BRISBANE, Calif.--(BUSINESS WIRE)--Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced today the completion of the transfer to Pfizer of the SB-525 Hemophilia A gene therapy 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.
“I want to congratulate our team for their success in developing SB-525 through to this important milestone where we have handed over the IND to Pfizer for Phase 3 development,” said Sandy Macrae, CEO of Sangamo. “We are thrilled to be in a partnership where both parties have cooperated to accelerate study timelines, resulting in completion of the IND transfer ahead of schedule. Pfizer and Sangamo are united in our common interest to help patients with Hemophilia A and will do everything that we can to safely and expeditiously advance this promising gene therapy candidate for patients in need.”
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.
About Sangamo Therapeutics
Sangamo Therapeutics is committed to translating ground-breaking science into genomic medicines with the potential to transform patients’ lives using gene therapy, ex vivo gene-edited cell therapy, and in vivo genome editing and gene regulation. For more information about Sangamo, visit www.sangamo.com.
Sangamo Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of United States securities law. These forward-looking statements include, but are not limited to, the therapeutic potential of SB-525; the enrollment of clinical trials and global registration and commercialization and the expected timing for milestones the expected benefits of Sangamo’s collaboration with Pfizer; the anticipated capabilities of Sangamo’s technologies; and other statements that are not historical fact. These statements are based upon Sangamo’s current expectations and speak only as of the date hereof. Sangamo’s actual results may differ materially and adversely from those expressed in any forward-looking statements. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to dependence on the success of clinical trials; the uncertain regulatory approval process; the costly research and development process, including the uncertain timing of clinical trials; whether interim, preliminary or initial data from ongoing clinical trials will be representative of the final results from such clinical trials; whether the final results from ongoing clinical trials will validate and support the safety and efficacy of product candidates; the risk that clinical trial data are subject to differing interpretations by regulatory authorities; the potential inability of Sangamo and its partners to advance product candidates into registrational studies; Sangamo’s reliance on itself, partners and other third-parties to meet clinical and manufacturing obligations; Sangamo’s ability to maintain strategic partnerships; competing drugs and product candidates that may be superior to Sangamo’s product candidates; and the potential for technological developments by Sangamo's competitors that will obviate Sangamo's gene therapy technology. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in Sangamo’s operations. These risks and uncertainties are described more fully in Sangamo's Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the Securities and Exchange Commission on March 1, 2019 and Sangamo's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 that it filed on or about November 6, 2019. Except as required by law, we assume no obligation, and we disclaim any intent, to update these statements to reflect actual results.