Type of information: Development agreement
Compound: up to three specified therapeutic product candidates for neurodegenerative diseases
Company: Takeda Pharmaceutical (Japan) Denali Therapeutics (USA - CA)
Therapeutic area: Neurodegenerative diseases
Type agreement: collaboration - development - commercialisation
Disease: neurodegenerative disorders, including Alzheimer’s disease and other indications
- • On January 5, 2018, Takeda Pharmaceutical and Denali
Therapeutics announced that they have entered into a strategic option and collaboration agreement to develop and commercialize up to three specified therapeutic product candidates for neurodegenerative diseases. Each program is directed to a genetically validated target for neurodegenerative disorders, including Alzheimer’s disease and other indications, and incorporates Denali’s ATV platform for increased exposure of biotherapeutic products in the brain.
- Denali will be responsible for all development activities and costs prior to IND filing for each of the three programs. Takeda has the option to co-develop and cocommercialize each of the three programs. If Takeda exercises the option, the parties will then jointly conduct clinical development and share all costs equally. Denali will lead early clinical development activities and Takeda will lead late stage clinical development activities. Takeda and Denali will jointly commercialize products in the United States and China, and Takeda will have exclusive commercialization rights in all other markets. The parties will share global profits equally.
- Under the terms of the agreement, Takeda will make an initial payment to Denali of $150 million through a combination of cash upfront payments and the purchase of Denali equity. In addition, Denali is eligible to receive development and commercial milestone payments, including $90 million in preclinical milestones and opt-in payments.