Bial

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Portela e C.ª, S.A.
Sociedade Anónima
IndustryMajor drugs, health care
FoundedApril 19, 1924
HeadquartersTrofa, Portugal
Key people
António Portela, CEO
ProductsPharmaceuticals
Number of employees
924 (2018)
Websitewww.bial.com

Bial (Portela e C.ª, S.A.) is a pharmaceutical company headquartered in São Mamede do Coronado, in Trofa, 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 in 4 continents: Europe, America, Africa and Asia.

Financing[edit]

On 21 September 2015, the 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, and therefore Bial has not been subject to EU rules on public procurement.[1]

Research and products[edit]

In 2008, Bial completed clinical evaluation of eslicarbazepine acetate, a drug for the adjunctive use in partial seizures in adults with epilepsy. The Japanese company Eisai gained the sole license to market, promote and distribute it as Zebinix or Exalief in Europe.[2] In America it is marketed by 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 (BIA 5–453) is a dopamine-β-hydroxylase inhibitor decreasing 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 inhibitor which decreases norepinephrine levels in peripheral sympathetically innervated tissues, without CNS effects.[6]

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

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

In 2015, Bial commissioned a contract research organization Biotrial to run a phase one clinical trial for BIA 10-2474, an FAAH inhibitor[9] that targets the endocannabinoid system.[10] The research in 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 on 10 January, leading Biotrial to suspend the study on 11 January. Five patients were hospitalized, with the first one receiving the multiple dose becoming brain dead.[11][12][13]

References[edit]

  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.
  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.
  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 & Mozambique Archived January 26, 2016, at the Wayback 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.
  10. ^ Reuters Editorial (15 January 2016). "Bial is maker of trial drug that hospitalised six volunteers - French minister". Reuters.
  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.

External links[edit]