Draft:Orphalan S.A
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| Company type | Private |
|---|---|
| Industry | Biotechnology |
| Founded | 2011 |
| Headquarters | Paris, France |
Key people | Naseem Amin (Chief Executive Officer) Shahzad Malik (Chairman of the Board) |
| Products | Trientine tetrahydrochloride/盐酸曲恩汀 (Cuprior/Cuvrior/科佩欧) |
Number of employees | 125 |
| Website | www.orphalan.com |
Company Summary
[edit | edit source]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..[1][2]
Its trientine tetrahydrochloride (盐酸曲恩汀) product, (branded as Cuprior in the EU[3] 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.[2]
History
[edit | edit source]Orphalan S.A. was founded in 2011.[2]
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.[6]
In September 2017, the European Medicines Agency (EMA) granted marketing authorization for trientine tetrahydrochloride (brand name Cuprior)[7] for the treatment of Wilson's disease in adults, adolescents and children ≥5 years intolerant to D-penicillamine therapy.[3]
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][1] This includes health data from consenting people with Wilson’s disease from various countries around the world.[9][1]
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
[edit | edit source]Trientine tetrahydrochloride, a copper-chelating agent for the treatment of Wilson’s disease.[3][4]
References
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