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Details:

Tocilizumab Biosimilar is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. It is approved for the treatment of RA, sJIA, and CRS.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: DRL_TC

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2023

Details:

Tocilizumab is an important anti-rheumatic agent used in the treatment of adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 19, 2022

Details:

Tyenne (tocilizumab biosimilar) is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. It is approved for the treatment of RA, sJIA, and CRS.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Tyenne

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 19, 2023

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Tyenne (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist, antibody indicated for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis & cytokine release syndrome.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Tyenne

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 15, 2024

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Columvi (glofitamab) is a CD20xCD3 T-cell engaging bispecific antibody, which is being evaluated in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: Columvi

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: F. Hoffmann-La Roche

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 15, 2024

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CT-P47 (tocilizumab-biosimilar) is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. It is being evaluated in phase 3 clinical trials for the treatment of moderate to severe active rheumatoid arthritis.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: CT-P47

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 28, 2024

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Tofidence (tocilizumab-bavi) is the first Actemra biosimilar approved in the United States for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Tofidence

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 08, 2023

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Tofidence (tocilizumab-bavi) is the first tocilizumab biosimilar approved in the United States for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Tofidence

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 29, 2023

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Actemra (tocilizumab) is designed to block the activity of IL-6, a type of inflammatory cytokine, which is indicated for the treatment of Cytokine Release Syndrome Induced by Cancer Therapy in Japan.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 25, 2023

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Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: Columvi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 11, 2023

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Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.


Lead Product(s): Glofitamab-gxbm,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: Columvi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 16, 2023

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Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: Columvi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2023

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Details:

Columvi (glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. It is approved by EU for relapsed or refractory diffuse large B-cell lymphoma.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: Columvi

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 26, 2023

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Actemra (tocilizumab) has been approved in taiwan as a treatment for COVID-19 in hospitalized adults. It works by binding to both soluble and membrane-bound and inhibits IL-6 receptors (sIL-6R and mIL-6R), a type of inflammatory cytokine.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 24, 2023

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Actemra (tocilizumab) binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. It is being developed for the treatment of cytokine release syndrome induced by cancer treatment.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 28, 2023

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BAT1806 (tocilizumab) is a recombinant humanized monoclonal antibody targeting IL-6R, which specifically binds to sIL-6R and mIL-6R and inhibits signaling mediated by sIL-6R or mIL-6R. Product is approved for the treatment of RA, sJIA, and CRS.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: BAT1806

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 16, 2023

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RO7082859 (Glofitamab) is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells, activating the release of cancer cell-killing proteins from the T-cell.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: RO7082859

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 06, 2023

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Actemra® (tocilizumab) intravenous (IV) for the treatment of COVID-19 in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 21, 2022

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Actemra® (tocilizumab) was the first humanised IL-6 receptor antagonist approved for the treatment of adult patients with moderately to severely active RA who have used one or more disease-modifying antirheumatic drugs, such as MTX, that did not provide enough relief.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 21, 2022

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Glofitamab (RO7082859), is an investigational CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: RO7082859

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 12, 2022

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The data from the Phase 3 comparative clinical trial demonstrated that the biosimilar candidate BIIB800 (tocilizumab) has equivalent efficacy and comparable safety and immunogenicity profile to the reference tocilizumab product.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: BIIB800

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 09, 2022

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Actemra (tocilizumab) is a monoclonal antibody that reduces inflammation by blocking the interleukin-6 receptor. In the case of COVID-19 infection, the immune system can become hyperactive, which may result in worsening of disease.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Canadian Government

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 02, 2022

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BIIB800, biosimilar candidate referencing RoACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor mAB is indicated in Europe as an intravenous formulation for severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: BIIB800

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 30, 2022

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Data from the Phase 3 comparative clinical trial demonstrated that the investigational biosimilar candidate BIIB800 has equivalent efficacy and comparable safety and immunogenicity profile to the reference Actemra (tocilizumab) product.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Bio-Thera Solutions

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 03, 2022

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Glofitamab is part of Roche’s industry-leading CD20xCD3 bispecific antibody development programme, which aims to address the diverse needs and preferences of people with blood cancers.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: RO7082859

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 27, 2022

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Pivotal data on RO7082859 (glofitamab), a potential first-in-class CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with aggressive lymphoma, will be presented as part of our industry-leading haematology portfolio.


