[{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EC Grants Marketing Authorization for New Subcutaneous Administration of TYSABRI to Treat Relapsing-Remitting Multiple Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data at ECTRIMS 2021 Highlight Biogen\u2019s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"BioLineRx","sponsor":"Washington University School of Medicine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BioLineRx Announces Clinical Trial Collaboration with Washington University School of Medicine to Evaluate Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Peptide","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Biogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data at AAN 2022 Highlight Real-World Evidence from Biogen's MS Portfolio and Emerging Research on Disease Progression","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Applications for Proposed First-of-a-kind Multiple Sclerosis Biosimilar Natalizumab Accepted by US FDA and EMA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Sandoz B2B","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Announces EMA Acceptance of Marketing Authorization Application for Proposed Biosimilar Natalizumab","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Polpharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Polpharma Biologics Announces FDA File Acceptance For Review Of Natalizumab, First Proposed Biosimilar To Tysabri\u00ae","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"POLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"BioLineRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioLineRx Announces Initiation of Randomized Phase 2 Clinical Trial in First Line Metastatic Pancreatic Cancer Based on Preliminary Data from Single-Arm Pilot Phase; Combination Trial Includes Investigational Candidate Motixafortide","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Peptide","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz Receives Positive CHMP Opinion for Multiple Sclerosis Biosimilar Natalizumab","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"July 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"BioLineRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioLineRx Announces Encouraging Data from Pilot Phase of Phase 2 Combination Clinical Trial with Motixafortide in First-Line Pancreatic Cancer (PDAC)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Peptide","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"BioLineRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Peptide","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Hematology","graph2":"Phase I"},{"orgOrder":0,"company":"Sandoz B2B","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sandoz launches First and Only Biosimilar for Multiple Sclerosis, Tyruko\u00ae (Natalizumab), in Germany","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Large molecule","productStatus":"Biosimilar","date":"January 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Natalizumab
Tysabri® (natalizumab) - a monotherapy for adult patients with relapsing-remitting multiple sclerosis (RRMS) and adults with moderately-to-severely active Crohn’s disease.
PB006 (natalizumab) is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.
Natalizumab a proposed biosimilar to Tysabri is a humanised monoclonal antibody that blocks integrin α4β1-mediated leukocyte migration from blood vessels to the brain and prevent highly active relapsing-remitting multiple sclerosis.
Tyruko (natalizumab-sztn - biosimilar) is a highly effective anti-α4 integrin monoclonal antibody. It is indicated for the treatment of relapsing-remitting forms of multiple sclerosis.
BioLineRx initiated Phase I clinical trial studies evaluating BL-8040 (motixafortide), CXCR4/SDF-1 inhibitor, as monotherapy and in combination with natalizumab for the treatment of sickle cell disease.
Aphexda (motixafortide) is a CXCR4 antagonist , which is investigated in combination with gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancers.
Natalizumab biosimilar is mAB that acts as α4 integrin antagonist to prevent leukocyte trafficking into central nervous system, demonstrated high efficacy in Phase III trials by reducing annualized relapse rate, preventing multiple sclerosis lesion accumulation.
BL-8040 (motixafortide) inhibits CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including pancreatic ductal adenocarcinoma (PDAC).
The aim of the collaboration is to advance a Phase 1 clinical trial that will evaluate the safety and feasibility of BL-8040 (motixafortide) to mobilize CD34+ hematopoietic stem cells (HSCs) for gene therapies in sickle cell disease (SCD).
An updated analysis of Tysabri, confirms results from earlier analyses, which found that EID with IV administration of natalizumab is associated with a significantly lower risk of progressive multifocal leukoencephalopathy (PML) than the approved every four-week (Q4W) dosing.
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide. 
