The agreement for exclusive rights to potential specialty blockbuster product in the US completed

On September 5th, Meda announced the exclusive license agreement with BioDelivery Sciences International Inc (BDSI) for marketing of a potential specialty blockbuster product in the US, Canada and Mexico. The product, BEMA Fentanyl, is patented with a unique delivery system designed to give rapid and reliable delivery of fentanyl for treatment of breakthrough pain in cancer patients. BEMA Fentanyl has shown in clinical studies important patient advantages compared to competing products, especially fewer side effects.

The agreement with BDSI was to become effective upon antitrust approval by the Federal Trade Commission (FTC). Meda has been informed by the FTC that this review will not be undertaken. The agreement with BDSI has therefore been completed and the collaboration starts with immediate effect. Filing for registration of BEMA Fentanyl with the FDA (Food and Drug Administration) is planned this year, giving a potential launch in late 2008.