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Details:
AVT05 (golimumab) is a TNF alpha Inhibitor antibody drug therapy, administered intravenously, it is being investigated for rheumatoid arthritis management.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: AVT05
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 November 29, 2023
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 candidates in Europe.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: AVT05
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Advanz Pharma
Deal Size: $343.4 million Upfront Cash: $60.1 million
Deal Type: Partnership May 24, 2023
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 arthritis.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: AVT05
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 04, 2023
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, psoriatic arthritis etc.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: AVT05
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 11, 2023
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.
Lead Product(s): Guselkumab,Golimumab
Therapeutic Area: Immunology Product Name: Tremfya
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 October 10, 2022
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.
Lead Product(s): Guselkumab,Golimumab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
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 February 19, 2022
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.,
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: BAT2506
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 09, 2021
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.
Lead Product(s): Golimumab
Therapeutic Area: Neurology Product Name: ION373
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
Approval based on results from the GO-VIVA Phase 3 clinical trial which revealed that pharmacokinetic exposure of SIMPONI ARIA was consistent with that of two pivotal Phase 3 clinical trials of the drug in adult patients with moderately to severely active RA and active PsA.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: Simponi Aria
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
Bio-Thera has reached a licensing agreement with Pharmapark LLC, for BAT2506, its golimumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries.
Lead Product(s): Golimumab
Therapeutic Area: Immunology Product Name: BAT2506
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Pharmapark
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 17, 2020
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