Orexo reports positive results from phase I study for OX19

Orexo reports positive results from phase I study for OX19 

Data from a phase I study confirms that Orexo's new nasal spray formula for the
administration of the desmopressin peptide for incontinence, shows significantly
better uptake than nasal sprays currently on the market. Next step for Orexo is
to seek partnership for further development of the product.

Many elderly people suffer from nocturia and in particular amongst women,
incontinence is a common problem. Treatment with the peptide desmopressin is
currently the most effective treatment for many of these patients. 

Orexo's ambition is to develop improved drug formulations of desmopressin for a
more efficient treatment of nocturia and incontinence. Orexo has developed a new
nasal spray formulation for the administration of desmopressin, and results from
a recently completed phase I study confirm significantly better absorption for
the new nasal spray formulation than for current nasal spray on the market. 

In the clinical study, Orexo compared its new nasal powder spray with a current
liquid nasal spray in 13 healthy volunteers. 
The study showed that the uptake of desmopressin into the blood stream was three
times higher than that of the current liquid nasal spray, with no delay in time
to reach maximal plasma concentration. The drug concentrations in the blood
showed lower variability compared to the reference product. Reduced variability
is essential for a reproduceable effect. The study also showed excellent
tolerance of both spray formulations and no unexpected adverse events. 

The study also included a sublingual tablet formulation. However, the
bioavailability of desmopressin did not increase enough to reach the primary
objective for the sublingual tablet formula. 

“We are pleased with the results of the study. Next step will be to seek a
partner for the continued development of the nasal powder formulation of
desmopressin.”, says Torbjörn Bjerke, President and CEO, Orexo AB.

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 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).  

www.orexo.com