RedHill Biopharma said today it acquired rights to the Phase II drug candidate Mesupron® from Wilex, in a $1 million-plus deal that expands the buyer’s pipeline of late clinical-stage drug candidates for inflammatory and gastrointestinal diseases.
Mesupron is an oncology drug targeting gastrointestinal and other solid tumor cancers. The first-in-class small molecule inhibits the urokinase-type plasminogen activator (uPA) system, which has been shown to play a key role in tumor cell growth, invasion and the metastasis process. Administered by oral capsule, Mesupron is designed to offer a new noncytotoxic approach to cancer therapy, employing several potential mechanisms of action to inhibit both tumor metastasis and growth.
Mesupron has completed several Phase I and Phase II clinical studies, including two Phase II proof-of-concept studies for locally advanced non-metastatic pancreatic cancer and metastatic breast cancer. Mesupron demonstrated safety and tolerability, and showed cancer-fighting activity measured by both tumor response rate and overall survival when administered in combination with first-line chemotherapeutic agents, RedHill said.
“We believe in its potential to become an important treatment option for cancer patients,” Dror Ben-Asher, RedHill's CEO, said in a statement. “It adds to RedHill's pipeline of six late clinical-stage drug candidates and fits well with our risk-mitigating business model”
RedHill agreed to pay Wilex $1 million upfront, plus tiered royalties on net revenues, ranging from the mid-teens up to 30%. RedHill will be responsible for all development, regulatory and commercialization of Mesupron.
In return, RedHill acquired exclusive development and commercialization rights for all indications to Mesupron worldwide except China, Hong Kong, Taiwan and Macao. In those four markets, Wilex awarded exclusive rights in March to Link Health of Guangzhou, China for a signing fee and milestone payments totalling more than €7 million ($9.6 million) during clinical development in the first four indications to be developed by Link Health, plus staggered “medium single digit” royalties.
Link Health agreed to perform and finance the entire clinical development of Mesupron in China in all oncological indications, including HER2-negative metastatic breast cancer and nonmetastatic pancreatic cancer, as well as for the regulatory process and product marketing. To receive regulatory approval from the Chinese State Food and Drug Administration, Mesupron‘s complete clinical development program from Phase I to Phase III must also be conducted in China.
Wilex and Link Health said the data they would generate may be used to support potential further development of Mesupron in other key markets.