Orexo shows positive results in completed comparative Phase III profile study of the Sublinox™ sleep aid involving insomnia patients

Orexo shows positive results in completed comparative Phase III profile study of
the Sublinox™ sleep aid involving insomnia patients

Orexo has completed a pharmocological profile study for Sublinox™ (OX22) - for
treatment of temporary sleeping disturbances. The study shows that Sublinox™
(OX22) acts 30 percent faster than Ambien® as a sleep aid for patients suffering
from sleep disturbances. The study also shows that patients remain asleep
throughout the night and strengthens existing documentation that Sublinox™
(OX22) represents a safe and effective treatment for temporary insomnia.

The completed effects study, combined with additional clinical documentation
produced by Orexo, will serve as the basis for the registration application that
Orexo plans to submit to the FDA later this year. 

“The recently completed profile study confirms what we presented at the APSS
(Associated Professional Sleep Societies) conference in Salt Lake City, Utah in
the US - that Sublinox™ (OX22) is a fast-acting sleep aid that allows patients
to sleep throughout the night without increased “day-after” residual effects,”
says Zsolt Lavotha, President and CEO of Orexo AB. “The results of the study
show that our product shortens sleep induction by more than 30 percent compared
with Ambien®, which in combination with the expected safety profile, represents
a significant competitive advantage over existing sleep products. We will be
intensifying ongoing discussions with licensing partners.”

Sublinox™ (OX22), which contains the well-documented substance zolpidem, 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.

For further information, please contact: 

Zsolt Lavotha, President and CEO 
Tel.: +46-18 780 88 12 
E-mail: zsolt.lavotha@orexo.com

Claes Wenthzel, Executive Vice President and CFO 
Tel: +46-18 780 88 44 
E-mail: claes.wenthzel@orexo.com


TO THE EDITORS

About Orexo 
Orexo is a pharmaceutical company which focuses on identifying suboptimal
therapeutic characteristics of existing products and developing more efficient
and effective delivery methods for them. By combining approved active substances
with Orexo´s drug delivery technologies it is possible to significantly enhance
their therapeutic value, such as providing quicker onset of action or ease of
administration. This business model is aimed at bringing products to market
faster with lower development risk and costs. 

Orexo, which has its global headquarters and development laboratories in Sweden,
currently operates across the world through development, licensing and
distribution agreements in all major markets. 

Orexo has a balanced portfolio with two products on the market, three in
registration and/or late stage clinical phase, one in clinical phase I and one
under formulation development. 

Orexo is listed on the OMX Nordic List Mid Cap (ticker;ORX). 
www.orexo.com

About insomnia 
Sleep is vital. It´s during sleep the body recovers and the brain works with and
stores information. Most part of all learning takes place during sleep. Besides,
the stress hormone cortisol is reduced during sleep. 

Lack of sleep leads to stress, which in turn leads to poorer sleep and can lead
to anxiety, less pain resistance and as an extension, to depression. At loss of
sleep the ability to among others, perform activities of daily life demanding
attention, thinking or make decisions, are influenced. Other effects of lack of
sleep are, for example, shifts of temper, difficulties with coordination and
ache. 

About Orexo´s oral sublingual tablet formulation 
Orexo´s sublingual tablet technology combines fast disintegration and
dissolution in the oral cavity with rapid, site-specific absorption of the
active substance across the sublingual mucosa. 

When administered, the tablet is placed under the tongue where it rapidly
disintegrates into ordered mucoadhesive units of the active substance. Orexo
believes that the rapid and reproducible absorption of the active substance
makes the dosage form ideal for treatment of conditions requiring immediate
onset of effect.