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RedHill Biopharma Ltd.

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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 forH. pyloriinfection 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 eradicatingH. pyloriinfection (p<0.001), supporting the potential superior efficacy of rhb-105 over current standard-of-care (soc) therapies< strong>
  • 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. pyloriis 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. pyloriinfection is estimated to affect over half of the adult population worldwide; The 2015 global and U.S. market potential forH. pylorieradication 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 ofH. pyloriinfection.

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 ofH. pyloriinfection. 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 eradicatingH. pyloriinfection 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 ofH. pyloriinfection, regardless of ulcer status, a significantly broader indication than current standard treatments forH. pylori,which are typically indicated only for patients with active or recent history of duodenal ulcer disease. If approved, RHB-105 may be the firstH. pylorieradication therapy to target this broader indication, which would significantly expand the potential patient population for this drug candidate.

H. pyloribacterial infection is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma.H. pyloriinfection is estimated to affect over half of the adult population worldwide. The growing resistance of theH. pyloribacteria to metronidazole and clarithromycin has resulted in increasing failure rates of current SoC forH. pylorieradication, 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 forH. pylorieradication 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 withH. pyloriinfection 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 ofH. pyloriinfection.H. pyloribacterial 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 eradicatingH. pylori, and met its protocol-defined primary endpoint of superiority in eradication ofH. pyloriinfection 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 ofHelicobacter pyloriinfection 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 SECon 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.

1Malfertheiner P.et al.Management ofHelicobacter pyloriinfection - the Maastricht IV/ Florence Consensus Report, Gut2012;61:646-664.

2Jerry Rosenblatt, Ph.D., a member of RedHill’s Advisory Board and Partner at Foster Rosenblatt, RedHill Biopharmapress release:RedHill Biopharma’s Investor Webcast Forum Provides Update on the RHB-105 Phase III Programand PotentialH. PyloriEradication 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

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