RedHill Biopharma reported that the Japan Patent Office has issued a Decision to Grant a Patent for a new patent covering RHB-104 in Japan. The patent is expected to be issued during 2014 and will have a 2029 expiry date. RHB-104 is a proprietary antibiotic combination oral capsule formulation for the treatment of Crohn's disease, currently undergoing a Phase III study in the U.S., Canada and Israel. RedHill further noted that it has initiated a long-term population pharmacokinetic study as part of the ongoing RHB-104 Phase III MAP US study. The Pop PK study, together with other supportive studies, including a recently completed food effect study, a drug-drug interaction study currently being reviewed and additional clinical and other studies, are designed to satisfy various regulatory requirements for future potential marketing applications of RHB-104. In addition to existing FDA clearance in the U.S., RedHill has received regulatory clearance to commence the Phase III MAP US study in Canadian and Israeli sites, and the first clinical sites in both countries have already initiated patient enrollment. As a result, there are currently 44 clinical sites in the U.S., Canada and Israel actively enrolling patients for the RHB-104 Phase III MAP US study. RedHill has increased the total number of planned clinical sites to up to approximately 90 sites in the U.S., Canada and Israel, and is planning additional clinical sites in other countries. RedHill is planning to commence a second Phase III study with RHB-104 for Crohn's disease in Europe following successful Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies and discussions with key opinion leaders in Europe. The company is currently in the process of selecting a contract research organization for the MAP Europe study. Subject to receiving all the required regulatory approvals and other preparations, the MAP Europe study is planned to commence during the second half of this year.
- Health Care Industry
- Pharmaceuticals & Drug Trials
- Japan Patent Office