Roche, through its member company Genentech, has signed a licensing and collaboration agreement with Blueprint Medicines, to receive exclusive rights for global co-development and commercialisation of pralsetinib outside the US and China.

Pralsetinib is Blueprint Medicine’s investigational oral therapy to treat RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) along with other thyroid cancers and solid tumours.

Also, the collaboration also encompasses the expansion of pralsetinib development in various treatment settings and explore the development of an advanced generation RET inhibitor.

Roche Pharma partnering head James Sabry said: “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.

“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.”

Blueprint seeks FDA NDA approval and EMA marketing authorisation for pralsetinib

Under the terms of the agreement, Roche will make an upfront payment of $675m in cash to Blueprint Medicines, and a make $100m equity investment in the firm’s common stock.

Blueprint Medicines is entitled to receive up to $927m, depending on the company reaching the development, regulatory and sales targets, along with royalties on the product sales outside the US.

Also, both companies will bear the global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US.

Blueprint has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) and a marketing authorisation application with the European Medicines Agency (EMA) for pralsetinib to treat RET fusion-positive NSCLC.

Also, the company has also submitted an NDA to the US FDA for RET mutation-positive MTC and RET fusion-positive thyroid cancer, which has been accepted by the agency for its Real-Time Oncology Review (RTOR) pilot programme.

Blueprint Medicines chief executive officer Jeff Albers said: “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.”