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 recruitingPhase 3IIT

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

02 Oct 2024·Journal of Asthma

Efficacy and safety of Once-Daily Vilanterol/Fluticasone furoate MDI in persistent asthma: Phase 3 OD-INHALE Study

Article

Author: Jain, Manish Kumar ; Mehta, Ravi T. ; Mondal, Asish ; Kumar, Raghumanda Sunil ; Barge, Vijaykumar Bhagwan ; Yadav, Harendra ; Redkar, Vivek Eknath ; Gupta, Neeraj ; Kumar, Avdhesh ; Pal, Amitava ; Rathore, Rahul Kumar ; Jaiswal, Ashok ; Daultani, Pavankumar

INTRODUCTIONOnce-daily inhalers have been shown to improve adherence leading to lesser discontinuation compared to twice- or thrice-daily inhalers in management of asthma. Combination of Vilanterol and Fluticasone Furoate (VI/FF) is approved for management of asthma and COPD and is available as a dry powder inhaler. Pressurized-Metered Dose Inhalers (pMDIs) offer ease-of-use and therapy alternatives for patients with low inspiratory flow. This study assessed the efficacy and safety of a new once-daily pMDI containing VI/FF in individuals diagnosed with persistent asthma.METHODSThis phase 3, double-blind, randomized controlled study assessed the non-inferiority of VI/FF (12.5 mcg/50 mcg & 12.5 mcg/100 mcg; 2 puffs once-daily) over Formoterol Fumarate and Fluticasone Propionate (FOR/FP, 6 mcg/125 mcg & 6 mcg/250 mcg; 2 puffs twice-daily) in patients with persistent asthma. Primary outcome was change from baseline in trough FEV1 at the end of study (12 weeks). Adverse events and number of exacerbations were used to evaluate safety.RESULTSA total of 330 patients were randomized into VI/FF (165) and FOR/FP (165). Trough FEV1 significantly improved in both the groups at week 12, with a mean difference (VI/FF minus FOR/FP) being 54.75 mL (95% CI, 8.42-101.08 mL, p = 0.02). The low dose VI/FF had similar efficacy to that of low dose FOR/FP and high dose VI/FF had similar efficacy to high dose FOR/FP. No serious adverse events were reported during the study.CONCLUSIONOnce daily VI/FF pMDI was non-inferior to twice daily FOR/FP pMDI in patients with persistent asthma.

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

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

BACKGROUND AND OBJECTIVEFluticasone 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.METHODSThis 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).RESULTSOf 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.CONCLUSIONIn 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

12 Nov 2024

·www.prnewswire.com

Sanofi/Regeneron Pharmaceuticals' DUPIXENT Approval Marks a Significant Shift in Chronic Obstructive Pulmonary Disease Treatment Landscape | DelveInsight

