A randomized controlled trial to compare safety and efficacy of inhalational long acting ß2 agonist Vilanterol with fluticasone furoate against Salmeterol with fluticasone furoate in adult patients with reversible obstructive airway disease. - NIL

Start Date06 May 2024

Sponsor / Collaborator-

CTRI/2024/03/064848

/ Not yet recruitingNot Applicable

A comparative study of Vilanterol/Fluticasone furoate with Formoterol/Budesonide in the management of stable bronchial asthma - nil

Start Date10 Apr 2024

Sponsor / Collaborator-

CTR20233844

/ Active, not recruitingNot Applicable

糠酸氟替卡松维兰特罗吸入粉雾剂在健康人空腹状态下的生物等效性试验

[Translation] Bioequivalence study of fluticasone furoate and vilanterol inhalation powder in healthy volunteers under fasting condition

主要研究目的：以Glaxo Wellcome Production公司生产的糠酸氟替卡松维兰特罗吸入粉雾剂（RELVAR/ELLIPTA）为参比制剂，评价正大天晴药业集团股份有限公司研制的糠酸氟替卡松维兰特罗吸入粉雾剂在空腹状态下的生物等效性（BE）。次要研究目的：观察受试制剂糠酸氟替卡松维兰特罗吸入粉雾剂和参比制剂RELVAR/ELLIPTA在健康试验参与者中的安全性。

[Translation]

Primary study objective: To evaluate the bioequivalence (BE) of fluticasone furoate vilanterol inhalation powder (RELVAR/ELLIPTA) produced by Glaxo Wellcome Production under fasting conditions. Secondary study objective: To observe the safety of the test preparation fluticasone furoate vilanterol inhalation powder and the reference preparation RELVAR/ELLIPTA in healthy trial participants.

Start Date03 Dec 2023

Sponsor / Collaborator

Lianyungang Runzhong Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Fluticasone Furoate/Vilanterol Trifenatate

100 Translational Medicine associated with Fluticasone Furoate/Vilanterol Trifenatate

100 Patents (Medical) associated with Fluticasone Furoate/Vilanterol Trifenatate

Literatures (Medical) associated with Fluticasone Furoate/Vilanterol Trifenatate

01 Jan 2025·RESPIRATORY MEDICINE

Particularities of deposition of two ICS-LABA fixed dose combination dry powder aerosol drugs in the airways of COPD patients

Article

Author: Kis, Erika ; Gálffy, Gabriella ; Ilyés, Norbert ; Horváth, Alpár ; Sánta, Balázs ; Böcskei, Renáta Marietta ; Farkas, Árpád ; Kovács, Tamás ; Bártfai, Zoltán ; Réti, Izolda ; Havadtői, Botond

The aim of this study was to analyse the effect of breathing parameters, age, gender and disease status on the lung doses of the two ICS + LABA fixed combination dry powder drugs. Breathing parameters of 113 COPD patients were measured while inhaling through emptied NEXThaler® and Ellipta® inhalers and the corresponding lung doses were calculated. Lung dose of Foster® NEXThaler® was superior to the lung dose of Relvar® Ellipta® in around 85 % of the patients. The average value of the ratio of bronchiolar to bronchial deposition fractions was 5.0 for Foster® NEXThaler® and 2.6 for Relvar® Ellipta®. Lung dose was sensitive to the inhalation parameters, such as peak inhalation flow, inhaled volume and breath-hold time. For both studied drugs the dose to the lungs was relatively high for moderate PIF values, but it declined for low (<35 L/min) and high (>95 L/min) PIFs. The lung dose increased by the increase of the inhaled volume, but saturated over 1.0 L of inhaled air. Longer breath-hold time led to higher lung deposition, but the dependence was drug-specific. FEV₁ (%) and FEV₁/FVC (%) did not influence the lung dose significantly (p = 0.05). Exacerbating patients had lower lung doses (28.8 ± 5.8 % for Foster® NEXThaler® and 23.7 ± 3.8 % for Relvar® Ellipta®) than their non-exacerbating counterparts (33.7 ± 6.1 % for Foster® NEXThaler® and for 24.9 ± 3.9 % for Relvar® Ellipta®). The exact clinical consequences of the differences between the deposition distributions of the two drugs could be assessed only by systematic clinical trials.

