On December 22, 2024, Pfizer Inc. ("Pfizer") reported that it has notified Sangamo Therapeutics, Inc. ("Sangamo") of its termination for convenience, effective April 21, 2025 (the "Termination Date"), of the Collaboration and License Agreement (the "Collaboration Agreement") by and between Pfizer and Sangamo dated May 10, 2017, pursuant to which Pfizer and Sangamo engaged in activities in furtherance of the research, development and commercialization of giroctocogene fitelparvovec, also known as SB-525, Sangamo’s gene therapy product candidate for hemophilia A (Filing, 8-K, Sangamo Therapeutics, DEC 22, 2024, View Source [SID1234649356]). Pfizer has indicated to Sangamo that the termination relates to its decision not to submit a Biologics License Application or Marketing Authorisation Application for, or pursue commercialization of, giroctocogene fitelparvovec.
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Under the terms of the Collaboration Agreement, Sangamo granted Pfizer an exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, to use certain technology controlled by Sangamo for the purpose of developing, manufacturing and commercializing giroctocogene fitelparvovec and related products. Pfizer granted Sangamo a non-exclusive, worldwide, royalty free, fully paid, perpetual, irrevocable license, with the right to grant sublicenses, to use certain manufacturing technology developed under the Collaboration Agreement and controlled by Pfizer to manufacture Sangamo’s products that utilize the adeno-associated virus (AAV) delivery system. Under the Collaboration Agreement, Sangamo was responsible for conducting the Phase 1/2 clinical study and certain manufacturing activities for giroctocogene fitelparvovec, while Pfizer was responsible for subsequent worldwide development, manufacturing, marketing and commercialization of giroctocogene fitelparvovec, including the Phase 3 AFFINE clinical trial in which giroctocogene fitelparvovec met both the primary and key secondary endpoints.
Pursuant to the Collaboration Agreement, Sangamo received an upfront license fee of $70.0 million, as well as an aggregate of $55.0 million in milestone payments, and was eligible to earn from Pfizer up to $220.0 million in remaining milestone payments for giroctocogene fitelparvovec and up to $175.0 million for other products that might have been developed under the Collaboration Agreement, subject to reduction on account of payments made under certain licenses for third-party intellectual property. In addition, Pfizer agreed to pay Sangamo royalties for each licensed product potentially developed under the Collaboration Agreement at rates equal to 14% – 20% of the annual worldwide net sales of such product, subject to certain reductions.
As of the Termination Date, the Collaboration Agreement will be terminated in its entirety, all licenses and other rights granted by Sangamo to Pfizer will terminate, and Sangamo will not be entitled to any royalties from Pfizer. In addition, Pfizer will not be liable for any milestone payment under the Collaboration Agreement that accrues between now and the Termination Date. At such time, Sangamo is entitled to receive an exclusive, worldwide, royalty-bearing, sublicensable license from Pfizer to use Pfizer’s relevant intellectual property to continue developing, manufacturing and commercializing giroctocogene fitelparvovec; in return, Pfizer would be eligible to receive low single digit royalties on net sales of giroctocogene fitelparvovec and would be released from certain liabilities to the extent they exist. In addition, at Sangamo’s request and expense following the Termination Date, Pfizer is required to transition the SB-525 program back to Sangamo and provide certain transition-related services to Sangamo. If requested by Sangamo within a reasonable period of time following the notice of termination, Pfizer and Sangamo are required to meet to mutually agree upon a transition plan to effect an orderly and timely transition to Sangamo of certain development, manufacturing and commercialization activities and responsibilities with respect to SB-525.
Over the coming months, Sangamo expects to seek a new potential partner to seek regulatory approvals for and, if approved, commercialize giroctocogene fitelparvovec.