Asthma - Competitive landscape, 2023

This “Asthma- Competitive landscape, 2023” report provides comprehensive insights about 110+ companies and 125+ drugs in Asthma Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Asthma: Understanding

Asthma: Overview

Asthma is a chronic disease that affects the airways. Asthma is characterized by inflammation and spasm of the airways. The airways are tubes that carry air in and out of the lungs. If a person has asthma, the inside walls of the airways become sore and swollen. The air passages in the lungs become narrow due to inflammation and tightening of the muscles around the small airways. This causes asthma symptoms: cough, wheeze, shortness of breath, and chest tightness. When the asthma symptoms become worse than usual, it's called an asthma attack. In a severe asthma attack, the airways can close so that the vital organs do not get enough oxygen. In some cases, people die from severe asthma attacks. An asthma attack is an episode in which bands of muscle around the airways are triggered to tighten. This tightening is called bronchospasm. During the attack, the lining of the airways becomes swollen or inflamed, and the cells lining the airways make more and thicker mucus than normal. Bronchospasm, inflammation, and mucus production cause symptoms such as trouble breathing, wheezing, coughing, shortness of breath, and trouble with normal daily activities. Asthma is usually caused by a combination of genetic and environmental factors. When a person have asthma, then the airways react to things in the environment. They are called as asthma triggers. Symptoms of asthma vary from person to person. A person may have infrequent asthma attacks or have symptoms only at a certain time such as when exercising or may have symptoms all the time. Symptoms of asthma resemble many respiratory infections. The first step in asthma diagnosis is a careful clinical history; identifying the characteristic symptoms and their duration, intensity, and relationship of symptoms with allergen and triggering agent; and the impact of these symptoms on the quality of life. If symptoms are present, a physician will perform a physical examination to rule out other possible conditions, such as a respiratory infection or chronic obstructive pulmonary disease (COPD). If the physician concludes that there is no evidence of a respiratory infection or COPD, then tests are performed to check lung function. There is no cure for asthma. However, it can be controlled with medication which may help to prevent or relieve the symptoms of asthma. Asthma is a chronic disease. It has to care for all the time not just when the symptoms are present. Asthma can be managed if a patient can identify and minimize contact with triggers; understand and take medications; recognize signs when they get worse and manage them and know what to do when asthma gets worse. Preventive measures play a vital role in managing and treating asthma. A patient may avoid all the allergen or triggering agents like dust, cold air, pollen, pet dander, smoke, perfumes, or allergy of any other kind. If a patient has aspirin-induced asthma, then they should avoid taking aspirin or any other NSAIDs. Food containing sulfites must be avoided by an asthmatic patient.

Report Highlights

• In January 2023, AstraZeneca had announced that its Tezspire (tezepelumab) received approval from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above. The CHMP granted a positive opinion for the self-administration of Tezspire in a single-use, pre-filled pen.
• In February 2022, Alvotech Holdings S.A. has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab). Under terms of the agreement, Alvotech received exclusive global rights for AVT23, a proposed biosimilar to Xolair. BiosanaPharma received an upfront payment and is eligible for certain tiered royalties. BiosanaPharma and Alvotech jointly further the development of AVT23, which is currently in late-stage development. BiosanaPharma has completed a pharmacokinetic (PK) study showing that AVT23's bioavailability, safety, tolerability and immunogenicity were comparable to those of Xolair.
• In October 2022, Aptar Digital Health, part of Aptar Pharma, a global leader in drug delivery and active material science solutions and services, announced a strategic partnership with the Chiesi Group, to bring to market a disease management platform for asthma and chronic obstructive pulmonary disease (COPD). The partnership leveraged Aptar's recently announced Disease Management Platform that is designed to empower patients to better understand and take control of their disease, provide healthcare professionals with data-driven insights to better manage their patients and build evidence for emerging reimbursement arrangements in the field of digital health for asthma and COPD.

Asthma: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Regeneron Pharmaceuticals

Regeneron, is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, the unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in the laboratories. The medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through the proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Product Description: Dupixent

Dupixent comes in a pre-filled syringe and is intended for injection under the skin (subcutaneous injection) under the guidance of a healthcare provider. It can be given in a clinic or, for convenience, at home by self-administration after training by a healthcare professional. Dupixent is also approved in the U.S. for the treatment of adults with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In the U.S., Dupixent is marketed by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi. DUPIXENT is a prescription medicine used with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. In May 2019,Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Commission (EC) approved a new indication for Dupixent® (dupilumab) in asthma. Dupixent was approved in the European Union (EU) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment.

