Rigel Pharmaceuticals Acquires US Rights to GAVRETO

Rigel Pharmaceuticals, Inc. recently announced it has entered into a definitive agreement to acquire the US rights to GAVRETO (pralsetinib) from Blueprint Medicines Corporation. GAVRETO is a once daily, small molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions. GAVRETO is approved by the US FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

“NSCLC is the most common type of lung cancer in the US with RET fusions representing 1%-2% of the patient population. GAVRETO is a targeted treatment option with an established safety profile that has shown durable responses in RET fusion-positive NSCLC patients and represents a compelling addition to our commercial portfolio,” said Raul Rodriguez, Rigel’s president and CEO. “We are excited about this transaction, as we continue to realize our corporate strategy to grow our hematology and oncology business while leveraging our existing commercial and medical affairs infrastructure and expertise. GAVRETO is the third commercial product in our portfolio, supporting top line growth and our commitment to providing differentiated therapies to patients in need.”

“GAVRETO is one of only two approved RET inhibitors on the market for patients. We are confident in our ability to effectively transition GAVRETO to our distribution network and utilize our robust capabilities to enable both existing and new patients to continue to have access to this important treatment option,” said Dave Santos, Rigel’s chief commercial officer. “The addition of GAVRETO will be highly synergistic with our current product portfolio, leveraging our existing commercial infrastructure and enabling us to expand into solid tumors.”

GAVRETO is also approved for the treatment of adult 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). This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Discussions with the FDA regarding confirmatory requirements are ongoing.

Under the terms of the agreement, Blueprint will receive a purchase price of $15.0 million, $10.0 million of which is payable upon first commercial sale by Rigel and an additional $5.0 million of which is payable on the first anniversary of the closing date, subject to certain conditions. Blueprint is also eligible to receive up to $97.5 million in future commercial milestone payments and up to $5.0 million in future regulatory milestone payments, in addition to tiered royalties ranging from 10% to 30%. Patents that have issued or are expected to issue covering GAVRETO will have statutory expiration dates between 2036 and 2041. Rigel expects to complete the transition of the asset and start recognizing product sales in the third quarter of 2024. Rigel will provide additional details on this transaction at its upcoming quarterly earnings call in early March.

Rigel’s acquisition of the US rights to GAVRETO is concurrent to a previously announced Roche decision to terminate the GAVRETO collaboration agreement with Blueprint effective February 22, 2024. According to a statement from the company, Genentech, a member of the Roche Group, is committed to patients and working with Rigel and Blueprint to ensure current and newly prescribed patients can access GAVRETO without interruption through the transition period, with specific next steps and timing to be communicated to key stakeholders, including healthcare providers, in the next few weeks.

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing, and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information, visit www.rigel.com.