# Bial

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For other uses, see [Bial (disambiguation)](/source/Bial_(disambiguation)).

**Bial** (**Portela e C.ª, S.A.**) is a [pharmaceutical](/source/Pharmaceutical) company headquartered in [São Mamede do Coronado](/source/Coronado_(S%C3%A3o_Rom%C3%A3o_e_S%C3%A3o_Mamede)), in [Trofa](/source/Trofa_Municipality), [Porto district](/source/Porto_district), [Portugal](/source/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

On 21 September 2015, the [European Investment Bank](/source/European_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 a [contracting entity](/source/General_contractor), and therefore, Bial has not been subject to [EU rules on public procurement](/source/Public_procurement_in_the_European_Union).[1]

## Research and products

In 2008, Bial completed a clinical evaluation of [eslicarbazepine acetate](/source/Eslicarbazepine_acetate), a drug for the adjunctive use in partial seizures in adults with [epilepsy](/source/Epilepsy). The Japanese company [Eisai](/source/Eisai_(company)) gained the sole license to market, promote, and distribute it as Zebinix or Exalief in Europe.[2] In America, it is marketed by [Sunovion](/source/Sunovion) 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](/source/Etamicastat) (BIA 5–453) is a dopamine-β-hydroxylase inhibitor decreasing [norepinephrine](/source/Norepinephrine) levels in peripheral sympathetically innervated tissues, without effect in brain tissues of spontaneously hypertensive rats.[5]

BIA 5-1058 is another reversible [dopamine beta-hydroxylase](/source/Dopamine_beta-hydroxylase) inhibitor that decreases norepinephrine levels in peripheral sympathetically innervated tissues, without CNS effects.[6]

[Opicapone](/source/Opicapone) (BIA 9-1067), Bial's second pharmaceutical, is a [COMT inhibitor](/source/COMT_inhibitor) for the treatment of Parkinson's disease.[7] It is under review by the [European Medicines Agency](/source/European_Medicines_Agency) (EMA).

On 9 September 2015, Bial entered into an agreement with the [Helsinn Group](/source/Helsinn_Group) for the exclusive distribution and license rights to the [Helsinn Group](/source/Helsinn_Group)'s drug [anamorelin](/source/Anamorelin) in Spain, Portugal, Angola, and Mozambique.[8]

In 2015, Bial commissioned a [contract research organization](/source/Contract_research_organization), Biotrial, to run a [phase one](/source/Phases_of_clinical_research) [clinical trial](/source/Clinical_trial) for [BIA 10-2474](/source/BIA_10-2474), an [FAAH](/source/FAAH) inhibitor[9] that targets the [endocannabinoid system](/source/Endocannabinoid_system).[10] The research in [Rennes](/source/Rennes) 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 at [Rennes University Hospital](/source/Rennes_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 the [Military Order of Saint James of the Sword](/source/Military_Order_of_Saint_James_of_the_Sword).[14]

## References

1. [BIAL INOVACAO RDI II](http://www.eib.org/projects/pipeline/2015/20150078.htm) European Investment Bank, 7 April 2015, retrieved 19 January 2016.

1. [Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix](http://www.prnewswire.co.uk/news-releases/eisai-and-bial-announce-partnership-agreement-for-the-european-commercialisation-of-the-novel-once-daily-anti-epileptic-zebinixr-153037325.html) PRNewswire, February 19, retrieved 19 January 2016

1. ["FDA approves Aptiom to treat seizures in adults"](https://web.archive.org/web/20131109091739/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374358.htm). [US FDA](/source/US_FDA). 8 November 2013. Archived from [the original](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374358.htm) on November 9, 2013.

1. [Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain](https://web.archive.org/web/20160125230348/https://clinicaltrials.gov/ct2/show/study/NCT01129960) Clinical trials.gov, U.S. National Institutes of Health, July 17, 2014, retrieved 19 January 2016

1. 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](https://doi.org/10.2165/11586310-000000000-00000). [PMC 3585840](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3585840). [PMID 21171669](https://pubmed.ncbi.nlm.nih.gov/21171669)

1. 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](https://doi.org/10.1097/01.hjh.0000420843.24708.5e). [S2CID 74785134](https://api.semanticscholar.org/CorpusID:74785134)

1. 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](https://doi.org/10.1111/bcp.12081). [PMC 3853535](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853535). [PMID 23336248](https://pubmed.ncbi.nlm.nih.gov/23336248)

1. [Helsinn Group inks pact with BIAL for distribution, licence of Anamorelin in Spain, Portugal, Angola & Mozambique](http://www.pharmabiz.com/ArticleDetails.aspx?aid=90468&sid=2) [Archived](https://web.archive.org/web/20160126233846/http://www.pharmabiz.com/ArticleDetails.aspx?aid=90468&sid=2) January 26, 2016 at the Wayback Machine pharmabiz.com, Saffron Media Pvt., 9 September 2015, retrieved 19 January 2016

1. Reuters Editorial (15 January 2016). ["BRIEF-Bial says firmly committed to ensure wellbeing of test participants"](https://www.reuters.com/article/idUSL8N14Z3VU). *Reuters*

1. Reuters Editorial (15 January 2016). ["Bial is maker of trial drug that hospitalised six volunteers - French minister"](https://www.reuters.com/article/france-health-test-minister-idUSP6N0ZI01Y). *Reuters*

1. Lizzie Dearden (15 January 2016). ["France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record"](https://www.independent.co.uk/news/world/europe/france-clinical-trial-prosecutors-investigating-accident-as-biotrial-defends-drug-testing-safety-a6814641.html). *The Independent*

1. ["France clinical trial: 90 given drug, one man brain-dead"](https://www.bbc.com/news/world-europe-35320895). *BBC News*. BBC News. 2016-01-15.

1. BISSERBE, NOEMIE. ["French drug trial for Bial leaves one person brain dead, four in hospital"](http://www.theaustralian.com.au/business/wall-street-journal/french-drug-trial-for-bial-leaves-one-person-brain-dead-four-in-hospital/news-story/e35d9856e0eaf7566209c10b7b6f4910). The Australian.

1. ["ENTIDADES NACIONAIS AGRACIADAS COM ORDENS PORTUGUESAS - Página Oficial das Ordens Honoríficas Portuguesas"](https://www.ordens.presidencia.pt/?idc=153&list=1). *www.ordens.presidencia.pt*. Retrieved 2024-10-31.

## External links

- [Bial](http://www.bial.com/en/)

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Adapted from the Wikipedia article [Bial](https://en.wikipedia.org/wiki/Bial) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Bial?action=history)). Available under [Creative Commons Attribution-ShareAlike 4.0 International](https://creativecommons.org/licenses/by-sa/4.0/). Changes may have been made.