Pseudotumor Cerebri

— 12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older — EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension), the first and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).1 It will be available in 2 mg/10 mL convenient, single-dose stick packs by the end of February. EOHILIA is a corticosteroid indicated for 12 weeks of treatment in patients 11 years and older with EoE.1 Developed specifically for EoE, EOHILIA’s novel formulation of budesonide confers thixotropic properties – flowing more freely when shaken and returning to a more viscous state when swallowed.1,2 “Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With EOHILIA, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” said Ikuo Hirano, MD, professor of medicine and director of the Kenneth C. Griffin Esophageal Center in the Division of Gastroenterology and Hepatology at Northwestern University Feinberg School of Medicine. “As the treatment needs and goals of patients with EoE can vary, I welcome the flexibility that EOHILIA offers as an oral medication.” The FDA approval of EOHILIA 2 mg twice daily is based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies (Study 1 and Study 2) in patients (ages 11 to 56 and 11 to 42, respectively) with EoE.1 In both studies, patients received at least one dose of either EOHILIA 2 mg twice daily or placebo orally twice daily. Efficacy endpoints included histologic remission (peak eosinophil count of ≤6 per high-powered field across all available esophageal levels) and the absolute change from baseline in patient-reported Dysphagia Symptom Questionnaire (DSQ) combined score after 12 weeks of treatment. The DSQ measures how often a patient with EoE has trouble swallowing and the behavioral adaptations they subsequently use, as reported directly by patients.3 Significantly more patients receiving EOHILIA achieved histologic remission vs. placebo in Study 1 (53.1% vs. 1%).1 In Study 2, 38% of EOHILIA patients achieved histologic remission vs. 2.4% of those in the placebo group. Absolute change from baseline in DSQ combined score in the EOHILIA vs. placebo groups in Study 1 was -10.2 (1.5) vs. -6.5 (1.8) and in Study 2, -14.5 (1.8) vs. -5.9 (2.1). During the last two weeks of each study, more patients receiving EOHILIA experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” as compared to placebo, as measured by the DSQ. EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. The most common adverse reactions (≥2% of patients receiving EOHILIA and at a rate greater than placebo) in Study 1 included: respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%) and erosive esophagitis (2%). The safety pro EOHILIA in Study 2 was generally similar to Study 1.1 “For most of us, eating is a simple experience. But for people living with eosinophilic esophagitis, sitting down for a meal can include painful and difficult swallowing, chest pain and a choking sensation,” said Brandon Monk, senior vice president and head, U.S. Gastroenterology Business Unit, Takeda. “With EOHILIA, patients and their physicians now have the first and only FDA-approved oral treatment option for EoE that was shown during two 12-week clinical studies to reduce esophageal inflammation and improve the ability to swallow.” EoE is a chronic, immune-mediated, inflammatory disease localized in the esophagus.4 Although the exact cause is unknown, it is believed to be triggered by a variety of stimuli including certain foods and environmental allergens.5,6 The chronic inflammation of EoE can lead to a range of symptoms, which can vary by person and age, and include difficulty swallowing, vomiting and pain.7 Identifying EoE can be complex and delayed diagnosis is common among patients. If left untreated, the inflammation of EoE can worsen and narrow the esophagus, which can lead to food impaction (when food becomes stuck in the esophagus).8,9 In fact, EoE is the leading cause of emergency room visits for food impaction.10 Takeda is assessing the financial impacts of the approval, including a reversal of impairment loss for intangible assets, on the fiscal year ending on March 31, 2024 (FY2023), but does not anticipate the impact to be material. Indication and Limitations of Use EOHILIA is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE). EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products. WARNINGS AND PRECAUTIONS Hypercorticism and Adrenal Axis Suppression Systemic effects such as hypercorticism and adrenal axis suppression may occur. Monitor patients for signs and symptoms and consider reducing the dosage of EOHILIA. Use is not recommended in patients with severe hepatic impairment (Child‑Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child‑Pugh Class B). Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended. Immunosuppression and Increased Risk of Infection Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen. Corticosteroid-associated infections can be mild, severe, and at times fatal. Monitor patients and consider discontinuation of EOHILIA if the patient develops an infection. Tuberculosis reactivation may occur. Closely monitor patients with latent tuberculosis or tuberculin reactivity while receiving EOHILIA. Varicella Zoster and Measles can be serious or fatal in non-immune patients taking corticosteroids. Avoid exposure. If a patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation can occur. Prior to starting EOHILIA for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Amebiasis: It is recommended that latent or active amebiasis be ruled out before starting EOHILIA in patients who have spent time in the tropics or have unexplained diarrhea. Avoid EOHILIA in patients with: systemic fungal infections, known or suspected Strongyloides (threadworm) infection, cerebral malaria, and active ocular herpes simplex. Localized Infections: In clinical trials, some patients developed Candida albicans infections in the mouth, throat, and esophagus. Instruct patients: do not eat or drink for 30 minutes after taking EOHILIA; after 30 minutes rinse mouth with water and spit without swallowing. If oropharyngeal or esophageal candidiasis develops, treat with appropriate antifungal therapy and consider discontinuing EOHILIA. Erosive Esophagitis Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline esophagogastroduodenoscopy (EGD), and most were receiving concomitant therapy with a proton pump inhibitor (PPI). Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation as appropriate. Effect on Growth Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The maximum recommended duration of treatment with EOHILIA is 12 weeks. Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids Monitor patients who are transferred from corticosteroids with high systemic effects to corticosteroids with lower systemic availability, such as EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema) previously controlled by the systemic drug. Other Corticosteroid Effects Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts, or with family history of diabetes, glaucoma, or with other conditions where corticosteroids may have unwanted effects. Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. The maximum recommended duration of treatment with EOHILIA is 12 weeks. ADVERSE REACTIONS Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis. DRUG INTERACTIONS Budesonide is a substrate for CYP3A4. Avoid concomitant use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, and grapefruit juice), which can increase systemic budesonide concentrations. USE IN SPECIFIC POPULATIONS Pregnancy: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Infants should be carefully observed for signs of hypoadrenalism and managed accordingly. Lactation: Lactation studies have not been conducted with EOHILIA. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EOHILIA and any potential adverse effects on the breastfed infant from EOHILIA, or from the underlying maternal condition. Hepatic Impairment: Not recommended in patients with severe hepatic impairment (Child-Pugh Class C). In patients with moderate hepatic impairment (Child-Pugh Class B), monitor for signs and/or symptoms of hypercorticism. Please click here for full Prescribing Information. Takeda’s Commitment to Gastroenterology With this latest milestone, Takeda continues to demonstrate a commitment to meeting the very real needs of those living with gastrointestinal (GI) diseases. We believe that GI and liver diseases are life-disrupting conditions. Beyond a fundamental need for effective treatment options, we understand that improving patients’ lives also depends on their needs being recognized. With more than 35 years of experience in gastroenterology, Takeda has made significant strides in addressing patient needs with treatments for inflammatory bowel disease (IBD), acid-related diseases, short bowel syndrome (SBS) and motility disorders. We are making significant strides toward closing the gap on new areas of unmet need. