Healthcare firm Swedish Orphan Biovitrum (Sobi) has entered a new three-year agreement with Valeant Pharmaceuticals Ireland to distribute Ammonul (sodium phenyl acetate and sodium benzoate) injection in Europe, the Middle East and North Africa.
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An existing agreement with Valeant Pharmaceuticals North America for the same territory is replaced by the new agreement.
Under the latest agreement, Sobi will receive exclusive rights and a licence for sales and distribution of the injection for named patient use (NPU) programmes within the countries until 31 December 2019.
Sobi chief operating officer Alan Raffensperger said: "We are very pleased to extend our long-term partnership with Valeant to continue to provide access to Ammonul in the territory.
"This agreement complements Sobi's portfolio within the area of Urea Cycle Disorders and creates a wider range of treatment alternatives for patients suffering from these rare conditions."
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By GlobalDataValeant has obtained the US Food and Drug Administration (FDA) approval for the use of Ammonul as an adjunctive therapy in paediatric and adult patients to treat acute hyperammonaemia.
The product has also secured FDA approval for the treatment of associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.
It is only available under NPU programmes and is yet to be registered in the European Union, Middle East and North Africa.
Sobi primarily develops therapies and services for haemophilia, inflammation and genetic diseases. The firm also markets specialty and rare disease products for partner companies.
Image: Alan Raffensperger, Sobi chief operating officer. Photo: courtesy of Sobi.
