Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 321

Almirall Exercises its Option with Dermira to License Rights to Lebrikizumab in Europe for atopic dermatitis

Posted by fidest press agency su mercoledì, 26 giugno 2019

Almirall, S.A. (ALM) and Dermira, Inc. (NASDAQ: DERM) announced today that Almirall has exercised its option to license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and certain other indications in Europe. Almirall and Dermira previously entered into an option and license agreement in February 2019 pursuant to which Almirall was granted this exclusive option in exchange for an upfront option fee of $30 MM. As a result of Almirall’s decision to exercise its option, the company will pay Dermira $50 MM and Dermira will be eligible to receive additional payments upon the achievement of certain milestones, including $30 million in connection with the initiation of certain Phase 3 clinical studies.Almirall’s decision follows positive topline results reported by Dermira in March 2019 from a Phase 2b dose-ranging study that showed all three doses of lebrikizumab met the primary endpoint, and demonstrated dose-dependent improvements across a range of measures characterizing the signs and symptoms of moderate-to-severe atopic dermatitis, including itch and skin inflammation, compared to placebo. The safety profile observed in the study was consistent with prior studies of lebrikizumab. The findings suggest that lebrikizumab has the potential to be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis. Following an end-of-Phase 2 meeting with the U.S. Food and Drug Administration, Dermira plans to initiate a Phase 3 clinical development program for lebrikizumab by the end of 2019.
Lebrikizumab is a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13) with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening and infection.


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