Date: 2019-12-23
Type of information: Licensing agreement
Compound: gene therapy programs for hemophilia A, including SB-525
Company: Sangamo Therapeutics (USA - CA) Pfizer (USA - NY)
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Type agreement: licensing - development - commercialisation
Action mechanism: gene therapy/genome editing product.
Disease: hemophilia A
Details:
- • On May 10, 2017, Sangamo Therapeutics announced an exclusive, global collaboration and license agreement for the development and commercialization of gene therapy programs for hemophilia A, including SB-525, one of Sangamo's four lead product candidates, which Sangamo expects will enter the clinic this quarter.
- Sangamo will be responsible for conducting the SB-525 Phase 1/2 clinical study and certain manufacturing activities. Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization activities for SB-525 and additional products, if any. Additionally, Sangamo will be collaborating with Pfizer on manufacturing and technical operations utilizing viral delivery vectors.
Financial terms:
- Under the terms of the collaboration agreement, Sangamo will receive a $70 million upfront payment from Pfizer. Sangamo will be responsible for conducting the SB-525 Phase 1/2 clinical study and certain manufacturing activities. Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization activities for SB-525 and additional products, if any. Sangamo is eligible to receive potential milestone payments of up to $475 million, including up to $300 million for the development and commercialization of SB-525 and up to $175 million for additional Hemophilia A gene therapy product candidates that may be developed under the collaboration. Sangamo will also receive tiered double-digit royalties on net sales.
Latest news:
- • On December 23, 2019, Sangamo Therapeutics announced the completion of the transfer to Pfizer of the SB-525 Investigational New Drug application (IND). Pfizer is advancing SB-525 into a Phase 3 registrational clinical study in 2020 and has already commenced enrolling patients into a Phase 3 lead-in study. Sangamo has now earned a $25 million milestone payment, per the terms of a December 2019 amendment to the parties’ collaboration agreement for the global development and commercialization of gene therapies for Hemophilia A.
- The SB-525 collaboration was established in May 2017. Under the terms of the collaboration agreement, Sangamo has been responsible for Phase 1/2 clinical development. Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization activities for SB-525. Sangamo is eligible to receive total potential milestone payments of up to $300 million for the development and commercialization of SB-525, and up to $175 million for additional Hemophilia A gene therapy product candidates that may be developed under the collaboration. Sangamo will, additionally, receive tiered royalties starting in the low teens and up to 20% of annual net sales of SB-525.
Is general: Yes
