Theravance Biopharma is a biopharmaceutical corporation that has successfully developed and commercialized one product, VIBATIV, through internal discovery and development. The company also possesses a portfolio of internally discovered product candidates and has established strategic partnerships with other pharmaceutical businesses.

Tags

Respiratory Diseases

Infectious Diseases

Other Diseases

Small molecule drug

Synthetic peptide

Chemical drugs

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	4
Endocrinology and Metabolic Disease	2
Nervous System Diseases	2
Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	8
Synthetic peptide	2
Chemical drugs	1

Top 5 Target	Count

JAK(Janus kinase)	2
JAK1 x JAK2 x JAK3 x TYK2	1
Hepatitis C virus NS 5 protein	1
mAChRs(Muscarinic acetylcholine receptor)	1
Peptidoglycan	1

Drugs associated with Theravance Biopharma, Inc.

Revefenacin

Target

mAChRs

Mechanism

mAChRs antagonists

Active Org.

The Ritedose Corp. [+3]

Originator Org.

Theravance Biopharma, Inc.

Active Indication

Pulmonary Disease, Chronic Obstructive [+2]

Inactive Indication

Liver Diseases [+1]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date09 Nov 2018

Telavancin Hydrochloride

Target

Peptidoglycan

Mechanism

Peptidoglycan inhibitors [+1]

Active Org.

Cumberland Pharmaceuticals, Inc. [+1]

Originator Org.

Theravance Biopharma, Inc.

Active Indication

Hospital-acquired pneumonia [+2]

Inactive Indication

Abscess [+11]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date11 Sep 2009

Ampreloxetine hydrochloride

Target

NET x SERT

Mechanism

NET inhibitors [+1]

Active Org.

Theravance Biopharma, Inc.

Originator Org.

Theravance Biopharma, Inc.

Active Indication

Multiple System Atrophy [+1]

Inactive Indication

Attention Deficit Disorder With Hyperactivity [+5]

Drug Highest PhasePhase 3

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Theravance Biopharma, Inc.

NCT05696717

/ RecruitingPhase 3

A Phase 3, Multi-center, Randomized Withdrawal and Long Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy

This is a Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment. This study includes 4 periods: Screening, open label, randomized withdrawal, and long-term treatment extension (LTE).

Start Date27 Jun 2023

Sponsor / Collaborator

Theravance Biopharma, Inc.

NCT05165485

/ CompletedPhase 4

A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)

Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.

Start Date07 Jan 2022

Sponsor / Collaborator

Theravance Biopharma, Inc.

[+1]

NCT05091723

/ CompletedPhase 1

Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of Inhaled Nezulcitinib (TD-0903) Administered in the Setting of Supplemental Oxygenation Scenarios in Healthy Participants

This is a Phase 1 pharmacokinetic (PK) study in healthy participants to assess the plasma pharmacokinetics, safety, and tolerability of a single inhaled dose of nezulcitinib (TD-0903) with supplemental oxygenation.

Start Date13 Oct 2021

Sponsor / Collaborator

Theravance Biopharma, Inc.

100 Clinical Results associated with Theravance Biopharma, Inc.

0 Patents (Medical) associated with Theravance Biopharma, Inc.

116

Literatures (Medical) associated with Theravance Biopharma, Inc.

22 Mar 2024·Canadian Respiratory Journal

Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow

Article

Author: Davis, Gabrielle N ; Mahler, Donald A ; Ohar, Jill A ; Crater, Glenn D ; Moran, Edmund J ; Lombardi, David A

