RedHill Biopharma Extends Option Agreement for Phase II-Stage Pancreatic Cancer Drug RP101

RedHill Biopharma Ltd. RDHL RDHL ("RedHill" or the "Company"), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today reported that it has elected to extend its August 2014 exclusive option agreement with RESprotect GmbH, a privately-held German-based biotech company for the acquisition of the oncology drug candidate RP101. RP101 is a proprietary, first-in-class, orally-administered, heat shock protein 27 (Hsp27) inhibitor intended to prevent the induction of resistance to chemotherapy (chemoresistance), thus maintaining sensitivity of the tumor to chemotherapy and potentially enhancing patient survival. RP101 has completed several clinical studies, including a Phase II study in pancreatic cancer and has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Under the terms of the binding exclusive option agreement with RESprotect GmbH, RedHill has the option to acquire the worldwide exclusive rights to RP101 for all indications, other than for the pancreatic cancer indication in South Korea. If RedHill elects to exercise this option, it will acquire the exclusive rights to RP101 for a total payment of $100,000, for both the exercise option and the acquisition of the rights, as well as potential milestone payments and tiered royalties on net revenues, ranging from single digits to mid-teens. RedHill has agreed to pay $25,000 for a one-year extension of the option agreement. RedHill recently commenced a preclinical development program for RP101 to examine the efficacy of the drug candidate in various tumor models. The preclinical program is intended to support the existing clinical data and to assess a potential clinical development path for RP101. About RP101: RP101 is a nucleoside analogue found by Prof. Rudolf Fahrig at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) in Hannover, Germany, to inhibit development of chemoresistance in various cancer models. It is an orally-administered, patent-protected small molecule which binds to heat shock protein 27 (Hsp27) and inhibits its multidrug-resistance gene amplification activity. Hsp27 is a chaperone protein which is found in abnormally high levels in cancer cells. The overexpression of Hsp27, which results in the amplification of a multidrug-resistance (MDR) gene, has been linked to tumor resistance to cytotoxic drugs and the development of metastasis. By inhibiting Hsp27, RP101 may prevent the induction of resistance to chemotherapy (chemoresistance) and maintain sensitivity of tumors to chemotherapy, thus potentially enhancing patient survival. RP101 has been studied in several Phase I and Phase II clinical studies with a total of 249 subjects treated, including a Phase II study in pancreatic cancer. RP101 has been granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).