PAION agreement with Lundbeck comes into force, securing future Desmoteplase development and EUR 8 million upfront-payment

30-Jan-2008

PAION AG announced that the expanded licensing agreement with H. Lundbeck A/S regarding the compound Desmoteplase has now come into force without any condition after Lundbeck's positive completion of its IP due diligence. As a result, PAION will receive an non-refundable upfront payment amounting to EUR 8 million which is due within the first quarter of 2008.

PAION and Lundbeck have expanded their existing relationship on Desmoteplase. Under the new agreement Lundbeck is responsible for future studies and the regulatory approval process. PAION will contribute its expertise. After market approval Lundbeck has the worldwide marketing rights with PAION retaining co-promotion rights in Germany, Switzerland and Austria.

Within the new deal structure, PAION will be eligible for a total of up to EUR 71 million in upfront and milestone payments. On top of the EUR 8 million which are to be paid within the first quarter of 2008, EUR 38 million consist of pre-commercialisation milestones and EUR 25 million are due post approval on first commercial sales and reaching undisclosed sales targets. In addition, PAION will receive double-digit royalties. These royalty rates are net of the royalties which PAION has to pay to Desmoteplase's originator Bayer-Schering Pharma AG.

While the initial top-line results of the DIAS-2 (Desmoteplase In Acute Ischemic Stroke) study with the compound Desmoteplase showed inconclusive results, an extended analysis of the data indicated that Desmoteplase may indeed prove beneficial for stroke patients. Key findings from this analysis include that, in contrast to the Phase II studies, almost half of the DIAS-2 patients lacked visible vessel occlusion before treatment and were thus less likely to benefit from thrombolysis. Moreover, when analyzing patient subgroups using presence of vessel occlusion as treatment criteria, a reduced response rate in the placebo group and a positive effect of Desmoteplase versus placebo was observed, however not statistically significant due to the small sample size.

Lundbeck plans to present data to the regulatory authorities in order to gain acceptance on the planned new clinical Phase III study expected to be initiated by Lundbeck in the second half of 2008.

https://www.bionity.com/en/news/77185/paion-agreement-with-lundbeck-comes-into-force-securing-future-desmoteplase-development-and-eur-8-million-upfront-payment.html