Chugai and Galderma Establish Partnership

Chugai Pharmaceutical and Galderma Pharma have entered into a global license agreement for nemolizumab (CIM331) the anti-IL-31 receptor A humanized monoclonal antibody created by Chugai, which is currently under development for atopic dermatitis and pruritus in hemodialysis patients.

“This agreement highlights the great expectation for nemolizumab which possesses a novel mechanism of action to improve atopic dermatitis by breaking the itch-scratch cycle,” said Tatsuro Kosaka, president and chief operating officer, Chugai. “Along with Galderma, we are committed to the development of nemolizumab to bring this innovative drug to patients with atopic dermatitis worldwide.”

Under the agreement, Chugai will grant Galderma an exclusive license for the development and marketing of nemolizumab worldwide, with the exception of Japan and Taiwan. Chugai will continue to be responsible for product manufacturing and supply of nemolizumab. Chugai will receive an upfront, milestone and royalty payments from Galderma.

“This new strategic agreement marks another important step in our journey to meet the needs of patients and healthcare professionals all around the world by delivering breakthrough innovative medical solutions along the entire spectrum of technological options,” said Stuart Raetzman, chief executive officer, Galderma Pharma.

Nemolizumab was discovered by Chugai, and uses Chugai’s proprietary antibody engineering technology ACT-Ig, which can extend the biological half-life of antibodies in blood. IL-31 has been identified as a pruritogenic cytokine,1 and reported to be associated with pruritus in many diseases including atopic dermatitis and hemodialysis.2,3 Nemolizumab is designed to inhibit the activities of IL-31 by competitively blocking binding with its receptor. Chugai has obtained positive results in a global phase ll study in patients with moderate-to-severe atopic dermatitis in five countries in U.S., Europe and Japan. Currently, a phase ll study for pruritus in hemodialysis patients is ongoing in Japan.

“Nemolizumab is a new innovative biotherapy candidate which will be developed as a clearly differentiated first in class solution for patients with moderate-to-severe atopic dermatitis,” said Thibaud Portal, vice president, prescription business, Galderma. “This first foray for Galderma in the field of biotherapies will be truly transformational for our prescription business and illustrates our ambitions to fulfill all the needs of our patients, from diagnosis to treatment, maintenance and prevention.”