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Bial

From Wikipedia, the free encyclopedia
Pharmaceutical company headquartered in Portugal
For other uses, seeBial (disambiguation).
Portela e C.ª, S.A.
Company typeSociedade Anónima
IndustryMajor drugs,health care
FoundedApril 19, 1924
HeadquartersTrofa,Portugal
Key people
António Horta Osório, Chairman (Appointed from April, 2021 onwards)
ProductsPharmaceuticals
Number of employees
924 (2018)
Websitewww.bial.com

Bial (Portela e C.ª, S.A.) is apharmaceutical company headquartered inSão Mamede do Coronado, inTrofa,Porto district,Portugal. It was founded in 1924, being among the largest companies of its kind in Portugal. Its products are sold in pharmacies in more than 58 countries on 4 continents: Europe, America, Africa, and Asia.

Financing

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On 21 September 2015, theEuropean Investment Bank signed a EUR 45 million financing agreement for Bial's R&D over the next 3 years. It was directed to "discover, develop and provide therapeutic solutions in [...] three major areas of research: central nervous system (CNS), cardiology and allergen immunotherapy". The EIB found Bial not to have the status of acontracting entity, and therefore, Bial has not been subject toEU rules on public procurement.[1]

Research and products

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In 2008, Bial completed a clinical evaluation ofeslicarbazepine acetate, a drug for the adjunctive use in partial seizures in adults withepilepsy. The Japanese companyEisai gained the sole license to market, promote, and distribute it as Zebinix or Exalief in Europe.[2] In America, it is marketed bySunovion under the name Aptiom.[3] Its use in epilepsy treatment in children is under development. A clinical trial of eslicarbazepine acetate as therapy in persons with diabetic neuropathic pain was prematurely halted.[4]

Etamicastat (BIA 5–453) is a dopamine-β-hydroxylase inhibitor decreasingnorepinephrine levels in peripheral sympathetically innervated tissues, without effect in brain tissues of spontaneously hypertensive rats.[5]

BIA 5-1058 is another reversibledopamine beta-hydroxylase inhibitor that decreases norepinephrine levels in peripheral sympathetically innervated tissues, without CNS effects.[6]

Opicapone (BIA 9-1067), Bial's second pharmaceutical, is aCOMT inhibitor for the treatment of Parkinson's disease.[7] It is under review by theEuropean Medicines Agency (EMA).

On 9 September 2015, Bial entered into an agreement with theHelsinn Group for the exclusive distribution and license rights to theHelsinn Group's druganamorelin in Spain, Portugal, Angola, and Mozambique.[8]

In 2015, Bial commissioned acontract research organization, Biotrial, to run aphase oneclinical trial forBIA 10-2474, anFAAH inhibitor[9] that targets theendocannabinoid system.[10] The research inRennes commenced in July 2015, evaluating male and female subjects aged between 18 and 55 years old receiving a single dose. On 7 January 2016, a trial involving multiple doses was started on six non-placebo subjects. The first patient receiving the multiple doses was hospitalized atRennes University Hospital on 10 January, leading Biotrial to suspend the study on 11 January. Five patients were hospitalized, with the first one receiving multiple doses and becoming brain-dead.[11][12][13]

On June 25, 2024, Bial was awarded the title of Honorary Member of theMilitary Order of Saint James of the Sword.[14]

References

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  1. ^BIAL INOVACAO RDI II European Investment Bank, 7 April 2015, retrieved 19 January 2016.
  2. ^Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix PRNewswire, February 19, retrieved 19 January 2016
  3. ^"FDA approves Aptiom to treat seizures in adults".US FDA. 8 November 2013. Archived fromthe original on November 9, 2013.
  4. ^Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain Clinical trials.gov, U.S. National Institutes of Health, July 17, 2014, retrieved 19 January 2016
  5. ^Nunes, Teresa; Rocha, José F.; Vaz-Da-Silva, Manuel; Igreja, Bruno; Wright, Lyndon C.; Falcão, Amílcar; Almeida, Luis; Soares-Da-Silva, Patricio (November 2010)."Safety, Tolerability, and Pharmacokinetics of Etamicastat, a Novel Dopamine-β-Hydroxylase Inhibitor, in a Rising Multiple-Dose Study in Young Healthy Subjects".Drugs in R&D.10 (4):225–242.doi:10.2165/11586310-000000000-00000.PMC 3585840.PMID 21171669.
  6. ^Igreja, Bruno; Pires, Nuno; Wright, Lyndon; Soares-Da-Silva, Patrício (2012)."Abstract 291: Antihypertensive Effect Of BIA 5-1058, a New Selective Peripheral Dopamine β-hydroxylase Inhibitor".Journal of Hypertension.30:e236–e237.doi:10.1097/01.hjh.0000420843.24708.5e.S2CID 74785134.
  7. ^Rocha, José Francisco; Almeida, Luis; Falcão, Amílcar; Palma, P. Nuno; Loureiro, Ana I.; Pinto, Roberto; Bonifácio, Maria João; Wright, Lyndon C.; Nunes, Teresa; Soares-Da-Silva, Patrício (November 2013)."Opicapone: A short lived and very long acting novel catechol-O-methyltransferase inhibitor following multiple dose administration in healthy subjects".British Journal of Clinical Pharmacology.76 (5):763–775.doi:10.1111/bcp.12081.PMC 3853535.PMID 23336248.
  8. ^Helsinn Group inks pact with BIAL for distribution, licence of Anamorelin in Spain, Portugal, Angola & MozambiqueArchived January 26, 2016, at theWayback Machine pharmabiz.com, Saffron Media Pvt., 9 September 2015, retrieved 19 January 2016
  9. ^Reuters Editorial (15 January 2016)."BRIEF-Bial says firmly committed to ensure wellbeing of test participants".Reuters.{{cite web}}:|author= has generic name (help)
  10. ^Reuters Editorial (15 January 2016)."Bial is maker of trial drug that hospitalised six volunteers - French minister".Reuters.{{cite web}}:|author= has generic name (help)
  11. ^Lizzie Dearden (15 January 2016)."France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record".The Independent.
  12. ^"France clinical trial: 90 given drug, one man brain-dead".BBC News. BBC News. 2016-01-15.
  13. ^BISSERBE, NOEMIE."French drug trial for Bial leaves one person brain dead, four in hospital". The Australian.
  14. ^"ENTIDADES NACIONAIS AGRACIADAS COM ORDENS PORTUGUESAS - Página Oficial das Ordens Honoríficas Portuguesas".www.ordens.presidencia.pt. Retrieved2024-10-31.

External links

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