Orexo announces Phase IIa data on OX914 in rhinitis

Orexo announces Phase IIa data on OX914 in rhinitis

Orexo (NASDAQ-OMX: ORX) today reported clinical results from an experimental
phase IIa safety and efficacy study in allergic rhinitis with OX914, the first
compound in its Phosphodiesterase 4 (PDE4) inhibitor program. This program is
intended to produce therapeutic molecules for the treatment of inflammatory
airway diseases including rhinitis, asthma and chronic obstructive pulmonary
disease (“COPD”).

The trial data showed that treatment with 15 mg or 50 mg per day of OX914 did
not show a statistically significant reduction in patient symptom scores after
allergen provocation, compared with placebo treatment. OX914 was safe and
well-tolerated and, unlike most other PDE4 inhibitors, did not show any
increased evidence of nausea or vomiting compared with placebo. 

While this result shows that oral treatment with OX914 is not likely to be an
effective therapy in allergic rhinitis, no assessment can be made from this
result in respect of its efficacy against COPD. In light of the preclinical in
vivo evidence of efficacy and the molecule's strong safety and tolerability
profile, Orexo will continue its ongoing discussions with several potential
development partners for OX914 and the suite of back-up molecules in this series
for COPD and other non-respiratory inflammatory indications. 

Charlotte Edenius, Chief Scientific Officer and Head of Preclinical Research &
Development commented:  "Although we are disappointed that the lead molecule did
not meet its primary endpoint after oral treatment in this rhinitis study, we
remain confident that the PDE4 program contains very potent and targeted
inhibitors of PDE4, a clinically-validated target for both COPD and asthma. We
will continue with our partnering discussions for OX914 and the program for
various inflammatory indications.”


Trial Design

OX914 was tested in a double blind, three-way cross-over trial using an
experimental model of allergic rhinitis.  Over the course of three two-week
periods, 36 pollen-allergic patients were treated orally with 15 mg or 50 mg of
OX914 or placebo, and on days 7-13 of each treatment period, a daily allergen
challenge was given in the nose.  The resulting symptoms were estimated by the
patient themselves using a pre-defined scale. The primary variable was the
comparison of nasal symptoms, 10 minutes after allergen provocation, between 50
mg of OX914 and placebo. 

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 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. 

Product portfolio 
Commercialized products with distribution- and marketing agreements
Product Indication Status
AbstralTM/Rapinyl Breakthrough cancer pain Marketed in EU, Phase III in US and
Japan
Partnered with: ProStrakan, Gedeon Richter, Hospira, Kyowa Hakko Kirin, Neopharm
and NovaMed
EdluarTM Insomnia FDA approved Partnered with Meda
Diabact® UBT / Heliprobe®System Diagnosis - Helicobacter pylori	Marketed in EU
and other territories*
*Marketed through Kibion AB, subsidiary of Orexo

Projects with licensing agreements
Product Indication Development phase Partner(s)
OX-NLA Rhinitis Phase III-ready Meda
OX-MPI Pain, inflammation Pre-clinical development Boehringer Ingelheim

Prioritized projects for which licensing discussions have begun
Product Indication Development phase
OX17 GERD Phase II/III
OX914 COPD/Asthma Phase II
Arachidonic Acid Franchise (OX2477/OX-CLI) Asthma/COPD	Pre-clinical
OX641 Migraine Formulation
OX-PKX Various projects with the PharmaKodex platform Formulation
OX19 Incontinence Phase I 

Projects with potential for further development
OX219 Opioid addiction Ready for clinical studies
OX30 Chronic pain Pre-project

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 24, 2009 at 14.30 CET.