RedHill Biopharma Ltd. (TASE: RDHL), an emerging Israeli biopharmaceutical company focusing primarily on development of late clinical-stage new formulations and combinations of existing drugs, has announced today 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.
Earlier last week RedHill Biopharma announced the results of a successful pivotal bioequivalence trial with yet another of the Company's drugs: RHB-102 for the prevention of nausea and vomiting in cancer patients.
Dr. (PhD) Elkan Gamzu, RHB-103 Product Manager, stated today: "We are excited about the commencement of an advanced clinical trial with a second product of the Company since the beginning of 2012, and we hope that RHB-103, an oral thin film drug for the treatment of migraine, will show positive results, similar to the recently announced successful results with RHB-102 for the prevention of nausea and vomiting in cancer patients."
About RedHill Biopharma Ltd.:
RedHill Biopharma is an emerging Israeli biopharmaceutical company focused primarily on development of late clinical-stage new formulations of existing drugs. In addition to RHB-103, an oral thin film formulation of a leading triptan for the treatment of acute migraine, and RHB-102 for the prevention of radiotherapy-induced nausea and vomiting, the Company's current product pipeline includes a once-daily formulation of a leading congestive heart failure and high blood pressure drug, a combination therapy for the treatment of MAP infection in Crohn's as well as a companion diagnostic test for detection of the MAP bacteria, a combination therapy for the treatment of resistant H. pylori bacteria causing ulcers, and a patent protected encapsulated formulation for bowel preparation ahead of certain gastro procedures. The Company's team includes prominent pharmaceutical experts. For more information please visit: www.redhillbio.com.
This Press Release does not constitute an offer or solicitation to acquire and/or sell the Company's securities or to participate in any investment in the Company. Statements in this Press Release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All of these forward-looking statements are subject to risks and uncertainties that may change at any time, and, therefore, actual results may differ materially from those expected. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement made by us or on our behalf as a result of new information, future events or other factors.
Senior Financial PR Account Manager
RedHill Biopharma Ltd.
VP Business Development & Licensing
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