RedHill Biopharma Reports Positive FDA Type B Meeting on RHB-105 for H. pylori Infection Ahead of Confirmatory Phase III Study
The confirmatory Phase III study with RHB-105 for H. pylori infection is planned to be initiated in H1/2017, after completion of the ongoing supportive PK program; Subject to a successful outcome, the confirmatory Phase III study and the supportive PK program are expected to complete the package required for a U.S. NDA for RHB-105, including clinical data and chemistry, manufacturing and controls (CMC)
Following the recent Type B CMC meeting, and subject to final minutes of the meeting, the FDA has accepted RedHill’s manufacturing plan towards filing the CMC package as part of a potential future U.S. New Drug Application (NDA) for RHB-105
The first Phase III study with RHB-105 successfully demonstrated 89.4% efficacy in eradicating H. pylori infection (p<0.001), supporting the potential superior efficacy of RHB-105 over current standard-of-care (SoC) therapies
RHB-105 was granted QIDP designation by the FDA under the GAIN Act, including Fast-Track development, NDA Priority Review and extended U.S. market exclusivity, for a total of eight years
With the rise in antibiotic resistance and consequent failure rates of SoC therapies, H. pylori is an increasingly important human pathogen; It is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma
- H. pylori infection is estimated to affect over half of the adult population worldwide; The 2015 global and U.S. market potential for H. pylori eradication therapies are estimated at approximately $4.83 billion and $1.45 billion, respectively
TEL-AVIV, Israel, Nov. 10, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
Subject to final minutes of the meeting, the FDA has accepted RedHill’s manufacturing plan towards filing the CMC package as part of a potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study.
Following a previous positive FDA meeting announced in April 2016, and in light of guidance received on the potential path for marketing approval of RHB-105, advanced preparations continue for the confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a high-dose amoxicillin and omeprazole regimen, is planned to be initiated in the first half of 2017, after completion of the ongoing supportive pharmacokinetic (PK) program. The confirmatory Phase III study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S.
The planned confirmatory Phase III study, along with the results from the successfully completed first Phase III study with RHB-105 (the ERADICATE Hp study) and data to be obtained from the ongoing supportive PK program, are expected to support an NDA for RHB-105.
The ERADICATE Hp Phase III study with RHB-105 successfully met its primary endpoint of superiority over historical standard-of-care (SoC) eradication rate of 70%, with high statistical significance (p<0.001). The ERADICATE Hp study results demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105. Notably, subsequent open-label treatment with SoC therapies of patients in the placebo arm of the ERADICATE Hp study demonstrated only 63% eradication rate, further supporting the potential superior efficacy of RHB-105 over SoC.
RHB-105 was granted Qualifying Infectious Disease Product (QIDP) designation by the FDA, providing a Fast-Track development pathway, as well as NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, 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 U.S. market exclusivity.
RedHill is pursuing with RHB-105 an indication of first-line treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori, which are typically indicated only for patients with active or recent history of duodenal ulcer disease. If approved, RHB-105 may be the first H. pylori eradication therapy to target this broader indication, which would significantly expand the potential patient population for this drug candidate.
H. pylori bacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. H. pylori infection is estimated to affect over half of the adult population worldwide. The growing resistance of the H. pylori bacteria to metronidazole and clarithromycin has resulted in increasing failure rates of current SoC for H. pylori eradication, reaching an estimated 30%1. Despite the strong unmet medical need, no new drug has been approved by the FDA for this indication in over a decade.
The 2015 global and U.S. market potential for H. pylori eradication therapies at current branded prices, were estimated at approximately $4.83 billion and $1.45 billion, respectively, and could potentially grow with increasing awareness of the health risks associated with H. pylori infection and the benefits of its eradication2.
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. pylori infection. 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 was completed in the U.S. with positive 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). A confirmatory Phase III study is planned to be initiated in the U.S. 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 NDA Priority Review status, potentially leading to a shorter NDA review time by the FDA, if filed. If approved, RHB-105 will also receive an additional five years of exclusivity, in addition to the standard exclusivity period, for a total of 8 years of U.S. market exclusivity.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill’s pipeline of proprietary products includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful 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 and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA™(ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered uPA inhibitor, targeting gastrointestinal and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to establish and maintain corporate collaborations; (vi) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company's business. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 25, 2016. 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 unless required by law.
1 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664.
2 Jerry Rosenblatt, Ph.D., a member of RedHill’s Advisory Board and Partner at Foster Rosenblatt, RedHill Biopharma press release: RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Program and Potential H. Pylori Eradication Market, May 18, 2015.
