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Details:

Johnson-approved product Darzalex (daratumumab), which is a CD38 inhibitor, currently it is being evaluated in Phase III clinical trials in combination with bortezomib, lenalidomide, dexamethasone for the treatment of multiple myeloma.


Lead Product(s): Daratumumab,Bortezomib,Lenalidomide

Therapeutic Area: Oncology Product Name: Darzalex

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 06, 2024

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Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone is being evaluated in phase 3 clinical trials for the maintenance treatment of adult patients who are newly diagnosed with multiple myeloma.


Lead Product(s): Daratumumab,Hyaluronidase,Lenalidomide

Therapeutic Area: Oncology Product Name: Darzalex Faspro

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 30, 2024

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Darzalex Faspro (daratumumab) is a CD38 inhibitor antibody drug candidate, which is currently being evaluated in combination with hyaluronidase & bortezomib for the treatment of patients with newly diagnosed multiple myeloma.


Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib

Therapeutic Area: Oncology Product Name: Darzalex Faspro

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 12, 2023

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DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications in multiple myeloma, three of which are in the frontline setting, including newly diagnosed patients who are transplant eligible and ineligible.


Lead Product(s): Daratumumab,Lenalidomide,Dexamethasone

Therapeutic Area: Oncology Product Name: Darzalex

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 12, 2022

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TECVAYLI™ (Teclistamab-cqyv), is a first-in-class, bispecific T-cell engager antibody therapy which uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T cells and to the B-cell maturation antigen (BCMA).


Lead Product(s): Teclistamab-cqyv,Daratumumab,Pomalidomide

Therapeutic Area: Oncology Product Name: Tecvayli

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 10, 2022

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Pepaxti® (melphalan flufenamide, also called melflufen) is a lipophilic peptide conjugated alkylating drug that rapidly and selectively is delivering cytotoxic agents into tumor cells. The drug is composed of a di-peptide and an alkylating moiety.


Lead Product(s): Melphalan Flufenamide,Daratumumab

Therapeutic Area: Oncology Product Name: Pepaxti

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 26, 2022

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In primary analysis, GRIFFIN study met primary endpoint, resulting in higher stringent complete response rate for DARZALEX®-RVd (daratumumab) compared with RVd alone by end of post-autologous stem cell transplant consolidation therapy meeting prespecified 1-sided alpha of 0.1.


Lead Product(s): Daratumumab,Lenalidomide,Bortezomib

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 27, 2022

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NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response.


Lead Product(s): NKTR-255,Daratumumab

Therapeutic Area: Oncology Product Name: NKTR-255

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 August 16, 2022

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Results from study showed encouraging responses in heavily pretreated patients with multiple myeloma who received JNJ-64407564 (talquetamab) at the recommended subcutaneous Phase 2 dose (RP2D) administered weekly (QW) or every two weeks (Q2W).


Lead Product(s): Talquetamab,Daratumumab,Teclistamab

Therapeutic Area: Oncology Product Name: JNJ-64407564

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 10, 2022

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The results show the synergistic effect of combining CYNK-101 with daratumumab to drive antibody dependent cellular cytotoxicity activity against CD38+ hematological malignancies in vitro and in vivo.


Lead Product(s): CYNK-101,Daratumumab

Therapeutic Area: Oncology Product Name: CYNK-101

Highest Development Status: PreclinicalProduct Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 13, 2021

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Investigational DARZALEX (daratumumab), quadruple combination regimen shows responses in newly diagnosed, transplant-eligible patients with multiple myeloma in randomised Phase 2 GRIFFIN study.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: Darzalex

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 11, 2021

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DARZALEX® and DARZALEX FASPRO® featured data continues to explore treatment combinations in newly diagnosed multiple myeloma. Additional data for XARELTO® (rivaroxaban), Nipocalimab and DARZALEX FASPRO® to highlight in other hematologic diseases.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 04, 2021

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Approval of daratumumab SC-based regimen in Light Chain (AL) amyloidosis is supported by the Phase 3 ANDROMEDA study, which demonstrated significantly higher haematologic complete response rate vs. commonly used standard-of-care regimen.


Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib

Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro

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 22, 2021

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  • Development Update

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Daratumumab, a CD38-directed cytolytic antibody used in combination with Lenalidomide and Dexamethasone in newly diagnosed transplant-ineligible multiple myeloma patient which demonstrated a 44% reduction in the risk of disease progression or death after treatment.


Lead Product(s): Daratumumab,Lenalidomide,Dexamethasone

Therapeutic Area: Oncology Product Name: Darzalex

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 12, 2021

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DARZALEX FASPRO® is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma and now AL amyloidosis.


Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib

Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 26, 2021

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The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of MM is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network.


Lead Product(s): Daratumumab,Bortezomib,Cyclophosphamide

Therapeutic Area: Genetic Disease Product Name: Darzalex

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 21, 2021

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Study suggests that therapies which target CD38-such as the multiple myeloma drug daratumumab-could hold promise against prostate cancer too, by reawakening the anti-cancer immune response.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: UndisclosedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 07, 2021

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DARZALEX® SC combination regimen is supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder.


Lead Product(s): Daratumumab,Bortezomib,Cyclophosphamide

Therapeutic Area: Genetic Disease Product Name: Darzalex

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 19, 2021

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Accelerated approval of DARZALEX FASPRO-based combination regimen supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder.


Lead Product(s): Daratumumab,Hyaluronidase-fihj,Bortezomib

Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro

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 15, 2021

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Shanghai Henlius Biotech announced that the Investigational New Drug application of the Company’s daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody injection) to be used in the treatment of multiple myeloma has been accepted by the NMPA.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: HLX15

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2021

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The phase 3 LIGHTHOUSE study is a randomized, open-label study in patients with relapsed refractory multiple myeloma who are refractory to an immunomodulatory agent and a proteasome inhibitor or who have had at least three prior lines of therapy, including these agents.


Lead Product(s): Melphalan Flufenamide,Dexamethasone,Daratumumab

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase IIIProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 21, 2020

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Subcutaneous daratumumab in combination with pomalidomide and dexamethasone reduced the risk of death or disease progression compared with pomalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma.


Lead Product(s): Daratumumab,Dexamethasone,Pomalidomide

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: European Myeloma Network

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 08, 2020

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The data showed a significantly higher complete hematologic response rate with DARZALEX FASPRO® treatment in patients with Light Chain Amyloidosis compared to the standard regimen and consistent decreases in markers of disease, indicative of deep hematologic responses.


Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide

Therapeutic Area: Genetic Disease Product Name: Darzalex

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 07, 2020

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Details:

Phase 2 GRIFFIN data presented at ASH 2020 show increased stringent complete response and minimal residual disease negativity rates with maintenance therapy for transplant-eligible patients.


Lead Product(s): Daratumumab,Lenalidomide,Bortezomib

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 07, 2020

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DARZALEX FASPRO® significantly reduced the risk of progression or death by 37 percent when added to Pd, compared to Pd alone (hazard ratio, 0.63; 95 percent confidence interval).


Lead Product(s): Daratumumab,Hyaluronidase,Pomalidomide

Therapeutic Area: Oncology Product Name: Darzalex Faspro

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 04, 2020

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The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.


Lead Product(s): Daratumumab,Recombinant human hyaluronidase PH20 enzyme

Therapeutic Area: Oncology Product Name: Darzalex Faspro

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Halozyme Therapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 12, 2020

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Investigational New Drug (IND) application of the Company’s daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody injection) to be used in the treatment of multiple myeloma has been accepted by the National Medical Products Administration.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: HLX15

Highest Development Status: IND EnablingProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 12, 2020

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Details:

The submission is based on the Phase 3 ANDROMEDA study of daratumumab and hyaluronidase-fihj in combination with VCd as treatment for patients with newly diagnosed AL amyloidosis.


Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide

Therapeutic Area: Genetic Disease Product Name: Darzalex

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 05, 2020

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Details:

Primary data from the Phase 3 APOLLO study of SC daratumumab in combination with pomalidomide and dexamethasone (D-Pd) in patients with multiple myeloma who have received one or more prior lines of therapy will be the subject of an oral presentation and official ASH.


