The deal comes as Dermira plans to initiate Phase III studies in the U.S.
Spain-based Almirall S.A. announced it will exercise its option to license the rights to Dermira, Inc.’s Phase III-ready lebrikizumab for the treatment of atopic dermatitis in Europe. The news caused shares of Dermira to jump more than 10% in premarket trading, wiping out Monday’s losses.
Almirall will develop and commercialize lebrikizumab, a novel, injectable, humanized monoclonal antibody designed to bind interleukin-13 (IL-13), in Europe for atopic dermatitis, as well as other unnamed indications, the company said this morning. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis.
Tom Wiggans, chief executive officer of Dermira, said his company was excited about the partnership and the chance to potentially bring the experimental treatment to patients in Europe through the partnership with Almirall. The two companies first entered into an agreement earlier this year. In February, Almirall paid Dermira $30 million to license the drug. Dermira licensed lebrikizumab from Roche in 2017.
Under the new agreement, Almirall will pay Dermira an additional $50 million and California-based 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 III clinical studies. For Dermira, the deal could generate up to $85 million upon the achievement of regulatory milestones and the first commercial sale of lebrikizumab in Europe. Dermira will also be entitled to receive milestone payments upon the achievement of certain thresholds for net sales of lebrikizumab in Europe, as well as royalty payments representing percentages of net sales that range from the low double-digits to the low twenties.
Almirall’s decision to exercise its options follows positive topline results reported by Dermira in March from a Phase IIb dose-ranging study that showed all three doses of lebrikizumab met the primary endpoint. The medication 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 remained consistent and Dermira said the findings suggest lebrikizumab has the potential to be a best-in-disease therapy for people living with moderate-to-severe atopic dermatitis. In the U.S., Dermira plans to initiate Phase III development of lebrikizumab by the end of 2019.
“The unique characteristics of lebrikizumab and positive findings observed in our Phase IIb dose-ranging study suggest that we have the potential to offer people living with moderate-to-severe atopic dermatitis, and the healthcare practitioners who care for them, a differentiated treatment option that delivers a compelling combination of safety, efficacy, tolerability, convenience and ease of use,” Wiggans said in a statement.
Peter Guenter, Almirall’s chief executive officer, said his company is excited about its collaboration with Dermira on the lebrikizumab clinical development program. In Europe, Almirall believes lebrikizumab could achieve peak sales of around €450 million (about $512 million).
“This transaction reinforces our shared commitment to the dermatology community and supports our vision of offering truly meaningful, new treatment advances to people living with chronic, life-altering skin conditions,” Guenter said in a statement.
