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Agreements

Date: 2016-09-28

Type of information: Licensing agreement

Compound: nemolizumab (CIM331)

Company: Chugai Pharmaceutical (Japan) Maruho (Japan)

Therapeutic area: Dermatological diseases

Type agreement:

licensing

Action mechanism:

monoclonal antibody. Nemolizumab is an anti-IL-31 receptor A humanized monoclonal antibody, currently under development for the indications of atopic dermatitis and pruritus in hemodialysis patients by Chugai. Nemolizumab was created by Chugai utilizing its proprietary antibody engineering technology called ACT-Ig, which can extend the biological half-life of antibodies in the blood. IL-31 has been identified as a pruritogenic cytokine, and reported to be involved in the generation of pruritus in atopic dermatitis and hemodialysis. Nemolizumab is designed to inhibit the biological activities of IL-31 by competitively blocking binding with its receptor. 

Disease: skin diseases

Details:

* On September 28, 2016, Chugai Pharmaceutical and Maruho announced that they have entered into a license agreement where Chugai grants Maruho the rights for the development and marketing of “nemolizumab” (CIM331) in the skin disease area for the Japanese market. Nemolizumab is an anti-IL-31 receptor A humanized monoclonal antibody, currently under development for the indications of atopic dermatitis and pruritus in hemodialysis patients by Chugai. Chugai has obtained positive results for both efficacy and safety at 12 weeks in a global phase ll study with moderate-to-severe atopic dermatitis patients in five countries including US, Europe and Japan. Currently, a phase ll study for pruritus in hemodialysis patients is ongoing in Japan as well.

Under the agreement, Chugai will grant Maruho a license for the development and marketing of nemolizumab for the skin disease area in Japan. Chugai will continue to be responsible for product manufacturing and supply of nemolizumab. Under the terms of the agreement, Chugai will receive an upfront and other payments from Maruho. The development and marketing of nemolizumab for pruritus in hemodialysis patients will be continued solely by Chugai.

For the overseas market, Chugai has out-licensed nemolizumab to Galderma Pharma and granted it an exclusive license for the development and marketing of the drug worldwide, with the exception of Japan and Taiwan.

 

 

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