Perampanel

Ligand Reports Fourth Quarter and Full Year 2023 Financial Results

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Martedì, Febbraio 27, 2024
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, MRK, Research, CRL, New Drug Application, Investment, Eisai, Growth, Sale, Parent, Novin, Focal segmental glomerulosclerosis, Streptococcus, LGND, FSGS, Breakthrough therapy, BLA, AED, GAAP, Therapy, NASH, Liver, NDA, Depreciation, Breast cancer, Total, Forecasting, Perampanel, Shanda, Telecanthus, ID, Retirement, PDUFA, Vaccine, Symantec Endpoint Protection, Type 2 diabetes, Safety, VRNA, Molluscum contagiosum, F2, Acquisition, Caregiver, Merck, AASLD, FDA, Telephone, Food, Pneumonia, Income tax, Hepatology, COVID-19, Element, Patient, SPA, Pharmaceutical industry

Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.

Key Points: 
  • Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.
  • Costs of Captisol sales were $1.6 million for the fourth quarter of 2023, compared with $21.6 million for the same period in 2022, with the decrease due to lower total Captisol sales during the fourth quarter of 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during the fourth quarter of 2022.
  • Amortization of intangibles was $8.3 million for the fourth quarter of 2023, compared with $8.5 million for the same period in 2022.
  • Travere also announced fourth quarter 2023 results reporting that it received 459 new patient start forms for FILSPARI in the fourth quarter of 2023 and net product sales of $14.9 million for the fourth quarter.

Eisai to Present Latest Data on Perampanel at The 77th American Epilepsy Society (AES) Annual Meeting

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Mercoledì, Novembre 22, 2023
Epilepsy, AED, AES, Patient, Safety, Eisai, Neurology, Sleep, Perampanel

Major presentations include the design and outcomes of a clinical research evaluating the safety of perampanel versus placebo (Poster No.

Key Points: 
  • Major presentations include the design and outcomes of a clinical research evaluating the safety of perampanel versus placebo (Poster No.
  • 1.493), and the data of evaluating the effects of perampanel on cognitive function and sleep (Poster No.
  • Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.

Catalyst Pharmaceuticals Announces Multiple Abstracts on FYCOMPA® (Perampanel) from Eisai Co, Ltd., to be Presented at the 35th International Epilepsy Congress

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Lunedì, Agosto 14, 2023
Abstract, Abstract (summary), Availability, Pharmacotherapy, Sleep, Q&A, AMPA, Safety, Catalyst Pharmaceuticals, Perampanel, Ageing, CIII, Doctor of Philosophy, Quality, Combination therapy, Congress, Eisai, MD, Quality of life, IEC, Effectiveness, Digital, Rare, CORAL, Treatment, Pharmaceutical industry, Medical imaging, Medical device, Online shopping, Residential care, Epilepsy, Patient, Catalysis

These are presentations by Eisai Co., Ltd. ("Eisai"), which holds the rights to FYCOMPA in countries and regions outside the U.S.

Key Points: 
  • These are presentations by Eisai Co., Ltd. ("Eisai"), which holds the rights to FYCOMPA in countries and regions outside the U.S.
  • Some abstracts will also be considered for publication in Epilepsia following the IEC.
  • The accepted abstracts and presentations detail the results from clinical and real-world studies, further documenting the uses of perampanel in both focal and generalized epilepsy across a diverse range of patients.
  • “These findings, which are being presented at IEC, further validate and add to the growing body of evidence supporting the benefits of perampanel in the treatment of seizure disorders,” said Gary Ingenito, MD, PhD, Chief Medical and Regulatory Officer of Catalyst.

Catalyst Pharmaceuticals Announces a Recent Third-Party Publication in Peer-Reviewed Journal Epilepsia Showing Perampanel (FYCOMPA®) Demonstrated High Efficacy in Patients with Rare Genetic Epilepsies

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Mercoledì, Marzo 8, 2023
Perampanel, Catalyst Pharmaceuticals, PIGA, NEU1, PCDH19, Patient, Network, Seizure, POLG2, SYNGAP1, Rare, Neurology, CORAL, GNAO1, Pharmaceutical industry, Catalysis, Epilepsy, SCN1A

The case review from a group of European neurologists treating rare epilepsies working under the framework of NETRE (Network for Therapy in Rare Epilepsies) reports how perampanel (FYCOMPA®) is capable of significantly reducing seizures in patients with epilepsies that result from specific genetic mutations.