After over a decade without notable progress in treating chronic obstructive pulmonary disease, patients with this ongoing condition now have two new treatment options, with more expected in the future. Regeneron and Sanofi recently revealed that the FDA has expanded the approved uses of their widely successful drug DUPIXENT to include COPD treatment. This marks the drug's sixth approved indication in the US, following its first approval seven years ago for atopic dermatitis. LAS VEGAS, Nov. 12, 2024 /PRNewswire/ -- Chronic obstructive pulmonary disease (COPD) is a progressive lung condition characterized by obstructed airflow, making breathing difficult. It primarily encompasses two main conditions: chronic bronchitis and emphysema, often coexisting. COPD typically develops due to long-term exposure to irritants such as cigarette smoke, air pollution, or occupational dust. As per DelveInsight analysis, the diagnosed prevalent population of COPD in the 7MM was around 44 million in 2023. These cases of COPD in the 7MM are expected to increase at a significant CAGR of 1.4% throughout the study period (2020–2034). As per the estimates, the majority of cases of COPD are in females as compared to males, in the US. But in EU4 and the UK, and Japan the diagnosed cases of males represent the majority of the cases. Overall, in the 7MM, females are predominantly high in number. In 2023, the US had around 3 million, 9 million, 5 million, and 1 million cases of GOLD 1, GOLD 2, GOLD 3, and GOLD 4, respectively based on the severity of airflow limitation. Estimates suggest that airflow limitation was higher in GOLD 2 severity. Various types of medications are used to manage COPD symptoms and complications, including bronchodilators, which help relax the muscles around the airways. This relaxation opens the airways and makes breathing easier. Most bronchodilators are administered via an inhaler. In more severe cases, the inhaler may also contain steroids to reduce inflammation. Some commonly used short-acting and long-acting bronchodilators for COPD management include Albuterol (ProAir HFA, Ventolin HFA, and others), Ipratropium (Atrovent HFA), Levalbuterol (Xopenex), Aclidinium (Tudorza Pressair), Arformoterol (Brovana), and Formoterol (Perforomist). In the LABA category, medications such as Striverdi Respimat, Arcapta/Onbrez, Serevent, and Brovana are included, while the LAMA class features drugs like Spiriva (available as Spiriva HandiHaler and Spiriva Respimat), Tudorza Pressair, Incruse Ellipta, Yupelri, Seebri Neohaler, and Lonhala Magnair. Since the generic version of Brovana was approved in April 2020, its market share has declined. Additionally, Arcapta Neohaler, Seebri Neohaler, and Utibron Neohaler were discontinued in the US in March 2020, which means they no longer contribute to market size. Patients who do not respond to single therapies are often prescribed double or triple therapy. Among the double therapies, the LABA+ICS combination is widely recommended, with drugs such as Symbicort, Breo Ellipta, and Advair. There are also LABA+LAMA combinations, including Anoro Ellipta, Stiolto Respimat, and Bevespi Aerosphere. In July 2020, the US FDA approved AstraZeneca's BREZTRI AEROSPHERE for the maintenance treatment of patients with COPD. Additionally, in October 2020, TRIXEO AEROSPHERE (a combination of formoterol fumarate, glycopyrronium bromide, and budesonide) received marketing authorization in the EU for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately controlled by either a combination of an ICS and LABA or a LABA and LAMA. Currently, two triple combination therapies are available in the US: BREZTRI and TRELEGY ELLIPTA. Learn more about the FDA-approved COPD drugs @ Drugs for COPD Treatment Recently, Sanofi/Regeneron Pharmaceuticals' DUPIXENT added one more jewel to its crown by getting a label expansion nod for COPD from the FDA, EU, and NMPA. DUPIXENT's approval as the first targeted therapy for COPD represents a significant advancement in the treatment landscape for the disease. Unlike conventional treatments, which largely aim to manage symptoms, DUPIXENT specifically targets the IL-4 and IL-13 pathways linked to type 2 inflammation, a key driver in a subset of COPD patients. This precision in targeting allows for a more tailored treatment, especially for patients with elevated eosinophils, who often experience more frequent exacerbations and worse outcomes. The Phase III BOREAS trial demonstrated that patients treated with DUPIXENT experienced a 30% reduction in moderate-to-severe exacerbations over 52 weeks, significant improvements in lung function, and enhanced quality of life. By Week 52, those on DUPIXENT had improved prebronchodilator FEV1 by 160 mL compared to 77 mL in the placebo group. DUPIXENT was also well-tolerated, with a low frequency of adverse events. These results suggest that DUPIXENT could drastically shift COPD management by reducing exacerbations, improving lung function, and offering a safer, targeted therapy for patients with type 2 inflammation. To know more about COPD treatment options, visit @ New Treatment for COPD The chronic obstructive pulmonary disease pipeline possesses potential drugs in mid-stage developments to be launched in the near future. Itepekimab (Sanofi/Regeneron Pharmaceuticals), Benralizumab (AstraZeneca), Tezepelumab (Amgen/AstraZeneca), Mepolizumab (GSK), and others shall further create a positive impact on the market. Discover which therapies are expected to grab major COPD market share @ COPD Market Report Itepekimab is a fully human monoclonal antibody that targets interleukin-33 (IL-33), a protein involved in both type 1 and type 2 inflammation. The drug is administered via subcutaneous injection. Preclinical studies demonstrated that REGN3500 effectively inhibited several markers of both inflammatory types. Regeneron and Sanofi are investigating REGN3500 in diseases related to respiratory and dermatological inflammation. Currently, REGN3500 is in a Phase III clinical trial for COPD and was developed using Regeneron's VelocImmune technology, which produces optimized fully human antibodies. The development is part of a global collaboration between Regeneron and Sanofi. FASENRA (benralizumab) is a humanized recombinant monoclonal antibody of the IgG1k immunoglobulin type that selectively targets the alpha chain of the interleukin 5 receptor (IL-5R) found on eosinophils and basophils. It prevents IL-5 from binding and stops the hetero-oligomerization of the IL-5R's alpha and beta subunits, thereby inhibiting signal transduction. Additionally, it is an afucosylated IgG, which enhances its affinity for the FcγRIIIα receptor on natural killer cells, macrophages, and neutrophils. Approved by the FDA in November 2017 for severe eosinophilic asthma, benralizumab was developed by MedImmune, AstraZeneca's global biologics R&D division. The company is currently conducting Phase III clinical trials for FASENRA as a treatment for COPD. TEZSPIRE (tezepelumab), a pioneering human monoclonal antibody created by Amgen and AstraZeneca, has shown considerable therapeutic potential for various respiratory conditions. Originally intended for treating COPD, TEZSPIRE has yielded encouraging results in decreasing moderate-to-severe exacerbations in patients with high blood eosinophil counts. Recent findings from the Phase IIa COURSE Trial, unveiled at the ATS 2024 conference, underscored TEZSPIRE's effectiveness in minimizing COPD exacerbations among patients with different eosinophil levels. Mepolizumab is currently undergoing Phase III clinical trials for COPD, particularly in patients with frequent exacerbations and elevated eosinophil levels. It is available as an injectable solution and a powder for reconstitution for subcutaneous administration. The IL-5 receptor complex activates several signaling pathways that lead to the release of cytokines, neuromediators, chemokines, and various kinases, which facilitate eosinophil differentiation, proliferation, recruitment, and degranulation. Mepolizumab works by inhibiting the formation of the IL-5 receptor complex, thereby preventing eosinophil activation. This disruption affects normal eosinophil maturation and function, leading to decreased eosinophilic airway inflammation and reduced eosinophil survival. Discover more about drugs for COPD in development @ COPD Clinical Trials The anticipated launch of these emerging therapies for COPD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the COPD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for COPD in the 7MM is expected to grow from USD 16 billion in 2023 with a significant CAGR of 5% by 2034. This growth is mainly driven by the rise in the number of prevalent cases of COPD, ongoing clinical research, and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Chronic Obstructive Pulmonary Disease Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the COPD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The COPD market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of COPD Subtype-specific Diagnosed Prevalent Cases of COPD Gender-specific Diagnosed Prevalent Cases of COPD Age-specific Diagnosed Prevalent Cases of COPD Diagnosed Prevalent Cases of COPD Based on Severity of Airflow Limitation Diagnosed Prevalent Cases of COPD Based on Symptoms and Exacerbation History The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM COPD market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this COPD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the COPD market. Also, stay abreast of the mitigating factors to improve your market position in the COPD therapeutic space. Related Reports Chronic Obstructive Pulmonary Disease Pipeline Chronic Obstructive Pulmonary Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key COPD companies, including Sanofi, Chiesi Farmaceutici S.p.A., United Therapeutics Corporation, Verona Pharma plc, Immunotek, Yungjin Pharm. Co., Ltd., Pulmotect, Inc., Tetherex Pharmaceutical, CSL Behring, AstraZeneca, Novartis, Genentech, Vertex Pharmaceuticals, EmeraMed, Afimmune, Mereo BioPharma, Synairgen, Adamis Pharmaceuticals, Quercegen Pharmaceuticals LLC, Regend Therapeutics, Meridigen Biotech Co., Ltd., Pulmatrix, Eisai, GlaxoSmithKline, EpiEndo Pharmaceuticals, 3SBio, OmniSpirant, Foresee Pharmaceuticals, Amgen, Organicell Regenerative Medicine, Arrowhead Pharmaceuticals, ProterixBio, RS BioTherapeutics, MitoRx, C4X Discovery, Respiratorius, ARK biosciences, Incannex, GNI Pharma, Celon pharma, Alveolus Bio, Kinaset therapeutics, Landos Biopharma, Parion Sciences, KeyMed Biosciences, Bioneer corporation, AlgiPharma, Palobiofarma, Dimerix Bioscience, Glenmark Pharmaceuticals, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3Phase 2

