Date: 2011-01-11
Type of information:
Compound: Orfadin® (nitisinone)
Company: Swedish Orphan Biovitrum (Sweden) BL&H Co Ltd (Better Life & Health) (South Korea)
Therapeutic area: Rare diseases
Type agreement: Distribution
Action mechanism:
Disease: tyrosinaemia type 1 (HT-1)
Details: The companies have signed a distribution agreement for the products Orfadin and Kepivance in South Korea Since, the South Korean Food and Drug Administration registration process is adapted to products already approved by the FDA or EMA, a registration and price reimbursement can be expected approximately one year from application. Sales on a named patient basis can be initiated already during 2011.
Financial terms: BL&H will pay Swedish Orphan Biovitrum (Sobi) an undisclosed transfer price for the products and will be responsible for registering the products in South Korea.
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