COVID-19- Competitive Landscape, 2022

COVID-19- Competitive Landscape, 2022

DelveInsight’s, “COVID-19- Competitive landscape, 2022,” report provides comprehensive insights about 420+ companies and 520+ drugs in Covid-19 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 COVID-19: Understanding COVID-19: Overview Coronaviruses are a group of related viruses that cause diseases in mammals and birds. In humans, coronaviruses cause respiratory tract infections that can range from mild illnesses such as common cold to lethal diseases such as severe acute respiratory syndrome. Novel coronavirus is a previously unidentified strain of coronavirus that first emerged in the Chinese city of Wuhan in December 2019. The virus belongs to the same family as the virus that causes severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Coronavirus disease (COVID-19) is an infectious disease caused by the most recently discovered corona virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease causes respiratory illness (like the flu) with symptoms such as a cough, fever, and difficulty breathing. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Elderly people and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. The COVID-19 virus is primarily transmitted through droplets of saliva or discharge from the nose when an infected person coughs or sneezes. People can catch COVID-19 if they breathe in droplets from a person with COVID-19 who coughs out or exhales droplets. It also spreads when a person touches a surface or objects that has the virus on it, and then touches their eyes, nose, or mouth. Currently, there is no specific medicine to prevent or treat COVID-19. It is important for people to protect themselves from the viral infection by following Basic protective measures against the new coronavirus stated by the WHO. Report Highlights • In September 2022, Bharat Biotech’s Covid-19 vaccine candidate codenamed BBV154, which has now been rechristened iNCOVACC, became the world’s first intranasal Covid-19 vaccine to be granted emergency use authorization (EUA) after the Indian drug regulator approved it for a two-dose primary immunization of those aged 18 years and above. COVID-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III • In July 2022, Revive Therapeutics Ltd. is pleased to provide an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase III clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The Company had unblinded the pre-dose selection data (the “Data”) to potentially support the amended Study protocol with the new primary efficacy endpoints. The assigned unblinded statistician team is currently analyzing the Data and the Company aims to submit the amended Study protocol to the FDA shortly thereafter. The proposed new primary efficacy endpoints may include the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in COVID-19 clinical outcome observed over the course of the pandemic, and, therefore, to have more meaningful study endpoints for the FDA to consider for potential Emergency Use Authorization • In April 2022, Direct Biologics, FDA approved the company to proceed with its Phase III clinical trial using its investigational EV drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to Covid-19. Direct Biologics is the first and only EV Company to receive FDA Phase III approval for an Investigational New Drug (IND) indication to date • In April 2022, Direct Biologics, announced that the US Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. • In March 2022, Akston Biosciences Corpand Biolexis, a division of Stelis Biopharma Ltd., entered into a licensing, manufacturing and commercialization agreement for Akston’s AKS-452, a protein subunit COVID-19 vaccine. Biolexis gained the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence and established relationships • In August 2021, Vanda Pharmaceuticals Inc. announced that enrollment had closed in the ODYSSEY study comparing tradipitant and placebo in hospitalized COVID-19 pneumonia patients. Enrollment was closed because the study met the pre-defined futility criteria, indicating that the study was unlikely to succeed in its pre-specified primary endpoint • In June 2020, Staidson, a biopharmaceutical company developing investigational products by targeting the complement system and Pivotal, a European-wide full-service CRO, headquartered in Madrid announced a new strategic collaboration to assess Staidson´s investigational product BDB-001, a monoclonal anti-C5a antibody, in a clinical trial in Europe in progressive severe COVID-19 patients caused by SARS-CoV-2 Company Profiles & their Late-stage Drug Profiles 1. Company Overview: Nobelpharma Nobelpharma