CAMBRIDGE, MA, USA I February 23, 2023 I Blueprint Medicines Corporation (NASDAQ: BPMC) today announced it will regain global commercialization and development rights to GAVRETO® (pralsetinib), excluding Greater China, following a decision by Roche to discontinue the collaboration agreement between the companies for GAVRETO for strategic reasons.
Under the terms of the agreement, the termination will be effective 12 months from the notification date of February 22, 2023. During the transition period, Blueprint Medicines and Roche are mutually committed to ensuring a smooth transition process with no anticipated interruptions or changes to patient access. In addition, the company will explore options to advance and simplify the continued global commercialization and development of GAVRETO.
“At Blueprint Medicines, we are dedicated to driving innovation and changing outcomes for patients with lung cancer. GAVRETO is an important treatment option for patients with RET fusion-positive lung cancer and other RET-altered cancers, and we are committed to ensuring that patients being treated with GAVRETO in the commercial and clinical trial settings continue to have access,” said Kate Haviland, Chief Executive Officer of Blueprint Medicines. “Over the next year, we will work alongside Roche to transition the GAVRETO program. In parallel, Blueprint will determine the optimal path forward to bring GAVRETO to patients in a way that maximizes its impact and value. As we do this, we will remain focused on our 2023 goals, with our highest priorities being the anticipated U.S. launch of AYVAKIT® (avapritinib) in indolent systemic mastocytosis and the ongoing advancement of our pipeline of investigational medicines.”
Since the initiation of the collaboration with Roche in July 2020, Blueprint Medicines has benefited from approximately $1 billion between upfront and milestone payments and from cost-sharing the commercialization and development of GAVRETO. The company anticipates no impact to its 2023 revenue guidance, which includes $40 million to $50 million in collaboration revenues from existing collaborations, or its anticipated operating expenses in 2023. In addition, the company continues to expect that its existing cash, cash equivalents and investments, together with anticipated future product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile.
About GAVRETO (pralsetinib)
GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of three indications: adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In addition, GAVRETO has conditional marketing authorization from the European Commission as a monotherapy for the treatment of adults with RET fusion-positive advanced NSCLC not previously treated with a RET inhibitor. GAVRETO is also approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine treatment is appropriate).
Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of GAVRETO in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.
GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. For more information, visit GAVRETO.com.
About Blueprint Medicines
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer, breast cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.
SOURCE: Blueprint Medicines
Post Views: 166
CAMBRIDGE, MA, USA I February 23, 2023 I Blueprint Medicines Corporation (NASDAQ: BPMC) today announced it will regain global commercialization and development rights to GAVRETO® (pralsetinib), excluding Greater China, following a decision by Roche to discontinue the collaboration agreement between the companies for GAVRETO for strategic reasons.
Under the terms of the agreement, the termination will be effective 12 months from the notification date of February 22, 2023. During the transition period, Blueprint Medicines and Roche are mutually committed to ensuring a smooth transition process with no anticipated interruptions or changes to patient access. In addition, the company will explore options to advance and simplify the continued global commercialization and development of GAVRETO.
“At Blueprint Medicines, we are dedicated to driving innovation and changing outcomes for patients with lung cancer. GAVRETO is an important treatment option for patients with RET fusion-positive lung cancer and other RET-altered cancers, and we are committed to ensuring that patients being treated with GAVRETO in the commercial and clinical trial settings continue to have access,” said Kate Haviland, Chief Executive Officer of Blueprint Medicines. “Over the next year, we will work alongside Roche to transition the GAVRETO program. In parallel, Blueprint will determine the optimal path forward to bring GAVRETO to patients in a way that maximizes its impact and value. As we do this, we will remain focused on our 2023 goals, with our highest priorities being the anticipated U.S. launch of AYVAKIT® (avapritinib) in indolent systemic mastocytosis and the ongoing advancement of our pipeline of investigational medicines.”
Since the initiation of the collaboration with Roche in July 2020, Blueprint Medicines has benefited from approximately $1 billion between upfront and milestone payments and from cost-sharing the commercialization and development of GAVRETO. The company anticipates no impact to its 2023 revenue guidance, which includes $40 million to $50 million in collaboration revenues from existing collaborations, or its anticipated operating expenses in 2023. In addition, the company continues to expect that its existing cash, cash equivalents and investments, together with anticipated future product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile.
About GAVRETO (pralsetinib)
GAVRETO (pralsetinib) is a once-daily oral targeted therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of three indications: adult patients with metastatic RET fusion-positive NSCLC as detected by an FDA approved test, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adults and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). In addition, GAVRETO has conditional marketing authorization from the European Commission as a monotherapy for the treatment of adults with RET fusion-positive advanced NSCLC not previously treated with a RET inhibitor. GAVRETO is also approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic RET fusion-positive NSCLC after platinum-based chemotherapy, adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who require systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine treatment is appropriate).
Blueprint Medicines has an exclusive collaboration and license agreement with CStone Pharmaceuticals for the development and commercialization of GAVRETO in Greater China, which encompasses Mainland China, Hong Kong, Macau and Taiwan.
GAVRETO is designed to selectively and potently target oncogenic RET alterations, including secondary RET mutations predicted to drive resistance to treatment. For more information, visit GAVRETO.com.
About Blueprint Medicines
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer, breast cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.
SOURCE: Blueprint Medicines
Post Views: 166