2. Company Overview: Novartis Pharmaceuticals

Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, Novartis uses innovative science and digital technologies to create transformative treatments in areas of great medical need. In the quest to find new medicines, company is consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and are finding innovative ways to expand access to the latest treatments. At Novartis, the focus is on improving the lives of the hundreds of millions of people living with respiratory diseases, including chronic obstructive pulmonary disease (COPD) and severe allergic asthma. Novartis Pharmaceuticals strategy is to deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches.

Product Description: QVM 149

QVM 149 (Enerzair Breezhaler), is intended as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year. This formulation combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate (high-dose ICS) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler device. In July 2020, Novartis announced that the European Commission (EC) has approved Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long‑acting beta2‑agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year. Once-daily Enerzair Breezhaler is the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination available in the EU for these patients. The approval also includes an optional digital companion with sensor and app that provides inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions. The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

Asthma: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Areteia Therapeutics

Areteia Therapeutics is a new biotechnology company committed to putting asthma patients in better control of their disease - and back in control of their lives - with the first potential oral drug for eosinophilic asthma. Areteia Therapeutics lead investigational candidate is dexpramipexole, a first-in-class oral medicine that inhibits the maturation of eosinophils before they can cause damage. Dexpramipexole's tolerability and eosinophil-lowering efficacy have been assessed in more than 1,500 patients in multiple indications, opening the potential for the first oral treatment ever approved for eosinophilic asthma. Areteia Therapeutics brings together seasoned drug developers with deep regulatory, commercial, and supply-chain experience - and a track record of bringing new medicines to global markets.

Product Description: Dexpramipexole

Dexpramipexole inhibits the maturation and release of eosinophils in bone marrow, based on evidence from cell cultures and human biopsies, thereby lowering peripheral blood eosinophil levels. Most recently in a Phase II study (EXHALE-1) in patients with moderate-to-severe eosinophilic asthma, treatment with dexpramipexole resulted in a significant, dose-dependent reduction in blood absolute eosinophil count at all doses tested (dexpramipexole doses of 37.5 mg, 75 mg, or 150 mg twice daily) compared to placebo. Dexpramipexole was well tolerated in the trial, with adverse events balanced across treatment and placebo groups, no serious adverse events, and no adverse events leading to discontinuation. Currently the drug is in Phase III stage of clinical trial evaluation for the treatment of Eosinophilic Asthma.

2. Company Overview: Connect Biopharma

Connect Biopharma is a global, clinical-stage biopharmaceutical company founded by a team with broad knowledge of the drug discovery industry and expertise in targeting immunological pathways. At Connect Biopharma, they are applying their expertise in T cell biology and the deep knowledge of the drug discovery industry to develop innovative therapies that treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. With operations in the United States and China, Connect Biopharma is building a rich pipeline of proprietary small molecules and antibodies targeting several aspects of T cell biology associated with inflammatory diseases. The Company's lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis and asthma. The Company's second most advanced product candidate, CBP-307, is a modulator of S1P1 T cell receptor and is in development for the treatment of ulcerative colitis (UC). The Company's third product candidate, CBP-174, is a peripherally acting antagonist of histamine receptor 3, in development for the treatment of pruritus associated with AD.

Product Description: CBP-201

CBP-201 is a human monoclonal antibody targeting IL-4Rα. As an inhibitor of IL-4Rα, CBP-201 blocks inflammatory signaling by both IL-4 and IL-13. CBP-201 binds to a region of IL-4Rα that is distinct from that bound by dupilumab (an antibody that targets IL-4Rα). CBP-201 prevents the receptor from interacting with other receptor subunits that are required for activation of the signaling pathways that ultimately give rise to Th2-mediated diseases, including atopic dermatitis, asthma and nasal polyps. Currently the drug is in Phase II stage of clinical trial evaluation for the treatment of Asthma.

3. Company Overview: United BioPharma

United BioPharma is an entrepreneurial biopharmaceutical company delivering life-changing solutions to improve global health. United BioPharma (UBP) is a late clinical stage biopharmaceutical company that is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs) for infectious and immunological diseases. UBP is headquartered in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has built a passionate global team, developing high-quality therapeutic mAbs and delivering affordable treatments to bring the patients better quality of life.

