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Details:
The Vivacity-MG study examined the safety, tolerability, and efficacy of nipocalimab in addition to standard of care treatment compared with placebo and standard of care treatment in 68 patients with moderate-to-severe gMG who had an insufficient response to ongoing treatment.
Lead Product(s): Nipocalimab
Therapeutic Area: Immunology Product Name: M281
Highest Development Status: Phase IIProduct Type: Large molecule
Recipient: Johnson & Johnson
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2021
Details:
Johnson & Johnson's pipeline gains a new class of drugs. Momenta’s FcRn inhibitor, nipocalimab, has the potential to transform treatment of autoantibody-driven autoimmune diseases.
Lead Product(s): Nipocalimab
Therapeutic Area: Immunology Product Name: M281
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Johnson & Johnson
Deal Size: $6,500.0 million Upfront Cash: $6,500.0 million
Deal Type: Acquisition October 01, 2020
Details:
This acquisition gives Johnson & Johnson a major entry point into a new class of drugs. Momenta’s FcRn inhibitor, nipocalimab, has the potential to transform treatment of autoantibody-driven autoimmune diseases.
Lead Product(s): Nipocalimab
Therapeutic Area: Immunology Product Name: M281
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Johnson & Johnson
Deal Size: $6,500.0 million Upfront Cash: $6,500.0 million
Deal Type: Acquisition August 19, 2020
Details:
Momenta's novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. FDA for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN.
Lead Product(s): Nipocalimab
Therapeutic Area: Immunology Product Name: M281
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 July 28, 2020
Details:
Phase 2 Vivacity-MG Study of Nipocalimab (M281) in Generalized Myasthenia Gravis, met primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL clinical benefit (p<0.0001).
Lead Product(s): Nipocalimab
Therapeutic Area: Immunology 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 June 15, 2020
Details:
Company is in active communication with clinical sites to be sure patients enrolled in studies have uninterrupted access to company's investigational drugs.
Lead Product(s): Nipocalimab
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2020
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