Metrochem Lacosamide Metrochem Lacosamide

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[{"orgOrder":0,"company":"UCB Pharma S.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 3 Data on UCB's Vimpat\u00ae CV in Primary Generalized Tonic-Clonic Seizures Published in Journal of Neurology, Neurosurgery & Psychiatry","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"UCB Pharma S.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"UCB\u2019s Anti-Epileptic Drug Vimpat[\u00ae] (lacosamide) Receives EU CHMP Positive Opinion for Primary Generalised Tonic-Clonic Seizures","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"UCB Pharma S.A","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"UCB's VIMPAT\u00ae CV Now Approved by FDA for Primary Generalized Tonic-Clonic Seizures and Expanded Pediatric use for Epilepsy","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals Receives ANDA Approval for Lacosamide Tablets Usp, 50 Mg, 100 Mg, 150 Mg and 200 Mg","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"MSN Laboratories","sponsor":"Breckenridge Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Breckenridge Pharmaceutical, Inc. Announces Launch of Lacosamide Tablets, USP (generic version of Vimpat\u00ae) Manufactured by MSN Laboratories Private Limited","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Tiefenbacher Group","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Market Launch: Tiefenbacher Pharmaceuticals Successfully Launches First Generic Version of The Epilepsy Medicine Lacosamide in Australia","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Fresenius Kabi AB Brunna","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fresenius Kabi Targets Treatment of Certain Seizures with Launch of Generic Lacosamide Injection, USP","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Aurobindo Pharma Limited","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aurobindo Receives FDA Approval for Lacosamide Tablets 50mg, 100mg, 150mg, & 200mg","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Aucta Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Aucta Pharmaceuticals, Inc. (\"Aucta Pharmaceuticals\") Launches MOTPOLY XR\u2122 (lacosamide) Extended-Release Capsules C-V, the First, and Only Once-Daily Formulation of Lacosamide","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]

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            Details:

            Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for the treatment of partial-onset seizures in adults and in pediatric patients.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Motpoly

            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 February 26, 2024

            Details:

            Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Lacosamide-Generic

            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 March 22, 2022

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            EMWA 2024

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            Details:

            Lacosamide selectively enhances slow inactivation of voltage-gated sodium channels and possibly interacts with collapsin response mediator protein-2. It is indicated for treating partial onset seizures.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Vimpat-Generic

            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 January 09, 2023

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            Details:

            Fresenius Kabi Lacosamide Injection, USP is an approved treatment option for partial-onset seizures in patients 17 years of age and older and is available in 200 mg per 20 mL single-dose vials.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Lacosamide-Generic

            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 December 15, 2022

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            Details:

            Lacosamide Tablets, USP (generic version of Vimpat), indicated for the prevention and control of seizures, enhances the slow inactivation of voltage-gated sodium channels without affecting the fast inactivation of voltage-gated sodium channels.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Lacosamide-Generic

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Breckenridge Pharmaceutical

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 19, 2022

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            Details:

            The approval granted by U.S.FDA for ANDA of Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg and 200 mg, a generic version of Vimpat®2 Tablets, 50 mg, 100 mg, 150 mg and 200 mg will be used for prevention and control of seizures.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Lacosamide-Generic

            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 March 21, 2022

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            Details:

            The PGTCS approval is based, in part, on results of a Phase 3 study. All three VIMPAT formulations, intravenous injections, are now indicated for the treatment of partial-onset seizures and as adjunctive therapy in the treatment of PGTCS in patients aged 4 and above.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Vimpat

            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 November 17, 2020

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            Details:

            The positive opinion is based, in part, on results from a phase 3 study of lacosamide as adjunctive treatment for uncontrolled primary generalized tonic-clonic seizures (PGTCS), recently published in the Journal of Neurology, Neurosurgery & Psychiatry.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Vimpat

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 22, 2020

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            Details:

            Study met primary and secondary endpoints of significantly lowering the risk of developing a second primary generalized tonic-clonic seizure during a 24-week treatment and a significantly higher rate of freedom from PGTCS during the treatment period compared with placebo.

            Lead Product(s): Lacosamide

            Therapeutic Area: Neurology Product Name: Vimpat

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2020

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