Product Description: UB-221

UB-221 is a humanized IgG1 that targets the Cε3 domain of IgE molecule with a high binding affinity (KD) of 5.9x10-11 nM. UB-221 has been shown to be a potent IgE neutralizer and a significant inhibitor of IgE neo-synthesis. UB-221 performs superior to omalizumab over a host of IgE-neutralization study events. UB-221 in an ex vivo IgE-PBMC study system has shown to inhibit IgE production at a far greater scale than omalizumab and ligelizumab (an investigational drug). UB-221 in free form (or IgE-complex form) can interact unrestricted with IgE:CD23 complex (or CD23), a unique feature that has never been observed before for any anti-IgE monoclonal antibody (mAb), and by which UB-221 differentiated it (as a new class of anti-IgE mAb) from omalizumab and ligelizumab that do not show significant interaction with CD23. Thus, it could be of clinical benefit to target IgE toward the non-inflammatory CD23 pathway. UB-221 is being developed as therapeutic biologics for treatment of allergic diseases such as chronic spontaneous urticaria, food allergy, atopic dermatitis, asthma, allergic rhinitis, etc.

4. Company Overview: 4D Pharma Plc.

Founded in February 2014, 4D is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease.  4D has developed a proprietary platform that rationally identifies novel bacteria based on a deep understanding of function and mechanism.  4D's Live Biotherapeutic products are orally delivered single strains of bacteria that are naturally found in the healthy human gut.  4D has four clinical studies in progress, namely a Phase II clinical study of Blautix in Irritable Bowel Syndrome, a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours and a Phase I/II study of MRx-4DP0004 in asthma. Other focus programmes include disease areas such as CNS disease.

 

Product Description: MRx-4DP0004

MRx-4DP0004 is an oral, immunomodulatory, single strain Live Biotherapeutic product. 4D pharma has demonstrated MRx-4DP0004's ability to reduce airway inflammation in a pre-clinical model of severe asthma. This is achieved through a concurrent reduction in both neutrophilic and eosinophilic infiltration and inflammation. Severe asthmatics constitute 5-10% of the overall asthma population and have significant unmet need. These patients are unable to control their symptoms using the maximum dose of inhalers and bronchodilators and require add-on therapy to ameliorate exacerbations. In particular, patients who present with a neutrophilic phenotype have very limited treatment options. 4D Pharma's lead candidate MRx-4DP0004 shows profound efficacy in preclinical models of severe asthma. Currently the drug is in Phase I/II stage of Clinical trial evaluation for the treatment of Asthma.

Asthma Analytical Perspective

In-depth Commercial Assessment: Asthma Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Asthma Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Asthma Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions Answered

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Asthma drugs?
• How many Asthma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Asthma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Asthma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Asthma and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Areteia Therapeutics
• Celltrion
• GlaxoSmithKline
• Connect Biopharma
• Shanghai Hengrui Pharmaceutical Co., Ltd.
• Jiangsu Hengrui Medicine Co.
• Chia Tai Tianqing Pharmaceutical Group
• Aldeyra Therapeutics, Inc.
• Trio Medicines
• AstraZeneca
• Janssen Research & Development
• Tetherex Pharmaceuticals Corporation
• Palobiofarma SL
• Sanofi
• RAPT Therapeutics
• Kashiv BioSciences
• Archivel Farma
• TFF Pharmaceuticals
• Evelo Biosciences, Inc.
• Landos Biopharma
• Adial Pharmaceuticals
• Holth Therapeutics
• Lanier Biotherapeutics
• Omega Therapeutics
• Transpire Bio
• DNARx
• Argenx
• MyMD Pharmaceuticals
• Ventyx Biosciences
• Kither
• Enterprise Therapeutics

Key Products

• Dexpramipexole
• CT-P39
• GSK3511294
• CBP-201
• SHR-1905
• SHR1703
• TQC2731
• ADX-629
• TR4
• MEDI 3506
• Lumicitabine
• SelK2
• PBF-680
• Rilzabrutinib
• RPT 193
• ADL-018
• RUTI
• Voriconazole Inhalation Powder
• EDP1867
• LABP-73
• PNV-5032
• HT004
• ABM125

Research Program: CXCL 1-8-targeting OEC

Research program: DPI Asthma

• Mepolizumab biosimilar
• ARGX-118
• MYMD-1

Research programme: interleukin 4 receptor alpha antagonists

• Research Program
• Mucoregulatory Therapies

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