Orexo announces results confirming the clinical profile of OX17 in reflux disease (GERD)

Orexo announces results confirming the clinical profile of OX17 in reflux
disease (GERD)

New clinical data from a phase II study confirms the competitive profile of
Orexo's product OX17 in GERD patients, i.e. fast, effective and sustained
inhibition of gastric acid production, a prerequisite for effective symptom
relief in the patient. The result demonstrates the clinical potential of OX17
and is an important step in the development of a competitive product.

GERD, gastroesofageal reflux disease, is a common ailment in the Western world.
Orexos product OX17 combines the advantages (rapid onset and sustained duration
of effect) of two existing treatments and therefore has the potential to become
an important alternative in the treatment of reflux disease. OX17 is a
combination of two well-known active substances both inhibiting the secretion of
gastric acid; a H2 receptor antagonist (famotidine) and a proton pump inhibitor
(omeprazole). 

In a controlled clinical trial with 59 GERD patients treated for 14 days, the
anti-secretory effect of OX17 was compared to omeprazole and famotidine. The
study was performed at Sahlgrenska university hospital in Gothenburg and
Berzelius Clinical Research Center in Linköping, Sweden. 
The primary endpoint was fulfilled: OX17 significantly reduces the acid
production compared to omeprazole day 1. The time with pH>4 the first 12 hours
after dosing was  on average 60% longer with OX17 compared to omeprazole.
(p<0.05).  After 14 days treatment, the time with gastric pH above 4 was twice
as long as after treatment with famotidine.  The patients need for rescue
medication (antacids) during the 14 day study period was considerably lower for
OX17 compared to both famotidine and omeprazole indicating good control of GERD
symptoms.

“The results confirm that OX17 has a favorable and unique clinical profile for a
drug intended for the treatment of GERD. This is an important strategic step in
our OX17-project, which further increases the project's commercial value. In
2006, the combined market for H2 receptor antagonists and proton pump inhibitors
amounted to some USD 27 bn”, said Torbjörn Bjerke, President and CEO of Orexo. 

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

TO THE EDITORS

About Orexo

Orexo is a specialty 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, and signed a 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).  

www.orexo.com