12 Nov 2024

·www.businesswire.com

Innoviva to Participate in the UBS Global Healthcare Conference

Drug ApprovalAcquisitionLicense out/in

06 Nov 2024

·www.businesswire.com

Innoviva Reports Third Quarter 2024 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 third quarter ended September 30, 2024, and highlighted select corporate achievements. “For the third quarter of 2024, we continue to deliver strong revenue growth, with solid performance from our core GSK royalty assets, and accelerating sales from our IST commercial products, GIAPREZA ® , XACDURO ® and XERAVA ® . Since the formation of IST, now in its second year of operation, we have shown consistent sales expansion in our commercial products, primarily driven by increasing product demand, validating our investment in hospital-based therapeutics,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Of special note, XACDURO ® was nominated for the Best Biotechnology Product by The Galien Foundation USA in recognition of its pioneering science and positive impact on patients. We are proud of this recognition which highlights the commitment and innovation we are bringing to this space, where there is significant unmet medical need and an immense demand for new drugs. We also continue to further advance our pipeline and are on track to submit a New Drug Application (“NDA”) for zoliflodacin, potentially first in class, single dose oral drug for the treatment of uncomplicated gonorrhea, to the U.S. FDA in early 2025.” Mr. Raifeld continued, “Over the past quarter, we also saw meaningful operational progress across our strategic healthcare assets. We remain focused on prudent capital allocation in our quest to maximize shareholder value and see multiple opportunities for continued value creation.” Financial Highlights Royalty revenue: Third quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was $60.5 million, compared to $57.0 million for the third quarter 2023. Net Product Sales: Third quarter 2024 net product sales were $27.8 million, which included U.S. net product sales of $19.7 million and ex-U.S. product sales of $8.1 million. U.S. net product sales consisted of $13.1 million from GIAPREZA ® , $2.3 million from XERAVA ® , and $4.3 million from XACDURO ® , a 68% increase compared to $11.8 million for the third quarter 2023. License Revenue: Third quarter 2024 license revenue of $4.6 million included product development cost-sharing reimbursements from our partner. Equity and long-term investments: Third quarter 2024 unfavorable net change in fair value of equity and long-term investments of $35.2 million was primarily due to lower share price of Armata Pharmaceuticals (“Armata”). Net income : Net income of $1.2 million, or $0.02 basic per share, for the third quarter of 2024, compared to a net income of $82.0 million, or $1.26 basic per share, for the third quarter of 2023. Cash and cash equivalents : Totaled $260.6 million. Royalty and product sales receivables totaled $91.1 million as of September 30, 2024. Key Business and R&D Highlights 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. XACDURO ® was recently nominated for the 2024 Prix Galien USA Award for Best Biotechnology Product, which recognizes excellence in scientific innovation that improves the state of human health. Zoliflodacin : a potential first-in-class, single dose, oral antibiotic is currently being developed in partnership with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. In September 2024, we presented additional findings on our investigational agent zoliflodacin at the 2024 Sexually Transmitted Infections Prevention Conference in Atlanta. The first oral presentation demonstrated that zoliflodacin had potent in vitro activity against 200 clinical isolates, consistent with previous U.S. surveillance data. The second presentation demonstrated that microbiological cure rates for specific subgroups were comparable to the primary endpoint analysis. Safety in these subgroups was also comparable. In October 2024, we had five presentations at IDWeek 2024, which took place in Los Angeles. One oral presentation on zoliflodacin included a review of the unique public-private partnership that led the clinical development of zoliflodacin. The second presentation highlighted the activity of sulbactam-durlobactam and standard-of-care antibiotics against Acinetobacter baumannii-calcoaceticus complex for hospitalized patients in the U.S. Three posters were presented including two on zoliflodacin: In vitro activity against baseline isolates in U.S. participants from the phase 3 trial and a pharmacometrics analysis supporting dose selection. Surveillance data of eravacycline against clinical pathogens, collected worldwide from multiple infections sites during 2018-2022 was also presented. We continue to advance zoliflodacin following its successful Phase 3 clinical trial results and expect to submit an NDA to the U.S. FDA in early 2025. 