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The Patient Reported Outcomes for Sarecycline Effectiveness and Safety (PROSES) study results show significant improvement in certain health-related quality of life measures for acne patients during 12-week treatment MALVERN, Pa.--(BUSINESS WIRE)-- Almirall LLC, a global biopharmaceutical company focused on skin health, is excited to announce the release of its privately funded PROSES study at this year’s Fall Clinical Dermatology Conference® in Las Vegas, Nevada, October 20-23, 2022. Over the course of the 12-week study, patients with moderate to severe non-nodular acne vulgaris showed a significant improvement in certain health-related quality of life measures during treatment with sarecycline. “This important real-world study demonstrated not only the impact that acne has on a patient’s mental health, but also that successful treatment can improve both a patient’s acne and related quality of life outcomes,” says Emmy Graber, MD, co-principal investigator of PROSES. The study evaluated patient-reported outcomes (PROs), using two separate questionnaires (ASIS and EPQ*), investigator global assessment (IGA), and safety of sarecycline use among patients with moderate to severe non-nodular acne vulgaris. Baseline results from PROs clearly reflect an impact of substantial burden on certain aspects of a patient’s quality of life across four distinct domains within the ASIS tool. When asked about the impact of acne on measures specific to social or emotional attributes over the past seven days, patient’s baseline response was recorded as all/most/some of the time in the following categories: 78.77% felt sad, 71.15% felt embarrassed, 76.68% felt self-conscious, and 35.57% chose not to be around others.1 “With the PROSES initiative, we are able to witness the emotional and physical suffering of individual acne patients and – for the first time – how treatment is able to make a difference for these patients,” says Hilary Baldwin, MD, co-principal investigator of PROSES. “We’re very excited to present PROSES results and look forward to publishing our findings in a peer-reviewed journal by the end of this year.” Overall, the change from baseline measures across all domains of the ASIS questionnaire reflected a significant improvement. Additionally, PROSES study results showed an overwhelming majority of physicians (88.1%) were satisfied/very satisfied with patient sarecycline treatment.1 Over the 12-week study period, EPQ responses displayed a significant increase in patients reporting no/least acne burden.2 “Almirall US is proud to have spearheaded this innovative real-world evidence study and we are looking forward to seeing the outcomes realized in how the dermatology community recognizes the importance of evaluating the patient beyond their skin,” says Pablo Alvarez, PhD, President & General Manager, Almirall, LLC. General understanding of acne impact on patients and burden of the disease beyond the skin is still evolving. Assessing the impact of sarecycline treatment on patient-reported outcomes in real-world community practice settings highlights the improvement of certain health-related quality of life measures. This study reinforces Almirall’s vision for improving patient lives. “I know from personal experience the profound impact acne can have on a young adult’s life. This is also compounded by social media and lack of understanding of these societal pressures. To this end, I am confident that the PROSES study will make a significant contribution to a deeper understanding of the true burden of acne and the potential impact novel therapies such as sarecycline can bring to patients,” says Volker Koscielny, MD, Almirall’s Chief Medical Officer. *ASIS = Acne Symptom and Impact Scale EPQ = Expert Panel Questionnaire About Acne: Acne vulgaris affects up to 50 million Americans and is the most common skin condition in the United States (U.S).3 Acne has been shown to negatively affect quality of life, resulting in low self-esteem and increased social and emotional anxiety.4,5 Moderate to severe acne is classified by papules, pustules, nodules, or cysts on the face, shoulders, chest or back. About PROSES Study Design: PROSES was a 12-week, single-arm, prospective observational study conducted in 300 moderate to severe non-nodular acne patients >9 years who were prescribed sarecycline in 30 real-world community practices in the US. Two hundred fifty-three (253) patients had full data and were included in the analyses. Study Limitations: This study may be subject to the typical limitations associated with real-world studies and single-arm, open-label studies