On May 9, 2024 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported the execution of an amended agreement with Sagard Healthcare for additional Anaptys Jemperli (dostarlimab) royalties (Press release, AnaptysBio, MAY 9, 2024, View Source [SID1234643035]). Anaptys intends to utilize the proceeds of the transaction to continue the broad development of its immune cell modulators (ICMs), including its best-in-class checkpoint agonists, in heterogeneous, systemic autoimmune and inflammatory diseases.
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"We believe this amended agreement with Sagard further validates the commercial potential of Anaptys-discovered Jemperli and brings significant non-dilutive funding to Anaptys, further strengthening our balance sheet," said Daniel Faga, president and chief executive officer of Anaptys. "This additional capital will further enable investment across our industry leading ICM portfolio where we expect to end 2024 with four programs in clinical development to potentially bring transformational medicines to patients."
"We are thrilled to amend our partnership with Anaptys on this royalty transaction which reflects our growing confidence in Jemperli plus chemotherapy as a treatment for patients with certain types of endometrial cancer, as well as the potential of Jemperli as a monotherapy and in combination with other therapeutics to treat a broad range of solid tumor cancers. Sagard’s investment is aligned with our goal of accelerating biopharmaceutical innovation by providing our partners with flexible sources of financing," said Ali Alagheband, partner at Sagard.
Upon closing of this transaction, which is anticipated by the end of next week, Sagard will pay Anaptys $50 million upfront in exchange for royalties payable to Anaptys under its GSK collaboration on all annual global net sales of Jemperli. The amended agreement now includes the royalty tiers of 12% to 25% for annual global net sales above $1 billion.
Unchanged from the prior agreement, Sagard receives royalties of 8% for annual global net sales below $1 billion and may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future Jemperli regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to Jemperli achieving the $1 billion in annual global net sales threshold.
A $75 million milestone due upon Jemperli achieving the $1 billion in annual global net sales threshold remains not subject to this agreement. Also, royalties and milestones due to Anaptys upon further development and commercialization of the Anaptys-discovered anti-TIM-3 antagonist (cobolimab, (GSK4069889)) antibody under the GSK collaboration remain not subject to this agreement.
The capped aggregate Jemperli royalties and milestones to be received by Sagard under this amended agreement have been revised. Now, once Sagard receives an aggregate of either $600 million if received by March 31, 2031, or $675 million if received at any time thereafter, the agreement will expire, resulting in Anaptys regaining all subsequent Jemperli royalties and milestones under the GSK collaboration.
Goodwin Procter LLP is acting as counsel to Anaptys, and Foley Hoag LLP is acting as counsel to Sagard, in this monetization transaction.
About Jemperli
Jemperli is a programmed death receptor-1 (PD-1)-blocking antibody that binds to the PD-1 receptor and blocks its interaction with the PD-1 ligands PD-L1 and PD-L2.
In the U.S., Jemperli is indicated in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is dMMR, as determined by a U.S. Food and Drug Administration (FDA)-approved test, or MSI-H, and as a single agent for adult patients with dMMR recurrent or advanced endometrial cancer, as determined by a U.S. FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. The sBLA supporting this indication in combination with carboplatin and paclitaxel for dMMR/MSI-H primary advanced or recurrent endometrial cancer received Breakthrough Therapy designation and Priority Review from the U.S. FDA. Jemperli is also indicated in the U.S. for patients with dMMR recurrent or advanced solid tumors, as determined by a U.S. FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. The latter indication is approved in the U.S. under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication in solid tumors may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Jemperli was discovered by Anaptys and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialization and manufacturing of Jemperli and cobolimab.