[{"orgOrder":0,"company":"Formycon","sponsor":"Bioeq IP AG","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Formycon and Bioeq Announce Launch of Phase III Study of FYB202, a Biosimilar Candidate for Stelara (Ustekinumab)","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Formycon"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Spesolimab Data Show Clinically Significant Improvement in Patients With Generalized Pustular Psoriasis (GPP) Flares","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Boehringer Ingelheim GmbH"},{"orgOrder":0,"company":"InflaRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InflaRx Provides Update for Vilobelimab in Pyoderma Gangrenosum and COVID-19","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"InflaRx"},{"orgOrder":0,"company":"InflaRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"01-2023-InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"InflaRx"},{"orgOrder":0,"company":"Formycon","sponsor":"Athos Therapeutics","pharmaFlowCategory":"D","amount":"$720.7 million","upfrontCash":"Undisclosed","newsHeadline":"Formycon AG And Athos KG Announce Closing of Transaction to Acquire Biosimilar Assets FYB201 And FYB202 As Well as Bioeq Gmbh","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"May 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Formycon"},{"orgOrder":0,"company":"STADA Arzneimittel","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"STADA and Alvotech Receive Positive CHMP Opinion for Europe's First Ustekinumab Biosimilar to Stelara","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"Biosimilar","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"STADA Arzneimittel"},{"orgOrder":0,"company":"InflaRx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"InflaRx"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Uzpruvo (ustekinumab) biosimilar candidate to Stelara is a human IgG1κ monoclonal antibody (mAb), which is investigated for the treatment of moderate to severe chronic plaque-type psoriasis.
Gohibic (vilobelimab) is a first-in-class monoclonal anti-human complement factor C5a antibody, which demonstrates high selectivity towards its target in human blood, investigated for the treatment of Pyoderma Gangrenosum.
IFX-1 (Vilobelimab) is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood.
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood.
The structure of the transaction will involve Formycon acquiring all the rights in FYB202, a biosimilar candidate for Stelara® (ustekinumab), as well as a 50% share in FYB201, a biosimilar candidate for Lucentis®2 (ranibizumab).
Efficacy and safety data from the Effisayil™ 1 trial showed rapid pustular and skin clearance was sustained over 12 weeks in patients with GPP flares treated with spesolimab, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R).
Lead Product(s):
Spesolimab
Therapeutic Area:DermatologyProduct Name: BI 655130
Highest Development Status:Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
The aim of the randomized, double-blind, multi-center Phase III study is to demonstrate the comparability of FYB202 and the reference product Stelara(R) in terms of efficacy, safety and immunogenicity in patients with moderate to severe psoriasis vulgaris.