01 Dec 2023·International journal of pharmaceutics: X

The effect of lung emptying before the inhalation of aerosol drugs on drug deposition in the respiratory system

Article

Author: Kugler, Szilvia ; Farkas, Árpád ; Tomisa, Gábor ; Szénási, Georgina ; Nagy, Attila ; Füri, Péter ; Horváth, Alpár ; Varga, János

The amount of drug depositing in the airways depends, among others, on the inhalation manoeuvre and breathing parameters. The objective of this study was to quantify the effect of lung emptying before the inhalation of drugs on the lung doses. Thirty healthy adults were recruited. Their breathing profiles were recorded while inhaling through six different emptied DPI devices without breathe-out and after comfortable or forced exhalation. The corresponding emitted doses and aerosol size distributions were derived from the literature. The Stochastic Lung Model was used to estimate the deposited doses. In general, forceful exhalation caused increased flow rate and inhaled air volume. Increased flow rate led to the increase of the average lung dose for drugs with positive lung dose-flow rate correlation (e.g. Symbicort®: relative increase of 6.7%, Bufomix®: relative increase of 9.2%). For drugs with negative correlation of lung dose with flow rate (all the studied drugs except the above two) lung emptying caused increased (Foster® by 2.7%), almost unchanged (Seebri®, Relvar®, Bretaris®) and also decreased (Onbrez® by 6.6%) average lung dose. It is worth noting that there were significant inter-individual differences, and lung dose of each drug could be increased by a number of subjects. In conclusion, the change of lung dose depends on the degree of lung emptying, but it is also inhaler and drug specific. Forceful exhalation can help in increasing the lung dose only if the above specificities are taken into account.

01 Oct 2023·Drug safety

Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea.

Article

Author: Cho, Eun-Yeong ; Jang, Seung Hun ; Cho, Jung-Eun ; Hwang, Ki-Eun

BACKGROUND AND OBJECTIVE:

Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period.

METHODS:

This was an open-label, multicentre, observational, post-marketing surveillance study in patients newly treated with FF/VI (100 or 200 μg/25 μg once daily). Safety endpoints were the incidence of adverse events (AEs), including unexpected AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was assessed after 24 weeks by Global Physician Assessment (logistic regression) and forced expiratory volume in 1 s (FEV₁; paired t-tests).

RESULTS:

Of the 3426 patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were included in the safety analysis (50.5% female; mean age ± standard deviation [SD]: 58.6 ± 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean FEV₁ (difference ± SD) increased significantly in patients with asthma (0.09 ± 0.29 L; p < 0.0001), COPD (0.11 ± 0.24 L; p = 0.0011), or both (0.05 ± 0.18 L; p = 0.0399), indicating improved lung function.

CONCLUSION:

In this real-world study, FF/VI administered to Korean patients was well tolerated and effective for the treatment of asthma and COPD. These results were consistent with other studies in Asian and global populations.

News (Medical) associated with Fluticasone Furoate/Vilanterol Trifenatate

20 May 2025

·www.businesswire.com

ZEVTERA ® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections

WALTHAM, Mass.--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company’s growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.i ZEVTERA is the latest approved MRSA SAB therapy since 2006. “The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.” MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death. In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).ii Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups.iii “ZEVTERA is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. “With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access.” Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 days.iv Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.v ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit www.innovivaspecialtytherapeutics.com for more information. ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil (“Basilea”) and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea. “We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand,” said David Veitch, Chief Executive Officer of Basilea. “The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections.” About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA's status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. 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. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@istx.com U.S. Food and Drug Administration 1‑800‑FDA‑1088 www.fda.gov/medwatch For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@istx.com) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, go to: https://innovivaspecialtytherapeutics.com/wp-content/uploads/2025/05/Prescribing-Information-Zevtera.pdf About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.vi About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.vii About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.viii About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit www.basilea.com. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including 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 and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including 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. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. ____________________ i Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk ii U.S. Food and Drug Administration. (2024, April 3). FDA approves new antibiotic for three different uses. [FDA News Release] https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses iii Holland TL, Cosgrove SE, Doernberg SB, et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. www.nejm.org/doi/full/10.1056/NEJMoa2300220 iv Van der Vaart, Thomas; All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study; Open Forum Infectious Diseases; December 2022, Volume 9, Issue 12; https://academic-oup-com.libproxy1.nus.edu.sg/ofid/article/9/12/ofac653/6854726 v Minejima, E., Mai, N., Bui, N., Mert, M., Mack, W. J., She, R. C., Nieberg, P., Spellberg, B., & Wong-Beringer, A. (2020). Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70(4), 566–573. https://doi-org.libproxy1.nus.edu.sg/10.1093/cid/ciz257 vi K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 vii J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 viii J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812

Phase 3License out/inClinical ResultDrug ApprovalPriority Review

20 May 2025

·innovivaspecialtytherapeutics.com

ZEVTERA® (ceftobiprole), an Advanced-Generation Cephalosporin Antibiotic Now Commercially Available in the U.S. to Treat Three Types of Bacterial Infections

