Valeant Pharmaceuticals has entered into a three-year agreement through its Ireland subsidiary with Swedish Orphan Biovitrum (Sobi) for the distribution of Ammonul (sodium phenyl acetate and sodium benzoate) injection, a drug for treating acute urea cycle disorders (UCDs), in Europe, the Middle East, and North Africa.

This new agreement replaces the current distribution agreement between Sobi and Valeant Pharmaceuticals North America 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 December 31, 2019 for named patient use (NPU) programs.

Ammonul is approved by the US Food and Drug Administration as adjunctive therapy in pediatric and adult patients for treating acute UCDs, including acute hyperammonemia and associated encephalopathy, but the product is not registered in the European Union, Middle East, or North Africa and is only available under NPU programs.

Source: Swedish Orphan Biovitrum