Blueprint’s Cancer Drug Gavreto Finds New Home at Rigel after Roche Split

23 Feb 2024
Drug ApprovalLicense out/inAccelerated ApprovalAcquisition
Pictured: Doctor showing a patient their lung scan/iStock, utah778 San Francisco-based Rigel Pharmaceuticals on Thursday announced it will acquire the U.S. rights to Blueprint Medicines’ FDA-approved non-small cell lung cancer drug Gavreto (pralsetinib). Under the agreement, Rigel will make a payment of $15 million, $10 million of which is payable on Rigel’s first commercial sale, while the remaining $5 million is due on the first anniversary of the deal’s closing date. Blueprint will also be entitled to up to $97.5 million in commercial milestones and up to $5 million in future regulatory milestones. Blueprint will also be eligible for tiered royalties on Gavreto sales ranging from 10% to 30%. Dave Santos, Rigel’s chief commercial officer, in a statement said that Gavreto is “highly synergistic with our current product portfolio” and that the acquisition will leverage Rigel’s “existing commercial infrastructure, enabling us to expand into solid tumors.” “We are confident in our ability to effectively transition Gavreto to our distribution network and utilize our robust capabilities to enable both existing and new patients to continue to have access to this important treatment option,” Santos said. Designed to be taken once a day, Gavreto is an oral small molecule inhibitor of both wild-type and oncogenic versions of the RET protein, which is a well-known driver of cancer. Other kinase inhibitors have also shown efficacy against RET-associated cancers. However, without Gavreto’s specificity of activity, these agents typically also come with significant toxicities. Gavreto first won the FDA’s approval in September 2020 for the treatment of adult patients with metastatic non-small cell lung cancer carrying RET fusions, as determined by an FDA-authorized test. This initial approval was given under the regulator’s accelerated pathway and Gavreto earned full approval in August 2023. In July 2020, just months before its accelerated approval, Roche bought the exclusive worldwide license from Blueprint to develop and commercialize the cancer drug for $775 million upfront and the promise of up to $927 million in milestones and other contingent payments. The deal also included a right to opt-in on a next-generation RET program. In the U.S., Roche’s Genentech and Blueprint equally shared commercialization responsibilities for Gavreto, as well as its profits and losses. However, in February 2023, Roche turned its back on the agreement and returned Gavreto’s global rights to Blueprint. In Thursday’s announcement, Rigel, Blueprint and Genentech said that they would work together to “ensure current and newly prescribed patients can access Gavreto without interruption through the transition period.” Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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