Roche, Blueprint in $1.7-Bn Deal for Targeted Cancer Drugs
Roche and Blueprint Medicines, a Cambridge, Massachusetts-based biopharmaceutical company, have signed a licensing and collaboration agreement, in a deal worth up to $1.7 billion, to develop and commercialize pralsetinib, an investigational oral drug for treating certain cancers with oncogenic RET alterations, including non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), other thyroid cancers, and other solid tumors.
Under the collaboration, Blueprint Medicines and Roche’s Genentech will co-commercialize pralsetinib in the US, and Roche will obtain exclusive commercialization rights for pralsetinib outside of the US, excluding Greater China. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a RET inhibitor as part of this collaboration.
Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $675 million and a $100-million equity investment from Roche. In addition, Blueprint Medicines is eligible to receive up to $927 million in contingent development, regulatory, and sales-based milestones and royalties on net product sales outside the US. Roche and Blueprint Medicines will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US.
Blueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA) and a marketing authorization application to the European Medicines Agency (EMA) for the treatment of RET fusion-positive NSCLC. The FDA granted priority review with an expected decision date of November 23, 2020. Blueprint Medicines has also submitted an NDA to the US FDA for RET mutation-positive MTC and RET fusion-positive thyroid cancer. The FDA has accepted the MTC application for its Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to make treatments available as early as possible.