{"id":83883,"date":"2023-12-19T09:42:00","date_gmt":"2023-12-19T12:42:00","guid":{"rendered":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/prnewswire\/prnewseconomia\/knight-therapeutics-celebra-um-acordo-de-licenca-exclusiva-com-a-supernus-pharmaceuticals-para-qelbree-viloxazina-no-canada-2\/"},"modified":"2023-12-19T09:42:00","modified_gmt":"2023-12-19T12:42:00","slug":"knight-therapeutics-celebra-um-acordo-de-licenca-exclusiva-com-a-supernus-pharmaceuticals-para-qelbree-viloxazina-no-canada-2","status":"publish","type":"post","link":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/prnewswire\/prnewseconomia\/knight-therapeutics-celebra-um-acordo-de-licenca-exclusiva-com-a-supernus-pharmaceuticals-para-qelbree-viloxazina-no-canada-2\/","title":{"rendered":"Knight Therapeutics celebra um acordo de licen\u00e7a exclusiva com a Supernus Pharmaceuticals para Qelbree® (viloxazina) no Canad\u00e1"},"content":{"rendered":"

PR NEWSWIRE<\/b><\/p>\n

\nMONTREAL<\/span><\/span>, 19 de dezembro de 2023<\/span> \/PRNewswire\/ —\u00a0 A Knight Therapeutics Inc., (TSX: GUD) (“Knight”), uma empresa pan-americana (ex-EUA) de especialidades farmac\u00eauticas, anunciou hoje que celebrou um acordo de licen\u00e7a exclusiva com a Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) (“Supernus”), uma empresa biofarmac\u00eautica com foco no desenvolvimento e comercializa\u00e7\u00e3o de produtos para o tratamento de doen\u00e7as do sistema nervoso central (SNC), concedeu \u00e0 Knight os direitos para obter aprova\u00e7\u00e3o regulat\u00f3ria e a comercializa\u00e7\u00e3o do Qelbree®<\/sup> no Canad\u00e1. Qelbree®<\/sup>\u00a0\u00e9 uma formula\u00e7\u00e3o de libera\u00e7\u00e3o prolongada de viloxazina, um agente modulador multimodal serotonin\u00e9rgico e noradren\u00e9rgico (SNMA), um medicamento n\u00e3o estimulante para o tratamento do Transtorno de Deficit de Aten\u00e7\u00e3o e Hiperatividade (TDAH). Os termos financeiros do acordo n\u00e3o foram divulgados.<\/p>\n
\n \"(CNW<\/a>\n <\/p>\n<\/p><\/div>\n

Qelbree®<\/sup> (c\u00e1psulas de libera\u00e7\u00e3o prolongada de viloxazina) est\u00e1 dispon\u00edvel comercialmente nos Estados Unidos como medicamento de prescri\u00e7\u00e3o para tratar o TDAH em pacientes com 6 ou mais anos de idade. Com base nos resultados de 4 estudos pivotais,1-4<\/sup> Qelbree®<\/sup>\u00a0foi aprovado pela Administra\u00e7\u00e3o de Alimentos e Medicamentos dos EUA (FDA) em 2021 para o tratamento de crian\u00e7as de 6-17 anos de idade e em 2022 para o tratamento em adultos. O Qelbree®<\/sup>\u00a0tamb\u00e9m est\u00e1 conduzindo v\u00e1rios estudos Fase 4, sendo o primeiro em combina\u00e7\u00e3o com psicoestimulantes para o tratamento de crian\u00e7as e adolescentes com TDAH (resultados positivos reportados em setembro de 20236<\/sup>). Um segundo ensaio cl\u00ednico de fase 4 em crian\u00e7as na idade pr\u00e9-escolar com TDAH est\u00e1 previsto para come\u00e7ar em janeiro de 2024. Um terceiro ensaio cl\u00ednico Fase 4 est\u00e1 em condu\u00e7\u00e3o para avalia\u00e7\u00e3o do impacto do Qelbree®<\/sup>\u00a0nos sintomas de humor com\u00f3rbidos em pacientes portadores de TDAH.<\/p>\n

“Esta parceria representa a execu\u00e7\u00e3o cont\u00ednua da nossa estrat\u00e9gia de expandir a nossa presen\u00e7a em SNC entrando em um dos segmentos mais importantes que ainda apresenta necessidades m\u00e9dicas n\u00e3o atendidas relevantes”, afirmou Samira Sakhia, Presidente e CEO da Knight. “Estamos muito motivados em buscar a aprova\u00e7\u00e3o regulat\u00f3ria e poder trazer um novo medicamento n\u00e3o estimulante para melhorar o tratamento de pacientes com TDAH.”<\/p>\n

