On October 20, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted MESUPRON (upamostat) Orphan Drug designation for the adjuvant treatment of pancreatic cancer (Press release, RedHill Biopharma, OCT 20, 2017, View Source [SID1234521043]).
The Orphan Drug designation allows RedHill to benefit from various development incentives to develop MESUPRON for this indication, including tax credits for qualified clinical testing, waiver of a prescription drug user fee (PDUFA fee) upon submission of a potential marketing application and, if approved, a seven-year marketing exclusivity period.
MESUPRON is a proprietary, first-in-class, orally-administered protease inhibitor, with several potential mechanisms of action to inhibit tumor invasion and metastasis. MESUPRON presents a new, non-cytotoxic approach to cancer therapy. MESUPRON has undergone several Phase I studies and two Phase II proof-of-concept studies.
RedHill recently announced the receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the use of MESUPRON and RedHill’s Phase II-stage investigational compound, YELIVA, in combination with a known antibiotic, for hard-to-treat cancers.
Pancreatic cancer is the third leading cause of cancer mortality in the U.S.1 and is characterized as a disease with a very high unmet medical need. The overall five-year survival rate for the disease is only 8.2% in the U.S.2, representing one of the poorest prognoses across all cancers. The majority of pancreatic cancer cases are diagnosed late, at which point the disease is already locally advanced or metastatic3. Furthermore, pancreatic cancer is predominately a cancer of the elderly, with the median age of diagnosis being 71 years in the U.S.4 It is estimated that 53,670 new cases5 will be diagnosed in 2017 in the U.S. The 2017 worldwide sales of pancreatic cancer therapies are estimated to reach approximately $1.6 billion6.
RedHill has an ongoing research collaboration agreement with the Department of Molecular Biology and Genetics of Aarhus University in Denmark for the evaluation of MESUPRON. With the recent identification of human trypsin-3 and human trypsin-2 as high-affinity molecular targets, RedHill is also evaluating utilization of MESUPRON in several inflammatory gastrointestinal indications.
About MESUPRON:
MESUPRON is a proprietary, first-in-class, orally-administered potent inhibitor of several proteases targeting cancer and inflammatory gastrointestinal diseases. Protease inhibitors have been shown to play key roles in tumor invasion and the metastasis process. High levels of certain proteases 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 undergone several Phase I studies and two Phase II proof-of-concept studies. The first Phase II study was in locally-advanced, unresectable pancreatic cancer and the second study in metastatic breast cancer in combination with first-line chemotherapeutic agents. RedHill recently announced the receipt of a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the use of MESUPRON and RedHill’s Phase II-stage investigational compound, YELIVA, in combination with a known antibiotic, for hard-to-treat cancers. RedHill acquired the exclusive worldwide rights to MESUPRON, excluding China, Hong Kong, Taiwan and Macao, from Germany’s WILEX AG for all indications.