Orexo's Rapinyl™ nearing regulatory decision in Europe

Orexo's Rapinyl™ nearing regulatory decision in Europe

Orexo´s European licensing partner ProStrakan Group plc, for the cancer
breakthrough pain product Rapinyl™ on the European market, today announced that
Rapinyl™ will be referred for review by the Committee for Medicinal Products for
Human Use (CHMP) of the EMEA. Of the 25 member states involved in the EU
Decentralised Procedure (DCP) for Rapinyl™, 21 consider this product to be
approvable.

Without consensus among all 25 member states, the product will now be referred
for review by the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA), where a majority decision is sufficient to
gain approval. The exact timings of the CHMP process are not yet clear, but it
seems likely that the approval process will extend into 2008.  

“While the process is taking some time, we remain confident in Rapinyl™ and its
merits, and optimistic about regulatory approval in the not too distant future”
said Zsolt Lavotha, CEO of Orexo.

Rapinyl™ is a product for the treatment of acute pain. The first indication is
breakthrough pain in cancer. Rapinyl™ is based on Orexo´s unique proprietary
technology for sublingual administration, where a tablet is placed under the
tongue and rapidly disintegrates into ordered mucoadhesive units of the active
substance. This novel pharmaceutical preparation combines the properties of fast
dissolution, quicker onset of action and predictable effect. 

The marketing rights for Rapinyl™ are licensed to Kyowa Hakko Kogyo Co. Ltd for
the Japanese market, to Endo Pharmaceuticals for the North American market and
to ProStrakan Group plc for the European market.


For further information, please contact: 

Zsolt Lavotha, President and CEO 
Tel.: +46-18 780 88 12 
E-mail: zsolt.lavotha@orexo.com

Claes Wenthzel, Executive Vice President and CFO 
Tel: +46-18 780 88 44 
E-mail: claes.wenthzel@orexo.com

To the editors

About Orexo 
Orexo is a pharmaceutical company which focuses on identifying suboptimal
therapeutic characteristics of existing products and developing more efficient
and effective delivery methods for them. By combining approved active substances
with Orexo´s drug delivery technologies it is possible to significantly enhance
their therapeutic value, such as providing quicker onset of action or ease of
administration. This business model is aimed at bringing products to market
faster with lower development risk and costs. 

Orexo, which has its global headquarters and development laboratories in Sweden,
currently operates across the world through development, licensing and
distribution agreements in all major markets. 

Orexo has a balanced portfolio with two products on the market, three in
registration and/or late stage clinical phase and one in clinical phase I and
one under formulation development. 

Orexo is listed on the OMX Nordic List Mid Cap (ticker;ORX).
www.orexo.com

About ProStrakan 
ProStrakan Group plc is a rapidly growing specialty pharmaceutical company
engaged in the research, development and commercialisation of prescription
medicines for the treatment of unmet therapeutic needs in major markets. 

With R&D facilities based in the UK and France, the company also markets a range
of products in major EU markets through its commercial operations based in the
UK, Germany, France and Spain. ProStrakan is listed on the London Stock
Exchange. 
www.prostrakan.com

About breakthrough pain 
Breakthrough pain is defined as one or several daily, often intermittent flares
("breakthroughs") of pain that can occur even though a person is taking
medications for regular pain control. Many patients with chronic cancer-related
pain also experience episodes of breakthrough cancer pain. 

About oral sublingual tablet formulation 
Orexo´s sublingual tablet technology combines fast disintegration and
dissolution in the oral cavity with rapid, site-specific absorption of the
active substance across the sublingual mucosa. 

When administered, the tablet is placed under the tongue where it rapidly
disintegrates into ordered mucoadhesive units of the active substance. Orexo
believes that the rapid and reproducible absorption of the active substance
makes the dosage form ideal for treatment of conditions requiring immediate
onset of effect such as acute pain. The technology can also be applied to
substances such as peptides, which cannot be absorbed from the gastrointestinal
tract.