Orexo has submitted the registration application (NDA) for Sublinox™ (OX22) to the FDA on May 14 2008

Orexo has submitted the registration application (NDA) for Sublinox™ (OX22) to
the FDA on May 14 2008

Sublinox™ (OX22), for treatment of short term insomnia, contains the
well-documented substance zolpidem, and is based on Orexo's sublingual
technology involving a tablet placed under the tongue. 

This 505 (b) (2) NDA which is based on the clinical data completed October 2007.
This data  shows unique properties for Sublinox™ (OX22) in insomnia patients,
including an earlier onset of sleep as compared to Ambien®. In addition to the
earlier onset of sleep, the data also shows maintenance of sleep throughout the
night.  Sublinox™ (OX22) also offers a more convenient way of administration
compared to oral tablets since it does not need to be swallowed with water. The
first evaluation will take about two months and FDA will thereafter decide if
the file is accepted for final evaluation.

Meda AB acquired the exclusive world-wide commercialization rights Sublinox™
(OX22) on April 14, 2008.
“This is an important first step to get Sublinox™ (OX22) out on the world market
and we are proud of this accomplishment” said Torbjörn Bjerke, Orexo's President
and CEO. 

For more information, please contact: 
Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708-66 19 90
E-mail: torbjorn.bjerke@orexo.com

Claes Wenthzel, Executive Vice President & CFO, Orexo AB 
Tel: +46 (0)18-780 88 44 
E-mail: claes.wenthzel@orexo.com


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. 

To date, Orexo have out-licensed the market rights for Rapinyl for the US, the
EU and Japan markets, the world-wide market rights for Sublinox (OX22) and
OX-NLA, and a out-license and research collaboration with Boehringer Ingelheim
regarding the development of a new class of drugs to treat pain and
inflammation. Also, Orexo has established a Nordic sales force by entering into
a joint venture with ProStrakan.

Orexo has head office in Uppsala and is listed on the OMX Nordic Exchange
Stockholm, Small Cap (ticker: ORX).  
Find out more, visit www.orexo.com

About Meda 

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 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.