Blueprint Medicines Corp. found a new U.S. commercialization home for Gavreto (pralsetinib) through an agreement with Rigel Pharmaceuticals Inc. potentially worth $117.5 million, now that Roche Holding AG has relinquished all rights. The product, a once-daily oral small-molecule kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions, received accelerated approval in 2020 by the U.S. FDA, under priority review and with orphan drug designation, to treat adults with metastatic RET fusion-positive non-small-cell lung cancer.
Blueprint Medicines Corp. shifted away from two early clinical therapies for EGFR-mutant non-small-cell lung cancer and dropped development and commercialization of lung and thyroid cancer drug Gavreto (pralsetinib) for areas outside of the U.S. and greater China, reducing its operating expenses, as it prepares for increasing Ayvakit sales and prioritizes development of other assets.
Blueprint Medicines Corp. CFO Mike Landsittel called his firm’s potential $1.25 billion financing deals with Sixth Street and Royalty Pharma “once in a lifetime” arrangements that came at the end of a competitive process in a formidable cash environment.
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
Suzhou-China based Cstone Pharmaceuticals Co. Ltd., which in-licensed RET inhibitor pralsetinib from Blueprint Medicines Corp. in 2018, has won Chinese approval for the drug to treat adult patients with locally advanced or metastatic RET fusion-positive non-small-cell lung cancer after platinum-based chemotherapy. Already approved as Gavreto in the U.S., the drug is Cstone’s first product approved in China and the country’s first selective RET inhibitor.
DUBLIN – Blueprint Medicines Corp. is banking $775 million, including $675 million up front and another $100 million as an equity investment, from a co-commercialization deal with Roche Holding AG and its Genentech subsidiary involving RET inhibitor pralsetinib. The deal also includes up to $927 million in development, regulatory and commercial milestones, $90 million of which are described as “near-term,” plus tiered royalties on ex-U.S. sales, ranging from the high-teens to mid-twenties.