Senior VP Business Development &
IR contact (U.S.):
Senior Vice President
The Trout Group
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Lexin Appoints Two New Directors to Expand Board22.3.2018 02:49 | Pressemelding
SHENZHEN, China, March 22, 2018 (GLOBE NEWSWIRE) -- LexinFintech Holdings Ltd. ("Lexin" or the "Company") (NASDAQ:LX), a leading online consumer finance platform for educated young adults in China, today announced the appointment of Dr. Neng Wang as an independent director of the Company's board of directors (the "Board"), and the appointment of Mr. Xiaoguang Wu as a director of the Board, effective on March 20, 2018. These two appointments have expanded the Board to eight members, from six previously. Dr. Wang is also serving as a member of the audit committee, the compensation committee and the nominating and corporate governance committee of the Board. Dr. Wang has replaced Mr. Keyi Chen, Mr. Jared Yi Wu, and Mr. Yibo Shao respectively from the abovementioned committees of the Board, all of whom remain as directors on the Board. Dr. Wang has been Chong Khoon Lin Professor of Real Estate at Columbia Business School since July 2007, and a research associate at the National Bureau of E
3Gtms Positioned in the Niche Players Quadrant of the Gartner Magic Quadrant for Transportation Management Systems21.3.2018 15:00 | Pressemelding
Inclusion marks the first time 3Gtms has been named to the Magic Quadrant SHELTON, Conn., March 21, 2018 (GLOBE NEWSWIRE) -- 3Gtms, Inc., a global provider of Tier 1 transportation management software, today announced it has been positioned by Gartner, Inc. in the Niche Players quadrant of the report, Magic Quadrant for Transportation Management Systems*. This is the first time 3Gtms has been positioned within the Magic Quadrant. According to the report, the research "focuses on holistic multimodal domestic TMSs for use by shippers (such as manufacturers, retailers, distributors and wholesalers) or non-asset-based, third-party logistics (3PL) organizations." Key criteria for the 2018 Magic Quadrant included: The breadth of the TMS; depth of the TMS; usability and adaptability; global go-to market strategy and offering; partner ecosystem; vision, thought leadership, roadmap, and track record; and a compelling SCE convergence strategy. The full report is available at no charge at the 3Gt
Further UHNWI Investment To Support FinTech Entrepreneur Zichain's Growth and Innovation21.3.2018 14:46 | Pressemelding
Zichain / Further UHNWI Investment To Support FinTech Entrepreneur Zichain's Growth and Innovation . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement. ZURICH, Switzerland, March 21, 2018 (GLOBE NEWSWIRE) -- Zichain, a Switzerland-based digital asset management company, is pleased to announce that it has secured an USD 1.2m investment from a syndicate of UHNW Hong-Kong based investors, supporting further development of its unique cryptocurrency products. The deal was confirmed while the Company was participating at the Goldman Sachs 2018 Disruptive Technology Symposium, held in London on 20-21 March. As a pioneer of the cryptocurrency index industry, Zichain has enjoyed exponential growth with the Company now taking a leading role in the creation of digital asset management industry. Zichain is focused on the development of three key products: Blockchain Asset Management Platform (BAMP), a unique and convenien
VistaJet Connects Customers and Their Passions With the Global British Polo Day Tour21.3.2018 14:17 | Pressemelding
Customers to join the most prestigious worldwide polo tournament LONDON, March 21, 2018 (GLOBE NEWSWIRE) -- VistaJet, the first and only global private aviation company, will be offering customers the opportunity to enrich their passion for polo as the company partners with British Polo Day for the 2018 worldwide tournament, following a successful inaugurate partnership last year. The sport is a key interest for many of VistaJet's customers, both as spectators and riders, and is in line with 39% of the world's animal-loving Ultra High Net Worth population having a passion for horses*. VistaJet continuously develops and offers exceptional experiences for its customers inspired by their true passions, including art, sport and travel, across all cultures worldwide. Its global partnership with British Polo Day will offer customers an exclusive opportunity to enjoy one of their most cherished interests by watching some of the sport's top players, including the world's number one player Adol
Datameer Partners with IBM in New Data Science and Machine Learning Platform21.3.2018 13:30 | Pressemelding
Datameer Operationalizes Self-Service Data Pipelines for IBM Cloud Private for Data SAN FRANCISCO, March 21, 2018 (GLOBE NEWSWIRE) -- Datameer, the leader in big data analytics, announced it will partner with IBM to create, manage and deploy business data pipelines for IBM's new data science and machine learning platform, Cloud Private for Data(announced Friday, March 16). The partnership is a comprehensive approach to simplifying and streamlining data integration, preparation, shaping and curation in order to extend data science and machine learning for business teams to make accelerated data-driven decisions. Recognizing that Datameer has the most mature business data pipeline platform for enterprises, IBM has partnered with Datameer to provide comprehensive pipeline creation and operationalization capabilities for the new Cloud Private for Data offering. Datameer will be an integrated part of the solution, offering a seamless customer and user experience that allows business users t
Brookfield and GLP Establish Partnership to Pursue Rooftop Solar Opportunities in China21.3.2018 09:00 | Pressemelding
All amounts in U.S. dollars unless otherwise stated GLP and Brookfield establish 50:50 joint venture to develop and operate rooftop solar projects on logistics and commercial rooftops in China Partnership intends to become the largest rooftop solar power provider in China Expected to develop and operate capacity of 300 megawatts over the next three years, with a broader 1 gigawatt development pipeline - equivalent to the annual consumption of approximately 750,000 households SHANGHAI, China and NEW YORK, March 21, 2018 (GLOBE NEWSWIRE) -- GLP, the leading global provider of modern logistics and industrial facilities and technology-led solutions, and Brookfield Asset Management (TSX:BAM.A) (NYSE:BAM) (Euronext:BAMA), a leading global alternative asset manager, today announced the formation of a 50:50 joint venture dedicated to building a leading platform for distributed solar energy on logistics and commercial rooftops in China. The joint venture, by affiliates of GLP and Brookfield, in
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom