Leo Pharma has stepped up to commercialize toripalimab in Europe, inking a deal with Shanghai Junshi Biosciences to secure the rights to promote and sell the PD-1 inhibitor in its home region.
Like Merck & Co.’s Keytruda and its slew of competitors, toripalimab is a checkpoint inhibitor designed to unleash immune attacks against cancer cells. Merck and its rivals make tens of billions of dollars a year from the mechanism and are now bracing for the loss of exclusivity on their molecules. Yet, Junshi and its collaborators see an opportunity for yet another PD-1/L1 drug.
The European Medicines Agency approved toripalimab in nasopharyngeal and esophageal cancer last year. Toripalimab, which is sold as Loqtorzi, is the only drug in Europe in the nasopharyngeal setting and the only first-line treatment for metastatic esophageal cancer, regardless of PD-L1 expression.
Leo is now responsible for distribution, promotion and sales of the antibody in up to 32 countries. Junshi subsidiary TopAlliance Biosciences Europe will remain responsible for manufacturing and other activities. Leo is paying an upfront fee to bag the rights and will pay milestones if it wants to pursue subsequently approved indications.
TopAlliance CEO Sheng Yao discussed the division of labor between the partners in Monday’s announcement.
“[TopAlliance] has already established a local operational center and is actively collaborating with local health authorities to prepare for the successful commercial launch of toripalimab in Europe,” Yao said. “As a century-old multinational pharmaceutical company headquartered in Europe, Leo Pharma has established a mature distribution network and rich marketing expertise in the local markets.”
Jean Monin, executive vice president of the thrombosis business unit at Leo, added details about how his team will handle the product, explaining that the drug complements the company’s “existing heparin-based anti-coagulation treatments for cancer-associated thrombosis and other specialty patients.”
Coherus BioSciences, which previously secured U.S. rights to toripalimab in a deal worth up to $1.1 billion, sees the ability of the antibody to improve outcomes in patients with lower levels of PD-L1 expression as a point of difference versus other checkpoint inhibitors. Speaking at the J.P. Morgan Healthcare Conference this month, Coherus CEO Dennis Lanfear said the drug drives “disproportionately strong T-cell activation.”
Lanfear said Coherus is targeting around 2,000 nasopharyngeal cancer patients a year in its markets, creating a $150 million to $200 million opportunity. Coherus, which won FDA approval for Loqtorzi in late 2023, is aiming to hit peak sales around four years after the launch.