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Lead Product(s): Ofatumumab
Therapeutic Area: Neurology Product Name: Kesimpta
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2021
Details:
Multicenter survey results show MS patients and nurses prefer the Sensoready autoinjector pen for subcutaneous self-administration of Kesimpta over other autoinjectors for their current treatment (84% vs 16%).
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Lead Product(s): Ofatumumab
Therapeutic Area: Neurology Product Name: Kesimpta
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2021
Details:
CHMP opinion is based on two Phase III ASCLEPIOS studies that met the primary endpoints where Kesimpta showed a reduction of the annual relapses by over 50% versus teriflunomide and achieved more than 30% relative risk reduction of 3-month confirmed disability progression.
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Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Angelini Pharma
Deal Size: $960.0 million Upfront Cash: $960.0 million
Deal Type: Acquisition January 04, 2021
Details:
Following Angelini Pharma’s acquisition of Arvelle Therapeutics, Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom).
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Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: European Medicines Agency
Deal Size: $207.8 million Upfront Cash: Undisclosed
Deal Type: Series A Financing October 26, 2020
Details:
The final tranche was triggered by the European Medicines Agency’s (EMA) recent acceptance of the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy, announced on 26 March 2020.
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Lead Product(s): Siponimod fumarate
Therapeutic Area: Neurology Product Name: Mayzent
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
Mayzent® (siponimod) is a once-daily treatment and the first recommended and only oral disease-modifying therapy approved by the Scottish Medicines Consortium for adult patients with SPMS with active disease evidenced by relapses or imaging features of inflammatory activity.
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Lead Product(s): Siponimod fumarate
Therapeutic Area: Neurology Product Name: Mayzent
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2020
Details:
Subgroup analyses of the EXPAND trial showed the value of early treatment initiation with Mayzent in patients with active SPMS as positive effects on disability, cognitive processing speed and relapse outcomes were sustained for up to five years.
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Lead Product(s): Satralizumab-mwge
Therapeutic Area: Neurology Product Name: Enspryng
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
The data for ENSPRYNG at MSVirtual2020 are promising and suggest it significantly reduces relapse severity and frequency, which are important goals of the treatment for people with NMOSD.
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Lead Product(s): Satralizumab-mwge
Therapeutic Area: Neurology Product Name: Enspryng
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2020
Details:
New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG, recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder.
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Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
UK’s Medicines and Healthcare Products Regulatory Agency has informed Cenobamate that a Promising Innovative Medicine designation has been issued for its investigational anti-seizure medication, cenobamate, for the treatment of drug-resistant focal-onset seizures in adults.
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Lead Product(s): Ocrelizumab
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2020
Details:
Applications are based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved OCREVUS dosing regimen.
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