RedHill Biopharma soars on Phase III trial results

pharmaceuticals

Another trial may be needed for marketing approval for the inflammatory and gastrointestinal diseases treatment.

Israeli biopharmaceutical company RedHill Biopharma Ltd. (Nasdaq: RDHL); TASE: RDHL) today reported positive results for its trial of a treatment for inflammatory and gastrointestinal diseases, including gastrointestinal cancers. The RedHill share responded with a leap on the TASE, and is also expected to attract interest on Wall Street.

The company announced that it had successfully achieved the goal of its Phase III trial for its antibiotic treatment of H. pylori infection (the main cause of ulcers). The trial was conducted without a control group; the results were compared with the recorded results of the existing antibiotics, and proved to be significantly better than the latter. RedHill's combination of antibiotics eliminated 89.4% of H. pylori cases, compared with only 70% using the existing treatment methods in a laboratory.

Products undergoing trials usually achieve better results than daily use of the same products in a clinic, but even taking this limitation into account, the difference in results is wide enough to indicate an advantage for Redhill's product in the range of cases it is designed to treat.

Although the trial was classified as Phase III on the US Food and Drug Administration's (FDA) b5052 fast track, another trial may be required before the company can submit a request to have its product approved for marketing. RedHill estimates the H. pylori treatment market at $1.45 billion in the US and $4.83 billion worldwide.

RedHill's main shareholders are the OrbiMed Advisors LLC fund and a number of US investors. Migdal Insurance and Financial Holdings Ltd. (TASE: MGDL) and Yelin Lapidot Investment House Ltd. have also invested in the company.

Published by Globes [online], Israel business news - www.globes-online.com - on June 15, 2015

© Copyright of Globes Publisher Itonut (1983) Ltd. 2015

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