Agreements

Date: 2017-05-10

Type of information: Licensing agreement

Compound: emicizumab (ACE910 - anti-factor IXa x anti-factor X humanized bispecific antibody)

Company: Chugai Pharmaceutical (Japan) JW Pharmaceutical (Republic of Korea)

Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases

Type agreement: licensing

Action mechanism: bispecific antibody. Emicizumab is a bispecific antibody that mimics coagulation factor VIII. The drug is designed to bind factors lXa and factors X, and promotes the interaction between factors lXa and factors X. In doing so, emicizumab provides the cofactor function of factor Vlll in people with hemophilia A, who either lack or have impaired coagulation function of factor Vlll).  It is currently investigated as a therapy for people with hemophilia A. Emicizumab was designated as a Breakthrough Therapy by the FDA in September 2015. This antibody is under co-development by Chugai, Roche and Genentech.

Disease: hemophilia A

Details:

• • On May 10, 2017, Chugai Pharmaceutical announced that it has entered into a license agreement with JW Pharmaceutical for the exclusive marketing right of emicizumab (ACE910) in Korea. Four global phase III clinical studies are currently ongoing as follows:
• HAVEN 1: Evaluating emicizumab dosed once weekly in people 12 years of age or older with hemophilia A and inhibitors to factor VIII HAVEN 2: Evaluating emicizumab dosed once weekly in children less than 12 years of age with hemophilia A and inhibitors to factor VIII HAVEN 3: Evaluating emicizumab dosed once weekly or once every other week in people 12 years of age or older with hemophilia A without inhibitors to factor VIII HAVEN 4: Evaluating emicizumab dosed every four weeks in people 12 years of age or older with hemophilia A with or without inhibitors to factor VIII Korean patients have been enrolled in both HAVEN 1 and HAVEN 3 studies.

Financial terms: Based on the agreement, Chugai will receive upfront, milestone payment and sales-tied royalties.

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