ZEVTERA is the first and only U.S. Food and Drug Administration-approved cephalosporin indicated to treat Staphylococcus aureus bacteremia (SAB), including right-sided endocarditis, caused by the methicillin-resistant Staphylococcus aureus (MRSA). Waltham, MA – May 20, 2025 – Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced the United States commercial availability of ZEVTERA® (ceftobiprole medocaril sodium for injection), the newest addition to the Company’s growing antibiotic portfolio. ZEVTERA is the only U.S. Food and Drug Administration (FDA) approved advanced-generation cephalosporin indicated to treat adult patients with Staphylococcus aureus bloodstream infection (bacteremia) (SAB), including those with right-side endocarditis caused by methicillin-susceptible and methicillin-resistant isolates.[i] ZEVTERA is the latest approved MRSA SAB therapy since 2006. “The availability of ZEVTERA in the U.S. marks the introduction of our second novel therapy in two years, addressing drug-resistant pathogens that pose significant health risks, particularly in hospitals and out-patient settings,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “This portfolio expansion demonstrates our commitment to delivering therapies that offer physicians new options for treating some of the most challenging and potentially deadly diseases by leveraging our market-leading hospital platform.” MRSA, a strain of Staphylococcus aureus, has developed resistance to methicillin and many other commonly used antibiotics. Infections with MRSA have a high morbidity and mortality rate. Each year, over one hundred thousand individuals in the U.S. experience bacteremia caused by Staphylococcus aureus, with nearly 20,000 of these cases resulting in death. In April 2024, the U.S. FDA approved ZEVTERA for three indications. It is the only FDA-approved MRSA cephalosporin antibiotic for treating adult patients with SAB and right-side endocarditis. In addition to Staphylococcus aureus bacteremia, ZEVTERA is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).[ii] Unlike earlier-generation cephalosporins, ZEVTERA retains effectiveness against Gram-negative bacteria and provides activity against MRSA and methicillin-susceptible Staphylococcus aureus (MSSA). In the Phase 3 ERADICATE study, ceftobiprole met the primary endpoint by demonstrating non-inferiority versus daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole, compared to 68.7% with daptomycin, in the Modified Intention-to-Treat (mITT) population at 70 days post-randomization. Both treatments were well tolerated. The overall rate of adverse events was similar between the ceftobiprole and daptomycin groups.[iii] “ZEVTERA is an excellent addition to our antibiotics portfolio and its market availability further underscores our strategic commitment to deliver meaningful innovations in infectious diseases,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics, Inc. “With the approval of ZEVTERA for three different indications, physicians and other health care providers will have a new option for serious bacterial infections, including Staphylococcal aureus bacteremia caused by methicillin-susceptible and methicillin-resistant isolates. Through our collaboration with specialty pharmacies and pharmacy distributors nationwide, ZEVTERA is available for immediate access.” Despite the availability of standard-of-care therapies, the mortality rate for SAB remains high, with approximately 30% of patients succumbing to the infection at 90 days.[iv] Patients with MRSA are three times more likely to experience prolonged bacteremia compared to those with methicillin-sensitive Staphylococcus aureus. Furthermore, MRSA bacteremia increased hospital length of stay and systemic infection vs. methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia.[v] ZEVTERA is supplied in a single-dose vial containing 667 mg of ceftobiprole medocaril sodium (equivalent to 500 mg of ceftobiprole) as a lyophilized powder for intravenous infusion after reconstitution. Please visit www.innovivaspecialtytherapeutics.com for more information. ZEVTERA was developed by Basilea Pharmaceutica Ltd, Allschwil (“Basilea”) and received Priority Review, Fast Track, and Qualified Infectious Disease Product designations for the CABP, ABSSSI, and SAB indications. In December 2024, Innoviva Specialty Therapeutics, Inc., acquired exclusive U.S. marketing rights through a licensing agreement with Basilea. “We congratulate our partner Innoviva Specialty Therapeutics on making ZEVTERA available in the U.S., which marks a significant