MEDICAL BULLETIN BOARD

Redhill’s AEMCOLO® Granted FDA

QIDP 5-YEAR EXCLUSIVITY EXTENSION

Aemcolo granted five years’ exclusivity under the FDA’s Qualified Infectious Disease Product (QIDP) designation in addition to the five years NCE data exclusivity, extending regulatory exclusivity through to 2028

Aemcolo (rifamycin) is a non-systemic antibiotic whose delivery is targeted to the site of noninvasive Escherichia coli (E. coli) infection in the distal small bowel and colon, approved by the FDA for the treatment of Travelers’ Diarrhea caused by non-invasive strains of E. coli in adults

Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book1

TEL AVIV, Israel and RALEIGH, N.C., December 5, 2022 RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration’s (FDA) Exclusivity Board has granted Aemcolo®2 five years’exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years’ data exclusivity granted as a new chemical entity (NCE) for the treatment of travelers’ diarrhea (TD) caused by non-invasive strains of Escherichia coli (E. coli) in adults.

Patricia Anderson, RedHill’s Senior Vice President of Regulatory Affairs said: “Given the great concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, Aemcolo represents an important innovation to meet significant unmet need. This FDA grant of five additional years’ exclusivity for Aemcolo under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in 2 addition to the five years awarded to Aemcolo based on new chemical entity exclusivity, will protect that innovation through to 2028.” Aemcolo, containing 194 mg of rifamycin as delayed-release tablets, is an orally-administered, nonsystemic antibiotic employing MMX® technology, a proprietary drug delivery system that distributes rifamycin in a controlled manner to the lower intestine. Due to its non-systemic delivery,Aemcolo is associated with limited side effects and minimal potential for interactions with other medications. Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book.1

About Traveler’s Diarrhea

Travelers’ Diarrhea (TD) is the most common travelrelated illness, affecting an estimated 10% to 40% of travelers annually.3 Each year, approximately 70 million Americans travel abroad.4 Attack rates of TD range up to 70% of travelers, depending on the destination and season of travel.5 TD may often result in short-term morbidity adversely impacting travel plans. Untreated diarrhea can also lead to an underappreciated risk of chronic complications, including functional bowel disorders.6

About Aemcolo (rifamycin)

Aemcolo (rifamycin) is an orally-administered, delayed-release, non-systemic antibiotic approved for the treatment of travelers’ diarrhea caused by non-invasive strains of Escherichia coli (E. coli) in adults. Aemcolo is the first antibiotic engineered with Cosmo Pharmaceuticals’ Multi Matrix Technology (MMX®). MMX technology is designed to deliver the active pharmaceutical ingredients in a delayed and controlled manner directly to the lower intestine. Due to its nonsystemic delivery, Aemcolo is associated with limited side effects and minimal potential for interactions with other medications. Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention

(CDC) Yellow Book. The recommended dosage of Aemcolo is 388 mg (two tablets) orally, twice daily for three days.

Important Safety Information

Aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in Aemcolo. Aemcolo should be swallowed whole. Do not crush, break or chew the tablets. Do not take Aemcolo concomitantly with alcohol. The most common adverse reactions

(incidence >2%) are headache and constipation. Clostridium difficile-Associated Diarrhea has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy.

Risk of Persistent or Worsening Diarrhea Complicated by Fever and/or Bloody Stool:

Aemcolo was not shown to be effective in patients with diarrhea complicated by fever and/ or bloody stool or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients. Discontinue use if diarrhea gets worse or persists more than 48 hours, and consider alternative antibacterial therapy.

You can report any side effects to RedHill Biopharma Inc. at 1-833-ADR-HILL or by contacting the FDA at 1-800-FDA-1088 or www. fda.gov/medwatch.

INDICATION

Aemcolo is indicated for the treatment of Travelers’ Diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults. It is not recommended for use in patients with diarrhea complicated by fever and/or bloody stool or due to pathogens other than noninvasive strains of E. coli.

About RedHill Biopharma Ltd.

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults,7 Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults,8 and Aemcolo® for the treatment of travelers’ diarrhea in adults.2 RedHill’s key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed, SK2 selective inhibitor targeting multiple indications, including for pandemic preparedness, with a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program in oncology and a radiation protection program ongoing; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed serine protease inhibitor with potential for pandemic preparedness and is in Phase 3-stage development as treatment for non-hospitalized symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; and (v) RHB-102, with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D.

