Orexo announces positive results supporting OX219 for treatment of opioid dependence

Orexo announces positive results supporting OX219 for treatment of
opioid dependence

 

Uppsala, Sweden, September 21, 2011 - Orexo AB (STO: ORX) today
announced that it has obtained positive results in a clinical study with
OX219, which is being developed for the treatment of opioid dependence.
The study was designed to decide the commercial formulation and dose for
OX219.

Orexo has consulted with the FDA to define the optimal development path
for OX219, and will plan to pursue a final drug development and
registration path according to the 505 (b) (2) procedure. This enables
regulatory clearance based on documentation from an already approved
drug, in this case Suboxone®. It allows for Orexo to obtain an approval
without costly clinical efficacy and safety studies, and thus leads to a
much faster route to market.

“Since the program started about a year ago, the development of OX219
has been carried out at fast pace. With the clear study results now
obtained, we have reached another significant milestone of having
selected final commercial formulation and dose for the product,” said
Anders Lundström, President and CEO of Orexo. “This shows the strength
in our strategy to develop new proprietary drugs based on successful
therapies already in clinical use.”

The formulation chosen is based exclusively on Orexo's proprietary
developed sublingual technology. As a consequence of this a portion of
previously acquired technology, carried at a value of approximately MSEK
38 on the balance sheet, will be written off in Q3. The decision will
have no impact on liquid assets.

The goal of OX219 is to create a new, proprietary drug for the treatment
of opioid dependence. Orexo is conducting the clinical development
program in the U.S., which is the main market for the current
market-leading product for treatment of opioid dependence, Suboxone. The
global market for products for the treatment of opiate dependence is
currently 1.4 billion USD and is estimated to amount to 2.2 billion USD
in 2019 (Datamonitor, 2010).

OX219 is one of the three development programs that Orexo intends to
take all the way to market launch on its own. All of these programs are
based on already known substances that Orexo has reformulated, using the
sublingual route of administration. By working with already known
substances, Orexo expects to reduce development risk, shorten
development time and thereby lower cost.

 

For further information, please contact:
Anders Lundström, President and CEO, Orexo AB
Tel: +46 706 67 22 66
Email: anders.lundstrom@orexo.com (anders.lundstrom@orexo.com)

 

About Orexo
Orexo is a pharmaceutical company focusing on developing treatments for
pain and inflammation. The company has four commercialized products,
several projects developed in partnership as well as three proprietary
development programs. Orexo's registered products are Abstral® for the
treatment of break through cancer pain, sold by Kyowa Hakko
Kirin/ProStrakan Group plc. in Europe and in the USA, the sleeping pill
Edluar™, sold by Meda in the USA, as well as two products for the
diagnosis of Helicobacter pylori which are being marketed by the
subsidiary Kibion. More information can be found at
www.orexo.com (http://www.orexo.com/).

 

Note
Orexo AB (publ) discloses the information provided in this press release
pursuant to the Securities Markets Act. The information was provided for
public release on September 21, 2011 at 08:00a.m. CET. This press
release has been prepared in both Swedish and English. In the event of
any discrepancy in the content of the two versions, the Swedish version
shall take precedence.