On June 30, 2014 RedHill Biopharma Ltd. (NASDAQ: RDHL; TASE: RDHL) ("RedHill"), an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including cancer, and WILEX AG (ISIN DE0006614720 / WL6 / FSE) ("WILEX"), a biopharmaceutical company focused on oncology, based in Munich, Germany, reported that they have signed an exclusive license agreement for the oncology drug candidate MESUPRON (Press release, RedHill Biopharma, JUN 30, 2014, View Source;LNGID=1&TMID=178&FID=1342&PID=0&IID=1857 [SID1234517321]). The MESUPRON small molecule (INN: Upamostat) is a proprietary, first-in-class, urokinase-type plasminogen activator (uPA) inhibitor administered by oral capsule. Wilex has completed several clinical studies with MESUPRON in different indications, including two Phase II proof of concept studies for pancreatic cancer and metastatic breast cancer.
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Under the terms of the agreement, RedHill acquired the exclusive development and commercialization rights to MESUPRON, excluding China, Hong Kong, Taiwan and Macao, for all indications. RedHill will pay Wilex an upfront payment of USD 1 million and potential tiered royalties on net revenues, ranging from mid-teens up to 30%. RedHill will be responsible for all development, regulatory and commercialization of MESUPRON.
MESUPRON inhibits the uPA system, which has been shown to play a key role in tumor cell growth, invasion and the metastasis process. High uPA levels are associated with poor prognosis in various solid tumor cancers, such as pancreatic, gastric, breast and prostate cancers. MESUPRON presents a promising new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit both tumor metastasis and growth. MESUPRON has completed several Phase I studies and two Phase II proof of concept studies. The first Phase II study in locally advanced non-metastatic pancreatic cancer and the second study in metastatic breast cancer, established the drug’s safety and tolerability profile. The Phase II studies with MESUPRON in both indications suggested activity as measured by both tumor response rate and overall survival of patients when administered in combination with first-line chemotherapeutic agents.
Dror Ben-Asher, RedHill’s CEO, said: "The acquisition of MESUPRON reflects our commitment to patients suffering from gastrointestinal and inflammatory diseases, including related cancers such as pancreatic cancer, gastric cancer and colorectal cancer. It adds to RedHill’s pipeline of six late clinical-stage drug candidates and fits well with our risk-mitigating business model. MESUPRON is a unique non-cytotoxic approach targeting oncology indications where there is a very strong demand for better therapeutic options. Thanks to the development work conducted by Wilex, MESUPRON is supported by extensive pre-clinical and clinical data, and we believe in its potential to become an important treatment option for cancer patients. Our experienced development team is enthusiastic to advance this important new drug. We look forward to collaborating with our new partner Wilex and would like to thank them for entrusting us with the development and commercialization of MESUPRON."
About MESUPRON :
MESUPRON is a proprietary, first-in-class urokinase-type plasminogen activator (uPA) inhibitor administered by oral capsule. The uPA system has been shown to play a key role in tumor cell growth, invasion and the metastasis process. High uPA levels are associated with poor prognosis in various solid tumor cancers, such as pancreatic, gastric, breast and prostate cancers. MESUPRON presents a promising new non-cytotoxic approach to cancer therapy with several potential mechanisms of action to inhibit both tumor metastasis and growth. MESUPRON has completed several Phase I studies and two Phase II proof of concept studies. The first Phase II study in locally advanced non-metastatic pancreatic cancer and the second study in metastatic breast cancer, established its safety and tolerability profile. The Phase II studies with MESUPRON in both indications suggested activity as measured by both tumor response rate and overall survival of patients when administered in combination with first-line chemotherapeutic agents.