Industry Trend Analysis - Almirall On Course To Adopt Leading Position In EU Dermatology Market - SEPT 2017


BMI View: Skilarence will capitalise on an existing but underutilised psoriasis product market; unlike the existing dimethyl fumarate product, Fumaderm, it will be available as a licensed medicine across the EU. The approval boosts Almirall's Dermatology segment, increasing its position as the firm's most important therapy area. Further revenues can be anticipated through Almirall's agreement with Sun Pharmaceutical Industries regarding tildrakizumab, the EU filing for which is progressing.

The EC has approved Almirall's Skilarence, a new oral formulation of dimethyl fumarate, for the treatment of patients with moderate-to-severe chronic plaque psoriasis. Skilarence is to be indicated as a first-line induction and long-term maintenance treatment. Almirall anticipates marketing the product in all EU member states, as well as in Iceland and Norway, from Q317.

Skilarence is the first fumaric acid ester for the treatment of psoriasis to be approved by the EC. Its approval in Europe is based on the positive results from the randomised, double-blind, placebo-controlled Phase III trial (BRIDGE), evaluating the efficacy and safety of this new oral formulation of dimethyl fumarate compared to Fumaderm, presented in September 2016 at the 25th EADV Congress in Vienna, Austria. The BRIDGE trial showed the non-inferiority of dimethyl fumarate compared to Fumaderm and a good efficacy and safety profile.

Dermatology Franchise Of Growing Importance To Almirall
Almirall's Financial Results (EURmn)
Source: Almirall, BMI

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