Swedish Orphan Biovitrum AB (Sobi™) today announces that the company has entered into a 3-year agreement with Valeant Pharmaceuticals Ireland for the distribution of Ammonul® (sodium phenyl acetate and sodium benzoate) injection in Europe, the Middle East and North Africa. The new agreement replaces the current distribution agreement with Valeant Pharmaceuticals North America LLC for the same territory. Under the new agreement, Sobi will have exclusive rights and license for sales and distribution of Ammonul in Europe, the Middle East and North Africa until 31 December 2019 for named patient use (NPU) programmes.
“We are very pleased to extend our long-term partnership with Valeant to continue to provide access to Ammonul in the territory,” says Alan Raffensperger, Chief Operating Officer at Sobi. “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”.
Ammonul is approved by the US Food and Drug Administration (FDA) for the treatment of acute Urea Cycle Disorders (UCDs). The product is not registered in the European Union, Middle East or North Africa but is only available under NPU programmes.
Ammonul is approved in the US and indicated as adjunctive therapy in paediatric and adult patients for the treatment of acute hyperammonaemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonaemic episodes, ammonia-lowering therapies should be considered. For full safety information please see fda.gov.