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Details:
Xcopri (cenobamate), is an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, is now approved as oral suspension or can be administered via a nasogastric tube.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2024
Details:
Xcopri (cenobamate) is a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel. It is approved as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2024
Details:
Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hikma Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 21, 2023
Details:
XCOPRI™ (cenobamate tablets) inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel, which is used for partial-onset seizures in adults with epilepsy.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Details:
Cenobamate – under the brand name ONTOZRY® – has been commercialized in five major European countries such as Germany, the UK, Italy, Spain, and France, accounting for about 73 percent of the total value of the continent’s epilepsy market.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Ontozry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Angelini Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 09, 2022
Details:
Ontozry (cenobamate) is a novel small molecule that provides a dual, complementary mechanism of action aimed at treatment of seizures also known as focal-onset seizures.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Ontozry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 07, 2022
Details:
Under the terms of agreement, SK Biopharmaceuticals has granted Eurofarma the exclusive rights to develop and commercialize Xcopri (cenobamate) in Latin America. SK Biopharmaceuticals will now be present in four continents: North America, Europe, Asia, and Latin America.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eurofarma
Deal Size: $62.0 million Upfront Cash: $15.0 million
Deal Type: Licensing Agreement July 14, 2022
Details:
The open-label extension of Study C017 demonstrated high response rates with no new safety signals identified in patients receiving XCOPRI (cenobamate) for up to 4 years.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Pivotal trial has demonstrated that Ontozry (cenobamate) at doses of 100 mg, 200 mg, and 400 mg/day significantly improved seizure control versus placebo for adult patients with focal-onset seizures taking 1-3 ASMs.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Ontozry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
XCOPRI® (cenobamate tablets) CV, is an anti-seizure medication (ASM), a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2022
Details:
The results of these two new post-hoc analyses provide evidence of the durable efficacy of XCOPRI, as many patients sustained 90% and 100% reductions of their seizures over the course of the entire maintenance period, lasting up to 40.2 months.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2021
Details:
Angelini Pharma plans to launch ONTOZRY® in the European Union and other countries in the European Economic Area. SK Biopharmaceuticals, which discovered and developed cenobamate, will collaborate with Angelini Pharma to launch ONTOZRY® in Europe.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Ontozry
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2021
Details:
The CHPM opinion is based on a trial (study 017) in which Cenobamate demonstrated significantly higher responder rates (percentage of patients achieving ≥50% reduction in seizures frequency) across all doses during the 12-week maintenance phase compared to placebo.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Ontozry
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SK Biopharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 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).
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct 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:
Presentations will feature new post-hoc analyses of safety, efficacy and pharmacokinetic clinical trial data from adult patients taking cenobamate for uncontrolled partial-onset (focal) seizures.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 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.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct 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:
SK Biopharmaceuticals will conduct a Phase 3 clinical study for partial-onset seizures in adults in Northeast Asia (Japan, China, and Korea). In addition, SK Biopharmaceuticals has an option for co-promotion with Ono in the Japanese market.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ono Pharmaceutical
Deal Size: $506.0 million Upfront Cash: $47.0 million
Deal Type: Collaboration October 13, 2020
Details:
The Phase 3 trial is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of cenobamate as an adjunctive therapy in subjects with partial-onset seizures, with an optional open-label extension.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 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.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 11, 2020
Details:
SK Biopharmaceuticals Co Ltd priced its initial public offering on Friday at the top of its indicative range, aiming to raise 959 billion won ($794 million) in South Korea's biggest IPO in three years.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $800.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 19, 2020
Details:
Proceeds will be used accelerate further advancement of the Company's pipeline which include, cenobamate, solriamfetol and among others.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Xcopri
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $822.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 15, 2020
Details:
28% of patients receiving cenobamate achieved seizure-freedom (zero seizures) during the study’s maintenance phase, versus 9% receiving placebo1.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
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