Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Undisclosed
Deal Size : Undisclosed
Deal Type : Financing
Alvotech Announces Closing of Private Debt Financing
Details : The net proceeds for this financing will be used to fund the clinical advancement of company's late-stage product AVT05 (golimumab), which is being evaluated for the treatment of rheumatoid arthritis.
Brand Name : AVT05
Molecule Type : Large molecule
Upfront Cash : Undisclosed
July 11, 2024
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Undisclosed
Deal Size : Undisclosed
Deal Type : Financing
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alvotech Announces Results from Confirmatory Study for AVT05 Biosimilar to Simponi®
Details : AVT05 (golimumab) is a TNF blocker indicated for treating moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis in adults.
Brand Name : AVT05
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 24, 2024
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AVT05 (golimumab) is a TNF alpha Inhibitor antibody drug therapy, administered intravenously, it is being investigated for rheumatoid arthritis management.
Brand Name : AVT05
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 29, 2023
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Preclinical
Sponsor : Advanz Pharma
Deal Size : $343.4 million
Deal Type : Partnership
Details : Advanz Pharma secures exclusive rights from Alvotech to commercialize AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab), AVT16, a proposed biosimilar to Entyvio (vedolizumab), and three additional early-stage, undisclosed biosimilar c...
Brand Name : AVT05
Molecule Type : Large molecule
Upfront Cash : $60.1 million
May 24, 2023
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Preclinical
Sponsor : Advanz Pharma
Deal Size : $343.4 million
Deal Type : Partnership
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AVT05 is a biosimilar candidate for Simponi and Simponi Aria (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha), a cytokine protein in the body. It is being investigated for moderate to severe rheumatoid...
Brand Name : AVT05
Molecule Type : Large molecule
Upfront Cash : Not Applicable
May 04, 2023
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : AVT05 (golimumab) is a biosimilar candidate for Simponi® and Simponi Aria®. It is a monoclonal antibody that inhibitsTNF alpha, elevated TNF alpha levels have been implicated in several chronic inflammatory diseases such as rheumatoid arthritis, psoria...
Brand Name : AVT05
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 11, 2023
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Guselkumab,Golimumab
Therapeutic Area : Immunology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) at 38 weeks.
Brand Name : Tremfya
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 10, 2022
Lead Product(s) : Guselkumab,Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Guselkumab,Golimumab
Therapeutic Area : Gastroenterology
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy guselkumab and golimumab, achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12.
Brand Name : Undisclosed
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 19, 2022
Lead Product(s) : Guselkumab,Golimumab
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The clinical study is a randomized, double-blind, parallel group, active control study to compare the efficacy and safety of BAT2506 to Simponi® in psoriatic arthritis (PsA) patients that is expected to enroll approximately 480 volunteers. In the U.S.,
Brand Name : BAT2506
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 09, 2021
Lead Product(s) : Golimumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Golimumab
Therapeutic Area : Neurology
Study Phase : Preclinical
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Ionis Treatment for Alexander Disease Receives Orphan Drug Designation from U.S. FDA
Details : ION373 is an Ionis-owned investigational antisense medicine designed to stop the mutated gene from producing excess GFAP. Earlier this year, the European Medicines Agency (EMA) granted orphan drug designation to ION373.
Brand Name : ION373
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 30, 2020
Lead Product(s) : Golimumab
Therapeutic Area : Neurology
Highest Development Status : Preclinical
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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