Salix is required to make an up-front payment and regulatory milestone payments to Dr Falk Pharma, with the majority contingent upon achievement of US regulatory approval. In addition, Salix will pay royalties on net sales.
The products are approved and marketed in Europe, in the UK and Germany. In the US the rectal foam and gastro-resistant capsule products have patent coverage until 2015 and 2016, respectively.
Dr Falk Pharma markets budesonide in the UK as Budenofalk 2mg rectal foam for the treatment of distal active ulcerative colitis and as Budenofalk 3mg Gastro-resistant capsules for the induction of remission of mild to moderate active Crohn’s disease.