News & Events zu Exelixis Inc (EXEL)EXELExelixis Inc

Adagene Achieves $2M Milestone with Exelixis

Adagene (ADAG) announced the achievement of a milestone in its ongoing collaboration and license agreement with Exelixis (EXEL). The milestone achievement is related to a preclinical milestone event for XB404 and resulted in a $2M milestone payment from Exelixis. XB404, built with Adagene's SAFEbody masking technology, is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while minimizing on-target, off-tumor side effects. An additional payment to Adagene was triggered by the selection of candidates for another SAFEbody antibody-drug conjugate program. Exelixis has the right to utilize Adagene's SAFEbody technology platform to generate masked monoclonal antibodies for the development of masked ADC candidates. Adagene is eligible to receive development and commercialization milestones and royalties on net sales of products developed.

Exelixis Wins Patent Lawsuit Against MSN Laboratories

Exelixis announced that in the lawsuit Exelixis, Inc. vs. MSN Laboratories Private Limited et al., Civil Action No. 22-00228, the U.S. Court of Appeals for the Federal Circuit has "affirmed a key portion of the 2024 judgment of the U.S. District Court for the District of Delaware in Exelixis' favor." The company said: "The appellate court upheld the District Court's decision that three patents covering the crystalline malate salt of cabozantinib (No. 11,091,439 [crystalline salt]; 11,091,440 [pharmaceutical compositions]; and 11,098,015 [methods of treatment]) are not invalid. Concurrently, the appellate court dismissed the appeal regarding the validity dispute over one of Exelixis' patents covering low-impurity cabozantinib formulations (U.S. Patent No. 11,298,349), ruling the matter moot. The Federal Circuit's decision upholds the validity of the '439, '440 and '015 crystalline salt patents, preserving market exclusivity of Exelixis' cabozantinib (marketed under the brand name CABOMETYX). While the appellate court issued a procedural ruling dismissing the '349 formulation patent appeal as moot, this decision does not impact the broader strength or integrity of the cabozantinib patent estate. Exelixis will continue to pursue all necessary legal actions to defend its intellectual property portfolio, which is essential to safeguarding the scientific innovation that drives the company's mission to help cancer patients recover stronger and live longer. Given today's decision, the earliest that MSN may be permitted to commercially launch its proposed generic product in the U.S. is January 15, 2030, subject to any additional appeals or regulatory exclusivity. MSN's ability to commercially launch would depend on the outcome of litigation involving another low-impurity formulation patent (U.S. Pat. No. 12,128,039) that expires in February 2032, with a trial scheduled to begin in November 2026."