“Supernus foi capaz de identificar na Knight a experi\u00eancia e os recursos comerciais adequados para buscar a aprova\u00e7\u00e3o do Qelbree®<\/sup>\u00a0e lan\u00e7\u00e1-lo com sucesso no Canad\u00e1”, afirmou Jack Khattar<\/span>, Presidente e CEO da Supernus Pharmaceuticals. “A Supernus orgulha-se de apoiar outras regi\u00f5es e pacientes que necessitam de solu\u00e7\u00f5es inovadoras para vencer os desafios do tratamento de uma doen\u00e7a complexa como a TDAH.”<\/p>\n

Sobre a TDAH8<\/sup><\/b><\/p>\n

A TDAH \u00e9 um transtorno do desenvolvimento neurol\u00f3gico que afeta tanto crian\u00e7as como adultos. A preval\u00eancia estimada da TDAH \u00e9 de 5-9% nas crian\u00e7as e de 3-5% em adultos. Este transtorno \u00e9 caracterizado por sintomas de distra\u00e7\u00e3o, hiperatividade e impulsividade que podem afetar significativamente a capacidade de um indiv\u00edduo de viver o seu dia a dia. Embora os sintomas da TDAH possam mudar com o tempo, os pacientes precisam geralmente de acompanhamento e tratamento cont\u00ednuos por toda a vida. As atuais farmacoterapias para a TDAH incluem psicoestimulantes \u00e0 base de anfetaminas ou metilfenidatos, bem como op\u00e7\u00f5es n\u00e3o psicoestimulantes de longa dura\u00e7\u00e3o. No entanto, nem todos os doentes respondem as atuais terapias. Consequentemente, continua a existir uma necessidade m\u00e9dica n\u00e3o atendida de op\u00e7\u00f5es de tratamento adicionais para os doentes com TDAH.<\/p>\n

Sobre a Knight Therapeutics Inc.<\/b><\/p>\n

A Knight Therapeutics Inc., com sede em Montreal<\/span>, Canad\u00e1, \u00e9 uma empresa farmac\u00eautica especializada com foco na aquisi\u00e7\u00e3o ou licenciamento e comercializa\u00e7\u00e3o de produtos farmac\u00eauticos para o Canad\u00e1 e a Am\u00e9rica Latina. As subsidi\u00e1rias latino-americanas da Knight operam sob os nomes United Medical, Biotoscana Farma e Laboratorio LKM. As a\u00e7\u00f5es da Knight Therapeutics Inc. s\u00e3o negociadas na TSX sob o s\u00edmbolo GUD. Para mais informa\u00e7\u00f5es sobre a Knight Therapeutics Inc., visite o site da empresa em www.knighttx.com<\/a> ou www.sedarplus.com<\/a>.<\/p>\n

Declara\u00e7\u00f5es prospectivas<\/b><\/p>\n

Este documento cont\u00e9m declara\u00e7\u00f5es prospectivas relacionadas \u00e0 Knight Therapeutics Inc. e suas subsidi\u00e1rias. Essas declara\u00e7\u00f5es prospectivas, por sua natureza, envolvem necessariamente riscos e incertezas que podem fazer com que os resultados reais sejam materialmente diferentes daqueles contemplados nessas declara\u00e7\u00f5es. A Knight Therapeutics Inc. considera razo\u00e1veis as premissas nas quais essas declara\u00e7\u00f5es prospectivas se baseiam no momento em que foram preparadas, mas adverte o leitor de que essas premissas sobre eventos futuros, muitos dos quais est\u00e3o al\u00e9m do controle da Knight Therapeutics Inc. e de suas subsidi\u00e1rias, podem acabar sendo incorretas. Fatores e riscos que podem fazer com que os resultados reais sejam materialmente diferentes das expectativas atuais s\u00e3o discutidos no Relat\u00f3rio Anual da Knight Therapeutics Inc. e no Formul\u00e1rio de Informa\u00e7\u00f5es Anuais da Knight Therapeutics Inc. para o ano encerrado em 31 de dezembro de 2022, conforme registrado em www.sedarplus.com<\/a>. A Knight Therapeutics Inc. nega qualquer inten\u00e7\u00e3o ou obriga\u00e7\u00e3o de atualizar ou revisar quaisquer declara\u00e7\u00f5es prospectivas devido a novas informa\u00e7\u00f5es ou eventos futuros, exceto se exigido por lei.<\/p>\n

INFORMA\u00c7\u00d5ES DE CONTACTO PARA KNIGHT:<\/div>\n
\n\n\n\n\n\n\n\n\n\n
\n

Contato de investidores:<\/b><\/span><\/p>\n<\/td>\n

<\/td>\n<\/td>\n<\/tr>\n
\n

Knight Therapeutics Inc.<\/span><\/p>\n<\/td>\n

<\/td>\n<\/td>\n<\/tr>\n
\n

Samira Sakhia<\/span><\/p>\n<\/td>\n

<\/td>\n\n

Arvind Utchanah<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Presidente e Diretora Executiva<\/span><\/p>\n<\/td>\n

