Orexo and Meda in a potential billion SEK deal

14 April 2008 · Pressrelease · Regulatory
Meda has acquired the exclusive world-wide commercialization rights from Orexo of two patented drugs in late development phase; Sublinox and OX-NLA.

Sublinox (treatment of insomnia) contains the well-documented active substance zolpidem, one of the world’s most used substances for this disorder. Sublinox uses a unique and patented tablet formulation for fast and effective absorption. A recent phase III study confirmed that Sublinox gave faster onset of action than other zolpidem tablet formulations. Regulatory submission to the Food and Drug Administration (FDA) in the United States is expected before the 3rd quarter 2008.

OX-NLA is a patented nasal spray formulation with the antihistamine substance cetirizine. The liposomes in OX-NLA give the product unique features. OX-NLA is being documented for the treatment of allergic and non-allergic rhinitis, one of Meda’s major therapeutic areas. The product is entering phase III and Meda will fund continued development. Meda also has exclusive rights to develop and commercialise combination products based on OX-NLA.

As consideration for exclusive world-wide commercialisation rights for Sublinox and OX-NLA, Meda has paid 20 MUSD. Meda has also agreed to the following one time milestone payments for each product, when a yearly sales level is reached;


Sublinox OX-NLA
At FDA approval 30 MUSD 15 MUSD
Sales milestones When net sales
> 150 MUSD
> 200 MUSD
> 400 MUSD Payment
20 MUSD
20 MUSD
20 MUSD When net sales
> 150 MUSD
> 300 MUSD
Payment
20 MUSD
20 MUSD

Orexo will receive double digit royalty on net sales. Meda’s gross margin for Sublinox and OX-NLA is estimated to become higher than 70%.

“This is a landmark event for Orexo. We believe Meda is going to be an excellent marketing partner for Sublinox and OX-NLA with their pan-European and US presence” said Torbjörn Bjerke, Orexo’s President and CEO. We believe Meda provides Orexo a commercial partner with global reach”.

“I’m really glad that two Swedish based pharma companies managed to secure this deal. We strengthen Meda’s pipeline and add another significant marketing opportunity in the US in the near term with Sublinox”, stated Anders Lönner, CEO Meda.

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