• Roche will obtain co-development and co-commercialisation rights for pralsetinib, an investigational, precision therapy in late-stage development for people with RET-altered non-small cell lung cancer, various types of thyroid cancer and other solid tumours.
• Blueprint Medicines and Roche will collaborate on the development of pralsetinib.
• Roche and Blueprint Medicines will co-commercialise pralsetinib in the US while Roche will be responsible for commercial activities outside the US, excluding Greater China*.
• Roche will pay an upfront of $675 million in cash in addition to a $100 million equity investment in Blueprint Medicines who is eligible to receive up to $927 million in potential milestones, plus royalties on net product sales outside the US.
Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other types of thyroid cancer, as well as other solid tumours.
In addition, pralsetinib has demonstrated tumour-agnostic potential. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor under the collaboration.
RET-activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and MTC, and treatment options that selectively target these genetic alterations are limited. With the ongoing need for more targeted therapies that may offer clinical benefit to people with these types of cancers, this collaboration reflects Roche’s strategy of providing treatments tailored specifically to a patient’s individual tumour profile and delivering truly personalised healthcare.
In lung cancer, pralsetinib will complement Roche’s broad portfolio of already approved medicines, alongside Alecensa, Rozlytrek, Tecentriq, Avastin and Tarceva and will further support our focus on understanding driver mutations in lung cancer through personalised treatment approaches. Beyond lung cancer, pralsetinib’s tumour-agnostic potential further expands Roche’s ongoing commitment to finding new approaches to treat cancer in a more personalised way based on the genetic mutation of the disease, irrespective of the tumour site of origin.
“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-altered cancers as quickly as possible,” said James Sabry, Head of Roche Pharma Partnering. “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 personalised treatments for patients.”
“With Roche’s global reach and unparalleled expertise in personalised healthcare, this collaboration will accelerate our ability to bring pralsetinib to patients with significant medical needs around the world and expand development of pralsetinib across multiple treatment settings where there is potential to benefit even broader patient populations,” said Jeff Albers, Chief Executive Officer of Blueprint Medicines.
Blueprint Medicines has submitted a new drug application (NDA) for pralsetinib to the US Food and Drug Administration (FDA) and a marketing authorisation 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 23 November 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 (RTOR) pilot programme, which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $675 million and a $100 million equity investment in Blueprint Medicines’ common stock. 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.
The closing of a minority portion of the equity investment is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions.
About RET-Altered Solid Tumours
RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC and multiple types of thyroid cancer. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC and approximately 10 to 20 percent of patients with papillary thyroid cancer, while RET mutations are implicated in approximately 90 percent of patients with advanced MTC. In addition, oncogenic RET alterations are observed at low frequencies in colorectal, breast, pancreatic and other cancers, and RET fusions have been observed in patients with treatment-resistant EGFR-mutant NSCLC.
Pralsetinib is an investigational, once-daily oral precision therapy designed to selectively target RET alterations, including fusions and mutations, regardless of the tissue of origin. Preclinical data have shown that pralsetinib potently inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment. Blueprint Medicines is developing pralsetinib for the treatment of patients with RET-altered NSCLC, various types of thyroid cancer and other solid tumours.
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- Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan.
- Nicolas Dunant