Lead Product(s): Glofitamab,Obinutuzumab,Tocilizumab

Therapeutic Area: Oncology Product Name: RO7082859

Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 24, 2022

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The sBLA submission is based on results from studies that evaluated Actemra/RoActemra for the treatment of COVID-19 , may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 04, 2022

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The results of the four studies (EMPACTA, COVACTA, REMDACTA and RECOVERY) suggest that Actemra (tocilizumab) may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 03, 2022

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Actemra/RoActemra is a first-in-class anti-interleukin-6 receptor (aIL-6R) therapy for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, in addition to COVID-19.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 11, 2022

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Actemra (tocilizumab), IL-6 inhibitor, approval is based on the results of RECOVERY phase III studies in hospitalized patients with COVID-19 for the treatment of SARS-CoV-2 pneumonia.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 21, 2022

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Theramex has entered into an agreement with Enzene Biosciences to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors.


Lead Product(s): Tocilizumab,Methotrexate

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Theramex

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement December 23, 2021

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EC approved RoActemra (tocilizumab), based on results from four phase III studies for the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: RoActemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 07, 2021

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Authorization will enable doctors to use the generic drug Tocilizumab for the treatment of Covid-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non- invasive or invasive mechanical ventilation, or ECMO.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Tocira

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 06, 2021

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The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 25, 2021

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In clinical trials, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 24, 2021

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Data from the trial of Actemra plus Veklury failed to meet its primary endpoint of improved time to hospital discharge for patients with severe Covid-19 pneumonia, as well as key secondary endpoints versus Veklury alone.


Lead Product(s): Tocilizumab,Remdesivir

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 11, 2021

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Details:

Hospitalized COVID-19 patients given the anti-inflammatory monoclonal antibody tocilizumab were less likely to die or require invasive mechanical ventilation.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 11, 2021

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Patients receiving tocilizumab and a second drug called sarilumab - both types of immune modulators - have a significant impact on patient survival and can reduce the relative risk of death by 24% when administered to patients within 24 hours of entering intensive care.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 07, 2021

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Tocilizumab and sarilumab reduce COVID-19 patient mortality by 8.5 percent. The findings come from the REMAP-CAP trial, which evaluates the effect of treatments on a combination of survival and length of time patients need support in an intensive care unit (ICU).


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IVProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 07, 2021

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Findings suggest that among critically ill patients with COVID-19, early treatment with tocilizumab may reduce mortality, although the findings may be susceptible to unmeasured confounding, and further research from randomized clinical trials is needed.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 20, 2020

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  • Development Update

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The study, published in JAMA Internal Medicine, showed just over 27% of ICU patients treated with tocilizumab died within a month, compared with 37% of those just as seriously ill but did not receive the drug.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 20, 2020

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Results from the study showed that the most effective treatment was the combination of corticosteroids-such as dexamethasone – with tocilizumab when compared to standard of care.


Lead Product(s): Dexamethasone,Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 20, 2020

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EMPACTA is the first global Phase III trial to show efficacy with Actemra in COVID-19 associated pneumonia and the first with a focus on enrolling largely underserved and minority patients.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 17, 2020

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The findings showed a statistically-significant decrease in hospital-related deaths among the patients who received the tocilizumab: a roughly 36 percent decrease in hospital-related mortality among the ICU patients who received the drug.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2020

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COVACTA trial did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced patient mortality.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 29, 2020

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Actemra did not reduce severe respiratory symptoms, intensive care visits, or death any better than standard treatments, the Italian Medicines Agency (Aifa), Italy’s drugs regulator which authorized the study.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Actemra

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 18, 2020

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Phase III, randomised, double-blind, multicentre study (REMDACTA) will evaluate the safety and efficacy of Actemra/RoActemra plus remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc.


Lead Product(s): Tocilizumab,Remdesivir

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 28, 2020

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Tocilizumab has been tested on 6 patients admitted at Seven Hills Hospital and 4 patients in Kasturba Hospital, both COVID-19 centres in Mumbai.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 12, 2020

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Phase III clinical trial is evaluating the safety and efficacy of tocilizumab plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia, vs placebo and standard of care.


Lead Product(s): Tocilizumab

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 06, 2020

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Richter receives worldwide rights to develop, manufacture and commercialise the biosimilar tocilizumab for the treatment of rheumatoid arthritis.


Lead Product(s): Tocilizumab

Therapeutic Area: Immunology Product Name: Undisclosed

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Gedeon Richter

Deal Size: $19.5 million Upfront Cash: $3.0 million

Deal Type: Agreement April 29, 2020

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