Key Points: 
  • The case review from a group of European neurologists treating rare epilepsies working under the framework of NETRE (Network for Therapy in Rare Epilepsies) reports how perampanel (FYCOMPA®) is capable of significantly reducing seizures in patients with epilepsies that result from specific genetic mutations.
  • Out of 137 patients treated with perampanel, 60 patients (43.5%) sustained over 75% reduction in seizure frequency, including 38 (27.5%) with greater than 90% reduction in seizure frequency.
  • High efficacy was consistently observed in certain rare genetic variants, including SCN1A, GNAO1, PIGA, PCDH19, SYNGAP1, POLG1, POLG2, and NEU1.
  • “We look forward to continuing to bring FYCOMPA® to all patients that may benefit from it.”

Eisai to Divest Rights for Anti-Epileptic Drug Fycompa (perampanel) CIII in United States to Catalyst Pharmaceuticals

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Martedì, Dicembre 20, 2022
Ecosystem, Anxiety, CIII, Drug discovery, Research, Epilepsy, Neurology, USD, Global Health, AED, Patient, Medicine, Lipid metabolism, Health, Catalyst Pharmaceuticals, RNA, Pharmaceutical industry, Perampanel, Eisai

Eisai will maintain its rights to Fycompa in countries and regions outside the U.S. and continue to contribute to patients with epilepsy.

Key Points: 
  • Eisai will maintain its rights to Fycompa in countries and regions outside the U.S. and continue to contribute to patients with epilepsy.
  • Closing of the transaction is contingent on completion of review under antitrust laws in the U.S.
  • In the U.S., Fycompa was approved in 2012 and has been prescribed to more than 50,000 patients.
  • Under the terms of the agreement, Eisai will receive a contractual up-front payment of $160 million (USD) upon closing of the transaction.

Eisai to Present Latest Data on Perampanel at the 76th American Epilepsy Society (AES) Annual Meeting

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Giovedì, Novembre 24, 2022
Adolescence, Epilepsy, III, AES, Poster, Patient, Neurology, Perampanel, Eisai, Disease, FOS, AED, Olex, Senior, Seizure, Ageing, AMPA, Safety, Pharmaceutical industry

Perampanel is a first-in-class AED discovered by Eisai's Tsukuba Research Laboratories.

Key Points: 
  • Perampanel is a first-in-class AED discovered by Eisai's Tsukuba Research Laboratories.
  • Eisai considers neurology, including epilepsy, a therapeutic area of focus.
  • Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families

EISAI TO PRESENT LATEST DATA ON FYCOMPA® (PERAMPANEL) CIII AT THE 76TH AMERICAN EPILEPSY SOCIETY (AES) ANNUAL MEETING

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Mercoledì, Novembre 23, 2022
Suicidal ideation, Neglected tropical diseases, Marketing, Clinical trial, Epilepsy, Headache, Hospital, Anticonvulsant, AED, Risk, Plasma, Behavior, Anxiety, Seizure, Weight gain, Fever, Bruise, Death, Anger, Disease, DRESS, Vomiting, Depression, Mortality, Gait, Vertigo, Falls, Health, Somnolence, Patient, Pharmacotherapy, Ageing, Lymphadenopathy, Irritability, Dizziness, Ataxia, Head Injuries, Caregiver, Aggression, Human, Rash, Psychiatry, Self-harm, Central nervous system, United Nations Sustainable Development Group, AMPA, Fatigue, Fracture, Perampanel, Sustainable Development Goals, CNS, Homicidal ideation, Neurology, Nausea, Abdominal pain, POS, SUDEP, CIII, Personality, Pharmaceutical industry, Residential care, Eisai

NUTLEY, N.J., Nov. 23, 2022 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the company will have a total of 34 posters, including the latest data on its in-house discovered and developed anti-seizure medication (ASM) FYCOMPA® (perampanel) CIII, at the 76th American Epilepsy Society Annual Meeting (AES 2022), to be held in Nashville, Tennessee and virtually from December 2-6, 2022.

