Production & Manufacturing

Roche agrees to sell eczema drug rights to Dermira

PBR Staff Writer Published 09 August 2017

Dermira has signed a licensing agreement with Roche to secure exclusive rights to lebrikizumab, a monoclonal antibody targeting interleukin 13 (IL-13), for atopic dermatitis and all other indications.

Lebrikizumab is a novel and humanized monoclonal antibody designed to specifically block the action of IL-13, a cytokine that is a central pathogenic mediator in atopic dermatitis.

Roche will hold certain rights for lebrikizumab, including exclusive rights to develop and promote lebrikizumab for interstitial lung diseases such as idiopathic pulmonary fibrosis.

As per terms of the agreement, Roche will receive an initial payment of $80m and payments totaling $55m in 2018.

Dermira will also make additional payments based on the achievement of certain milestones, including $40m upon the initiation of Dermira’s first Phase 3 clinical study.

The deal will also include the payment of up to $210m upon the achievement of regulatory and first commercial sale milestones in certain territories, as well as up to $1.02bn based on the achievement of certain thresholds for net sales of lebrikizumab for indications other than interstitial lung disease.

Two exploratory phase 2 clinical studies, including Treble and Arban, assessed the safety and efficacy of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis.

Dermira intends to start a phase 2b dose-ranging trial for the evaluation of lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018.

The trial’s objective is to enhance the dose of lebrikizumab for the design of a phase 3 program.

Subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, the deal is expected to complete in the third quarter of this year.

Dermira chairman and CEO Tom Wiggans said: “Atopic dermatitis is one of the most common skin diseases in the world, affecting millions of adults and children, and moderate to severe forms of this condition present a tremendous burden for patients.”

Dermira chief medical officer Eugene Bauer said: “Lebrikizumab is a potent and specific inhibitor of IL-13 with a differentiated mechanism of action and attractive pharmacokinetic properties.”

Image: Site Roche Basel. Photo: courtesy of F. Hoffmann-La Roche Ltd.