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 on 4 continents: Europe, America, Africa, and Asia.
Financing
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
In 2008, Bial completed a 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 that 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's 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 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.[14]
External links
References
- BIAL INOVACAO RDI II European Investment Bank, 7 April 2015, retrieved 19 January 2016.^
- 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^
- FDA approves Aptiom to treat seizures in adults US FDA, 8 November 2013^
- Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain Clinical trials.gov, U.S. National Institutes of Health, July 17, 2014, retrieved 19 January 2016^
- 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^
- Bruno Igreja, Nuno Pires, Lyndon Wright, Patrício Soares-Da-Silva. Abstract 291: Antihypertensive Effect Of BIA 5-1058, a New Selective Peripheral Dopamine β-hydroxylase Inhibitor Journal of Hypertension, 2012^
- José Francisco Rocha, Luis Almeida, Amílcar Falcão, P. Nuno Palma, Ana I. Loureiro, Roberto Pinto, Maria João Bonifácio, Lyndon C. Wright. 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, November 2013^
- 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^
- Reuters Editorial. BRIEF-Bial says firmly committed to ensure wellbeing of test participants Reuters, 15 January 2016^
- Reuters Editorial. Bial is maker of trial drug that hospitalised six volunteers - French minister Reuters, 15 January 2016^
- Lizzie Dearden. France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record The Independent, 15 January 2016^
- France clinical trial: 90 given drug, one man brain-dead BBC News, BBC News, 2016-01-15^
- NOEMIE BISSERBE. French drug trial for Bial leaves one person brain dead, four in hospital The Australian^
- ENTIDADES NACIONAIS AGRACIADAS COM ORDENS PORTUGUESAS - Página Oficial das Ordens Honoríficas Portuguesas www.ordens.presidencia.pt, retrieved 2024-10-31^