Nasdaq GlobeNewswire

RedHill Biopharma Reports Positive FDA Type B Meeting on RHB-105 for H. pylori Infection Ahead of Confirmatory Phase III Study

Del
  • 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.

About RHB-105:
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.

         Company contact:
         Adi Frish
         Senior VP Business Development &
         Licensing
         RedHill Biopharma
         +972-54-6543-112
         adi@redhillbio.com
         
         IR contact (U.S.):
         Marcy Nanus
         Senior Vice President
         The Trout Group
         +1-646-378-2927
         Mnanus@troutgroup.com

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
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

GSV Asset Management Announces Strategic Investment from HMC Capital-Led Group14.12.2017 21:03Pressemelding

WOODSIDE, Calif. and NEW YORK, Dec. 14, 2017 (GLOBE NEWSWIRE) -- GSV Asset Management, LLC ("GSV"), a modern merchant bank that identifies, advises, and invests in the fastest growing, most dynamic companies in the world - the Stars of Tomorrow - today announced a strategic investment from a group led by HMC Capital ("HMC"), a leading Latin American advisory and investment firm. While terms of the deal were not disclosed, the investment will result in a minority ownership interest for the HMC-led group in GSV Asset Management. Proceeds will be used to enhance GSV's ongoing investment activities, as well as to accelerate its strategic expansion into new business areas and geographies. "We are very excited to partner with HMC Capital, a multi-billion dollar asset manager that brings a range of complimentary capabilities to GSV Asset Management," said Michael Moe, founder of GSV. "GSV stands for Global Silicon Valley and our alliance with HMC reflects our shared commitment t

TrueCommerce Datalliance Releases Third 2017 Update for Vendor Managed Inventory Platform14.12.2017 19:28Pressemelding

Latest Software Update Enhances Browser, Productivity Experience CINCINNATI, Dec. 14, 2017 (GLOBE NEWSWIRE) -- TrueCommerce Datalliance, a leading vendor managed inventory service solutions provider, announced today that it released the third scheduled 2017 update to its VMI platform. The free update is part of TrueCommerce Datalliance's commitment to improving the functionality of its cloud-based supply chain software. Highlights of the release include several improvements to its system architecture and capabilities: Google Chrome is now officially supported Order Worksheets are now easier to view in Internet Explorer One-click access to recently changed or added items Mass Launch Order Preview lists all items suggested or added via allocation "We promise our customers three major updates every year," said Connie Shafer, TrueCommerce Datalliance Producti

ATTO announces support for Apple® Release of the new iMac Pro14.12.2017 18:37Pressemelding

ATTO's line of ThunderboltTM technology enabled products continue to revolutionize connectivity to storage AMHERST, N.Y., Dec. 14, 2017 (GLOBE NEWSWIRE) -- ATTO Technology, Inc., a global leader of storage and network connectivity and infrastructure solutions for data-intensive computing environments, today confirmed their continued commitment to the newly released line of product updates and innovations from Apple. With the powerful and new iMac Pro® now shipping, ATTO continues to support the new offerings from this industry leading manufacturer. "Our deep relationship with Apple over the last 30 years continues to drive our position as a leading force within the Apple community," said Timothy J. Klein, president and CEO at ATTO Technology. The iMac Pro sets a new standard for Apple design and performance and complements why users select ATTO products. As Apple pushes the boundaries of desktop computing, ATTO continues to provide industry leading products that op

Seaborn Networks' CEO Larry Schwartz is Named in List of 100 Most Powerful People in Telecoms Worldwide14.12.2017 16:12Pressemelding

BOSTON, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Seaborn Networks ("Seaborn"), a leading developer-owner-operator of submarine fiber optic cable systems, is pleased to announce that Larry Schwartz, Seaborn's Chairman & CEO, has been named one of the 100 most powerful people in the telecoms industry by Global Telecoms Business ("GTB"). The Power 100 List annually identifies the most influential people in telecoms, content and Internet companies, selecting nominations from readers of the publication. Larry is one of only six people included on the list from the global subsea and data center industries. GTB notes that these top 100 were "those the industry felt were the real power, the real influencers, behind the telecoms sector" and were chosen by the editorial team with input from GTB's readers. In only a few years, Larry has led Seaborn from being a start-up to now being a leading player in the global telecommunications industry, setting precedents with its business model, fina

Mayo Clinic to begin Prospective Clinical Study with Medibio Technology for Expanded Market Opportunities14.12.2017 15:10Pressemelding

Study designed to determine differential diagnosis in depression patients Study designed to monitor patient data following pharmacological treatment SYDNEY, Australia and MINNEAPOLIS, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Medibio Limited (MEB or the Company) (ASX:MEB) (OTCQB:MDBIF), a mental health technology company that has pioneered the use of objective biometrics to assist in the screening, diagnosing, monitoring and management of depression and other mental health conditions,  is pleased to announce the first prospective clinical trial with Mayo Clinic under a 5-year Master Clinical Trial Agreement that was signed in October of this year.  This initial study, undertakes the prospective diagnosis and longitudinal monitoring of both unipolar and bipolar depression, along with the depressive subtypes (melancholic and atypical). The primary goal is to characterize longitudinal autonomic, circadian, and

The 1st free cross-border ecommerce library available to online merchants14.12.2017 10:00Pressemelding

A competitive edge instrumental in succeeding in today's dynamic retail world AMSTERDAM, The Netherlands, Dec. 14, 2017 (GLOBE NEWSWIRE) -- Acapture, a global, data-driven omnichannel PSP, has released a complete library of free infographics for merchants, outlining the latest exclusive data for 31 of the world's most exciting ecommerce markets. Online retailers, marketplaces, and other ecommerce merchants are given a competitive edge, instrumental in succeeding in today's dynamic retail world. With each infographic providing actionable stats, facts and figures from a major ecommerce region, illustrated with clear, reader-friendly graphics, the collection is essential reading for all merchants looking to seize current cross-border opportunities. By understanding the preferred local payment methods, the most popular B2B and B2C product categories, top import and export regions, most popular ecommerce sites and much more, merchants can make

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom