PAION's Partner Forest Terminates Co-development On Desmoteplase
Aachen, Germany, Aug 30, 2007 - Aachen (Germany), 30 August 2007 - PAION AG (Frankfurt Stock Exchange, Prime Standard: PA8) today announced that Forest Laboratories, Inc. has informed them about the termination of the co-development partnership regarding the compound Desmoteplase. Based on the results of the Phase III study DIAS-2 (Desmoteplase in Acute Ischemic Stroke) and the anticipated delay in development as well as the additional investments necessary, Forest has decided to return all rights to Desmoteplase for North America to PAION. A detailed analysis of the study data is still ongoing.
As previously reported, the primary efficacy endpoint of the recently completed DIAS-2 study was not met due to a lack of improvement in the Desmoteplase groups over placebo while observing an unexpectedly high response rate in the placebo group. Since the presentation of top-line results in late May this year, the partners have been conducting an in-depth analysis of the available study data.
In a joint effort, PAION and its other licensee, H. Lundbeck A/S are currently finalizing the analysis in order to discuss further steps and their commercial implication. Lundbeck has not yet announced their decision on the partnership due to the ongoing analysis. Furthermore, PAION is evaluating additional options to proceed with the program.
As already stated in detail in the financial report for the first half-year 2007, the termination of the cooperation by Forest leads to a one-time profit in the amount of EUR 4.3m (based on the amounts stated on 30 June 2007) which includes, among others, the derecognition of the provision for the repayment obligation towards Forest resulting from the reimbursement of development expenses. The termination of the cooperation has no impact on the cash and cash equivalents. These effects will be reflected in the financials for the third quarter 2007.