First combination of NSAID and proton pump inhibitor approved

First combination of NSAID and proton pump inhibitor approved  

The decentralised registration procedure for the combination product ketoprofen
and omeprazole has been finalised with a positive assessment. Ketoprofen is a
NSAID (Non Steroidal Anti-Inflammatory Drug) for the treatment of rheumatic
disorders and omeprazole is an acid reducing proton pump inhibitor (PPI). Both
substances are well known and broadly used. Co-prescription of NSAIDs and PPIs
as single substances represent a market of around SEK 3 billion in Europe. 

”We are very pleased to announce registration approval for this first
combination product of a NSAID and a PPI. This product prevents gastrointestinal
side effects from use of NSAIDs. The once daily administration increases patient
compliance”, said Anders Lönner, Meda's CEO.

The product is patent protected and uses a capsule formulation for ketoprofen
sustained-release granulate and omeprazole enteric-coated granulate. The product
was filed for registration using the decentralised procedure on certain key
European markets; Italy, Spain, Germany, Portugal, Poland and the UK. The
decentralised part of the procedure has now been finalised, and it's expected
that the decision of the reference authority in the UK will be adopted in most
of these countries. Thereafter, national phases will follow that include local
adoption of labelling texts and summary of products characteristics and
reimbursement / pricing approval. This is expected to take nine to twelve months
which would enable launch during fourth quarter 2009. Registration processes in
other European countries will start in parallel.


For more information contact:

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

MEDA AB (publ) is a leading international specialty pharma company. The company
specialises in marketing and pharmaceutical development in late clinical stage.
Acquisitions and long-term partnerships are fundamental factors that drive the
company's strategy. Meda is represented by its own organisations in about 40
countries. Meda's products are sold in 120 countries worldwide. The Meda share
is listed under Large Cap on the OMX Nordic Stock Exchange. Find out more, visit
www.meda.se.