More information about the Company is available at:

redhillbio.com

twitter.com/RedHillBio

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; 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®, and Aemcolo® and Movantik®; (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 March 18, 2021. All forwardlooking 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-5 looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact:

Adi Frish
Chief Corporate and Business Development
Officer

RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

References

  1. https://wwwnc.cdc.gov/travel/yellowbook/2020/preparing-international-travelers/travelers-diarrhea.
  2. Aemcolo® (rifamycin) is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.aemcolo.com.
  3. FDA.https://www.fda.gov/news-events/press-announcements/fdaapproves-new-drug-treat-travelers-diarrhea.
  4. Cosmo Pharmaceuticals Investor Presentation July 2019.
  5. CDC Yellow Book.
  6. Steffen R, et al. JAMA. 2015;313(1):71-80.
  7. Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
  8. 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.

Prometheus Biosciences Announces Positive Results for PRA023 in Both ARTEMIS-UC Phase 2 and APOLLOCD Phase 2a Studies Enabling Pathway to Both Firstin-Class and Best-in-Class Anti-TL1A mAb
– ARTEMIS-UC trial met primary endpoint with 26.5% of patients on PRA023 achieving clinical remission compared to 1.5% of patients on placebo at Week 12 (p<0.0001) – ARTEMIS-UC Cohort 1 met all ranked secondary endpoints – APOLLO-CD trial showed 26.0% endoscopic response and 49.1% clinical remission rates (p=0.002 and p<0.001, respectively, compared to prespecified historical placebo rates) – PRA023 demonstrated favorable safety and tolerability results across both studies with no safety signal identified – ARTEMIS-UC Cohort 1 interim analysis suggests a trend towards increased PRA023 response in CDx+ patients over all comers – PRA023 showed a significant impact on multiple markers of inflammation and fibrosis in APOLLO-CD – Prometheus intends to advance PRA023 into
Phase 3 studies for UC and CD in 2023

SAN DIEGO, Dec. 07, 2022 (GLOBE NEWSWIRE) – Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, today reported results from its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023 demonstrating strong efficacy and favorable safety results in both studies. Based on the totality of the data in these two studies, Prometheus intends to advance PRA023 into Phase 3 studies for ulcerative colitis (UC) and Crohn’s disease (CD) in 2023.

Topline Results from the ARTEMIS-UC Phase 2 Study

Prometheus’ Phase 2 ARTEMIS-UC clinical trial was a 12-week, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of PRA023 in patients with moderate-toseverely active UC who have failed conventional or advanced therapy. PRA023 met the primary and all ranked secondary endpoints including clinical, endoscopic, histologic, and patient-reported outcome measures in the initial cohort (Cohort 1) of the trial. 68/68 (100%) of PRA023-treated patients completed the Cohort 1 study, compared to 60/67 (89.6%) in the placebo group. The topline results for the key endpoints were as follows:

  • 26.5% of patients on PRA023 reached the primary endpoint of clinical remission (per modified Mayo Score), compared to 1.5% on placebo, for a placebo-adjusted clinical remission rate of 25.0% on the primary endpoint (p<0.0001)
  • 36.8% of patients on PRA023 reached the secondary endpoint of endoscopic improvement (Mayo endoscopy subscore of ≤ 1), compared to 6.0% on placebo, for a placebo-adjusted endoscopic improvement rate of 30.8% on the secondary endpoint (p<0.0001)
  • All secondary endpoints met with statistical significance

PRA023 was well tolerated in Cohort 1, with no treatment-emergent serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe AEs, opportunistic infections or infusion reactions reported in the PRA023 treatment group. The only AE that occurred in more than two patients and at a higher frequency in the PRA023 group compared to placebo was COVID-19 (5/68 [7.4%] and 3/67 [4.5%], respectively).

Based upon confidence in its precision approach and speed to market, the company conducted an interim companion diagnostic (CDx) analysis of Cohort 1 to evaluate the effectiveness of the CDx candidate in ARTEMIS-UC. Although from limited patient numbers, data from the subset of patients who tested positive on the CDx in Cohort 1 (N=32) demonstrated a placebo-adjusted clinical remission rate of 37.5%, compared with the placebo-adjusted remission rate of 25.0% for all-comers. The expansion cohort (Cohort 2), which is statistically powered to further assess the treatment effect of PRA023 in CDx+ patients will continue to enroll, and the company expects results in the second quarter of 2023.

