US-based biotech Blueprint Medicines has announced that Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has returned ex-Greater China global rights to its RET inhibitor Gavreto (pralsetinib), citing strategic reasons. This decision marks a significant shift in the commercial strategy for the drug, which was previously licensed to Roche for global commercialization (excluding the US and Greater China).
Background on the Licensing Deal
Roche struck a USD 1.7 billion licensing deal with Blueprint in June 2020, securing exclusive commercialization rights to Gavreto around the globe, with the exception of the US and Greater China. The drug was approved in the US in September 2020 for the treatment of RET fusion-positive metastatic non-small cell lung cancer (NSCLC).
Clinical Development and Market Presence
GBI SOURCE data indicates that Roche has initiated 10 clinical studies for pralsetinib around the world. Industry insiders have commented that fierce competition in the market might be a contributing factor to Roche’s decision to return the rights. Notably, China’s CStone Pharmaceuticals (HKEX: 2616) obtained exclusive development and commercialization rights to the drug in Greater China via a deal in June 2018. Gavreto is approved to treat NSCLC with positive RET gene fusion, RET-mutant medullary thyroid carcinoma (MTC), and RET fusion-positive thyroid cancer (TC) in the Chinese mainland and Taiwan. The drug is also commercially available to treat metastatic NSCLC with positive RET gene fusion in Hong Kong.
Strategic Implications
The return of global rights to Blueprint Medicines for Gavreto represents a strategic adjustment by Roche. This move allows Blueprint to regain control over the commercialization of Gavreto outside of Greater China, potentially opening new opportunities for the company to expand its market reach and partnerships. For Roche, this decision may reflect a focus on other strategic priorities and a reevaluation of the competitive landscape in the RET inhibitor market.-Fineline Info & Tech
