Meda and Orexo in a potential billion SEK deal

Meda has acquired exclusive world-wide commercialisation 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 sublingual 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
At FDA approval 30 MUSD
Sales milestones
When net sales > 150 MUSD, payment 20 MUSD
When net sales > 200 MUSD, payment 20 MUSD
When net sales > 400 MUSD, payment 20 MUSD

OX-NLA
At FDA approval 15 MUSD
Sales milestones
When net sales > 150 MUSD, payment 20 MUSD
When net sales > 300 MUSD, payment 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.