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . Important Notice For the purposes of this notice, “press release” means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: or at . Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. References 1 EOHILIA (budesonide oral suspension) Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc. 2 Mewis J, Wagner NJ. Advances in Colloid and Interface Science. 2009; 214–227. 3 Hudgens S, Evans C, Phillips E, et al. J Patient Rep Outcomes. 2017;1(1):3. 4 Furuta GT, Katzka DA. N Engl J Med. 2015;373(17):1640-1648. 5 Clayton F, Peterson K. Gastrointest Endosc Clin N Am. 2018;28(1):1-14. 6 O’Shea KM, Aceves SS, Dellon ES, et al. Gastroenterology. 2018;154(2):333-345. 7 Muir AB, Brown-Whitehorn T, Gowin B, et al. Clin Exp Gastroenterol. 2019;12:391-399. 8 Shaheen NJ, Mukkada V, Eichinger CS, et al. Dis Esophagus. 2018;31(8):1-14. 9 Hirano I, Furuta GT. Gastroenterology. 2020;158(4):840-851. 10 Dellon ES, Hirano I. Gastroenterology. 2018;154(2):319-332.e3. US-BOS-0537v1.0 02/24

AJOVY® (fremanezumab) efficacy and safety demonstrated in migraine patients with obesity in post hoc analysis of HALO-LTS1 and FOCUS2 phase 3 studies Obesity is a known risk factor for migraine and is frequently associated with an increase in migraine frequency, severity and disability3 Data revealed at the 17th European Headache Congress, Barcelona, Spain TEL AVIV, Israel--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announces that a post hoc analysis4 of two phase 3 clinical studies presented today at the European Headache Congress has shown the effectiveness of the migraine prevention treatment AJOVY® (fremanezumab) in reducing migraine attacks in patients with migraine and co-morbid obesity. Migraine and obesity are both associated with high levels of disability3 and both conditions are more prevalent amongst females5,6. It is estimated that 59% of people in Europe are either overweight or obese, with almost a quarter (23%) of adults living with obesity5. A higher body mass index (BMI) is frequently associated with increased migraine prevalence and severity, and an increased number of adverse effects3. As such, assessing the efficacy and safety of migraine preventative treatment in patients with obesity can help guide migraine management and treatment decisions. The post hoc analysis of the HALO-LTS1 and FOCUS2 phase 3 studies compared the safety and efficacy of fremanezumab migraine preventive treatment in obese migraine patients vs normal weight migraine patients for a period of 6 months. Obesity was defined as having a Body Mass Index (BMI) ≥30 kg/m2 (BMI-high, 578 patients), and normal weight patients with a BMI <30 kg/m2 (BMI-normal, 1859 patients). The analysis showed that the efficacy of fremanezumab was the same in migraine patients with BMI-high vs BMI-normal: At baseline, monthly migraine days in migraine patients with BMI-high vs BMI-normal were 13.7 vs 13.6 respectively. After 6 months of treatment with fremanezumab, monthly migraine days in migraine patients with BMI-high vs BMI-normal was reduced to 6.8 vs 7.2 respectively. Furthermore, adverse events (AEs) in patients with obesity were similar to AEs in non-obese patients treated with fremanezumab. Lead study author, Consultant Neurologist Dr Pablo Irimia Sieira, of Clinica Universidad de Navarra, Pamplona, Spain said: “This analysis is encouraging as it shows fremanezumab can reduce migraine attacks as effectively in obese patients as it does in patients of normal weight. Considering the higher burden of migraine in patients with co-morbid obesity, it is important for treatments to demonstrate efficacy and safety in migraine patients with this particular comorbidity.” Dr. Dieter Schultewolter, Vice President of Global Medical Affairs Neuroscience at Teva said: “We are seeing clinicians moving towards more personalised treatment decisions in migraine, which are tailored to the patient’s profile. So it is informative to see that the efficacy of fremanezumab for migraine prevention has now been demonstrated across multiple subgroups, including those with older age, obesity, psychiatric comorbidities like depression, and difficult-to-treat migraine.”7,8,9 AJOVY® (fremanezumab), a humanized monoclonal antibody (mAb) developed by Teva Pharmaceuticals, selectively targets the calcitonin gene-related peptide (CGRP) and is approved for the prevention of migraine in adults who have at least 4 migraine days per month. NOTES TO EDITORS About AJOVY▼ (fremanezumab-vfrm) injection AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. AJOVY▼ European SmPC can be found here. