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Agreements

Date: 2014-06-30

Type of information: Licensing agreement

Compound: Mesupron® (upamostat)

Company: RedHill Biopharma (Israel) Wilex (Germany)

Therapeutic area: Cancer - Oncology

Type agreement:

licensing

Action mechanism:

Mesupron® small molecule (Upamostat) is a proprietary, first-in-class, urokinase-type plasminogen activator (uPA) inhibitor administered by oral capsule. 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.

Disease:

Details:

* On June 30, 2014, RedHill Biopharma, an Israeli biopharmaceutical company focused on late clinical-stage drugs for inflammatory and gastrointestinal diseases, including cancer, and Wilex, a biopharmaceutical company focused on oncology, based in Munich, Germany, announced that they have signed an exclusive license agreement for Mesupron® (upamostat). 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. 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.

Financial terms:

RedHill will pay Wilex an upfront payment of $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®.

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