Ceftobiprole Medocaril Sodium

Presentations span ceftobiprole and zoliflodacin, highlighting post-approval evidence generation across antimicrobial-resistant and difficult-to-treat infections WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics (IST), a subsidiary of Innoviva, Inc. (NASDAQ: INVA), announced today it will present data from four abstracts at IDWeek 2026, the annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS). The meeting will be held October 21–24, 2026, at the Walter E. Washington Convention Center in Washington, D.C. The presentations cover two FDA-approved antibiotics marketed by Innoviva Specialty Therapeutics, ceftobiprole (ZEVTERA ® ) and zoliflodacin (NUZOLVENCE ® ), and represent the company’s ongoing commitment to clinically meaningful data generation following regulatory approval. “Antimicrobial resistance remains one of the most urgent global health challenges, requiring continued innovation and rigorous evidence generation. The data we are presenting at IDWeek demonstrate the breadth of our work across infectious diseases, from evaluating ceftobiprole against contemporary clinical isolates and advancing its use in pediatric patients to sharing new insights from our zoliflodacin clinical program,” said David Altarac, M.D., Chief Medical Officer at Innoviva Specialty Therapeutics. “Together, these findings reflect our commitment to advancing meaningful treatment options for clinicians and patients facing serious infectious diseases.” Poster Presentations Title: In Vitro Activity of Ceftobiprole and Comparator Agents Against Contemporary U.S. Clinical Isolates Collected in 2025 Following FDA Approval Date: Thursday, October 22, 2026 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B–C Title: Pediatric Ceftobiprole Dose Selection — Model-Based Approach for Staphylococcus aureus Bacteremia Including Right-Sided Infective Endocarditis Date: Thursday, October 22, 2026 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B–C Title: Ceftobiprole for Pediatric ABSSSI — Informing Ceftobiprole Use in Pediatric Acute Bacterial Skin and Skin Structure Infections Through Adult and Pediatric Data Date: Saturday, October 24, 2026 Time: 12:15 PM – 1:30 PM ET Location: Poster Hall B–C Oral Presentation Title: Zoliflodacin Maintains High Rates of Microbiologic Eradication of Urogenital Neisseria gonorrhoeae in Patients Co-infected with Chlamydia trachomatis Date: Saturday, October 24, 2026 Time: 2:15 PM – 2:30 PM ET Location: Room 206 For additional information or to speak with a Medical Affairs or Commercial team representative, please stop by IDWeek booth #515 or visit and follow us on LinkedIn. About ZEVTERA ® (ceftobiprole medocaril sodium for injection) Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced-generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus , including methicillin-resistant strains (MRSA), and Gram-negative bacteria. Outside the U.S., the brand is currently approved and marketed in several European countries and beyond as ZEVTERA ® and Mabelio ® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements covering more than 80 countries. INDICATIONS & USAGE Indications ZEVTERA ® (ceftobiprole medocaril sodium for injection), for intravenous use, is indicated for the treatment of: Adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae . Adult and pediatric patients (3 months to less than 18 years) with community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae , Haemophilus parainfluenzae , Escherichia coli , and Klebsiella pneumoniae . Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZEVTERA and other antibacterial drugs, ZEVTERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION Contraindications ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and Precautions Increased mortality with unapproved use in ventilator-associated bacterial pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Serious hypersensitivity reactions, including anaphylaxis, were observed in ZEVTERA-treated patients in clinical trials. Serious and occasionally fatal hypersensitivity reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Before therapy with ZEVTERA is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or other beta-lactam antibacterial drugs should be made. Maintain clinical supervision if this product is to be given to a penicillin- or other beta-lactam-allergic patient, because cross sensitivity among beta-lactam antibacterial agents has been established. Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been reported during treatment with ZEVTERA and other cephalosporins. If CNS adverse reactions, including seizures, occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, the risk/benefit of continuing treatment with ZEVTERA should be assessed. Adverse Reactions SAB (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia, pyrexia, abdominal pain, fungal infection, headache, and dyspnea. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increase, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension, and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis, and pyrexia. About NUZOLVENCE® (zoliflodacin) for oral suspension NUZOLVENCE is a first-in-class, single-dose, oral antibiotic FDA-approved for the treatment of uncomplicated urogenital gonorrhea, including strains resistant to current first-line therapies. NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. The NUZOLVENCE mechanism of action is distinct from that of currently approved antibiotics and has demonstrated activity against drug-resistant Neisseria gonorrhoeae . Important Safety Information (ISI) Indication and Usage Indication NUZOLVENCE® is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. Usage to Reduce Development of Drug-Resistant Bacteria: To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Contraindications Known history of hypersensitivity to NUZOLVENCE. Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the NUZOLVENCE efficacy. Warnings and Precautions Embryo-Fetal Toxicity: Potential Risk for Pregnant Females Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Avoid use during pregnancy. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Obtain a pregnancy test prior to initiation in persons of reproductive potential. Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential: Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after NUZOLVENCE administration. Testicular Toxicity and Risks to Male Fertility: Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. An assessment of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility. Hypersensitivity Reactions: Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Before therapy with NUZOLVENCE is instituted, carefully inquire about previous hypersensitivity reactions to NUZOLVENCE. If an allergic reaction to NUZOLVENCE occurs, discontinue NUZOLVENCE and institute appropriate supportive measures. Clostridioides difficile Infection (CDI): CDI 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. Development of Drug-Resistant Bacteria: Prescribing NUZOLVENCE in the absence of a proven or strongly suspected bacterial infection or 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 (≥2%) are headache, dizziness, nausea, and diarrhea. Laboratory abnormalities (neutropenia, leukopenia) were also observed. Drug Interactions Concomitant use with moderate or strong CYP3A4 inducers is contraindicated. Use in Specific Populations Pregnancy: Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861. Lactation: There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur. Females and Males of Reproductive Potential: Based on animal studies, NUZOLVENCE may cause fetal malformations when administered to a pregnant female at clinically relevant doses. Additionally, based on data from an animal study, the risk of early pregnancy loss may be increased in partners of males treated with NUZOLVENCE. Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE. Contraception: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after their single-dose treatment of NUZOLVENCE. Infertility: Based on data from repeat-dose animal toxicity and fertility studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. Pediatric Use: The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established. Geriatric Use: Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Reporting Adverse Events You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics™ 1-800-651-3861 medinfo@istx.com U.S. Food and Drug Administration 1-800-FDA-1088 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 affiliates, include GIAPREZA ® (angiotensin II), XERAVA ® (eravacycline), XACDURO ® (sulbactam for injection; durlobactam for injection), and NUZOLVENCE ® (zoliflodacin). Innoviva Specialty Therapeutics also markets ZEVTERA (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva Specialty Therapeutics, please visit . 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 ® , GIAPREZA ® , XERAVA ® , XACDURO ® , ZEVTERA ® and NUZOLVENCE® 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); the timing, manner, and amount of potential capital returns to shareholders; the development of the LYNX® platform; 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 timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. 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, 2025 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. Contacts Media Amanda Galgay Vice President, Communications amanda.galgay@inva.com Investors Irwin Tendler Head of Investor Relations Executive Director, Corporate Development investors.relations@inva.com

Allschwil, Switzerland, September 14, 2026 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its partner Asahi Kasei Therapeutics Corp. started a phase 2 clinical study in Japan with the antifungal Cresemba® (isavuconazole) for pediatric patients at risk of deep mycoses. Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very pleased with the start of the pediatric study for Cresemba by our partner Asahi Kasei Therapeutics Corp. Invasive fungal infections pose a critical threat for children suffering from hematologic malignancies or immunodeficiency disorders. Despite this high-risk setting, treatment options remain limited. Making Cresemba available to pediatric patients in Japan would represent a major advance in addressing this important medical need.” The multicenter, open-label, non-controlled study is assessing the safety and pharmacokinetics of Cresemba in children at risk from deep mycoses. Cresemba is already approved for the treatment of children in the US, Canada, Europe and China. In Japan, Cresemba is approved for the treatment of adults with severe fungal infections, but currently not for use in pediatric patients. About Cresemba® (isavuconazole) Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. Cresemba is marketed in more than 70 countries. In Japan, orally and intravenously administered isavuconazole is approved for use in adults for the treatment of aspergillosis (invasive aspergillosis, chronic progressive pulmonary aspergillosis, simple pulmonary aspergilloma), mucormycosis, and cryptococcosis (pulmonary cryptococcosis and disseminated cryptococcosis). Isavuconazole is also approved in the European Union1, the United Kingdom2, the United States (US)3 and many additional countries, including in the Asia Pacific region.4 According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between April 2025 and March 2026 amounted to USD 782 million, a 27 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.5 Deep mycoses Deep mycoses like invasive aspergillosis (IA), invasive mucormycosis (IM) and invasive cryptococcosis are life-threatening fungal infections that spread beyond superficial sites into deep tissues, including lung, eyes, brain, bones, the bloodstream, and other sites or organs. They predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with immunodeficiency disorders. These infections are associated with high morbidity and mortality, also in pediatric patients.6, 7, 8 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerlandPhone+41 61 606 1102E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This press release can be downloaded from www.basilea.com. References European Public Assessment Report (EPAR) Cresemba: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: September 13, 2026]Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: September 13, 2026]Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: September 13, 2026]The registration status and approved indications may vary from country to country.IQVIA Analytics Link, March 2026. In-market sales reported as moving annual total (MAT) in US dollar. J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10Z. D. Pana E. Roilides, A. Warris et al. Epidemiology of Invasive Fungal Disease in Children. Journal of the Pediatric Infectious Diseases Society 2017 (6), suppl. 1, S3-S11 Attachment Basilea Press release