Results from the APOLLO-CD Phase 2a Study

Prometheus’ Phase 2a APOLLO-CD clinical trial was a 12-week open-label study that enrolled 55 patients with moderate-to-severely active CD with endoscopically active disease who had failed conventional or biologic therapy. The study enrolled a highly refractory patient population with 70.9% of patients previously treated with at least one biologic therapy and 52.7% treated with two or more biologic therapies. The results on the key endpoints were as follows:

  • 26.0% of patients on PRA023 achieved endoscopic response (p=0.002 compared to 12% prespecified historical placebo rate)
  • 49.1% of patients on PRA023 achieved clinical remission (p<0.001 compared to 16% prespecified historical placebo rate)

PRA023 was well tolerated in the APOLLOCD study. There were no treatment-emergent serious adverse events (SAE), adverse events (AE) leading to discontinuation, or severe AEs assessed as related to PRA023 by the investigator. There were no opportunistic infections or infusion reactions reported. AEs that occurred in more than two patients included COVID-19, urinary tract infection, CD, anemia, nasopharyngitis and fatigue.

The predictive power of the company’s prespecified genetic markers was validated using an alternative Crohn’s-specific CDx algorithm which showed 45.0% (9/20) endoscopic response relative to all-comers of 26% (13/50). While the original algorithm provided limited benefit on some of the endpoints, the alternative algorithm demonstrated enhanced performance across both clinical and endoscopic outcomes. The company plans to advance this alternative algorithm in registrational studies for CD. In addition, a compelling reduction in markers of inflammation and fibrosis was observed between pre-treatment and post-treatment with PRA023, as measured by circulating cytokine levels, immunohistochemistry and gene expression in disease tissue.

“We are beyond enthusiastic with these study results and what they could mean for patients suffering from IBD. The performance of PRA023 in both UC and Crohn’s patients has surpassed our expectations,” said Mark McKenna, Chairman and CEO of Prometheus Biosciences. “We believe PRA023 and our precision medicine approach has the potential to change the paradigm of IBD treatment and we look forward to discussions with regulatory agencies as we prepare to advance into Phase 3 studies in Ulcerative Colitis and Crohn’s Disease.”

“PRA023 has clearly demonstrated clinical proof-of-concept in CD and remarkable efficacy for the treatment of UC,” added Allison Luo, MD, Chief Medical Officer. “We are grateful to all of our investigators and patients for their participation and look forward to further evaluating PRA023 in Phase 3 studies with the goal of bringing this promising candidate to the market.”

Next Steps

As a result of these positive data, Prometheus plans to advance PRA023 into pivotal development in 2023, following discussions with regulators. The full data sets from these studies will be presented at a future medical meeting.

About PRA023: Pipeline in a Product Candidate

PRA023 is an IgG1 humanized monoclonal antibody that has been shown to block tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membraneassociated human TL1A with high affinity and specificity and has the potential to substantially improve outcomes for moderate-to-severe IBD patients predisposed to increased TL1A expression. Prometheus is developing PRA023 for the treatment of immune-mediated diseases including UC, CD, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

About Prometheus Biosciences

Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment

of immune-mediated diseases. The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.

Forward Looking Statements

Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the potential of PRA023 to improve IBD treatment and to be both a first-in-class and best-in-class anti-TL1A mAb; the timing of results from Cohort 2 of the ARTEMIS-UC trial; plans to advance PRA023 into Phase 3 studies in UC and CD, including the timing thereof, as well as plans to use an alternative CDx algorithm for CD. The inclusion of forwardlooking statements should not be regarded as a representation by Prometheus that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results Prometheus reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; Prometheus’ approach to the discovery and development of precision medicines based on Prometheus360 is unproven; interim results of a clinical trial such as with Cohort 1 CDx analysis do not predict final results and the clinical outcomes may materially change as patient enrollment in Cohort 2 continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient data become available, including from from Cohort 2; potential delays in the commencement, enrollment and completion of clinical trials and

of immune-mediated diseases. The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.

Forward Looking Statements

Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the potential of PRA023 to improve IBD treatment and to be both a first-in-class and best-in-class anti-TL1A mAb; the timing of results from Cohort 2 of the ARTEMIS-UC trial; plans to advance PRA023 into Phase 3 studies in UC and CD, including the timing thereof, as well as plans to use an alternative CDx algorithm for CD. The inclusion of forward looking statements should not be regarded as a representation by Prometheus that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results Prometheus reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; Prometheus’ approach to the discovery and development of precision medicines based on Prometheus360 is unproven; interim results of a clinical trial such as with Cohort 1 CDx analysis do not predict final results and the clinical outcomes may materially change as patient enrollment in Cohort 2 continues, following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient data become available, including from from Cohort 2; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; the results of clinical trials are not necessarily predictive of future results; Prometheus’ dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus’ ability to develop companion diagnostics for its therapeutic product candidates; unexpected adverse side effects or inadequate efficacy of its product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; planned future trials of PRA023 may not support regulatory registration; regulatory developments in the United States and foreign countries; Prometheus’ ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its preclinical studies, clinical trials, manufacturing and supply chain; and other risks described in the Company’s prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Prometheus’ most recent quarterly report on Form 10-Q and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forwardlooking statements, which speak only as of the date hereof, and Prometheus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SEBELA PHARMACEUTICALS® ACQUIRES EXCLUSIVE LICENSING RIGHTS TO DEVELOP AND COMMERCIALIZE TEGOPRAZAN IN THE U.S. AND CANADA

