Redhill Trial for Migraine

RedHill Biopharma Ltd. (TASE: RDHL), has announced the commencement of a pivotal bioequivalence clinical trial with RHB-103, an oral thin-film formulation of a leading triptan for the treatment of acute migraine. RedHill has completed screening and recruitment
of all subjects for this clinical trial and announced subjects’ first dosing on April 23rd, 2012.

The RHB-103 clinical trial is a bioequivalence study which aims to compare the bioavailability of RedHill’s oral thin film drug and a well known, leading, approved drug, in the migraine market, with annual sales of hundreds of millions of Dollars.

The pivotal trial is being conducted in Canada under a CTA (Clinical Trial Application) from Health Canada. Based on preliminary discussions held with FDA and based on advice from RedHill’s regulatory advisors, if

positive results are obtained and certain FDA requirements are met, the clinical trial will be used by the Company and its Canadian co-development partner, IntelGenx, Corp. for submitting a US marketing approval application (NDA – New Drug Application) to the FDA.
The RHB-103 clinical trial is expected to take several months until final analysis of its results.

Last month RedHill Biopharma announced the results of a successful pivotal bioequivalence trial with RHB-102 for the prevention of nausea and vomiting in cancer patients.