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. ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies. 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 ® and XACDURO ® 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 impact of the novel coronavirus (“COVID-19”); 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, 2023 and 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. INNOVIVA, INC. Condensed Consolidated Statements of Income and Comprehensive Income (in thousands, except per share data) (unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Revenue: Royalty revenue, net (1) $ 57,056 $ 53,558 $ 179,213 $ 172,681 Net product sales 27,822 13,701 68,557 40,942 License revenue 4,630 - 19,135 11,000 Total revenue 89,508 67,259 266,905 224,623 Expenses: Cost of products sold (inclusive of amortization of inventory fair value adjustments) 9,990 10,182 29,433 27,910 Cost of license revenue - - - 1,600 Selling, general and administrative 26,219 28,636 84,364 71,913 Research and development 3,551 3,989 9,989 31,566 Amortization of acquired intangible assets 6,511 6,511 19,391 15,274 Changes in fair values of equity method investments, net 18,231 (71,980 ) 42,997 (67,886 ) Changes in fair values of equity and long-term investments, net 16,936 2,640 60,827 4,887 Interest and dividend income (5,500 ) (4,114 ) (13,373 ) (11,032 ) Interest expense 5,807 4,396 17,460 13,205 Other expense, net 914 1,047 3,123 4,289 Total expenses, net 82,659 (18,693 ) 254,211 91,726 Income before income taxes 6,849 85,952 12,694 132,897 Income tax expense, net 5,636 3,906 9,634 14,706 Net income and comprehensive income $ 1,213 $ 82,046 $ 3,060 $ 118,191 Net income per share Basic $ 0.02 $ 1.26 $ 0.05 $ 1.79 Diluted $ 0.02 $ 0.98 $ 0.05 $ 1.45 Shares used to compute net income per share Basic 62,569 64,953 62,759 66,016 Diluted 62,951 86,164 63,020 87,504 (1) Total net revenue is comprised of the following (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 (unaudited) (unaudited) Royalties $ 60,512 $ 57,014 $ 189,581 $ 183,049 Amortization of capitalized fees (3,456 ) (3,456 ) (10,368 ) (10,368 ) Royalty revenue, net $ 57,056 $ 53,558 $ 179,213 $ 172,681 INNOVIVA, INC. Condensed Consolidated Balance Sheets (in thousands) (unaudited) September 30, December 31, 2024 2023 Assets Cash and cash equivalents $ 260,630 $ 193,513 Royalty and product sale receivables 91,058 84,075 Inventory 34,236 40,737 Prepaid expense and other current assets 14,697 25,894 Property and equipment, net 544 483 Equity and long-term investments 507,718 560,978 Capitalized fees paid, net 73,416 83,784 Right-of-use assets 2,789 2,536 Goodwill 17,905 17,905 Intangible assets 210,944 230,335 Deferred tax asset, net 14,875 - Other assets 2,800 3,267 Total assets $ 1,231,612 $ 1,243,507 Liabilities and stockholders’ equity Other current liabilities $ 30,357 $ 33,435 Accrued interest payable 833 3,422 Deferred revenue 717 1,277 Convertible senior notes, due 2025, net 191,843 191,295 Convertible senior notes, due 2028, net 255,972 254,939 Other long-term liabilities 71,449 71,870 Deferred tax liabilities, net - 563 Income tax payable, long-term 11,899 11,751 Innoviva stockholders’ equity 668,542 674,955 Total liabilities and stockholders’ equity $ 1,231,612 $ 1,243,507 INNOVIVA, INC. Cash Flows Summary (in thousands) (unaudited) Nine Months Ended September 30, 2024 2023 Net cash provided by operating activities $ 129,451 $ 107,808 Net cash used in investing activities (48,308 ) (61,610 ) Net cash used in financing activities (14,026 ) (157,250 ) Net change 67,117 (111,052 ) Cash and cash equivalents at beginning of period 193,513 291,049 Cash and cash equivalents at end of period $ 260,630 $ 179,997