Phase 3 Trials Initiated with Tegoprazan for the Treatment of Erosive Esophagitis and Non-erosive Reflux Disease

Braintree, Mass. — Sebela Pharmaceuticals® has entered an exclusive partnership with HK inno.N Corporation to license tegoprazan in the United States and Canada. Under the agreement, Braintree Laboratories, a leader in gastroenterology and an affiliate of Sebela Pharmaceuticals, will be responsible for clinical development, registration, marketing, and sales in the United States and Canada. Tegoprazan, a novel potassium-competitive acid-blocker (P-CAB), is currently approved and marketed in several territories, including South Korea and China.

“We are delighted to add tegoprazan to our product pipeline,” said Alan Cooke, President and CEO of Sebela Pharmaceuticals. “For over 35 years we have been committed to the gastroenterology space and to those affected by GI diseases. Tegoprazan expands our gastroenterology portfolio into an exciting new therapeutic class. Tegoprazan already has an established track record of safety and efficacy in multiple clinical studies and represents a potential new treatment option for people living with GERD.”

“We are delighted to partner with Sebela Pharmaceuticals,” Dal-Won Kwak, CEO, HK inno.N said in a statement. “Sebela has vast development, regulatory and commercial experience and expertise in the US, having obtained FDA approval and successfully launched multiple gastroenterology products over more than three decades. We believe Sebela Pharmaceuticals is the ideal partner to develop and commercialize tegoprazan in the United States and Canada.” Following successful discussions with the US Food and Drug Administration, Sebela Pharmaceuticals has initiated Phase 3 studies of tegoprazan in patients with gastroesophageal reflux disease (GERD). The Phase 3 GERD program, known as the TRIUMpH program, includes a large, multi-center, double-blind study evaluating the safety and efficacy of tegoprazan versus a PPI control for the indications of healing of all grades of erosive esophagitis (EE) and the maintenance of EE healing and relief of heartburn. The TRIUMpH program also includes a large, multicenter, doubleblind, placebo-controlled study designed to demonstrate the safety and efficacy of tegoprazan in patients with non-erosive reflux disease (NERD).

About Tegoprazan

Tegoprazan is a novel agent in development for the treatment of acid-related gastrointestinal diseases. It is a member of a class of oral medications known as P-CABs, or potassium-competitive acid blockers, which have been shown to have rapid onset of action and the ability to control gastric pH for longer periods of time than proton pump inhibitors (PPIs). Tegoprazan has already received marketing authorization in multiple territories, including South Korea and China.

About GERD

GERD is a chronic and highly prevalent disorder caused by repeated backflow (or reflux) of gastric contents into the esophagus. GERD is characterized by a wide variety of symptoms, including heartburn and acid regurgitation. The main phenotypic presentations of GERD include non-erosive reflux disease (NERD) and erosive esophagitis (EE). EE is usually clinically differentiated from NERD by the presence of mucosal inflammation and lesions in the distal esophagus. Poorly treated EE can lead to Barrett’s esophagus which increases the risk of esophageal cancer. It is estimated that GERD affects approximately 65 million people in the US with 60% to 70% suffering from NERD. While proton pump inhibitors are the mainstay of therapy for both EE and NERD, 35% to 54% of patients fail to achieve complete relief of symptoms. This represents a large unmet and underappreciated patient need.

About Sebela Pharmaceuticals®

Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women’s health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development. In addition, Sebela Women’s Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth.

Please visit sebelapharma.com for more information or call 800-874-6756.

About HK inno.N Corporation

HK inno.N (KOSDAQ: 195940) is a public South Korean pharmaceutical company that develops, manufactures, and commercializes pharmaceuticals for both the domestic and international markets. HK inno.N’s key businesses are in the areas of prescription drugs, health supplements and beauty products. Since its establishment in 1984, through exports and global alliances, the company is growing into an international pharmaceutical firm. Drawing on the company’s experience and knowhow in developing novel drugs, HK inno.N succeeded in launching new GERD treatment ‘K-CAB®” (Tegoprazan), the 30th novel drug to be developed and registered in Korea, to great acclaim. For more information, visit: inno-n.com/eng

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