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and innovative medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative medicines research and operations supporting our growing portfolio of innovative medicines and biopharmaceutical products. Learn more at . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AJOVY (fremanezumab) for the treatment of migraine in adults; our ability to successfully compete in the marketplace, including our ability to develop and commercialize competition for our innovative medicines, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the third quarter of 2023 and in our Annual Report on Form 10-K for the year ended December 31, 2022, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. References: ____________________________ 1 HALO-LTS, NCT02638103 2 FOCUS study NCT03308968 3 Westgate CSJ, et al. Understanding the link between obesity and headache- with focus on migraine and idiopathic intracranial hypertension. J Headache Pain. 2021;22(1):123. 4 Sieria Pablo, et al. Efficacy and Safety of Fremanezumab in Patients with Migraine and Obesity: Post Hoc Analysis of the Phase 3 HALO-LTS and FOCUS Clinical Trails. Presented at the European Headache Congress December 2023. PO35 Poster 5 WHO Regional European Obesity Report 2022 6 Linda Al-Hassany, et al. Giving Researchers a Headache – Sex and Gender Differences in Migraine. Frontiers in Neurology. 2020 7 Nahas SJ, et al. J Headache Pain. 2021;22:141. 8 Lipton RB, et al. Presented at AHS 2023; Austin, TX, 15–18 June (P-231). 9 Ferrari MD, et al. Lancet. 2019;394(10203):1030–1040. View source version on businesswire.com: Contacts PR: Eden Klein +972 (3) 906 2645 Fiona Cohen +31 6 2008 2545 Source: Teva Pharmaceutical Industries Limited View this news release online at:

Oral presentation highlights new findings about the efficacy of XACDURO® for the treatment of monomicrobial and polymicrobial Acinetobacter baumannii-calcoaceticus infections Researchers share global surveillance data on the in vitro activity of XERAVA® (eravacycline) for injection on resistant isolates and Gram-positive clinical pathogens Total of nine presentations on XACDURO® and XERAVA® to be revealed during IDWeek 2023 WALTHAM, Mass.--(BUSINESS WIRE)-- Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), announced today plans to present an oral abstract and four poster sessions from their portfolio of U.S. Food and Drug Administration (FDA)-approved critical care and infectious disease therapies at IDWeek 2023, October 11-15, held in Boston, MA. The company will deliver one oral abstract presentation and two poster sessions highlighting findings on their newly approved therapy, XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, which is the first and only antibiotic specifically developed to target the Acinetobacter pathogen in adults. XACDURO is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In addition, four company-sponsored research studies on XACDURO will also be presented by the company’s research partners in poster sessions. “Antibiotic-resistant pathogens are one of the most significant and challenging threats to healthcare providers on the frontlines of infectious disease care,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva Specialty Therapeutics. “IDWeek is an opportunity for us and for our research partners to share new clinical insights that help us better understand these therapies on a deeper level to improve treatment strategies.” Researchers from Innoviva Specialty Therapeutics will also present new surveillance data on XERAVA® (eravacycline), an anti-bacterial for the treatment of complicated intra-abdominal infections (cIAI) caused by multidrug-resistant bacteria during the scientific poster sessions. Company Presentations: Oral Abstract Presentation Efficacy of Sulbactam-Durlobactam (SUL-DUR) Compared to Colistin (COL) Against Acinetobacter baumannii-calcoaceticus Complex (ABC) Monomicrobial and Polymicrobial Infections in a Phase 3 Trial Authors: Alita A. Miller, Sarah M. McLeod, Adam Shapiro, Khurram Rana, David Altarac Innoviva Specialty Therapeutics, Waltham, MA, United States Session Date: Thursday, October 12, 2023; 10:30 – 10:45 AM ET Session Topic: Clinical Trials Session Location: 102 AB Poster Sessions Pharmacometric Analyses to Support Sulbactam-Durlobactam (SUL-DUR) Dosing Regimens in Patients with Altered Renal Function (2549) Authors: Kajal Larson, Sujata Bhavnani, Jeffrey Hammel, Anthony Cammarata, John O'Donnell, Christopher Rubino; Innoviva Specialty