milestone for the brand,” said David Veitch, Chief Executive Officer of Basilea. “The U.S. is the most critical commercial market for newer antibacterials, and there is a substantial medical need for treatments targeting Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are excited to support Innoviva Specialty Therapeutics in bringing ZEVTERA to patients in the U.S. who are suffering from these severe infections.” About MRSA According to the Centers for Disease Control and Prevention (CDC), methicillin-resistant Staphylococcus aureus (MRSA) is considered a serious public health threat. MRSA is a type of staph infection that has become resistant to commonly used antibiotics, including methicillin, oxacillin, penicillin, and amoxicillin. This resistance has contributed to MRSA’s status as a significant public health concern. MRSA infections can lead to severe complications both in healthcare settings and in the community, including pneumonia, sepsis, surgical site infections, and endocarditis. Individuals at highest risk for contracting MRSA include those who have prolonged hospital stays, have been admitted to intensive care, underwent recent invasive procedures, or reside in nursing homes. Healthcare workers who come into direct contact with patients infected with MRSA are also at increased risk. 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. You are encouraged to report negative side eﬀects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact: Innoviva Specialty Therapeutics, Inc.™ 1‑800‑651‑3861 medinfo@istx.com U.S. Food and Drug Administration 1‑800‑FDA‑1088 www.fda.gov/medwatch For smaller pieces, AE language can be: To report suspected adverse reactions, contact Innoviva Specialty Therapeutics, Inc. at 1‑800‑651‑3861 (medinfo@istx.com) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For full prescribing information, go to: https://innovivaspecialtytherapeutics.com/wp-content/uploads/2025/05/Prescribing-Information-Zevtera.pdf About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB.[vi] About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in healthcare settings. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved.[vii] About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US.[viii] About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea is committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. Basilea has successfully launched two hospital brands, Cresemba (isavuconazonium sulfate), for the treatment of invasive fungal infections and ZEVTERA for the treatment of bacterial infections. In addition, the Company has preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit www.basilea.com. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including 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 and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including 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. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd, Allschwil. Investors and Media: Innoviva, Inc. David Patti Corporate Communications (908) 421-5971 david.patti@inva.com Eleanor Barisser Investor Relations Eleanor.barisser@inva.com [i] Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk [ii] U.S. Food and Drug Administration. (2024, April 3). FDA approves new antibiotic for three different uses. [FDA News Release] https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses [iii] Holland TL, Cosgrove SE, Doernberg SB, et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. www.nejm.org/doi/full/10.1056/NEJMoa2300220 [iv] Van der Vaart, Thomas; All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study; Open Forum Infectious Diseases; December 2022, Volume 9, Issue 12; https://academic-oup-com.libproxy1.nus.edu.sg/ofid/article/9/12/ofac653/6854726 [v] Minejima, E., Mai, N., Bui, N., Mert, M., Mack, W. J., She, R. C., Nieberg, P., Spellberg, B., & Wong-Beringer, A. (2020). Defining the Breakpoint Duration of Staphylococcus aureus Bacteremia Predictive of Poor Outcomes. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 70(4), 566–573. https://doi-org.libproxy1.nus.edu.sg/10.1093/cid/ciz257 [vi] K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology 2020 (1), 35-48 [vii] J. Edelsberg, C. Taneja, M. Zervos et al. Trends in US hospital admissions for skin and soft tissue infections. Emerging Infectious Diseases 2009 (15), 1516-1518 [viii] J. A. Ramirez, T. L. Wiemken, P. Peyrani et al. Adults hospitalized with pneumonia in the United States: Incidence, epidemiology, and mortality. Clinical Infectious Diseases 2017 (65), 1807-1812