including recall bias, reporting bias, and selection bias. In addition, concomitant acne medications were allowed in this study, as per usual care. Study Endpoints: The Acne Symptom and Impact Scale (ASIS) questionnaire collected responses at baseline and at week 12 from subjects (>12 years) and caregivers (for subjects 9-11 years). ASIS is a 17-item validated instrument that asks patients about symptoms and impacts associated with acne vulgaris.6 The Expert Panel Questionnaire (EPQ) is an exploratory tool created by a selected steering committee of medical experts. EPQ was developed using a three-step modified Delphi method, and established consensus on how acne impacts the patients’ emotional and social functioning, activities of daily living, as well as the perspectives and concerns of parents and caregivers.7 Secondary outcome measures included both safety and clinical effectiveness by way of investigator global assessment (IGA), which was collected on a five-point adjectival response scale (score 0 [clear] - 4 [severe]). IGA success was assessed as >2-grade improvement in IGA and a score 0 [clear] or 1 [almost clear] at week-12. About SEYSARA®: INDICATIONS AND USAGE SEYSARA (sarecycline) tablet is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.8 Limitations of Use: Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. SEYSARA has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS SEYSARA is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. WARNINGS AND PRECAUTIONS Like other tetracyclines, SEYSARA can cause fetal harm when administered to a pregnant woman. If SEYSARA is used during pregnancy, or if the patient becomes pregnant while taking SEYSARA, the patient should be informed of the potential hazard to the fetus and treatment should be stopped immediately. The use of SEYSARA during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. If Clostridium difficile Associated Diarrhea (antibiotic associated colitis) occurs, discontinue SEYSARA. Central nervous system side effects, including light-headedness, dizziness or vertigo, have been reported with tetracycline use. Patients who experience these symptoms should be cautioned about driving vehicles or using hazardous machinery. These symptoms may disappear during therapy and may disappear when the drug is discontinued. Intracranial hypertension in adults and adolescents has been associated with the use of tetracyclines. Clinical manifestations include headache, blurred vision and papilledema. Although signs and symptoms of intracranial hypertension resolve after discontinuation of treatment, the possibility for sequelae such as visual loss that may be permanent or severe exists. Concomitant use of isotretinoin and SEYSARA should be avoided because isotretinoin, a systemic retinoid, is also known to cause intracranial hypertension. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using SEYSARA. Bacterial resistance to tetracyclines may develop in patients using SEYSARA. Because of the potential for drug-resistant bacteria to develop during the use of SEYSARA, it should only be used as indicated. As with other antibiotic preparations, use of SEYSARA may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, SEYSARA should be discontinued and appropriate therapy instituted. ADVERSE REACTIONS Most common adverse reaction (incidence ≥ 1%) is nausea. Please see full Prescribing Information. About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients' world by helping them realize their hopes and dreams for a healthy life.” We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros. For more information, please visit . Legal warning This document includes only summary information and is not intended to be exhaustive. The facts, figures and opinions contained in this document, in addition to the historical ones, are "forward-looking statements". These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. References: Graber E, Baldwin H, Harper J, et al. Patient reported outcomes and investigator global assessment of acne vulgaris among patients with moderate to severe non-nodular acne vulgaris administered sarecycline in real-world community practices across the U.S. SKIN The Journal of Cutaneous Medicine. Forthcoming, 2022 Fried R, Rieder, E, Alexis, A, et al. Impact of acne on social functioning, emotional functioning, and activities of daily living with moderate to severe non-nodular acne vulgaris administered sarecycline in real-world community practices across the U.S. SKIN The Journal of Cutaneous Medicine. Forthcoming, 2022 Bickers DR, Lim HW, Margolis D, et al. J Am Acad Dermatol. 2006; 55:490-500 Timms RM. Psychol Health Med. 2013; 18(3):310–320 Revol O, Milliez N, Gerard D. Br J Dermatol. 2015; 172(Suppl 1):52–58 Hudgens S, Harper JC, Daniels SR, et al. J Drugs Dermatol. 2015; 14(6):552-9 Baldwin H, Graber E, Fried R, et al. An expert panel questionnaire for assessing patient-reported and caregiver-reported outcomes in acne vulgaris. SKIN The Journal of Cutaneous Medicine. Forthcoming, 2022 SEYSARA [package insert]. Malvern, PA: Almirall, LLC, 2021

