Bial Explained

Portela e C.ª, S.A.
Type:Sociedade Anónima
Foundation:April 19, 1924
Location:Trofa, Portugal
Key People:António Horta Osório, Chairman (Appointed from April, 2021 onwards)
Num Employees:924 (2018)
Industry:Major drugs, health care
Products:Pharmaceuticals
Homepage:www.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

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 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]

External links

Notes and References

  1. http://www.eib.org/projects/pipeline/2015/20150078.htm BIAL INOVACAO RDI II
  2. 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 Eisai and Bial Announce Partnership Agreement for the European Commercialisation of the Novel Once Daily Anti-Epileptic Zebinix
  3. News: FDA approves Aptiom to treat seizures in adults. US FDA. 8 November 2013.
  4. https://web.archive.org/web/20160125230348/https://clinicaltrials.gov/ct2/show/study/NCT01129960 Eslicarbazepine Acetate as Therapy in Diabetic Neuropathic Pain
  5. 10.2165/11586310-000000000-00000. 21171669. 3585840. 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. November 2010. Nunes. Teresa. Rocha. José F.. Vaz-Da-Silva. Manuel. Igreja. Bruno. Wright. Lyndon C.. Falcão. Amílcar. Almeida. Luis. Soares-Da-Silva. Patricio.
  6. 10.1097/01.hjh.0000420843.24708.5e. Abstract 291: Antihypertensive Effect Of BIA 5-1058, a New Selective Peripheral Dopamine β-hydroxylase Inhibitor. Journal of Hypertension. 30. e236–e237. 2012. Igreja. Bruno. Pires. Nuno. Wright. Lyndon. Soares-Da-Silva. Patrício. 74785134 . free.
  7. 10.1111/bcp.12081. 23336248. 3853535. 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. November 2013. 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.
  8. http://www.pharmabiz.com/ArticleDetails.aspx?aid=90468&sid=2 Helsinn Group inks pact with BIAL for distribution, licence of Anamorelin in Spain, Portugal, Angola & Mozambique
  9. Web site: BRIEF-Bial says firmly committed to ensure wellbeing of test participants. Reuters Editorial. 15 January 2016. Reuters.
  10. Web site: Bial is maker of trial drug that hospitalised six volunteers - French minister. Reuters Editorial. 15 January 2016. Reuters.
  11. Web site: France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record. Lizzie Dearden. 15 January 2016. The Independent.
  12. News: France clinical trial: 90 given drug, one man brain-dead. BBC News. BBC News. 2016-01-15.
  13. News: BISSERBE. NOEMIE. French drug trial for Bial leaves one person brain dead, four in hospital. The Australian.