Introduction. Many patients with chronic obstructive pulmonary disease (COPD) may derive inadequate benefit from dry powder inhalers (DPIs) because of suboptimal peak inspiratory flow (sPIF). Objectives. To assess the clinical burden of COPD by characterizing the clinical characteristics of participants with sPIF against medium-low resistance DPIs versus those with optimal PIF (oPIF) from two phase 3 clinical trials. Methods. Baseline data were collected from two randomized, controlled, phase 3 trials (NCT03095456; NCT02518139) in participants with moderate-to-severe COPD. oPIF (60 L/min) against the medium-low resistance DPIs was used as the threshold for defining the PIF subgroups (<60 L/min (sPIF) vs ≥60 L/min (oPIF)). Results. Most participants included in this analysis were White (92%) and male (63%); the mean (range) age was 65 (43–87) years. Participants with sPIF had significantly greater dyspnea than those with oPIF as measured using the modified Medical Research Council scoring (mean (95% CI): 2.1 (2.0–2.2) vs 1.6 (1.4–1.7);

P < 0.001

) and baseline dyspnea index (mean (95% CI): 5.1 (4.9–5.4) vs 6.1 (5.8–6.3);

P < 0.001

). Based on COPD Assessment Test scores, participants with sPIF had a higher COPD symptom burden than those with oPIF (mean (95% CI): 21.5 (19.7–23.3) vs 19.5 (18.6–20.4);

P = 0.0

5). Conclusion. In these trials, participants with COPD who had sPIF against the medium-low resistance DPIs had more dyspnea and worse health status than those with oPIF. These results demonstrate that sPIF is associated with a higher clinical burden as measured by patient-reported outcomes.

01 Mar 2024·CHEST

Guidance on Mitigating the Risk of Transmitting Respiratory Infections During Nebulization by the COPD Foundation Nebulizer Consortium

Review

Author: Martinez, Sergio ; Sood, Akshay ; Johnson, Karmon ; Ari, Arzu ; Barjaktarevic, Igor Z ; Radonovich, Lewis J ; Mahler, Donald A ; Tal-Singer, Ruth ; Yates, Julie ; Cochran, Lauren ; Li, Jie ; Mannino, David M ; Christiani, David C ; Suggett, Jason ; Biney, Isaac N ; Ohar, Jill ; Tashkin, Donald ; Drummond, M Bradley ; Carlin, Brian ; Kuehl, Philip J ; Cambridge, Lisa ; Kealing, Dan ; Dailey, Patricia A ; Dhand, Rajiv

BACKGROUNDNebulizers are used commonly for inhaled drug delivery. Because they deliver medication through aerosol generation, clarification is needed on what constitutes safe aerosol delivery in infectious respiratory disease settings. The COVID-19 pandemic highlighted the importance of understanding the safety and potential risks of aerosol-generating procedures. However, evidence supporting the increased risk of disease transmission with nebulized treatments is inconclusive, and inconsistent guidelines and differing opinions have left uncertainty regarding their use. Many clinicians opt for alternative devices, but this practice could impact outcomes negatively, especially for patients who may not derive full treatment benefit from handheld inhalers. Therefore, it is prudent to develop strategies that can be used during nebulized treatment to minimize the emission of fugitive aerosols, these comprising bioaerosols exhaled by infected individuals and medical aerosols generated by the device that also may be contaminated. This is particularly relevant for patient care in the context of a highly transmissible virus.RESEARCH QUESTIONHow can potential risks of infections during nebulization be mitigated?STUDY DESIGN AND METHODSThe COPD Foundation Nebulizer Consortium (CNC) was formed in 2020 to address uncertainties surrounding administration of nebulized medication. The CNC is an international, multidisciplinary collaboration of patient advocates, pulmonary physicians, critical care physicians, respiratory therapists, clinical scientists, and pharmacists from research centers, medical centers, professional societies, industry, and government agencies. The CNC developed this expert guidance to inform the safe use of nebulized therapies for patients and providers and to answer key questions surrounding medication delivery with nebulizers during pandemics or when exposure to common respiratory pathogens is anticipated.RESULTSCNC members reviewed literature and guidelines regarding nebulization and developed two sets of guidance statements: one for the health care setting and one for the home environment.INTERPRETATIONFuture studies need to explore the risk of disease transmission with fugitive aerosols associated with different nebulizer types in real patient care situations and to evaluate the effectiveness of mitigation strategies.