committed to development of critical but neglected drugs in order to fulfill social mandate. Nobelpharma have constantly been aspiring to conduct research and development of drugs that are not the prime targets for many pharmaceutical companies due to questionable economic viability with a small number of patients. Company development pipeline mainly includes the drugs such as orphan drugs that have been strongly requested by patients, academic societies, or the government, as well as off-label drugs and pediatric medicines. Product Description: Sargramostim Sargramostim is a man-made version of a particular natural substance made in the body. It is used to increase the production of white blood cells in the body. Sargramostim is given to people who have reduced abilities for producing white blood cells. It is also used in certain treatment procedures (such as bone marrow/stem cell transplant). It is a supportive medication but does not help in the treatment of cancer. Currently the product is in Phase II/III stage of development for the treatment of COVID-19. 2. Company Overview: Vir Biotechnology Vir Biotechnology Inc (Vir) is a biotechnology company which carries out the development of therapeutic products to prevent and treat serious infectious diseases. It develops treatments for viral and bacterial diseases and those that induce protective and therapeutic immune responses. The company undertakes a multi-program, multi-platform approach to apply these breakthroughs. Vir primarily focuses on chronic infectious diseases including hepatitis B, tuberculosis, and HIV; respiratory diseases, including influenza, respiratory syncytial virus (RSV), and metapneumovirus (MPV); and healthcare-acquired infections. It operates in Portland, Oregon, Boston, Massachusetts, Bellinzona, Switzerland. Vir is headquartered in San Francisco, California, the US. Product Description: Sotrovimab Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor, Inc.’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. 3. Company Overview: Sarepta Therapeutics SK bioscience is a vaccine company that was spun off from SK Chemicals in 2018. SK bioscience is an innovative biopharmaceutical company, standing committed to global pandemic preparedness in vaccine development and manufacturing to create more equitable access to vaccines. In leveraging strengths on cutting-edge vaccine development technologies, SK bioscience has been dedicated to improving healthcare from prevention to cure across the globe. Under collaborations of domestic and international governments, regulatory agencies, healthcare providers, doctors and medical experts, SKBS has firmly established globally certified R&D and manufacturing technologies. SK bioscience has conducted a homologous booster clinical trial of SKYCovione in South Korea and a heterologous booster trial in both South Korea and abroad. Product Description: SKYCovione SKYCovione (GBP510), is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovione™ has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI) with support from the European Union´s Horizon 2020 Programme 4. Company Overview: Sinovac Biotech Sinovac Biotech Ltd., (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases. SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A and B, seasonal influenza, pneumococcal disease, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella, mumps, and poliomyelitis. Its COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. Its Healive®, hepatitis A vaccine, passed WHO prequalification requirements in 2017. Product Description: SARS-CoV-2 vaccine SARS-CoV-2 vaccine (inactivated) has been manufactured by Sinovac and is currently being investigated for patients suffering from COVID-19. 5. Company Overview: Vanda Pharmaceuticals Vanda Pharmaceuticals Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of a portfolio of clinical-stage, small molecule product candidates for central nervous system disorders. The company's marketed products include HETLIOZ for the treatment of non-24-hour sleep-wake disorders; and Fanapt oral tablets for the treatment of schizophrenia. Its products under development include HETLIOZ (tasimelteon) for the treatment of jet lag disorder, smith-magenis syndrome, pediatric Non-24, autism spectrum, and delayed sleep phase disorder; Fanapt (iloperidone) for the treatment of bipolar disorder and a long acting injectable formulation program for the treatment of schizophrenia; and Tradipitant (VLY-686), a small molecule neurokinin-1 receptor (NK-1R) antagonist, for the treatment of atopic dermatitis, gastroparesis, COVID-19 pneumonia, and motion sickness Product Description: Tradipitant Tradipitant is a