Blueprint Medicines and Genentech, a member of the Roche group, entered into a global collaboration to develop and commercialize pralsetinib, an investigational once-daily oral precision therapy for the treatment of people with cancer driven by oncogenic RET alterations, including non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), other thyroid cancers and other solid tumors.
Under the terms of the agreement, Blueprint Medicines will grant Roche an exclusive worldwide license excluding Greater China and the U.S., and a co-exclusive license in the U.S. to develop and commercialize pralsetinib. Roche will also have the right to opt in to a next-generation RET compound co-developed under the collaboration. Blueprint Medicines will receive $775 million in upfront payments, including a cash payment of $675 million and an equity investment by Roche of $100 million in Blueprint Medicines’ common stock at a purchase price of $96.57 per share. Blueprint Medicines will be eligible to receive up to an additional $927 million in contingent payments. CStone Pharmaceuticals will retain all rights to the development and commercialization of pralsetinib in Greater China under its existing collaboration with Blueprint Medicines
A regulatory submission is currently under review by the U.S FDA for the use of pralsetinib in RET-altered non-small cell lung cancer and medullary thyroid cancer. An FDA decision in non-small lung cancer is expected November 23. The FDA has granted breakthrough therapy designation to pralsetinib for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation positive MTC that requires systemic treatment and for which there are no acceptable alternative treatments. In addition, a marketing authorization application has been to the European Medicines Agency for the treatment of RET fusion-positive NSCLC.
“We are very excited to enter into this collaboration with Blueprint Medicines, a partner we have already been working with for four years, with the goal of bringing a potentially transformative treatment option to patients with rare RET-driven cancers as quickly as possible,” James Sabry, head of Roche Pharma Partnering said in a statement. “In bringing pralsetinib to patients, we will leverage our global reach and expertise in oncology, as well as our capabilities in diagnostics and the use of real-world data toward our aim of providing personalized treatments for patients.”