The global, randomized, double-blind, multicenter study was conducted to evaluate the superiority of daclizumab vis-à-vis Avonex, as a potential treatment for relapsing-remitting multiple sclerosis.
The results from the study showed that daclizumab was significantly superior and demonstrated a 45% reduction in ARR compared to Avonex. We note that the primary endpoint in the DECIDE study was the reduction in annualized relapse rate (ARR). On the other hand, although the safety profile of daclizumab in the study was consistent with what was observed in the prior studies, there was an increased incidence of serious infections, serious cutaneous reactions and elevations of liver transaminases in patients treated with daclizumab compared to Avonex.
Based on encouraging data from the study, both Biogen and AbbVie intend to work with regulatory agencies and determine appropriate timelines for filing. The full results from the DECIDE study will be presented at a conference later.
We note that Biogen holds a strong position in the multiple sclerosis (MS) market with drugs like Avonex, Tysabri and the recently launched oral MS treatment, Tecfidera. Tecfidera is off to a strong start in the U.S. and already holds a leading position in the oral MS market.
Meanwhile, Biogen is working on further strengthening its position in the MS market. The company has another candidate, Plegridy, in its pipeline, being evaluated for relapsing forms of MS.
Biogen recently received a boost when the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion for Plegridy.
We believe the successful development and approval of daclizumab and Plegridy will further strengthen its MS franchise.
Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include companies like Gilead Sciences Inc. (GILD) and Allergan (AGN). Both carry a Zacks Rank #1 (Strong Buy).