neurokinin-1 receptor antagonist licensed by Vanda from Eli Lilly and Company. Tradipitant is currently in clinical development for gastroparesis, COVID-19 pneumonia, motion sickness and atopic dermatitis. The FDA has imposed a partial clinical hold on tradipitant clinical protocols of longer than 12 weeks duration Further product details are provided in the report…….. Future of Competitive Landscape of COVID-19 is estimated to be very strong. Key emerging drugs include Vir Biotechnology’ Sotrovimab and many other. COVID-19 Analytical Perspective by DelveInsight • In-depth COVID-19 analysis: Assessment of Products 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. • COVID-19 clinical assessment of products The report comprises of comparative clinical assessment of products by development stage, product type, and route of administration, molecule type. COVID-19 Report Assessment • Company Analysis • Therapeutic Assessment • Pipeline Assessment • Inactive drugs assessment • Unmet Needs Key Questions Current Treatment Scenario and Emerging Therapies: • How many companies are developing COVID-19 drugs? • How many COVID-19 drugs are developed by each company? • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of COVID-19? • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the COVID-19 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 COVID-19 and their status? • What are the key designations that have been granted to the emerging and approved drugs?   Key Players • Westvac Biopharma • Xenothera • Windtree Therapeutics • Vir Biotechnology • ViiV Healthcare • Verastem • VBL Therapeutics • Vasomune Therapeutics, Inc. • Valneva • Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. • Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories • UNION Therapeutics • Trustem • Toscana Life Sciences • Throne Biotechnologies • Thirty respiratory Limited • Theravance Biopharma • TC BioPharm • Syntax for Science, S.L • SyneuRx • Swedish Orphan Biovitrum • Swedish Herbal Institute AB • Stemedica Cell Technologies • Staidson (Beijing) Biopharmaceuticals Co., Ltd • Sound Pharmaceuticals • Sorrento Therapeutics, Inc. • Sorrento Therapeutics, Inc. • Sorrento Therapeutics • Sorrento Therapeutics • SolAeroMed • SK Bioscience • Sinovac Biotech Co., Ltd • Sinocelltech • Shenzhen Kangtai Biological Products Co., Ltd. • Shaperon • Senhwa Biosciences, Inc. • Selva Therapeutics • Archivel Farma • R-Pharm • Rohto Pharmaceutical • Revimmune • Resverlogix Corporation • Restorbio • Resolve Therapeutics • Renibus Therapeutics • ReiThera • Regeneron Pharmaceuticals • RedHill Biopharma • Red de Terapia Celular • Reata Pharmaceuticals, Inc. • Qurient Co • Quercis Pharma • PureTech • Pulmotect • PTC Therapeutics • Pluristem Ltd. • Pliant Therapeutics • Pharming Technologies B.V. • Pharmenterprises • Pharmamel S.L. • Pharma Holdings • Pharco Pharmaceuticals • Pfizer • Petrovax • Paion UK Ltd. • Ashvattha Therapeutics, Inc. (Orpheris) • OPKO Health • Oncotelic Inc. • National Resilience, Inc. (Ology Bioservices) • Olatec Therapeutics LLC • Novavax • Novartis Pharmaceuticals • Notitia Biotechnologies Company • Noorik Biopharmaceuticals • Nobelpharma • NA • Moderna • MetrioPharm • Merck Sharp & Dohme Corp. • Medicago Inc. • Mallinckrodt • Mabwell (Shanghai) Bioscience Co., Ltd. • Lifefactors Zona Franca • Leading BioSciences • Kiniksa Pharmaceuticals, Ltd. Key Products • XAV-19 • Sinapultide • VIR-7831 • Maraviroc • Duvelisib • VB 201 • AV-001 • VLA2001 • T3 solution for injection • UNIKINON • UNI911 • Umbilical cord derived mesenchymal stem cells • MAD0004J08 • Stem Cell Educator therapy • RESP301 • TD-0903 • TCB008 • Bemiparin • Pentarlandir™ UPPTA • Emapalumab • Kan Jang capsules • hMSC • BDB-001 • Ebselen • COVI-DROPS| Placebo • STI-5656 • COVI-AMG • PSC-04 • S-1226 • GBP510 • SARS-COV-2 inactivated vaccine • SCTA01 • SARS-CoV-2 Vaccine (Vero Cells), Inactivated • NuSepin • Silmitasertib • SLV213 • RUTI® vaccine • Olokizumab + RPH-104 • Mesenchymal stem cell (ADR-001) • CYT107 • Apabetalone • RTB101 • RSLV-132 • RBT-9 • GRAd-COV2 • REGN-COV2 Antibody Cocktail • ABC 294640 • Upamostat • Mesenchymal Stromal Cells • Bardoxolone methyl • Telacebec • IQC-950AN • LYT-100 • PUL-042 • PTC-299 • PLX-PAD • PLN-74809 • Conestat alfa • Treamid • Melatonin • LTX-109 • Selenium • Ramipril • PF-06650833 • Polyoxidonium • Remimazolam • OP-101 • Rayaldee • OT-101 • ADM03820 • OLT 1177 • NVXCoV 2373 • DFV890 • Crizanlizumab • MAS-825 • NBT-NM108 • Ambrisentan • Sargramostim • Gam-COVID-Vac • mRNA-1283 • mRNA-1273 • MP1032 • Molnupiravir • M5049 • Covifenz • INOmax • MW33 • COVID-19 convalescent plasma • LB1148 • Mavrilimumab

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