<\/td>\n\n

Diretor Financeiro<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Tel.: 514.484.4483 <\/span><\/p>\n<\/td>\n

<\/td>\n\n

Tel.: 598.2626.2344\u00a0<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

F: 514.481.4116<\/span><\/p>\n<\/td>\n

<\/td>\n<\/td>\n<\/tr>\n
\n

Email:\u00a0IR@knighttx.com<\/a><\/span><\/p>\n<\/td>\n

<\/td>\n\n

Email:\u00a0IR@knighttx.com<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n

\n

Website:\u00a0www.knighttx.com<\/a><\/span><\/p>\n<\/td>\n

<\/td>\n\n

Website:\u00a0www.knighttx.com<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n<\/table>\n<\/div>\n

Refer\u00eancias:<\/b><\/p>\n

    \n
  1. Nasser A et al. (2020). A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit\/Hyperactivity Disorder in School-age Children. Clinical Therapeutics<\/i>, 42(8), 1452-1466. DOI: https:\/\/doi.org\/10.1016\/j.clinthera.2020.05.021<\/a>\n<\/li>\n
  2. Nasser A\u00a0et al. (2021). Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. Clinical Therapeutics<\/i>, 43(4), 684-700.\u00a0 DOI: https:\/\/doi.org\/10.1016\/j.clinthera.2021.01.027<\/a>\n<\/li>\n
  3. Nasser A et al. (2021). A Phase 3, Placebo-Controlled Trial of Once-Daily Viloxazine Extended-Release Capsules in Adolescents With Attention-Deficit\/Hyperactivity Disorder. Journal of Clinical Psychopharmacology<\/i>, 41(4), 370-380. DOI: 10.1097\/JCP.0000000000001404<\/a>\n<\/li>\n
  4. Nasser A et al. (2022). A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Viloxazine Extended-Release Capsules in Adults with Attention-Defcit\/Hyperactivity Disorder. CNS Drugs<\/i>, 36(8), 897-915. DOI: https:\/\/doi.org\/10.1007\/s40263-022-00938-w<\/a>\n<\/li>\n
  5. US National Library of Medicine. (2021, March 8<\/span> – ). Open-label study of SPN-812 administered with psychostimulants in children and adolescents with ADHD (ADHD). Identifier NCT04786990. https:\/\/clinicaltrials.gov\/study\/NCT04786990<\/a>\n<\/li>\n
  6. Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms. (2023, September 10<\/span>). Retrieved from https:\/\/ir.supernus.com\/node\/13856\/pdf<\/a>\n<\/li>\n
  7. US National Library of Medicine. (2021, March 4<\/span> – ). Evaluation of SPN-812 (viloxazine extended-release capsule) in preschool-age children with ADHD. Identifier NCT04781140. https:\/\/clinicaltrials.gov\/study\/NCT04781140<\/a>\n<\/li>\n
  8. CADDRA – Canadian ADHD Resource Alliance. (2020). Canadian ADHD Practice Guidelines, 4.1 Edition. https:\/\/adhdlearn.caddra.ca\/wp-content\/uploads\/2022\/08\/Canadian-ADHD-Practice-Guidelines-4.1-January-6-2021.pdf<\/a>\n<\/li>\n
  9. Apresentado durante Supernus Pharmaceuticals R&D Day; 18 de Outubro de 2023<\/li>\n<\/ol>\n

    Logo – https:\/\/mma.prnewswire.com\/media\/2304053\/logos_todos.jpg<\/a><\/p>\n

    FONTE Knight Therapeutics Inc.<\/p>\n<\/div>\n

    \"\"<\/p>\n

    A OESP<\/b> n\u00e3o \u00e9(s\u00e3o) respons\u00e1vel(is) por erros, incorre\u00e7\u00f5es, atrasos ou quaisquer decis\u00f5es tomadas por seus clientes com base nos Conte\u00fados ora disponibilizados, bem como tais Conte\u00fados n\u00e3o representam a opini\u00e3o da OESP<\/b> e s\u00e3o de inteira responsabilidade da PR Newswire Ltda<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"PR NEWSWIRE MONTREAL, 19 de dezembro de 2023 \/PRNewswire\/ —\u00a0 A Knight Therapeutics Inc., (TSX: GUD) (“Knight”), uma empresa pan-americana (ex-EUA) de especialidades farmac\u00eauticas,","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_monsterinsights_skip_tracking":false,"footnotes":""},"categories":[29],"tags":[],"class_list":["post-83883","post","type-post","status-publish","format-standard","hentry","category-prnewseconomia"],"acf":[],"yoast_head":"\nKnight Therapeutics celebra um acordo de licen\u00e7a exclusiva com a Supernus Pharmaceuticals para Qelbree® (viloxazina) no Canad\u00e1 - Ag\u00eancia de Comunica\u00e7\u00e3o<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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