Phase 3Clinical ResultLicense out/inDrug ApprovalQualified Infectious Disease Product

07 May 2025

·www.businesswire.com

Innoviva Reports First Quarter 2025 Financial Results; Highlights Recent Company Progress

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the first quarter ended March 31, 2025, and highlighted select corporate progress and achievements. “We are pleased with our strong first quarter financial results, highlighted by robust cash flows from our GSK royalties portfolio and continued excellent growth from the IST-marketed products,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Our therapeutics business remains a key driver, with an NDA filing for zoliflodacin on track and the U.S. commercial launch of ZEVTERA® (ceftobiprole) anticipated by mid-2025, underscoring our commitment to delivering innovative treatments to patients and our ability to leverage the operating platform.” “Additionally, we remain dedicated to creating value for our shareholders by strategically enhancing our healthcare assets. We are cognizant of the increased market volatility and believe that the strength of our balance sheet, combined with a disciplined approach to capital allocation, positions us well to advance our diversified portfolio and capitalize on new opportunities, thereby supporting sustained growth across market environments,” concluded Mr. Raifeld. Financial Highlights Royalty revenue: First quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $61.3 million, compared to $61.9 million for the first quarter of 2024. Net product sales: First quarter 2025 net product sales totaled $30.3 million, consisting of $26.4 million in U.S. net product sales and $3.9 million in ex-U.S. net product sales, compared to $19.1 million in net product sales for the first quarter of 2024. U.S. net product sales included $17.4 million from GIAPREZA ® , $5.8 million from XACDURO ® , and $3.2 million from XERAVA ® , representing a 52% increase compared to total U.S. net product sales of $17.4 million in the first quarter of 2024. Income from operations: First quarter 2025 income from operations was $41.4 million, an increase of 61% from $25.8 million in the first quarter of 2024. Equity and long-term investments: First quarter 2025 unfavorable changes in fair values of equity and long-term investments totaled $78.8 million, compared to favorable changes of $22.0 million in the first quarter of 2024, primarily due to the share price depreciation of Armata Pharmaceuticals and certain equity investments managed by ISP Fund LP. Net income: First quarter 2025 net loss was $46.6 million, or ($0.74) basic per share, compared to net income of $36.5 million, or $0.58 basic per share, for the first quarter of 2024. Cash and cash equivalents: Totaled $319.1 million. Royalty and net product sales receivables totaled $77.9 million as of March 31, 2025. Key Business and R&D Highlights Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed together with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. ZEVTERA ® (ceftobiprole): an advanced-generation cephalosporin antibiotic that is approved in the U.S. for three specific treatment indications. ZEVTERA ® is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and endocarditis. ZEVTERA ® is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $457.6 million as of March 31, 2025. In the first quarter of 2025, we invested a total of $34.7 million in various strategic healthcare assets, including $15.0 million in a convertible note of Gate Neurosciences and $10.0 million in a term loan to Armata Pharmaceuticals. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other commercial and marketed products include infectious disease and critical care assets: GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock; XERAVA® (eravacycline), approved for the treatment of complicated intra-abdominal infections in adults; and XACDURO® (sulbactam for injection; durlobactam for injection), approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. In addition, ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, will be exclusively commercialized by us in the U.S. under a distribution and license agreement with Basilea Pharmaceutica Ltd., (“Basilea”), entered into in December 2024. We continue to advance our pipeline with zoliflodacin, a potentially first in class, single-dose oral treatment for uncomplicated gonorrhea. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd., Allschwil. 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® and ZEVTERA® 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 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, 2024 and subsequently Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. 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. 2025 2024 $ 57,807 $ 58,415 30,279 19,084 546 — 88,632 77,499 8,842 10,971 6,475 6,440 73,315 60,088 27,491 30,405 4,396 3,878 31,887 34,283 41,428 25,805 (13,549 ) 35,342 (65,299 ) (13,335 ) 4,538 4,399 (4,711 ) (5,851 ) (996 ) (1,236 ) (38,589 ) 45,124 (7,995 ) (8,592 ) $ (46,584 ) $ 36,532 $ (0.74 ) $ 0.58 $ (0.74 ) $ 0.46 62,709 63,185 62,709 84,531 2025 2024 $ 61,263 $ 61,871 (3,456 ) (3,456 ) $ 57,807 $ 58,415 2025 2024 $ 319,090 $ 304,964 77,936 86,366 41,479 33,725 15,727 21,719 127,790 107,532 483 514 329,844 393,957 66,505 69,961 2,110 2,453 17,905 17,905 201,958 208,433 12,294 12,054 41,269 41,477 $ 1,254,390 $ 1,301,060 $ 40,695 $ 39,507 833 3,422 1,002 1,126 192,215 192,028 256,670 256,316 62,009 64,275 54,061 53,227 646,905 691,159 $ 1,254,390 $ 1,301,060 2025 2024 $ 48,617 $ 37,047 (34,674 ) (43,038 ) 183 (9,165 ) $ 14,126 $ (15,156 ) 304,964 193,513 $ 319,090 $ 178,357