Therapeutics, Waltham, MA, United States, Institute for Clinical Pharmacodynamics, Inc. – Schenectady, NY United States Session Date: Saturday, October 14, 2023; 12:15 - 1:30 PM ET Session Topic: PK/PD Studies Session Location: Hall B + C In Vitro Susceptibility of Recent Clinical Isolates of P. aeruginosa and Enterobacterales to Imipenem or Meropenem Alone or in Combination with Sulbactam-Durlobactam (2138) Authors: Sarah M. McLeod, Nicole M. Carter, Samir H. Moussa, Alita A. Miller; Innoviva Specialty Therapeutics, Waltham, MA, United States Session Date: Saturday, October 14, 2023; 12:15 - 1:30 PM ET Session Topic: Antimicrobial Novel Agents Session Location: Hall B + C Surveillance of Eravacycline Against Enterobacterales and Non-Fermenter Clinical Isolates, Including Resistant Isolates, Collected Worldwide from Multiple Infection Sites During 2021 (2132) Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: Antimicrobial Novel Agents Session Location: Hall B + C Surveillance of Eravacycline Against Gram-Positive Clinical Pathogens, Including Resistant Isolates, Collected Worldwide From Multiple Infection Sites During 2021 (2133) Authors: Stephen Hawser, Nimmi Kothari, Federica Monti, Tony Hodges, Kristie Zappas; IHMA Europe, Monthey (Valais), Switzerland; Innoviva Specialty Therapeutics, Inc, Waltham (MA), United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: Antimicrobial Novel Agents Session Location: Hall B + C Company-Sponsored Research Presentations: Poster Sessions In vitro Synergy of the Combination of Sulbactam-Durlobactam and Cefepime at Clinically Relevant Concentrations Against A. baumannii, P. aeruginosa, and Enterobacterales (2121) Authors: Aliaa Fouad, PhD, David P. Nicolau, PharmD, FCCP, FIDSA, and Christian M. Gill, PharmD, Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, United States, Division of Infectious Diseases, Hartford Hospital, Hartford, CT United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: PK/PD Studies Session Location: Hall B + C Ex Vivo Assessment of Sulbactam-Durlobactam (SUL-DUR) Clearance During Continuous Renal Replacement Therapy (CRRT) (2526) Authors: Yasmeen Abouelhassan, Yuwei Shen, Xiaoyi Ye, David P Nicolau, Joseph L. Kuti Ctr. for Anti-Infect. Res. & Dev., Hartford Hospital, Hartford, CT Inpatient Hemo-Therapeutics, Hartford Hospital, Hartford, CT United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM ET Session Topic: New Antimicrobial Drug Development Session Location: Hall B + C (2515) Evaluation of the Equivalency of the Oxoid Sulbactam-Durlobactam (10/10µg) Antimicrobial Disc to the CLSI M07 Broth Microdilution Frozen Reference Method Authors: K. L. Hajek B.S., A.J Lovatt BSc., S. Bhalerao PhD., N. Khan BSc., D.T Staats M.S. M.M Hendrix B.S., N.M Holliday B.S., C.C Knapp M.S. Thermo Fisher Scientific, Cleveland, OH, United States; Thermo Fisher Scientific, Basingstoke, United Kingdom Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM Session Topic: New Antimicrobial Drug Development Session Location: Hall B + C (2517) Activity of Sulbactam-Durlobactam, Antibacterial Combinations, and Comparators Against a Challenge Set of 66 Acinetobacter Baumannii-Calcoaceticus Species Complex Isolates Authors: MD Huband, RE Mendes, G Bartleson, H Huynh, M Castanheira JMI Laboratories, North Liberty, IA, United States Session Date: Saturday, October 14, 2023; 12:15 – 1:30 PM Session Topic: New Antimicrobial Drug Development Session Location: Hall B + C About Acinetobacter Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients, often resulting in severe pneumonia and bloodstream infections.1 They can infect other body sites, such as the urinary tract and the skin.1 Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance.2 Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.2 The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.3 Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.4 Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).5 In the U.S., there are more than 40,000 cases of Acinetobacter each year and approximately bout 40 percent of those are carbapenem-resistant.6,7 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.6 More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.4 About XACDURO® XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use, is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter. XACDURO® INDICATION & USAGE Indication XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is indicated in adults for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii- calcoaceticus complex. Limitations of Use XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XACDURO and other antibacterial drugs, XACDURO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Contraindications: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO or other beta-lactam antibacterial drugs. Warnings and Precautions: Hypersensitivity was observed in patients treated with XACDURO in clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. If an allergic reaction occurs, discontinue XACDURO. Clostridioides difficile-associated diarrhea (CDAD) 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. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with XACDURO should be assessed. Prescribing XACDURO in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Adverse Reactions: The most common adverse reactions reported in >10% of patients treated with XACDURO were liver test abnormalities (19%), diarrhea (17%), anemia (13%), and hypokalemia (12%). To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or . Before administering, please see the Full Prescribing Information for XACDURO. XERAVA® Important Safety Information Indications and Usage XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older. Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA. The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia. The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis. The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%). XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected. To report SUSPECTED ADVERSE REACTIONS, contact Innoviva Specialty Therapeutics, Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or Please see Full Prescribing Information for XERAVA. About Innoviva Specialty Therapeutics Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., is focused on delivering innovative therapies in critical care and infectious disease. Innoviva Specialty Therapeutics’ products, through its affiliate, La Jolla Pharmaceutical Company, include GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock, and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva Specialty Therapeutics’ products, through its affiliate, Entasis Therapeutics Inc., include XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). For more information about Innoviva Specialty Therapeutics, please visit here. About Innoviva Innoviva, Inc., is a diversified holding company with a portfolio of royalties and other healthcare assets, including Innoviva Specialty Therapeutics, a subsidiary focused on delivering innovative therapies in critical care and infectious disease. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, FF/VI) and ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, UMEC/VI). Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. For more information on Innoviva, please visit here. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and, formerly, TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (COVID-19). Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2022 and Quarterly Reports on Form 10-Q, which are on the Securities and Exchange Commission (SEC) and available on the SEC’s website at . Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. References 1 Ballouz T, Aridi J, Afif C, et al. (2017) Risk Factors, Clinical Presentation, and Outcome of Acinetobacter baumannii Bacteremia. Front. Cell. Infect. Microbiol. 7:156. doi: 10.3389/fcimb.2017.00156 2 Kyriakidis I, Vasileiou E, Pana ZD, Tragiannidis A. Acinetobacter baumannii Antibiotic Resistance Mechanisms. Pathogens. 2021 Mar 19;10(3):373. doi: 10.3390/pathogens10030373. PMID: 33808905; PMCID: PMC8003822. 3 Centers for Disease Control and Prevention, “Carbapenem-resistant Acinetobacter baumannii (CRAB): An urgent public health threat in United States healthcare facilities,” August 2021: . Accessed: August 7, 2023 4 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022; 399(10325):629-655. (21)02724-0/fulltext 5 World Health Organization, “WHO publishes list of bacteria for which new antibiotics are urgently needed,” February 27, 2017: . Accessed: August 7, 2023 6 Spellberg B, Rex JH. The Value of Single-Pathogen Antibacterial Agents. National Review Drug Discovery. 2013 Dec;12(12):963. doi: 10.1038/nrd3957-c1. Epub 2013 Nov 15. 7 Gupta V, Ye G, Olesky M, Lawrence K, Murray J, Yu K. National prevalence estimates for resistant Enterobacteriaceae and Acinetobacter species in hospitalized patients in the United States. Int J Infect Dis. 2019 Aug;85:203-211. doi: 10.1016/j.ijid.2019.06.017. Epub 2019 Jun 20. PMID: 31229615.