Orexo's Edluar (Sublinox) receives FDA approval for the treatment of insomnia

Orexo's Edluar (Sublinox) receives FDA approval for the treatment of insomnia 

•	Meda expects to launch Edluar in the USA during 2nd half of 2009
•	Orexo receives a milestone payment of USD 5 million from Meda
•	Orexo's second major product approval in 12 months

Orexo (NASDAQ-OMX:ORX) today announces that the US Food and Drug Administration
(FDA) has approved Edluar (formerly Sublinox) 5 mg and 10 mg sublingual tablets
for the short-term treatment of insomnia characterized by difficulties with
sleep initiation. Orexo's partner Meda (NASDAQ-OMX: MEDA A) acquired the
exclusive worldwide commercialization license for Edluar last year and they
expect to launch the product in the US market during the 2nd half of 2009. Orexo
will receive royalties on Meda's sales of Edluar.

This approval triggers a milestone payment to Orexo from Meda. The amount of the
milestone is USD 5 million and is based upon the product labelling.

Commenting on the news Torbjörn Bjerke, CEO of Orexo, said “I am delighted that
the FDA has approved Edluar for the treatment of short-term insomnia. This is a
great achievement by Orexo. Edluar provides a convenient sublingual
administration and we believe that this offers insomnia sufferers an effective
alternative. This is the second product approved in a major market within 12
months and is an excellent achievement. The milestone payment and the
anticipated product launch during 2nd half of 2009 will continue Orexo's
progress towards profitability.”


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

Johan Andersson, Investor Relations Manager, Orexo 
Tel: +46 (o) 702-10 04 51 
E-mail: johan.andersson@orexo.com

Notes to Editors 

About Edluar
Edluar (formerly known as Sublinox) is a fast-acting, sublingual formulation of
the well-known substance zolpidem and has been approved for the temporary
treatment of insomnia. It is based on Orexo's sublingual technology, involving a
tablet placed under the tongue for fast and effective absorption of the active
substance across the oral mucosa. 

About Insomnia
Insomnia is the disturbance of a normal sleep pattern, characterized by the
inability to fall asleep, or to stay asleep long enough to get a proper night's
sleep. It is thought to affect 1 in 4 adults at some point during their lives.
According to the U.S. Department of Health and Human Services, approximately 64
million Americans suffer from insomnia on a regular basis each year. Insomnia
occurs 1.4 times more commonly in women than in men.

Insomnia can last for days, months or years and can be split into three
categories:

•	Transient insomnia, which lasts for 2-3 days
•	Short-term insomnia, which lasts for more than a few days, but less than three
weeks
•	Chronic insomnia, which can be defined as insomnia most nights for three weeks
or longer

About Orexo
Orexo is a pharmaceutical company focused on developing drugs for the treatment
of pain and inflammation. The company has three products on the market as well
as a competitive product portfolio in late stages of development. Sales and
product development are mainly carried out through worldwide partnership
agreements with larger pharmaceutical companies. Orexo has 128 employees, and
has its head office located in Uppsala, Sweden. 


Note:
This is information that Orexo AB (publ) is required to disclose pursuant to the
Swedish Securities Markets Act. The information was provided for public release
on March 16, 2009 at 08:30 CET.