On August 20, 2020, AnaptysBio, Inc. ("AnaptysBio") reported that sent a notice of breach to GlaxoSmithKline and TESARO, Inc., a wholly-owned subsidiary of GSK (collectively, "GSK"), stating that GSK is in breach of its obligations under the Collaboration and Exclusive License Agreement by and between TESARO, Inc. and AnaptysBio (the "GSK Agreement"), and notifying GSK that the GSK Agreement will terminate with regard to PD-1 antagonists, including dostarlimab, which will thereby revoke any licenses and rights granted pertaining to the program, if such breach is not cured within the 60-day time period required by the GSK Agreement (Filing, 8-K, AnaptysBio, AUG 20, 2020, View Source [SID1234563906]).
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Pursuant to the GSK Agreement, GSK has a license to certain antibodies originally developed by AnaptysBio, including dostarlimab, a PD-1 antibody product candidate in the late-stages of clinical development, with FDA approval of an accepted biological license application (BLA) for a first indication anticipated during 2020 and regulatory submission for a second indication anticipated in the first half of 2021, according to GSK.
Under the terms of the GSK Agreement, GSK agreed that it would not conduct or participate in research, development, manufacturing or commercialization of any PD-1 antagonist other than those licensed by AnaptysBio to GSK. The GSK Agreement also provides that GSK will "use Commercially Reasonable Efforts to . . . (e) commercialize Products and attempt to obtain the optimum commercial return for each Product in all major markets throughout the world." In contravention of the exclusivity and diligence provisions of the GSK Agreement, GSK recently announced plans to begin a Phase 3 clinical trial involving a third-party anti-PD-1 antibody, Merck’s Keytruda, and GSK’s drug, Zejula in non-small cell lung cancer. The aforementioned Phase 3 trial is being initiated subsequent to previous proposals from Tesaro to waive PD-1 antagonist exclusivity terms under the GSK Agreement, which AnaptysBio has explicitly declined.
While we hope to resolve this matter amicably, we have also, as of August 20, 2020, filed a Verified Complaint (the "Complaint") in Delaware Chancery Court, requesting a preliminary injunction to enjoin GSK’s current planned clinical trial using GSK’s Zejula in combination with Keytruda, without the consent of AnaptysBio and in breach of the GSK Agreement. In addition to enjoining this planned clinical trial, AnaptysBio is seeking specific performance of return of all PD-1 antagonist related rights under the GSK agreement, including the dostarlimab program, across all clinical indications, to AnaptysBio, pursuant to the termination provision of the GSK Agreement. In addition to the Complaint, AnaptysBio also filed a Motion to Expedite Proceedings, requesting a court schedule to expedite trial to occur as soon as possible but no later than March 2021. Milestone and royalty payment obligations due to AnaptysBio pursuant to the GSK Agreement will continue during the proceedings.