Lead Product(s): Daratumumab,Recombinant human hyaluronidase PH20 enzyme

Therapeutic Area: Oncology Product Name: Darzalex Faspro

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 05, 2020

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Details:

The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma.


Lead Product(s): Melphalan Flufenamide,Dexamethasone,Daratumumab

Therapeutic Area: Oncology Product Name: Melflufen

Highest Development Status: Phase I/ Phase IIProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 04, 2020

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Details:

Second part of the Phase 3 CASSIOPEIA study of daratumumab as maintenance treatment for patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant met the primary endpoint of progression-free survival at a pre-planned interim analysis.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 21, 2020

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The sBLA is supported by positive results from the Phase 3 ANDROMEDA study. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone compared to VCd alone and met its primary endpoint.


Lead Product(s): Daratumumab,Hyaluronidase,Cyclophosphamide

Therapeutic Area: Genetic Disease Product Name: Darzalex Faspro

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 10, 2020

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U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX® (daratumumab) plus dexamethasone (DKd) in two dosing regimens.


Lead Product(s): Carfilzomib,Daratumumab,Dexamethasone

Therapeutic Area: Oncology Product Name: Kyprolis

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 20, 2020

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DARZALEX® SC reduces administration time from hours to minutes and demonstrates consistent efficacy with a reduction in administration-related reactions compared to intravenous DARZALEX® (daratumumab).


Lead Product(s): Daratumumab,Bortezomib,Melphalan

Therapeutic Area: Oncology Product Name: Darzalex SC

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 04, 2020

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Details:

Phase 3 APOLLO randomized study evaluating subcutaneous daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in relapsed or refractory multiple myeloma met the primary endpoint of improving progression-free survival.


Lead Product(s): Daratumumab,Pomalidomide,Dexamethasone

Therapeutic Area: Oncology Product Name: Darzalex

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 31, 2020

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Details:

The milestone payment is associated with the first commercial sale in the European Union of Janssen's subcutaneous formulation of DARZALEX® (daratumumab) utilizing ENHANZE®, which was recently granted marketing authorization by the European Commission.


Lead Product(s): Daratumumab,Recombinant human hyaluronidase PH20 enzyme

Therapeutic Area: Oncology Product Name: Darzalex

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement June 22, 2020

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Details:

The Phase III ANDROMEDA (AMY3001) study of subcutaneous daratumumab utilizing ENHANZE® in combination with cyclophosphamide, bortezomib and dexamethasone for patients with newly diagnosed light-chain amyloidosis met its primary endpoint.


Lead Product(s): Daratumumab,Cyclophosphamide,Dexamethasone

Therapeutic Area: Genetic Disease Product Name: Darzalex

Highest Development Status: Phase IIIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 13, 2020

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Phase III ANDROMEDA study of subcutaneous daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone for patients with newly diagnosed light-chain (AL) amyloidosis met the primary endpoint of patients with hematologic complete response.


Lead Product(s): Daratumumab,Cyclophosphamide,Dexamethasone

Therapeutic Area: Genetic Disease 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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Details:

The milestone payment is associated with the first commercial sale in the United States of Janssen's DARZALEX FASPROTM (daratumumab and hyaluronidase - fihj) utilizing ENHANZE®, which was recently approved by the U.S. Food and Drug Administration.


Lead Product(s): Daratumumab,Hyaluronidase

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

Deal Size: $15.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 14, 2020

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Details:

New subcutaneous formulation reduces the time taken for patients to receive daratumumab treatment from hours to approximately three to five minutes, with similar efficacy.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology 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 April 30, 2020

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The NDA is supported by data from the Phase 3 COLUMBA study which compared daratumumab SC formulation vs daratumumab IV administration in patients with multiple myeloma.


Lead Product(s): Daratumumab,Hyaluronidase

Therapeutic Area: Oncology 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 April 26, 2020

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Details:

Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology 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 February 10, 2020

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Details:

The license agreement terms for Janssen Biotech, Inc. to develop, manufacture and market DARZALEX under the exclusive worldwide license.


Lead Product(s): Daratumumab

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: ApprovedProduct Type: Large molecule

Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration January 22, 2020

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