Recipharm Signs Agreement with RedHill Biopharma for Manufacturing of RHB-105 for treatment of H. pylori infection
26 August 2015: Recipharm AB, Stockholm, today announces that it has signed an agreement with Israeli biopharmaceutical company RedHill Biopharma Ltd (TASE/NASDAQ: RDHL) ("RedHill") for the manufacturing of RedHill's leading, late-stage patented drug candidate, RHB-105. RHB-105 is being developed for the treatment of Helicobacter pylori (H. pylori) bacterial infection, a global market estimated at about $4.8 billion. Recipharm will be responsible for the supply of the remaining clinical trial material and ongoing future commercial supply.
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics (amoxicillian and rifabutin) and a proton pump inhibitor (omeprazole) combined into an all-in-one oral capsule with a planned indication for treatment of H. pylori infection. In June of this year, RHB-105 successfully met its primary endpoint in its first Phase III study.
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.
Erik Haeffler – VP Manufacturing services Recipharm commented "This is a fantastic example of how Recipharm has been able to offer an integrated solution to solve a complex manufacturing project. We are looking forward to working on this project and supporting a successful clinical trial and launch of RHB-105".
Guy Goldberg, Chief Business Officer of RedHill, said "We are very pleased that we have entered into this partnership with Recipharm for this important and exciting product. Recipharm is able to offer us a one stop shop solution that is fairly unique. We are confident in Recipharm's ability to deliver and look forward to working with them. With the successful first Phase III study we have just announced, we plan to meet with FDA in the coming months to discuss a path for approval for RHB-105. We believe RHB-105 could provide an important solution for patients and physicians for this critical infectious disease."
Erik Haeffler, VP Manufacturing Services Recipharm,[email protected], +46 8 6025 285
Adi Frish, Senior VP Business Development & Licensing, RedHill Biopharma, [email protected], +972-54-6543-112
Recipharm is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry employing some 2,200 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material including API and pharmaceutical product development. Recipharm manufactures more than 400 different products to customers ranging from Big Pharma to smaller research- and development companies. Recipharm's turnover is approximately SEK 3.3 billion and the Company operates development and manufacturing facilities in Sweden, France, the UK, Germany, Spain, Italy and Portugal and is headquartered in Jordbro, Sweden. The Recipharm B-share (RECI B) is listed on NASDAQ Stockholm.
For more information on Recipharm and our services, please visit www.recipharm.com
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is an emerging Israeli biopharmaceutical company primarily focused on the development of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of inflammatory and gastrointestinal diseases, including gastrointestinal cancers. RedHill's current pipeline of proprietary products includes: (i)RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful top-line results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study; (iii) BEKINDA™ (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted in December 2014; (iv)RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) ABC294640 - an orally-administered first-in-class SK2 selective inhibitor targeting multiple inflammatory-GI diseases and related oncology indications with a first Phase I/II initiated for refractory/relapsed diffuse large B-cell lymphoma (DLBCL); (vi) MESUPRON® - a Phase II-stage first-in-class uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers; (vii) RP101 - currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT™ (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines with a U.S. NDA currently under discussions with the FDA and a European marketing application submitted in October 2014; and (ix) RHB-101 - a once-daily oral pill formulation of the cardio drug carvedilol.
RHB-105 is a new and proprietary fixed-dose oral combination therapy of two antibiotics and a proton pump inhibitor (PPI) in an all-in-one oral capsule with a planned indication for the treatment of H. pyloriinfection. H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (MALT) lymphoma. A first Phase III study with RHB-105 is ongoing in the U.S. with positive top-line results (the ERADICATE Hp study). The study demonstrated an overall success rate of 89.4% in eradicating H. pylori, and met its protocol-defined primary endpoint of superiority in eradication of H. pylori infection over historical standard of care efficacy levels of 70%, with high statistical significance (p<0.001). RedHill plans to conduct a second Phase III study. Additional studies may be required, subject to FDA feedback. RHB-105 has been granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as Priority Review status, potentially leading to a shorter review time by the FDA of an NDA, if filed. If approved, RHB-105 will also receive an additional five years of U.S. market exclusivity, on top of the standard exclusivity period, for a total of 8 years of market exclusivity.
Recipharm AB (publ)
Corporate identity number 556498-8425
Address Lagervägen 7, SE-136 50 Jordbro, Sweden, Telephone 46 8 602 52 00, Fax 46 8 81 87 03
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