On October 26, 2020 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported that AnaptysBio and GlaxoSmithKline (GSK) have amended their immuno-oncology collaboration agreement (Press release, AnaptysBio, OCT 26, 2020, View Source [SID1234570356]). The amended agreement provides AnaptysBio with increased royalties on dostarlimab sales under the collaboration, a royalty on GSK’s Zejula and a one-time cash payment. GSK receives freedom to conduct combination development and commercialization of Zejula with third party molecules.
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"We are pleased to continue our strategic immuno-oncology collaboration with GSK and look forward to the anticipated first FDA approval of dostarlimab," said Hamza Suria, chief executive officer of AnaptysBio. "The three clinical-stage antibodies under this collaboration were generated by AnaptysBio using our somatic hypermutation technology platform. While our internal focus is the advancement of AnaptysBio’s wholly-owned first-in-class anti-inflammatory antibody pipeline, we are pleased to partner with GSK in advancing novel immuno-oncology therapies for patients suffering with cancer."
Originally signed with Tesaro in March 2014, the GSK collaboration is focused on advancing checkpoint receptor antagonist antibodies against PD-1, TIM-3 and LAG-3 in oncology. Dostarlimab is an anti-PD-1 antagonist antibody currently under development by GSK for multiple oncological disorders, including endometrial cancer, non-small cell lung cancer, ovarian cancer, colorectal cancer and mismatch repair deficient solid tumors. Cobolimab, an anti-TIM-3 antagonist antibody, and GSK4069889A, an anti-LAG-3 antagonist antibody, are also under development under this collaboration for various solid tumors. Dostarlimab is being combined with certain antibodies and small molecule agents, including cobolimab, GSK4069889A and Zejula. First US FDA approval of dostarlimab is anticipated in Q4 2020 for the treatment of endometrial cancer, while MAA review is also underway for the same indication. A second BLA filing for dostarlimab, for the treatment of mismatch repair deficient cancers on a pan-tumor basis, is anticipated in the first half of 2021. Zejula is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, which has received US approval for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy regardless of biomarker status, and is under development for additional cancer indications.
Under the terms of the amended agreement, GSK has agreed to increase the royalties due to AnaptysBio upon net sales of dostarlimab. Previously, royalties ranged from 4-8%, where the 8% royalty tier was applicable to global net sales above $1 billion. The amended royalty terms range from 8-25%, where AnaptysBio will receive 8% of annual global net sales below $1 billion, and 12-25% of net sales above $1 billion. The $1.1 billion in cash milestone payments due under the collaboration agreement remain unchanged, and AnaptysBio anticipates receiving $75 million in such cash milestones over the next 18 months as dostarlimab obtains FDA and EMA regulatory approval for the first two indications. An additional $165 million in sales milestones is anticipated by AnaptysBio upon achievement of certain dostarlimab annual sales revenues. GSK has also agreed, starting January 1, 2021, to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of Zejula. In addition, GSK has agreed to pay AnaptysBio a one-time cash payment of $60 million within 30 days.
In exchange, AnaptysBio has provided GSK with freedom to conduct development and commercialization of Zejula in combination with any third-party molecules.