Orexo launches next step in strategy, new development programs and announces change of CEO

Orexo launches next step in strategy, new development programs and
announces change of CEO

Uppsala, August 20, 2010 - Orexo AB's (STO: ORX) Board of Directors
today have launched the next step in its strategy to focus its business
model on deploying Orexo's well established and proven reformulation
technologies to develop new proprietary products targeted at the
Specialty Pharmaceutical market. As part of this strategy, Orexo has
initiated the first three development programs. The company intends to
commercialise these products through an Orexo-owned marketing and sales
organization, starting in one of the major markets EU or USA.

To optimise execution of this strategy, the company is seeking to add
leadership with broad international commercial experience. The company
has therefore initiated a search for a new Chief Executive Officer.
Torbjörn Bjerke will continue his leadership position as President and
Chief Executive of Orexo AB until a successor has been found. To
leverage Torbjörn Bjerke's successful history with the company and his
business development expertise, Orexo's two largest shareholders,
Healthcap and Novo A/S, will recommend the nomination committee of Orexo
to nominate him to become a non-executive director.

Chairman of the Board Håkan Åström commented: “Orexo has built detailed
knowledge of drug-formulation, clinical development and regulatory
approval processes, and has established itself as a high-quality
organisation with a track record of developing competitive products.
Until today, we have focused on out-licensing our products to
international partners.

Our successful partnership agreements with ProStrakan Group plc and
others related to AbstralTM, the recent alliance with
Ortho-McNeil-Janssen Pharmaceuticals and Janssen Pharmaceutica within
the areas of asthma and inflammatory diseases, the collaboration with
Boehringer Ingelheim within pain and inflammation, the agreement with
Meda regarding EdluarTM and OX-NLA, and the agreement with Novartis
within gastrointestinal disorders are important out-licensing
agreements, which represent significant potential financial value for
Orexo. The potential development milestones of these assets amount to
more than SEK 6 billion, not including sales milestones or royalties.
Torbjörn Bjerke's leadership has played an important role in completing
these agreements, and we are very pleased with his achievements during
his time as CEO of the company.

The Board of Directors today decided that future programs should be
aimed at developing proprietary products which Orexo intends to
commercialise itself, starting in one of the major markets; the EU or
the USA.  This will involve the building or acquisition of an
international sales organisation in order to retain more of the economic
value from sales of products developed by Orexo.

From an R&D perspective, the new strategy is fully aligned with the core
competences in Orexo, which have previously resulted in successful
development, regulatory approval and commercialization of several
products in EU and the US, of which AbstralTM is the most promising
today.

Current funds will support all the programs below through clinical Phase
I, and at least one of these programs through to approval, even in the
absence of additional milestones from partnered discovery and
development programs. Further development activities on currently
un-partnered programs will be discontinued.”

Three new development programs within specialty areas initiated
Orexo today announces that the first patients have been dosed in a Phase
I  clinical study with a proprietary reformulation product candidate,
OX219, directed towards treatment of opioid addiction. OX219 is an
improved version of the product candidate originally acquired with the
PharmaKodex transaction using Orexo proprietary technologies. This
product will compete in the opioid addiction market which is today worth
an estimated US$ 1.4 billion globally and is currently dominated by
Suboxone®. Results from the initial study will be communicated during
the fourth quarter along with further details of the development
program.

Later this year a Phase I clinical trial of a second reformulation
program, OX51, will be initiated aiming at treatment and prevention of
acute intense pain episodes in opioid-tolerant and opioid-naïve patients
treated in the hospital setting. This program addresses a market
opportunity of approximately 100 million acute intense pain episodes in
Europe and the USA. Results from the initial clinical trial of this
program will be communicated during the first quarter of 2011 along with
further details of the development program.

Finally, Orexo also announces today progress of a third new
reformulation program, OX27, directed towards the treatment of
breakthrough pain in cancer patients, which will reach clinical Phase I
early in Q1-2011. The program, built on Orexo's experience and expertise
in developing AbstralTM, will aim to provide further clinical benefits,
and thereby advance the treatment of breakthrough pain for cancer
patients further.  This market amounts to approximately US$ 1.5 billion
in the EU and the USA. AbstralTM constitutes a leading brand on the EU
markets where it is available today. Results from this program will be
communicated during the second quarter of 2011 along with further
details of the development program.

Orexo owns all commercial rights to OX219, OX51 and OX27 globally.

All three new development programs are based on the proprietary Orexo
sublingual tablet formulation technologies and know-how originally
developed for AbstralTM and EdluarTM. Further technology improvements,
which for example enable taste improvements, faster and more controlled
absorption and lower inter- and intra-patient variability, are also
being deployed.

Orexo's President and CEO Torbjörn Bjerke comments: “Since my
appointment as CEO, Orexo has undergone a major transformation, from
having both discovery of new chemical entities and programs with product
re-formulation towards becoming a commercially-focused specialty pharma
company which is directing its internal development activities on
reformulation of products with known chemical entities.  During my time
at Orexo, we have accomplished a number of important milestones; we have
proven that we are capable of developing products up until the marketing
phase, we have reached successful license agreements with strong
partners around the world and we have implemented radical cost savings
during the last year which have significantly improved our cost
efficiency.  These measures have collectively created a foundation for
Orexo's future and with the launch of the next step in our strategy, we
now have a stronger company.”

Audiocast telephone conference held today at 10:00 CET:
Orexo's Chairman Håkan Åström and CEO Torbjörn Bjerke will present the
updated strategy in a telephone conference at 10.00 CET.
To participate in the telephone conference, please use the following
details to dial-in:
SE: +46 (0)8 505 598 53
UK: +44 (0) 203 043 24 36
To listen to the telephone conference via internet, please use the
following link
http://webcast.zoomvision.se/clients/orexo/100820/ (http://webcast.zoomv
ision.se/clients/orexo/100820/)or visit
www.orexo.com (https://connect.ne.cision.com/www.orexo.com).

Contact details:
Håkan Åström, Chairman of the Board, Orexo AB
Tel: +46 (0)70 374 72 13
Email: hakan.astrom@orexo.com (hakan.astrom@orexo.com)

Torbjörn Bjerke, President and CEO, Orexo AB
Tel: +46 (0)708 66 19 90
Email: torbjorn.bjerke@orexo.com (torbjorn.bjerke@orexo.com)

 

More information about Orexo can be found at
www.orexo.com (https://connect.ne.cision.com/www.orexo.com).

 

Suboxone® is a registered trade mark of Reckitt Benckiser plc.

 

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 August 20, 2010 at 08:00 a.m. CET.