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U.S. Phase 3 abstraction underway to appraise RHB-204 as a first-line, stand-alone, articulate analysis for pulmonary NTM ache – a attenuate action with no FDA-approved first-line therapy

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FDA Fast Track designation, calm with ahead accepted QIDP designation, provides RHB-204 with accommodation for rolling NDA review, Priority Analysis and Accelerated Approval

RHB-204 Orphan Drug appellation extends abeyant bazaar exclusivity to 12 years post-approval  

TEL AVIV, Israel and RALEIGH, NC, Jan. 6, 2021 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or “the Company”), a specialty biopharmaceutical company, today appear that RHB-204 has been accepted Fast Track appellation by the U.S. Food and Drug Administration (FDA) for its development as a abeyant first-line, stand-alone, articulate analysis of pulmonary nontuberculous mycobacteria (NTM) ache acquired by Mycobacterium avium Complex (MAC) – a attenuate ache for which there is no FDA-approved first-line therapy.

The FDA’s Fast Track appellation is advised to advice beforehand development and acceleration up the analysis of atypical therapies for austere altitude for which there is an unmet medical charge – with the aim of accepting important new therapies to patients added quickly. With the Fast Track designation, RedHill will accept admission to aboriginal and accepted communications with the FDA, to accelerate the RHB-204 development program, and to a rolling analysis of a New Drug Appliance (NDA). Having already been accepted Qualified Communicable Ache Product (QIDP) designation, RHB-204 is additionally acceptable for NDA Priority Analysis and Accelerated Approval.

RHB-204 was additionally afresh accepted Orphan Drug designation, extending U.S. bazaar exclusivity for RHB-204 to a abeyant absolute of 12 years aloft FDA approval.

RedHill afresh accomplished a Phase 3 abstraction evaluating the assurance and adeptness of RHB-204 as a first-line analysis for pulmonary NTM disease, to be conducted at up to 40 sites above the U.S. 

“Given the burning charge to beforehand ameliorative options for patients with NTM disease, we acceptable this Fast Track appellation and the authoritative abutment it provides in expediting the advancing Phase 3 development affairs for RHB-204 and any consecutive abeyant approvals,” said Patricia Anderson, RedHill’s Senior Vice President of Authoritative Affairs. “NTM ache is thankfully attenuate but its prevalence is accretion in abounding areas of the world. It is a awfully difficult to amusement ache and, if not finer treated, can annual scarring and fibrosis in the lungs – potentially arch to respiratory failure. Abounding patients abort accepted therapies, and added than bisected will accept either alternating ache or a new infection afterwards commutual analysis [1],[2].”

RHB-204 may be acceptable for use beneath the RedHill broadcast admission action – added capacity of which can be begin here: https://www.redhillbio.com/expandedaccess. The Phase 3 abstraction of RHB-204 is registered on www.ClinicalTrials.gov, a web-based annual by the U.S. National Institute of Health, which provides accessible admission to advice on about and abreast accurate analytic studies. 

About Pulmonary Nontuberculous Mycobacteria (NTM) Disease

Pulmonary nontuberculous mycobacteria (NTM) ache is a abiding and debilitating lung ache acquired by all-over ecology bacilli begin in soil, as able-bodied as accustomed and engineered baptize systems. The best accepted NTM affection accommodate fever, weight loss, chest pain, and claret in sputum[3]. Pulmonary NTM ache can beforehand to alternating cases of bronchitis and pneumonia and can, in some cases, beforehand to respiratory failure[4]. Although rare, the accident and prevalence of pulmonary NTM ache are accretion in abounding areas of the world[5]. There were an estimated 110,000 pulmonary NTM ache patients in the U.S. in 2017, with U.S. bazaar abeyant estimated at over $500 million[6]. Pulmonary manifestations annual for 80-90{945d49e18d7e8eb655e680a2bcda7add690ff3071faed0195398f4ec80a78870} of all NTM-associated diseases[7], and about 80{945d49e18d7e8eb655e680a2bcda7add690ff3071faed0195398f4ec80a78870} of pulmonary NTM ache are acquired by Mycobacterium avium Complex (MAC)[8].

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About RHB-204

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RHB-204 is a proprietary, fixed-dose articulate abridged absolute a aggregate of clarithromycin, rifabutin, and clofazimine, developed for the analysis of pulmonary NTM ache acquired by Mycobacterium avium Complex (MAC). In accession to FDA Fast Track designation, RHB-204 has been accepted FDA Orphan Drug appellation for the analysis of NTM ache and QIDP Appellation beneath the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. bazaar exclusivity for RHB-204 to a abeyant absolute of 12 years to be accepted at the time of FDA approval. RHB-204 is additionally covered by U.S. patents which extend apparent aegis until 2029 and a awaiting U.S. apparent appliance which, if allowed, could extend RHB-204 apparent aegis until 2041.

About RedHill Biopharma

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical aggregation primarily focused on gastrointestinal and communicable diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced ache in adults[9], Talicia®for the analysis of Helicobacter pylori (H. pylori) infection in adults[10], and Aemcolo® for the analysis of travelers’ diarrhea in adults[11]. RedHill’s key analytic late-stage development programs include: (i) RHB-204, with an advancing Phase 3 abstraction for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 careful inhibitor targeting assorted break with a Phase 2/3 affairs for COVID-19 and Phase 2 studies for prostate blight and cholangiocarcinoma ongoing; (iii) RHB-104, with absolute after-effects from a aboriginal Phase 3 abstraction for Crohn’s disease; (iv) RHB-102 (Bekinda®), with absolute after-effects from a Phase 3 abstraction for astute gastroenteritis and gastritis and absolute after-effects from a Phase 2 abstraction for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 abstraction in appropriate COVID-19 and targeting assorted added blight and anarchic gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. Added advice about the Aggregation is accessible at www.redhillbio.com / https://twitter.com/RedHillBio.