15 Dec 2023·Cureus

The Laboratory Characterization of Fugitive Aerosol Emissions From a Standard Jet Nebulizer With and Without a Filtered Mouthpiece

Article

Author: Ching, Ai Ling ; Frankenfield, John ; Hughes, Patrick G ; Clay, Candice ; Verma, Siddhartha ; Dhanak, Manhar ; McKinney, Adriana ; Lo, Arthur

Background and objective The risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission from patients with coronavirus disease 2019 (COVID-19) during nebulization is unclear. In this study, we aimed to address this issue. Methods Fugitive emissions of aerosolized saline during nebulization were observed using a standard jet nebulizer fitted with unfiltered and filtered mouthpieces connected via a mannequin to a breathing simulator. Fugitive emissions were observed by using a laser sheet and captured on high-definition video, and they were measured by using optical particle counters positioned where a potential caregiver may be administering nebulization and three other locations in the sagittal plane at various distances downstream of the mannequin. Results The use of a standard unfiltered mouthpiece resulted in significant emission of fugitive aerosols ahead of and above the mannequin (spread over 2 m in front). A mouthpiece with a filter-adaptor effectively suppressed the emissions, with only minor leakage from the nebulizer cup. Particle count measurements supported the visual observations, providing total particle count levels and aerosol concentration levels at the measurement locations. The levels decayed slowly with downstream distance. Conclusions The visualization described above captured the dispersion of emitted aerosols in the plane of the laser sheet, aligned with the sagittal plane. The particle count measurements provided temporal and spatial distributions of the aerosol concentration levels over the time and locations considered. However, the exhaled air and aerosolized droplets spread three-dimensionally in front of and above the mannequin. The results visually highlight the effectiveness of using a filtered mouthpiece in suppressing the fugitive aerosols and identify an approach for limiting the occupational exposure of healthcare workers to these emissions while administering nebulized therapies.

111

News (Medical) associated with Theravance Biopharma, Inc.

17 Dec 2024

·www.prnewswire.com

Theravance Biopharma to Conduct Investor Meetings During the J.P. Morgan 43rd Annual Healthcare Conference

DUBLIN, Dec. 17, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced that members of its management team will hold investor meetings during the 43rd Annual J.P. Morgan Healthcare Conference, January 13-16, 2025, in San Francisco, CA. To request a one-on-one meeting with the Theravance Biopharma management team, please contact us at [email protected]. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

20 Nov 2024

·www.prnewswire.com

Theravance Biopharma to Participate in an Upcoming Investor Conference

DUBLIN, Nov. 20, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) will participate in a Fireside Chat at the 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 at 11:15 am EST (8:15 am PST/4:15 pm GMT) and will be hosting in-person meetings with the investment community at the conference. Webcast of the event may be accessed by visiting Theravance.com, under the Investors section, Events and Presentations. Replay of the webcast will be archived on the Company's website for 30 days. About Theravance Biopharma Theravance Biopharma, Inc.'s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value. For more information, please visit . THERAVANCE BIOPHARMA®, THERAVANCE® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing in this press release are the property of their respective owners. Contact: [email protected] 650-808-4045 SOURCE Theravance Biopharma, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

