Roche and Blueprint Medicines Corp. have recently signed a licensing and collaboration agreement. The deal will offer exclusive rights to Roche for the global commercialization and co-development of pralsetinib outside the U.S., excluding Greater China.
In the U.S., Roche’s subsidiary, Genentech, will gain the co-commercialization rights to develop pralsetinib. Pralsetinib is a once-daily, investigational oral precision therapy offered by Blueprint, which has been used for the treatment of patients with RET-altered NSCLC (non-small cell lung cancer), MTC (medullary thyroid cancer), and other forms of thyroid cancer. It has also been adopted for treating solid tumors. Additionally, the therapy has demonstrated a tumor-agnostic potential.
Under the recent collaboration, the two companies are targeting to expand the pralsetinib development in various treatment settings as well as exploring the next gen RET-inhibitor development. RET-activating mutations and fusions are the key drivers of several cancer types. Treatment options that target these genetic alterations are currently limited.
Pralsetinib will complement the broad portfolio of existing approved medicines of Roche, such as Tarceva, Avastin, Tecentriq, Rozlytrek, and Alecensa. The therapy will also support the company’s focus on understanding the lung cancer mutations through its personalized treatment approaches.
Blueprint Medicines has submitted an NDA (new drug application) for pralsetinib to the U.S. FDA and an MAA (marketing authorization application) to the EMA (Emergency Medicines Agency) to treat RET-fusion-positive NSCLC. The company also has submitted an NDA to the U.S. FDA to treat RET fusion-positive thyroid cancer and RET mutation-positive MTC.
As per the terms of the deal, Blueprint will receive a $675 million upfront cash payment & a $100 million equity investment in its common stock. Additionally, the company will be eligible for receiving up to $927 million in regulatory- and sales-based milestones, contingent development, and royalties on the net product sales outside the U.S.
Under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions, the closing of the equity investment’s minority portion is subject to the termination of the waiting period.