NEW YORK – Menarini Group on Tuesday announced a sub-licensing agreement with SciClone Pharmaceuticals to develop and commercialize the endocrine therapy Orserdu (elacestrant) in China.
Under the exclusive agreement, Hong Kong-based SciClone will develop and register Orserdu as a treatment for patients with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer in China and commercialize Orserdu in the country if it receives regulatory approval.
Orserdu was approved this year in the US and Europe as a second-line treatment for this subset of patients. In a pivotal Phase III trial, Orserdu-treated patients had better median progression-free survival compared to those on investigator's choice of endocrine monotherapy. In a separate analysis, researchers found Orserdu also outperformed standard-of-care endocrine therapy in patients who had prior CDK4/6 inhibitor treatment.
Florence, Italy-headquartered Menarini and SciClone said in a statement that their deal to bring Orserdu to China includes an undisclosed upfront payment as well as the opportunity for milestone payments and sales royalties but didn't disclose the financial details.
"China accounts for 20 percent of breast cancer prevalence worldwide, and we know that these patients need new therapeutic options, particularly in the metastatic setting," SciClone CEO Zhao Hong said in a statement. "We believe that this agreement will enable us to work toward providing oncologists with an important option in the treatment armamentarium for their ER-positive, HER2-negative metastatic breast cancer patients whose tumors have an ESR1 mutation."