RedHill Biopharma Ltd 6-K, filed Jan 21, 2025
RedHill Biopharma Ltd. (RDHL)
6-K
2025-01-21
For: 2025-01-21
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April 07, 2026
About this 6-K
RedHill Biopharma Ltd filed this 6-K on January 21, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of January 2025
Commission File No.:001-35773
Commission File No.:001-35773
REDHILL BIOPHARMA LTD.
(Translation of registrant’s name into English)
21 Ha'arba'a Street, Tel Aviv, 6473921, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form
40-F.
Form 20-F ☒ Form 40-F ☐
Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: “RedHill’s Talicia®
Adds 8 Million Lives With Coverage by Humana®’s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published”.
This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and
Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No.
333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001) and on June 20, 2024 (File No.
333-280327), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on
August 9, 2024 (File No. 333-281417).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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REDHILL BIOPHARMA LTD.
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(the "Registrant")
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Date: January 21, 2025
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By:
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/s/ Dror Ben-Asher
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Name:
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Dror Ben-Asher
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Title:
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Chief Executive Officer
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Press Release
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RedHill’s Talicia® Adds 8 Million Lives With Coverage by
Humana®’s Part D Plan. Also, New Data Supporting
Simplified Three-Times Daily Talicia
Dosing Published
Talicia is now covered by Humana’s Part D Plan, providing access to Talicia for H. pylori
therapy to more than eight million additional Medicare lives, without requiring prior therapeutic
steps or authorization
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The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists
Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most
prescribed branded H. pylori therapy by U.S. gastroenterologists
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Additionally, new data describing the foundations for Talicia’s recent FDA-approved label
change to a more convenient three-times daily (TID) “breakfast, lunch, and dinner” dosing
routine, supporting patient adherence, has been published in the Journal of Clinical
Pharmacology
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The published data describe the use of physiologically-based pharmacokinetic (PBPK) modeling
and simulation to demonstrate pharmacokinetic equivalence of the TID regimen to the previous
every 8-hour (Q8H) dosing regimen
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H. pylori infection affects approximately 35% of the U.S. adult population and is classified by
the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk
factor for gastric cancer and a major risk factor for peptic ulcer disease
RALEIGH, N.C. and
TEL-AVIV, Israel, January 21, 2025, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the coverage of Talicia by Humana’s Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without the requirement for prior therapeutic steps or authorizations, for both treatment-naïve and treatment-experienced patients, effective as of January 1, 2025.
“There is broad recognition of the clinical efficacy of Talicia and the recently updated American College of Gastroenterology
(ACG) Clinical Guideline, listing Talicia as a first-line treatment option. Talicia is the only FDA-approved low-dose rifabutin-based therapy for the eradication of H. pylori, and continues to be the most prescribed branded H. pylori therapy by
U.S. gastroenterologists1,” said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. “We are
pleased that coverage in the Medicare arena is growing as the Part D payers recognize the importance of treating H. pylori with the
right therapy the first time and look forward to expanding coverage in Medicare.”
The Company also announced the publication of new data in The Journal of Clinical Pharmacology2. The published data describe the foundations for Talicia’s recently FDA-approved label change to a more convenient three-times daily (TID) with food (at
least 4 hours apart, e.g., breakfast, lunch, and dinner) dosing routine, further simplifying the patient experience and supporting increased patient adherence.
The result of a successful collaboration with Certara, the published study utilized Certara’s Simcyp™ Simulator for
physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence in plasma and within the stomach for all three of Talicia’s components, regardless of dosing TID or Q8H. These data support the
provision of a more patient-friendly Talicia regimen and further demonstrate RedHill’s ongoing commitment to enhanced patient experience and outcomes.
“Treating H. pylori
infection is challenging and often requires patients to take multiple different pills multiple times a day. Simplified dosing regimens improve patient adherence. In the treatment of H. pylori infection, adherence to dosing is critical for
optimizing patient outcomes, while also mitigating against the development of bacterial resistance. Therefore, it is important to use an effective therapy that is most likely to eradicate H. pylori infection at the first attempt,” said Colin W. Howden, MD, Professor Emeritus,
University of Tennessee College of Medicine, and co-author of the paper. “These important data, and the retention of Talicia’s pharmacokinetic profile across dosing regimens, support the change to a more simplified TID dosing schedule.
Talicia’s efficacy, tolerability, and resistance profile, along with its convenient all-in-one formulation and TID dosing, further support its inclusion as an empirically prescribed first-line option in the 2024 ACG Clinical Guideline on the
treatment of H. pylori infection3.”
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%4 of the U.S. population, with an estimated two million patients treated annually3. Worldwide, around 66% of the population has H. pylori infection5, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8. More than 27,000 Americans are diagnosed with gastric cancer annually9. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies10.
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About Talicia®
Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. More specifically, the high rates of H. pylori resistance to clarithromycin have led to significant increases in treatment failures with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the WHO in recent years.
Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a
proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori
infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the
intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill’s pivotal Phase 3 study. Further, in an analysis of data from this study,
it was observed that subjects who were confirmed adherent11 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm12.
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
Patients should check coverage details with their health plan.
TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and
rifabutin, a rifamycin antibacterial--, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
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IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a
rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been
reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may
range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These
events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia,
oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S commercialization and
development of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults13. RedHill’s key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple
indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology;
(ii) RHB-107 (upamostat),
an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety
of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2
study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
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Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of Talicia® in the
treatment of Helicobacter pylori infection. 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: market and other conditions; the Company's ability to
maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development
Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that
observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved
to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized
COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for
regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well
as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the
commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical
trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type 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 and Talicia®;
(v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) 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; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its
therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) 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; (xi) parties from whom the Company licenses its
intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences
using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. 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 April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement,
whether as a result of new information, future events or otherwise unless required by law.
All information contained herein is the sole responsibility of RedHill Biopharma Ltd.
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Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
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Category: Commercial
1 IQVIA XPO Data on file
2 Vakil N, Howden CW, Shah SC, Chen KF, Offman E, Almenoff JS, Sheldon KL. Physiologically Based Pharmacokinetic
Modeling and Simulation to Support a Change in the FDA-Labeled Dosing Frequency of RHB-105 Low-Dose Rifabutin Triple Therapy for Helicobacter pylori Eradication. J Clin Pharmacol. 2025 Jan 2. doi: 10.1002/jcph.6178. Epub ahead of print. PMID:
39745109.
3 Chey, William D. MD, FACG1; Howden, Colin W. MD, FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH,
FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6; Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology 119(9):p 1730-1753, September 2024. | DOI:
10.14309/ajg.0000000000002968
4 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
5 https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/helicobacter-pylori
6 Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
7 NIH – Helicobacter
pylori and Cancer, September 2013.
8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
9 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
10 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O’Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment
of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
11 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence
of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
12 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).
13 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori
infection in adults. For full prescribing information see: www.Talicia.com.
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