Lodotra is a proprietary programmed-release formulation of low-dose prednisone and has received regulatory approval in Europe for reduction in morning stiffness associated with rheumatoid arthritis (RA).
Merck Serono holds marketing rights to Lodotra in Germany and Austria and Mundipharma holds marketing rights to Lodotra for the rest of Europe.
Mundipharm has completed a Phase 3 trial for Lodotra in the US for the treatment of the signs and symptoms of RA. The company anticipates submitting a new drug application for Lodotr for the treatment of the signs and symptoms of RA to the US Food and Drug Administration in the fourth quarter of 2010.
Horizon Pharma chairman, president and CEO Timothy Walbert said that with the signature of this agreement, patients suffering from morning stiffness associated with RA would have a new therapeutic option.
Mundipharma Asia Pacific regional managing director Henrik Glarbo said that they were excited about the addition of Lodotra to their existing product portfolio.