The NDA for BEMA Fentanyl submitted in the US

The NDA for BEMA Fentanyl submitted in the US

Today, the NDA (New Drug Application) for BEMA Fentanyl was submitted to the FDA
(Food and Drug Administration) in the US. 

Meda has exclusive rights to the specialty product BEMA Fentanyl in the US,
Europe, Canada and Mexico.

BEMA Fentanyl, inlicensed from BioDelivery Sciences International Inc (BDSI), is
patented with a unique delivery system designed to give rapid and reliable
delivery of fentanyl for treatment of breakthrough pain in cancer patients. The
product consists of a small, dissolvable, polymer disc, formulated with the
opioid narcotic fentanyl, for application to the buccal (inner lining of cheek)
membranes. BEMA Fentanyl has shown in clinical studies important patient
advantages compared to competing products.

“Our ambition with this unique product within the breakthrough cancer pain
indication is to reach well over USD 200 million in yearly sales in the US only.
Our US marketing organisation has good experience in the pain area and is well
acquainted with the target group.”, says Anders Lonner, CEO Meda AB


For more information, please contact:

Anders Larnholt, Investor Relations, tel. +46 709 458 878

MEDA AB (publ) is an international specialty pharma company that concentrates on
marketing and market-adapted product development. Acquisitions and long-term
partnerships are fundamental factors that drive the company's strategy. Meda is
represented with own organisations in 26 countries and with more than 1 500
employees within marketing and sales. Meda's products are sold in approximately
120 countries world-wide. The Meda share is listed under Large Cap on the OMX
Nordic Stock Exchange. Find out more, visit www.meda.se.