Bial

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For other uses, see Bial (disambiguation).
Portela e C.ª, S.A.
Sociedade Anónima
Industry Major drugs, health care
Founded April 19, 1924
Headquarters Trofa, Portugal
Key people
Luís Portela, CEO
Products Pharmaceuticals
Number of employees
650 (2009)
Website www.bial.com

Bial (Portela e C.ª, S.A.) is a pharmaceutical company headquartered in Sao Mamede do Coronado, in Trofa, Porto district, Portugal. It was founded in 1924, being among the largest companies of its kind in Portugal.

Bial is an International Pharmaceutical Group[when?]. Its products are sold in pharmacies in more than 40 countries in 4 continents: Europe, America, Africa and Asia. Some of the group companies are: Laboratórios Bial, Medibial, Bialfar, Bialport, Bial Aristegui, Medimport and Medangol.

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 Helsinn for the exclusive distribution and license rights to Helsinn'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. ^ Acetate as Therapy in Diabetic Neuropathic Pain Clinical trials.gov, U.S. National Institutes of Health, July 17, 2014, retrieved 19 January 2016
  5. ^ Teresa Nunes, José F. Rocha, Manuel Vaz-da-Silva, Bruno Igreja, Lyndon C. Wright, Amílcar Falcão, Luis Almeida, Patricio Soares-da-Silva. 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, November 2010, Volume 10, Issue 4, pp 225-242. doi: 10.2165/11586310-000000000-00000. retrieved 19 January 2016
  6. ^ Igreja, Bruno; Pires, Nuno; Wright, Lyndon; Soares-da-Silva, Patrício [BIA 5-1058 is a new noncompetitive dopamine-β-hydroxylase inhibitor] Journal of Hypertension 30:e236-e23,·August 2012, DOI: 10.1097/01.hjh.0000420843.24708.5e. retrieved 19 January 2016
  7. ^ José Francisco Rocha, Luis Almeida, Amílcar Falcão et al. 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, Volume 76, Issue 5, pages 763–775, November 2013, DOI: 10.1111/bcp.12081, retrieved 19 January 2016
  8. ^ Helsinn Group inks pact with BIAL for distribution, licence of Anamorelin in Spain, Portugal, Angola & Mozambique 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. 
  13. ^ BISSERBE, NOEMIE. "French drug trial for Bial leaves one person brain dead, four in hospital". The Australian. 

External links[edit]