Orphalan S.A
| Company type: | Private |
| Industry: | Biotechnology[1] |
| Founded: | 2011[1] |
| Headquarters: | Paris, France[1] |
| Key people: | Naseem Amin (Chief Executive Officer)[1]
Shahzad Malik (Chairman of the Board)[1] |
| Product: | Trientine tetrahydrochloride/盐酸曲恩汀 (Cuprior/Cuvrior/科佩欧)[2][3][4][5] |
| Number of employees: | 125 |
| Website: | https://www.orphalan.com/ |
== Company summary ==
Orphalan S.A. is an international orphan drug development and commercialization company headquartered in Paris, France, which specializes in the development of treatments for patients with rare diseases..[6][1]
Its trientine tetrahydrochloride (盐酸曲恩汀) product, (branded as Cuprior in the EU[2] and some key markets, Cuvrior in the USA[4] and 科佩欧 (Ke Pei Ou) in China[5]) is a treatment for Wilson’s disease, which is available in over 30 countries.[1]
History
Orphalan S.A. was founded in 2011.[1]
In March 2016, trientine tetrahydrochloride (brand name Cuvrior in the USA) was granted orphan drug designation in the USA by the Food and Drug Administration (FDA) for the indication: treatment of Wilson's disease excluding patients intolerant to penicillamine.[7]
In September 2017, the European Medicines Agency (EMA) granted marketing authorization for trientine tetrahydrochloride (brand name Cuprior)[3] for the treatment of Wilson's disease in adults, adolescents and children ≥5 years intolerant to D-penicillamine therapy.[2]
In October 2017, Naseem Amin joined Orphalan as Chief Executive Officer.
In 2019, trientine tetrahydrochloride was launched commercially in the EU[8]
In 2021, the International Wilson Disease (iWD) Registry was established (a centralized database that is sponsored and managed by Orphalan SA).[9][6] This includes health data from consenting people with Wilson’s disease from various countries around the world.[9][6]
In April 2022, trientine tetrahydrochloride (brand name Cuvrior in the USA) was approved by the FDA and granted Orphan Drug Exclusivity (ODE).[10] as a copper chelator indicated for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine, based on results from the CHELATE trial[10]
In September 2022, results from the CHELATE trial were published in The Lancet Gastroenterology & Hepatology.[11][12]
In November 2022, Shahzad Malik was appointed Chairman of the Orphalan Board.
In April 2023, trientine tetrahydrochloride was launched commercially in the USA.[8]
In December 2023, China’s National Medical Products Administration (NMPA) approved trientine tetrahydrochloride (盐酸曲恩汀, brand name 科佩欧) for the treatment of Wilson’s disease in adults, adolescents and children ≥5 years intolerant to D-penicillamine therapy.[5][13][14]
In March 2025, trientine tetrahydrochloride was launched commercially in China.[5]
Products
Trientine tetrahydrochloride, a copper-chelating agent for the treatment of Wilson’s disease.[2][4]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 "About Us". Orphalan SA. Retrieved 2025-11-13.
- ↑ 2.0 2.1 2.2 2.3 "Cuprior | European Medicines Agency (EMA)". www.ema.europa.eu. 2017-09-05. Retrieved 2025-11-13.
- ↑ 3.0 3.1 "Cuprior | European Medicines Agency (EMA)". www.ema.europa.eu. 2017-09-05. Retrieved 2025-11-27.
- ↑ 4.0 4.1 4.2 "DailyMed - CUVRIOR- trientine tetrahydrochloride tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2025-11-27.
- ↑ 5.0 5.1 5.2 5.3 Kothari, Minesh (2025-03-07). "Orphalan becomes the first European company to enter in China's Wilson Disease market". Orphalan SA. Retrieved 2025-11-13.
- ↑ 6.0 6.1 6.2 "Our Work". Orphalan SA. Retrieved 2025-11-13.
- ↑ "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Archived from the original on 2025-04-16. Retrieved 2025-11-13.
- ↑ 8.0 8.1 admin (2023-04-20). "Orphalan announces US commercial launch of Cuvrior™ for the treatment of Wilson disease". Orphalan SA. Retrieved 2025-11-13.
- ↑ 9.0 9.1 "Home". Wilson's Disease Registry. Retrieved 2025-11-13.
- ↑ 10.0 10.1 admin (2022-05-02). "Orphalan announces FDA approval of Cuvrior™ for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine". Orphalan SA. Retrieved 2025-11-27.
- ↑ Schilsky, Michael L.; Czlonkowska, Anna; Zuin, Massimo; Cassiman, David; Twardowschy, Carlos; Poujois, Aurelia; Gondim, Francisco de Assis A.; Denk, Gerald; Cury, Rubens G.; Ott, Peter; Moore, Joanna; Ala, Aftab; D'Inca, Renata; Couchonnal-Bedoya, Eduardo; D'Hollander, Koenraad (2022-12). "Trientine tetrahydrochloride versus penicillamine for maintenance therapy in Wilson disease (CHELATE): a randomised, open-label, non-inferiority, phase 3 trial". The Lancet. Gastroenterology & Hepatology. 7 (12): 1092–1102. doi:10.1016/S2468-1253(22)00270-9. ISSN 2468-1253. PMID 36183738 Check
|pmid=value (help). Check date values in:|date=(help) - ↑ Kothari, Minesh (2022-09-30). "Orphalan announces publication of results from the CHELATE trial in The Lancet Gastroenterology & Hepatology". Orphalan SA. Retrieved 2025-11-27.
- ↑ admin (2024-01-18). "Orphalan announces China NMPA's approval of its trientine tetrahydrochloride product for the treatment of Wilson disease". Orphalan SA. Retrieved 2025-11-27.
- ↑ "国家药品监督管理局". www.nmpa.gov.cn. Archived from the original on 2025-06-12. Retrieved 2025-11-27.
Category:Companies Category:Biotechnology Category:Orphan drugs
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