Roche Terminates Global Partnership on RET Inhibitor Pralsetinib, Returning Rights to Blueprint Medicines After $1B Investment

On February 23, Blueprint Medicines announced that Roche had decided to terminate their collaboration agreement on the Rearranged during Transfection (RET) inhibitor Gavreto (pralsetinib) for strategic reasons. This means that, excluding Greater China, Blueprint will regain global commercialization and development rights for the drug.

Pralsetinib is an oral, once-daily, potent and highly selective RET inhibitor that has been successively approved by the FDA and NMPA for the treatment of patients with RET fusion-positive non-small cell lung cancer, medullary thyroid cancer, and thyroid cancer.

According to the terms of the agreement, the termination will take effect within 12 months from the date of notice (February 22, 2023). During the transition period, Blueprint and Roche will ensure a smooth transition without interrupting or altering the treatment of patients using pralsetinib. In addition, Blueprint will explore various options to advance and streamline the continued global commercialization and development of pralsetinib.

"At Blueprint, we are committed to driving innovation and transforming treatment outcomes for patients with lung cancer. Pralsetinib is an important treatment option for patients with RET fusion-positive lung cancer and other RET-altered cancers. We will work to ensure that patients receiving Gavreto can continue to access treatment in both commercial and clinical trial settings," said Kate Haviland, CEO of Blueprint. "Over the next year, we will collaborate with Roche to transition the pralsetinib program. At the same time, Blueprint will identify the optimal development path to maximize the value of pralsetinib and benefit more patients. Meanwhile, we will remain focused on our 2023 goals, with top priority given to the U.S. launch of avapritinib for the treatment of indolent systemic mastocytosis, as well as advancing our pipeline of investigational drugs."

Since launching the collaboration with Roche in July 2020, Blueprint Medicines has benefited approximately $1 billion, including upfront payments, milestone payments, and cost-sharing for the commercialization and development of pralsetinib. Blueprint Medicines expects that the termination of this deal will not impact its 2023 revenue guidance, encompassing collaboration revenue of $40 million to $50 million from existing partnerships, as well as anticipated operating expenses for 2023. Additionally, Blueprint Medicines anticipates that its current cash, cash equivalents, and investments, combined with expected future product revenue, will provide sufficient funding to achieve a sustainable financial position.

In June 2018, CStone Pharmaceuticals entered into an exclusive collaboration and licensing agreement with Blueprint Medicines, obtaining the rights for the clinical development and commercialization of pralsetinib as a monotherapy or in combination in Greater China (including mainland China, Hong Kong, Macao, and Taiwan).

In addition, Innovent also introduced Eli Lilly's RET inhibitor, Selpercatinib. In March 2022, Innovent deepened its strategic cooperation with Eli Lilly in the field of oncology, which included the exclusive commercialization rights for Selpercatinib in China. In October of the same year, Selpercatinib was approved for marketing in China, with the same indications as Pralsetinib.

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