13 Nov 2024

·endpts.com

89bio’s $125M offering; Another FDA hold for Kezar

Plus, news about Nippon Shinyaku, Atsena, Orna Therapeutics, Ovid Therapeutics, Graviton Bioscience, Eupraxia, Entero Therapeutics, Journey Therapeutics, Theravance Biopharma, Alpha Cognition and Travere Therapeutics: 89bio’s $125M offering: The liver and cardiometabolic biotech is selling shares $ETNB at $8.50 apiece, or about 55 cents below Tuesday’s closing price. Its stock slid nearly 10% on Tuesday. — Kyle LaHucik FDA places partial hold on Kezar study: The company is testing an immunoproteasome inhibitor called zetomipzomib in autoimmune hepatitis. The currently enrolled patients will be allowed to complete the trial, but four patients who are still in the blinded portion cannot proceed to the open-label extension. It’s the second hold for the drug since the start of October when another trial was placed on full clinical hold after four patients died. Topline data are expected in the first half of 2025. — Max Gelman Nippon Shinyaku licenses Atsena’s gene therapy in the US and Japan: Financial details of the deal were not disclosed, though Nippon Shinyaku will reimburse Atsena for continued development work for the rare eye disease treatment, including an expected pivotal study. Atsena also gets to keep the rights to a priority review voucher if it receives one. Nippon Shinyaku plans to market the therapy in the US via its subsidiary, NS Pharma. — Lei Lei Wu Orna cuts more staffers: The circular RNA-focused biotech told Endpoints News in a statement that it “restructured its team” as part of a broader pipeline prioritization, but did not disclose the number of cuts. The drugmaker previously laid off less than 25% of its staff in November 2023 in what it described as a “defensive reduction.” — Ayisha Sharma Ovid, Graviton pause starting Phase 2 trial: The companies are holding back from initiating their study of OV888 in people with cerebral cavernous malformations (CCM) to “evaluate clinical design learnings emerging from competitor” readouts. In September, Recursion Therapeutics’ CCM drug showed strong safety but mixed efficacy in a Phase 2 trial. — Ayisha Sharma Eupraxia touts additional Phase 1b/2a data: The company said that data from two cohorts of the trial, which is investigating EP-104GI as a treatment for eosinophilic esophagitis, showed reductions in the severity, symptoms and extent of the disease. In one cohort, a patient achieved complete histological remission. Eupraxia CEO James Helliwell said that “higher dosing levels are yielding improved patient responses.” — Katherine Lewin Entero’s reverse merger: The company is handing its Nasdaq spot to ADC biotech Journey Therapeutics three months after letting go of nearly all its employees and seeking strategic alternatives. Journey will get 99% of Entero’s equity, and its CEO Henry Ji will lead the combined company. — Kyle LaHucik Theravance forms strategic review committee: In its third-quarter financial results , the company said it would “assess all strategic alternatives,” including those related to its COPD drugs Yupelri and Trelegy. Theravance pulled in $16.9 million in revenue this quarter, but it all came from the Viatris collaboration for Yupelri. Along with announcing the review, Theravance separated the roles of board chair and CEO, naming Susannah Gray as chair while Rick Winningham will continue as CEO. The company made staff and program cuts last year. Its stock $TBPH was up about 11% on Wednesday morning. — Katherine Lewin Alpha Cognition prices $50M upsized public offering: The neuro biotech received a notice of allowance for its patent application covering its Alzheimer’s drug, called Zunveyl, through 2044. The funds from the public offering are expected to go toward the commercialization and launch of Zunveyl, R&D and other commercial and general corporate purposes. Zunveyl scored FDA approval in July. — Katherine Lewin Travere upsized its public offering . It raised a total of $143.8 million. — Jaimy Lee

Clinical ResultDrug ApprovalPhase 2Executive ChangeFinancial Statement

100 Deals associated with Theravance Biopharma, Inc.

100 Translational Medicine associated with Theravance Biopharma, Inc.

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Pipeline

Pipeline Snapshot as of 27 Jan 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Phase 3 Clinical

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Telavancin Hydrochloride ( Peptidoglycan )	Complicated skin and skin structure infection More	Approved
Ampreloxetine hydrochloride ( NET x SERT )	Multiple System Atrophy More	Phase 3
Cefilavancin Trihydrochloride ( PBPs )	Gram-Positive Bacterial Infections More	Phase 3
Revefenacin ( mAChRs )	Respiratory Insufficiency More	Phase 2
TD-0903 ( JAK1 x JAK2 x JAK3 x TYK2 )	Fibrosis More	Phase 2

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