Key Points: 
  • Epilepsy is one of the most common neurological disorders, which affects 3.4 million people in the United States, including 470,000 children.
  • Partial-onset seizures are the most common types of seizures seen in people with epilepsy, accounting for 60 percent of all seizures.
  • Missed medication doses are the number one cause of breakthrough seizures, which can cause significant injury to patients.
  • Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Knight Therapeutics Inc. Announces Approval of Halaven® in Colombia

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Giovedì, Gennaio 6, 2022
Perampanel, Therapy, Tumor hypoxia, HIV disease progression rates, Patient, Anthracycline, Adult, Eribulin, Intention, Cancer, GUD, Annual report, Breast cancer, TSX, Leiomyosarcoma, Phenotype, Gene, Liposarcoma, Woman, Museo-laboratorio della Civiltà Contadina (Museum-workshop of the Peasant Culture), OS, GLOBE, Halichondrin B, Taxane, Nature, Pharmaceutical industry, Medical imaging, Knight, Uniting Medically Supervised Injecting Centre, Eisai

MONTREAL, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) (Knight or the Company) announced today that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection.

Key Points: 
  • MONTREAL, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX:GUD) (Knight or the Company) announced today that its Colombian affiliate, Biotoscana Farma S.A. has obtained INVIMA approval for Halaven (eribulin) injection.
  • Halaven (eribulin) injection has shown to significantly improve overall survival in patients with advanced or metastatic breast cancer after anthracycline and taxane treatment.
  • Were pleased to announce the approval of Halaven (eribulin) injection in Colombia as it provides a new treatment option for metastatic breast cancer and liposarcoma, said Samira Sakhia, President & Chief Executive Officer.
  • Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2020 as filed on www.sedar.com .

Eisai Presents Final Results Of Phase IV Elevate Study Of Anti-Epileptic Drug FYCOMPA® (perampanel) At The American Epilepsy Society (AES) 2021 Annual Meeting

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Martedì, Dicembre 7, 2021
Generalized tonic–clonic seizure, Pittsburgh Sleep Quality Index, PSQI, Population, Medical Affairs Bureau, AES, EIASM, Annual general meeting, Seizure, Perampanel, Quality of life, Ageing, Trial of the century, Cognition, Depression, Overalls, Quality, SD, Maintenance, American Epilepsy Society, Combination therapy, Observation, CIII, AED, GTCS, FOS, Dizziness, Fatigue, Pharmaceutical industry, Coal, Wine, Health insurance

WOODCLIFF LAKE, N.J., Dec. 7, 2021 /PRNewswire/ --Eisai Inc. presented analyses of the ELEVATE study of its antiepileptic drug (AED) FYCOMPA (perampanel) CIII at the 2021 American Epilepsy Society (AES) Annual Meeting.

Key Points: 
  • WOODCLIFF LAKE, N.J., Dec. 7, 2021 /PRNewswire/ --Eisai Inc. presented analyses of the ELEVATE study of its antiepileptic drug (AED) FYCOMPA (perampanel) CIII at the 2021 American Epilepsy Society (AES) Annual Meeting.
  • Summary: The open-label, multicenter study consisted of screening, titration ( 13 weeks), maintenance (39 weeks), and follow-up (4 weeks) periods.
  • Dose increases were 2 weeks for patients taking a non- enzyme-inducing anti-seizure medication (EIASM) and weekly for those taking an EIASM.
  • Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.

Eisai to Present Latest Data on Perampanel and E2730 at the 75th American Epilepsy Society Annual Meeting

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Martedì, Novembre 30, 2021
Patient, Eisai, Safety, FOS, Perampanel, Seizure, AED, Neurology, AMPA, III, GABA, Poster, Clinical trial, Epilepsy, Lists of diseases, Pharmaceutical industry

Additionally, an overview of phase III and other clinical studies (Poster number: 2.218) and a real-world pooled analysis of perampanel for elderly patients (Poster number: 1.215), will be presented.

Key Points: 
  • Additionally, an overview of phase III and other clinical studies (Poster number: 2.218) and a real-world pooled analysis of perampanel for elderly patients (Poster number: 1.215), will be presented.
  • For E2730, a poster presentation will be given on the non-clinical study results (Poster number 2.197).
  • Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.