Benzinga | Jul 14, 2020 05:42AM EDT

Blueprint Medicines Announces Global Collaboration with Roche to Develop and Commercialize Pralsetinib for Patients with RET-Altered Cancers; Blueprint to Receive $775M in Upfront Payments

Blueprint Medicines Corporation (NASDAQ:BPMC) today announced that it has entered into a global collaboration with Roche and Genentech, a member of the Roche Group (OTC:RHHB), 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 collaboration, Blueprint Medicines and Genentech will co-commercialize pralsetinib in the U.S. and Roche will obtain exclusive commercialization rights for pralsetinib outside of the U.S., excluding Greater China. The companies also plan to expand development of pralsetinib in multiple treatment settings and explore development of a next-generation RET inhibitor as part of this collaboration.

The collaboration combines Blueprint Medicines' pralsetinib and precision therapy expertise with Roche's global reach, integrated personalized healthcare capabilities and portfolio of cancer therapies. Marketing applications for pralsetinib are submitted or planned for RET fusion-positive NSCLC, RET mutation-positive MTC and RET fusion-positive thyroid cancer in the U.S., Europe and other geographies.

"With Roche's global reach and unparalleled expertise in personalized 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. "In addition, the collaboration is transformative for Blueprint Medicines and our efforts to build the leading precision medicine company, as it enables us to continue to build best-in-class commercial capabilities, further invest in our rapidly growing pipeline including our systemic mastocytosis programs and fortify our strong financial position to bridge the company to a self-sustaining future."

"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," 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."

Based on its current operating plans, Blueprint Medicines anticipates its existing cash and investments, together with the upfront payments and anticipated product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile as the company continues to commercialize and expand development of its approved medicine AYVAKIT(tm) (avapritinib) and advance new innovative research programs.

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. In addition, Roche will 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, including specified development, regulatory and sales-based milestones for pralsetinib and any licensed product containing a next-generation RET compound.

In the U.S., Blueprint Medicines and Genentech will work together to co-commercialize pralsetinib, with the companies equally sharing responsibilities, profits and losses. In addition, Blueprint Medicines is eligible to receive tiered royalties ranging from high-teens to mid-twenties on annual net sales of pralsetinib outside the U.S.

Blueprint Medicines and Roche have agreed to co-develop pralsetinib globally in RET-altered solid tumors, including NSCLC, MTC and other thyroid cancers, as well as other solid tumors. The companies will share global development expenses based on pre-specified cost-sharing.

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.

CStone Pharmaceuticals will retain all rights to the development and commercialization of pralsetinib in Greater China under its existing collaboration with Blueprint Medicines.

* Greater China encompasses Mainland China, Hong Kong, Macau and Taiwan.