Edluar for insomnia treatment receives regulatory approval in Europe

Orexo AB ("Orexo")(STO:ORX) is pleased to report that Edluar® has received regulatory approval in Europe, according to information supplied by Meda AB ("Meda"), Orexo's global commercial partner for the product. Edluar®, a sublingual formulation of zolpidem, is indicated for treatment of insomnia characterized by difficulties with sleep initiation, and was developed by Orexo using the Company's proprietary sublingual formulation technologies

Two products based on Orexo sublingual know how now approved in EU and US

Edluar® is the second product developed by Orexo, which following Abstral®, has achieved the milestone of securing both EU and US regulatory approval. Edluar® has already been launched by Meda in the US and Canada, and will be launched in Europe during 2013, following completion of the national regulatory process in each country. Abstral, which is the leading new fast acting fentanyl product for treating episodes of break through pain in cancer patients has, since 2009, been launched successfully in many EU countries.

Edluar® and Abstral® with clear advantages from Orexo sublingual formulations

Edluar® and Abstral® are products which both utilise Orexo's proprietary sublingual formulation technologies. Since launch in Europe, Abstral® has recorded continuous strong growth in sales and increasing market share. This has been driven by patient and physician preference for Orexo's sublingual formulation which is able to provide rapid onset of effect, fast tablet disintegration, fast drug absorption and good local tolerability. Using Orexo's sublingual formulation technology Edluar®, like Abstral®, demonstrates these same product attributes.

Orexo will receive double digit royalty on Edluar® sales in Europe

Orexo received 20 MUSD upon signing of the agreement with Meda and 5 MUSD when Edluar® was approved by the FDA. The approval in Europe is not associated with any additional milestone payments, but Orexo is entitled to double digit royalties on European sales. Furthermore, Orexo will receive a similar royalty rate as Meda expands to new markets.

Anders Lundström, Chief Executive Officer, of Orexo said:

"The approval of Edluar® in Europe provides additional proof of our research and development capabilities at Orexo and underscores the strength of our proprietary sublingual technologies and know how. The approval of both Edluar® and Abstral® in the key markets of US, Canada and Europe further increases our confidence that we can repeat such success with our three proprietary projects (OX219, OX51 and OX27) which also are all based on Orexo's sublingual administration technology."

Nikolaj Sørensen, Chief Commercial Officer, of Orexo said:

"I am very pleased that our partner Meda has successfully obtained the European registration approval for Edluar®, and I am looking forward to the commercial launch in Europe 2013. I am confident the sublingual formulation is appreciated by the European patients and that there are attractive business opportunities for Edluar® in Europe."