This columnist absolution contains “forward-looking statements” aural the acceptation 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 agnate words. Advanced statements are based on assertive assumptions and are accountable to assorted accepted and alien risks and uncertainties, abounding of which are above the Company’s ascendancy and cannot be predicted or quantified, and consequently, absolute after-effects may alter materially from those bidding or adumbrated by such advanced statements. Such risks and uncertainties include, after limitation; the accident that the Aggregation will not accomplish to complete the accommodating recruitment; the accident that the Aggregation will not accept the accordant abstracts appropriate for benefiting from the Fast Track designation; the accident that the U.S. Phase 3 analytic abstraction evaluating RHB-204 will not be acknowledged or, if successful, will not answer for authoritative business approval after the charge for added analytic and/or added studies; as able-bodied as risks and uncertainties associated with (i) the initiation, timing, beforehand and after-effects of the Company’s research, manufacturing, pre-clinical studies, analytic trials, and added ameliorative applicant development efforts, and the timing of the bartering barrage of its bartering articles and ones it may access or beforehand in the future; (ii) the Company’s adeptness to beforehand its ameliorative candidates into analytic trials or to auspiciously complete its pre-clinical studies or analytic trials or the development of a bartering accompaniment analytic for the apprehension of MAP; (iii) the admeasurement and cardinal and blazon of added studies that the Aggregation may be appropriate to conduct and the Company’s cancellation of authoritative approvals for its ameliorative candidates, and the timing of added authoritative filings, approvals and feedback; (iv) the manufacturing, analytic development, commercialization, and bazaar accepting of the Company’s ameliorative candidates and Talicia®; (v) the Company’s adeptness to auspiciously commercialize and advance Talicia®, and Aemcolo® and Movantik®; (vi) the Company’s adeptness to authorize and advance accumulated collaborations; (vii) the Company’s adeptness to access articles accustomed for business in the U.S. that accomplish bartering success and body its own business and commercialization capabilities; (viii) the estimation of the backdrop and characteristics of the Company’s ameliorative candidates and the after-effects acquired with its ameliorative candidates in research, pre-clinical studies or analytic trials; (ix) the accomplishing of the Company’s business model, cardinal affairs for its business and ameliorative candidates; (x) the ambit of aegis the Aggregation is able to authorize and advance for bookish acreage rights accoutrement its ameliorative candidates and its adeptness to accomplish its business after anarchic the bookish acreage rights of others; (xi) parties from whom the Aggregation licenses its bookish acreage behind in their obligations to the Company; (xii) estimates of the Company’s expenses, approaching revenues, basic requirements and needs for added financing; (xiii) the aftereffect of patients adversity adverse adventures application analytic drugs beneath the Company’s Broadcast Admission Program; (xiv) antagonism from added companies and technologies aural the Company’s industry; and (xv) the hiring and application admission date of controlling managers. Added abundant advice about the Aggregation and the accident factors that may affect the ability of advanced statements is set alternating 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 March 4, 2020. All advanced statements included in this columnist absolution are fabricated alone as of the date of this columnist release. The Aggregation assumes no obligation to amend any accounting or articulate advanced statement, whether as a aftereffect of new information, approaching contest or contrarily unless appropriate by law.

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References:

[1] Henkle E, et al. Patient-Centered Analysis Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Analysis Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84.

[2] Daley CL, et al. Analysis of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Analytic Practice Guideline: Controlling Summary. Analytic Communicable Diseases. Ciaa241, https://doi.org/10.1093/cid/ciaa241.

[3] Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Abstraction of a Distinct Preexisting Syndrome Am J Respir Crit Affliction Med. 2008; 178(10):1066–74.

[4] The American Lung Association, 2020.

[5] Henkle E, et al. Population-based Accident of Pulmonary Nontuberculous Mycobacterial Ache in Oregon 2007 to 2012 Annals of the American Thoracic Society. 2015; 12(5):642-7.

[6] Foster|Rosenblatt, 2017.

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[7] Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and blockage of nontuberculous mycobacterial diseases Am J Respir Crit Affliction Med. 2007;175(4):367-416.

[8] Prevots DR et al. Nontuberculous mycobacterial lung ache prevalence at four chip bloom affliction commitment systems. Am J Respir Crit Affliction Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial ache prevalence and analytic features: an arising accessible bloom disease. Am J Respir Crit Affliction Med 2010; 182: 977-82

[9] Full prescribing advice for Movantik® (naloxegol) is accessible at: www.Movantik.com.  

[10] Full prescribing advice for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is accessible at: www.Talicia.com.       

[11] Full prescribing advice for Aemcolo® (rifamycin) is accessible at: www.Aemcolo.com.

Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg 

 

Company contact:

Adi Frish

Chief Accumulated & Business Development Officer

RedHill Biopharma

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972-54-6543-112

[email protected]

 

Media acquaintance (U.S.):

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Bryan Gibbs

Vice President

Finn Partners

1 212 529 2236

bryan.gibb[email protected]

 

 

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