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100 Deals associated with Fluticasone Furoate/Vilanterol Trifenatate

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-	Fluticasone Furoate/Vilanterol Trifenatate	R03AK10	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Bronchitis, Chronic	Japan	GlaxoSmithKline KK	02 Dec 2016
Pulmonary Emphysema	Japan	GlaxoSmithKline KK	02 Dec 2016
Asthma	Japan	GlaxoSmithKline KK	20 Sep 2013
Pulmonary Disease, Chronic Obstructive	United States	Glaxo Group Ltd.	10 May 2013

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Ischemic Attack, Transient	Phase 3	United States	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Canada	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Czechia	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Germany	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Poland	GSK Plc	01 Apr 2012
Ischemic Attack, Transient	Phase 3	Romania	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	United States	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	Canada	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	Czechia	GSK Plc	01 Apr 2012
Myocardial Infarction	Phase 3	Germany	GSK Plc	01 Apr 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ATS2025	Not Applicable	-	177	Vilanterol/Fluticasone Furoate (VI/FF) DPI	gbvipafzge(nxfnempvfs) = cqbzbtenki zezzsdtvci (dykujbllmp ) View more	Positive	16 May 2025
ATS2023	Not Applicable	Asthma	-	Fluticasone Furoate/Vilanterol	mlyhnwjujx(mnisdozklm) = Similar proportions of participants experienced ≥1 on-treatment adverse event (AE) in both populations (5-17 year-olds: n=181/454 [40%] receiving FF/VI versus n=163/448 [36%] receiving FF; 5-11 year-olds: n=133/337 [39%] receiving FF/VI versus n=122/336 [36%] receiving FF) ameybgrerw (kaltafgeta )	-	21 May 2023
ATS2022	Not Applicable	Pulmonary Disease, Chronic Obstructive \| Asthma	3,426	Fluticasone furoate/vilanterol 100 µg/25 µg	jwitcahkri(ujoldygrfu) = iaywjaknvx eyopiqqfxa (eclwmvbaia ) View more	Positive	15 May 2022
				Fluticasone furoate/vilanterol 200 µg/25 µg	jwitcahkri(ujoldygrfu) = ikcrjfyuau eyopiqqfxa (eclwmvbaia ) View more
NCT01551758 (HZC115151, Pubmed \| Ther Adv Respir Dis)	Phase 3	Pulmonary Disease, Chronic Obstructive	2,802	Fluticasone furoate/vilanterol 100/25 µg	eduqzpdijm(xngiaowiar) = pflhobmvrm qdzssucnli (jczoekiyxu ) View more	-	01 Jan 2021
				fluticasone furoate/vilanterol	eduqzpdijm(xngiaowiar) = nfjzxyzjob qdzssucnli (jczoekiyxu ) View more
NCT03380429 (CTgov)	Phase 4	Asthma	437	Relvar/Breo+salbutamol (Cohort 1: Data on Maintenance Use Supplied to Par and HCP)	yxkqezxqss(fbzaqhdbgg) = qqdlpflwmy bgyfvogbwn (kigamlbkio, 3.19) View more	-	05 Feb 2020
				Relvar/Breo+salbutamol (Cohort 5: No Data Supplied to Par or HCP)	yxkqezxqss(fbzaqhdbgg) = sbegnkxszf bgyfvogbwn (kigamlbkio, 3.19) View more
NCT01706198 (Asthma Salford Lung, Pubmed \| J Asthma)	Phase 3	Asthma Maintenance	4,233	Fluticasone furoate/vilanterol	kfobhwaaji(spaucjusuw) = ibzzesnaoi aptryatrre (rtlrqlupsx )	Positive	01 Jul 2019
				Fluticasone propionate/salmeterol	kfobhwaaji(spaucjusuw) = yjphfjmmzx aptryatrre (rtlrqlupsx )
NCT01957150 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	283	VI (Participants Administered VI)	hqaitjbgra(jnrfucsell) = bmzufmjjxg uwbdgmbhoy (gutrnhpmnf, oqrglgskev - gfysyknjsr) View more	-	10 Apr 2019
				VI (Participants Administered FF/VI)	hqaitjbgra(jnrfucsell) = gwygvnqdau uwbdgmbhoy (gutrnhpmnf, ldvimlifni - btsbmswlar) View more
NCT01706198 (Salford Lung Study in Asthma \| Asthma Salford Lung \| SLS asthma, CTgov)	Phase 3	Asthma	4,233	fluticasone furoate + vilanterol+inhaled corticosteroid with or without a long acting beta2-agonist	dwycjogikb = pvayvdspdh tygdmxbjyj (prehinijrr, zybbtiinnl - xjzdqbarto) View more	-	24 Jan 2019
NCT02301975 (GSK study 201378, Pubmed \| J Asthma)	Phase 3	Asthma	1,504	Fluticasone furoate/vilanterol 100/25 µg	swzwnrotrr(rhsflzcbpq) = bnqkioevww wfmsddczad (wqpjlyopwt )	-	01 Sep 2018
NCT02730351 (201832, CTgov)	Phase 4	Asthma \| Asthma, Exercise-Induced	75	Placebo+FF/VI (FF/VI 100/25 µg QD Via ELLIPTA + Placebo BID Via DISKUS)	xogxtxtaxw(uotctsebmf) = ltsmvzayam ciayorepuj (egediycosq, 1.058) View more	-	13 Oct 2017
				FP (FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA)	xogxtxtaxw(uotctsebmf) = ihnjvufcur ciayorepuj (egediycosq, 1.095) View more

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