Date: 2015-08-26
Type of information: Production agreement
Compound: RHB-105 (amoxicillin, rifabutin and omeprazole)
Company: Redhill Biopharma (Israel) Recipharm (Sweden)
Therapeutic area: Infectious diseases
Type agreement: production manufacturing
Action mechanism: antibiotic/ proton pump inhibitor. RHB-105 is a new and proprietary fixed-dose combination therapy of two antibiotics ((amoxicillian and rifabutin) and a proton pump inhibitor (omeprazole), in an all-in-one oral capsule, designed for the treatment of H. pylori bacterial infection - a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. The RHB-105 combination was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases, who developed the first approved triple therapy treatment for H. pylori associated with peptic ulcer disease. RHB-105 was designated by the FDA as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to incentivize the development of new antibiotic drugs for the treatment of serious or life-threatening infections. The designation allows RedHill to benefit from Fast-Track development status for RHB-105, providing for an expedited development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of a New Drug Application (NDA), if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity in addition to the standard exclusivity period, for a total of 8 years of market exclusivity.
Disease: Helictobacter pylori infection
Details: * On August 26, 2015, Recipharm announced that it has signed an agreement with Israeli biopharmaceutical company RedHill Biopharma for the manufacturing of its leading, late-stage patented drug candidate, RHB-105. RHB-105 is being developed for the treatment of Helicobacter pylori bacterial infection. Recipharm will be responsible for the supply of the remaining clinical trial material and ongoing future commercial supply.
This complex project straddles and integrates three of Recipharm’s manufacturing facilities making it the first project of its kind within the organization. The FDA approved facilities in Fontaine and Pessac will manufacture the Omeprazole mini-tablets, whilst in Strangnäs the final product will be encapsulated and packaged ready for final release.
In order to support this project, Recipharm will invest approximately 13M SEK (1.55M USD) in manufacturing capabilities. In addition, the Strängnäs facility will be registered with the U.S. FDA. Commercial supply is expected to commence with initial launch into the U.S. market, after regulatory approval by U.S. FDA. Supply to E.U. markets is anticipated after this upon EU
regulatory approval.
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