The UK’s National Institute for Health and Care Excellence (NICE) and Public Health England (PHE) have published a new jointly developed guideline on antimicrobial prescribing for Clostridioides difficile (C. difficile) infection. The new recommendations outlined in the guideline include advice for managing C. difficile infection in both community and hospital settings. The guideline has made a change to current practice, recommending that the first-line choice of antibiotic for adults for a first episode of mild or moderate C. Difficile infection should be oral vancomycin rather than metronidazole. In a statement, NICE said the change is based on evidence showing metronidazole had lower initial cure rates and higher recurrence rates compared to vancomycin. Combined with cost-effectiveness evidence, this shows that using vancomycin was both more effective and less pricey compared to prescribing metronidazole in this setting. In addition, the guidance recommends that for children and young people under the age of 18 years, treatment with an oral antibiotic for suspected or confirmed C. Difficile infection should be started by, or after advice from either a microbiologists, paediatric infectious disease specialist or paediatric gastroenterologist. Fidaxomicin should also be offered as a second-line antibiotic for a first episode of mild, moderate or severe C. Difficile infection if vancomycin in ineffective, according to the new guideline. Further recommendations relate to the choice of antibiotic for a further episode of C. Difficile infection within 12 weeks of symptom resolution and for a further episode of C. Difficile infection more than 12 weeks after symptom resolution. According to NICE, approximately 20-30% of cases of antibiotic-associated diarrhoea are due to C. Difficile infection – this makes it the primary cause of infectious diarrhoea in hospitalised patients. PHE data shows that, in 2019/20, there were around 13,000 reported cases of C. Difficile infections in acute trusts and clinical commissioning groups in England.

DELRAY BEACH, Fla., April 13, 2021 (GLOBE NEWSWIRE) --AzurRx BioPharma Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today that it has entered into an agreement with PPD, Inc. (NASDAQ: PPD), a leading global contract research organization (CRO), for its planned Phase 1b/2a clinical trial evaluating proprietary formulations of micronized niclosamide for grade 1 colitis and diarrhea in oncology patients receiving treatment with immune checkpoint inhibitors (ICIs). Under the terms of the agreement, PPD will manage the Phase 1b/2a clinical trial using both oral immediate-release tablet and topical rectal enema foam formulations of micronized oral niclosamide, also known as FW-420. AzurRx anticipates initiating the trial during the second quarter of 2021. “The goal of our FW-420 clinical program is to develop a safe, effective, and non-systemic treatment for immune checkpoint inhibitor-associated colitis, and we are excited to once again partner with PPD to begin the preparations for our Phase 1b/2a clinical trial,” said James Sapirstein, President and CEO of AzurRx BioPharma. “The development of immune checkpoint inhibitors has marked a major advance in cancer therapeutics, but the drugs can induce a serious inflammation of the bowels, which if left unchecked, can prove life-threatening and force patients to halt treatment. There are currently no treatments available for grade 1 colitis resulting from the use of ICIs. We believe an oral, non-absorbed treatment, such as FW-420, could prevent the condition from progressing and enable patients to continue their treatment regimen uninterrupted. We hope to rapidly advance the FW-420 program with the support of PPD.” The agreement with PPD marks the second clinical trial involving niclosamide that the CRO will manage for AzurRx. As previously announced, PPD is also managing AzurRx’s Phase 2 clinical trial to investigate niclosamide as a treatment for COVID-19-related gastrointestinal infections, planned for the second quarter of 2021. Daniel Burch, M.D., Senior Vice President and Global Head of PPD® Biotech, stated, “We are pleased to have this opportunity to broaden our collaboration with AzurRx as it expands