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2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"National Research Council Industrial Research Assistance Program","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Orion Biotechnology Receives Funding to Test OB-002 for Treatment of COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Preclinical","country":"CANADA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orion\u2019s Phase 3 REFALS Trial Evaluating Oral Levosimendan in Treatment of ALS Patients Did Not Reach its Pre-Specified Endpoints","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orion Biotechnology Successfully Completes Phase 1 Clinical Trial of a First-in-Class Precision Engineered Ligand Analog for HIV Prevention","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"AnaBios","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AnaBios and Orion Publish Scientific Article Describing Novel Cardiac Compound","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Preclinical","country":"CANADA","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Bayer AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orion and Bayer Expand Development Program for Darolutamide in Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nubeqa\u00ae (darolutamide) Receives EU Approval as A New Treatment for Men with Non-Metastatic Castration-Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Darolutamide Plus Androgen Deprivation Therapy Significantly Increased Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marketing Authorization Granted for Darolutamide in Japan","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Orion Biotechnology","sponsor":"Peptilogics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Orion Biotechnology and Peptilogics Enter Strategic Research Collaboration to Enable AI-Driven Drug Discovery Against Undrugged GPCR Target","therapeuticArea":"Oncology","highestDevelopmentStatus":"Discovery Platform","country":"CANADA","productType":"Peptide","productStatus":"Undisclosed","date":"July 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Discovery Platform"}]
Find Clinical Drug Pipeline Developments & Deals by Orion Biotechnology
Peptilogics’ Nautilus™ platform enables in silico predictive peptide design across diverse targets to efficiently access new functional chemical space and custom design therapeutics.
Nubeqa (darolutamide) is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.
Lead Product(s):Darolutamide,Androgen Deprivation Therapy
AnaBios provided ex vivo data from human heart tissue to assess the pro-arrhythmic risk of the new NCX1.1 inhibitor, ORM-11372 (developed in Orion Pharma).
The Phase 1 study design included open-label single-dose (vaginal and rectal) and multi-dose product (vaginal) administration of OB-002H gel to study participants followed by a randomised, double-blind, placebo-controlled multi-dose (vaginal) phase of product administration.
Funding from the National Research Council Industrial Research Assistance Program will support the development of Orion’s lead compound, OB-002, a promising treatment for SARS-CoV-2 infection associated acute respiratory distress syndrome (ARDS).
The primary endpoint of the trial was to show a statistically significant difference between levosimendan and placebo in slow vital capacity (SVC) in supine position at 12 weeks compared to the baseline.
The transaction follows the Sales of Nubeqa® (darolutamide), jointly developed by Orion Corporation and Bayer for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC), started in the EU and Japan.
The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel which is being developed for a HIV prevention indication.
The approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favorable safety profile.
Results from Phase III ARAMIS trial that investigated Nubeqa (darolutamide) in men with nMCRC, show a statistically significant improvement in overall survival in patients receiving darolutamide plus androgen deprivation therapy compared to placebo plus ADT.
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