Phase 3Financial StatementDrug ApprovalNDAClinical Result

100 Deals associated with Fluticasone Furoate/Vilanterol Trifenatate

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KEGG	Wiki	ATC	Drug Bank
-	Fluticasone Furoate/Vilanterol Trifenatate	R03AK10	-

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Persistent asthma	Preclinical	PH	GSK Plc	01 Jun 2010
Asthma	Preclinical	TH	GSK Plc	19 Oct 2009
Asthma	Preclinical	UA	GSK Plc	19 Oct 2009
Pulmonary Disease, Chronic Obstructive	Discovery	AR	GSK Plc	25 Sep 2009
Pulmonary Disease, Chronic Obstructive	Discovery	CL	GSK Plc	25 Sep 2009
Pulmonary Disease, Chronic Obstructive	Discovery	PH	GSK Plc	25 Sep 2009
Pulmonary Disease, Chronic Obstructive	Discovery	AU	GSK Plc	25 Sep 2009
Pulmonary Disease, Chronic Obstructive	Discovery	MX	GSK Plc	25 Sep 2009
Pulmonary Disease, Chronic Obstructive	Discovery	ZA	GSK Plc	25 Sep 2009
Pulmonary Disease, Chronic Obstructive	Discovery	PE	GSK Plc	25 Sep 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CAPTAIN (ATS2024)	Phase 3	Maintenance	-	FF/UMEC/VI 100/62.5/25mcg	(tlhfxrpxvy) = jimmntxret dopgvqclar (wecrzygkpd )	-	19 May 2024
				FF/UMEC/VI 200/62.5/25mcg	(tlhfxrpxvy) = asqscvddrk dopgvqclar (wecrzygkpd )
ATS2023	Not Applicable	-	-	Fluticasone Furoate/Vilanterol	tvkhbqsecd(hhyfhymytp) = 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) pcxkplsqvu (onkczrjydy )	-	21 May 2023
ATS2022	Not Applicable	Pulmonary Disease, Chronic Obstructive \| Asthma	3,426	Fluticasone furoate/vilanterol 100 µg/25 µg	(qpvjbgvmik) = ziegbmobpx msvrtdggdf (saykqhxzye ) View more	Positive	15 May 2022
				Fluticasone furoate/vilanterol 200 µg/25 µg	(qpvjbgvmik) = nwdeamsszt msvrtdggdf (saykqhxzye ) View more
NCT01551758 (HZC115151, Pubmed \| Ther Adv Respir Dis)	Phase 3	Pulmonary Disease, Chronic Obstructive	2,802	Fluticasone furoate/vilanterol 100/25 µg	ekctboznxz(txlofdamra) = fujzxeplqz wrdszdpsvi (ajyzqsfcte ) View more	-	01 Jan 2021
				fluticasone furoate/vilanterol	ekctboznxz(txlofdamra) = aytgexrwhf wrdszdpsvi (ajyzqsfcte ) View more
NCT03380429 (CTgov)	Phase 4	Asthma	437	Relvar/Breo+salbutamol (Cohort 1: Data on Maintenance Use Supplied to Par and HCP)	uvuvtvqdor(taxmoxaccj) = lrtaopcyeh qkuwhlymvu (xjpxamdjal, mkkkqvkjrp - wdphciyliu) View more	-	05 Feb 2020
				Relvar/Breo+salbutamol (Cohort 5: No Data Supplied to Par or HCP)	uvuvtvqdor(taxmoxaccj) = rstgojycxt qkuwhlymvu (xjpxamdjal, cahdykvwag - ykwmbdphic) View more
NCT01706198 (Salford Lung Study in Asthma \| Asthma Salford Lung \| SLS asthma, CTgov)	Phase 3	Asthma	4,233	fluticasone furoate + vilanterol+inhaled corticosteroid	cqihavztks(fftlhzefoo) = crqippnxbo dhnmseemxq (iakwokcyhl, eyjplkuuzs - ndjhrltzyz) View more	-	24 Jan 2019
IMPACT (ERS2018)	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Fluticasone furoate/umeclidinium/vilanterol 100/62.5/25µg (FF/UMEC/VI)	lpofozggoh(yoralpzlcb) = pttqfxctsp jdeeemrdqq (cqdngkkafk ) View more	Positive	15 Sep 2018
				Fluticasone furoate/vilanterol 100/25µg (FF/VI)	lpofozggoh(yoralpzlcb) = ibzsmwybjv jdeeemrdqq (cqdngkkafk ) View more
NCT02301975 (GSK study 201378, Pubmed \| J Asthma)	Phase 3	Asthma	1,504	Fluticasone furoate/vilanterol 100/25 µg	(mjviiyccbr) = wwryzcbnuo qruukmmvnm (svwnecvmwj )	-	01 Sep 2018
NCT01313676 (SUMMIT, Pubmed)	Phase 3	Moderate chronic obstructive pulmonary disease	16,568	Fluticasone Furoate	(elubpgiqlh) = bzbsbqtsmg gesjfncbeo (oqtglykmvz )	-	01 Jan 2018
				Vilanterol	(elubpgiqlh) = otanhoxabh gesjfncbeo (oqtglykmvz )
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)	iewexxtmpv(wbredpftyr) = gbaypuvqgb doyezjzxdj (hrkzpuegqf, akvipamtjn - zcsbarkgdy) View more	-	13 Oct 2017
				FP (FP 250 µg BID Via DISKUS + Placebo QD Via ELLIPTA)	iewexxtmpv(wbredpftyr) = ghtlrohcsy doyezjzxdj (hrkzpuegqf, mvzmkgvcph - kthktdpbcx) View more

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