The FDA has accepted for filing the registration application for Sublinox

The FDA has accepted for filing the registration application for Sublinox

The submitted registration application for Sublinox has been accepted by the FDA
as complete for substantive review after initial evaluation. Sublinox contains
the well-known active substance zolpidem and is based on Orexo's sublingual
technology, involving a rapidly disintegrating tablet placed under the tongue.

Meda AB acquired the exclusive world-wide commercialization rights for Sublinox
on April 14, 2008. “This FDA's acceptance increases the chances for a
registration approval during 2009”, said Anders Lonner, CEO of Meda.
The data supporting the product includes a clinical study in insomnia patients
that was completed in October 2007. That study showed that Sublinox induced
sleep 30 percent earlier compared to Ambien and that patients remained asleep
throughout the night with comparable safety. 

“This is an important first step to get Sublinox out on the world markets”, said
Torbjörn Bjerke, Orexo's President and CEO.


For more information contact:
Meda AB 	Anders Larnholt, Vice President Investor Relations
Tel: +46 (0)709 458 878, E-mail: anders.larnholt@meda.se 
Orexo AB 	Claes Wenthzel, Executive Vice President & CFO, 
Tel: +46 (0)18-780 88 44, E-mail: claes.wenthzel@orexo.com



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 by its own organisations in 26 countries and has more than 1 500
employees within marketing and sales. Meda's products are sold in about 120
countries worldwide. The Meda share is listed under Large Cap on the OMX Nordic
Stock Exchange. Find out more, visit www.meda.se.

About Orexo
Orexo is a pharmaceutical company, focusing on development of new, patented
drugs by combining well-documented substances with innovative technologies, and
the development of new treatments for respiratory and inflammatory diseases.
Orexo has a broad and competitive late-stage product portfolio, including two
marketed products, five products in clinical phase and two undergoing
registration. Orexo has head office in Uppsala and is listed on the OMX Nordic
Exchange Stockholm, Small Cap (ticker: ORX) www.orexo.com.