its clinical program for niclosamide to bring relief to patients suffering from immune checkpoint inhibitor-associated colitis. We look forward to utilizing our expertise and capabilities to advance the development of FW-420, beginning with the upcoming clinical trial.” About Immune Checkpoint Inhibitor-Associated Colitis Immune checkpoint inhibitors (ICIs) are monoclonal antibodies that target down-regulators of the anti-cancer immune response and have revolutionized the treatment of a variety of malignancies. The global market for ICIs is significant; it was over $22 billion in 2019 and growing rapidly.1 Approximately 44% of patients with advanced cancer tumors (more than 260,000 patients) are eligible to receive immune checkpoint inhibitors.2 However, many immune-related adverse events, especially diarrhea and colitis, limit their use. The incidence of immune-mediated colitis (IMC) ranges from 1% to 25% depending on the type of ICI and whether they are used in combination used in combination.2 Approximately 30% of ICI patients develop diarrhea, which can progress to colitis. The onset of diarrhea in ICI-AC patients occurs within 6-7 weeks and progressively worsens, and the progression to colitis is rapid and unpredictable. For example, in patients taking ipilimumab (Yervoy), between 25% and 30% of patients developed diarrhea and roughly 8% to 12% developed colitis.3 Moreover, the trend is towards the use of combination ICI therapies (e.g., Yervoy and Opdivo) and this will lead to a concomitant increase in both diarrhea and colitis. Administration of corticosteroids, or treatment with certain immunosuppressive biologics, while withholding ICI therapy are recommended for grade 2 or more severe colitis (National Cancer Institute 2020). The impact of this colitis complication and treatment may reduce the goal of progression free cancer survival. An oral, non-absorbed treatment, such as niclosamide, for grade 1 colitis (diarrhea) may prevent progression to grade 2 disease. There currently is no approved treatment for grade 1 colitis. About Niclosamide Niclosamide is a prescription small molecule drug listed as an essential medicine by the World Health Organization (WHO). Niclosamide has been safely used on millions of patients for other clinical indications. In the U.S., niclosamide was approved by the U.S. Food and Drug Administration (FDA) in 1982 for the treatment of intestinal tapeworm infections. In addition to its antihelminthic activity, niclosamide has demonstrated anti-inflammatory and anti-viral properties. About FW-420 FW-420 is a niclosamide-based small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in metastatic cancer patients. FW-420 will be supplied in two formulations, as an oral immediate-release tablet and as a topical rectal enema foam. The standard care for treating inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s Disease, corticosteroids and 5-ASAs, can cause problems when used for check point inhibitor patients due to their immunosuppressant effects. FW-420 has the potential to safely treat grade 1 ICI-associated colitis and diarrhea and prevent its progression to more serious and potentially fatal later stages. The overall goal of early niclosamide treatment is to enable oncology patients to remain on, or spend minimal time off, their ICI treatment programs without interruption. About AzurRx BioPharma, Inc. AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis. AzurRx is also advancing two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor: FW-1022, for COVID-19 gastrointestinal infections and FW-420, for grade 1 Immune Checkpoint Inhibitor-associated colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit . About PPD PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health. For more information, visit . Forward-Looking Statement This press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: AzurRx BioPharma, Inc. 1615 South Congress Avenue Suite 103 Delray Beach, Florida 33445 Phone: (646) 699-7855 info@azurrx.com Media contact: Tiberend Strategic Advisors, Inc. Johanna Bennett/Ingrid Mezo (212) 375-2665/(646) 604-5150 jbennett@tiberend.com / imezo@tiberend.com 1 Immune Checkpoint Inhibitors Market, ResearchAndMarkets.com, 2020. 2 Wang et al. Patients with ICPI-induced diarrhea or colitis have improved survival outcomes. J Immunother Cancer. 2018; 6: 37. Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418 3 Wang DY, Ye F, Zhao S, et al. Incidence of immune checkpoint inhibitor-related colitis in solid tumor patients: a systematic review and meta-analysis. Oncoimmunology 2017; 10: e1344805; Som et al., World J Clin Cases. Feb 26, 2019; 7(4): 405-418