Sublinox registration application submitted to the FDA

Sublinox registration application submitted to the FDA

The registration application for Sublinox has been submitted to the US Food and
Drug Administration (FDA). Sublinox (treatment of insomnia) contains zolpidem, a
well-documented active substance, which is one of the world's most used
substances for this disorder. Sublinox uses a unique, patented sublingual tablet
formulation for fast, effective absorption. A recent phase III study confirmed
that Sublinox gave faster onset of action than other zolpidem tablet
formulations. 

On 14 April, Meda acquired exclusive worldwide rights to Sublinox from Orexo, a
Swedish pharma company. The greatest Sublinox sales potential is in the US,
where Meda has its own marketing subsidiary, Meda Pharmaceuticals Inc. Market
launch can be initiated after regulatory approval by the FDA. The submission to
the FDA does not trigger a milestone payment to Orexo.


For more information, please contact:

Anders Larnholt, Investor Relations, tel. +46 709 458 878 or +46 8 630 19 62
email: anders.larnholt@meda.se

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.