRESS) of commercial topiramate use to rule out risk of birth defects with Qnexa. Jefferies said that VVUS reiterated its refiling guidance of 4Q11. “Although VVUS discussed a new backup strategy to limit Qnexa to men and non-child-bearing women if FORTRESS results are unfavorable, we remain concerned with approvability. Our $3 PT is based on 20X 2016E EPS, discounted 35%. The 20x multiple is in line with small/ mid-cap biotechs. Risks: regulatory approval, patent protection and commercial uptake.” VIVUS closed yesterday at $7.80.