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Back PAION and Lundbeck agree on conducting a second Phase III study with Desmoteplase
 

The biopharmaceutical company PAION

(Frankfurt Stock Exchange, Prime Standard: PA8) today announced that, with

approval of Forest Laboratories, Inc. it has agreed with its partner

H. Lundbeck A/S to conduct a second Phase III study in Europe and other

countries excluding the US and Canada with PAION’s Desmoteplase for the

treatment of acute ischaemic stroke. Subject to regulatory consultation and

approval, this new study is anticipated to start still in Q4 2006. PAION will

assume major responsibility for financing and conducting the study. Under

certain conditions, the costs borne by PAION may be reimbursed in full or in

part by Forest and/or Lundbeck at a later point in time. Within the scope of the

agreement, Lundbeck will assume a part of the development cost for the

production process of Desmoteplase beyond the already reimbursed cost.

This will result in revenues of approx. EUR 3 million for the period from

11 July 2005 to 30 June 2006 that PAION will recognize in the third quarter

2006. Along with the Phase III study DIAS-2 currently in progress, this second

confirmatory Phase III study aims to enlarge the basis of available safety data

for Desmoteplase. It will do so by increasing the total number of patients

treated with Desmoteplase, thus enhancing the data package for the

compound.

 

We are encouraged that we will start a second Phase III study by year-end

with the support of our partners”, states Dr. Mariola Söhngen, PAION’s CMO.

The study aims to contribute to the overall safety database and efficacy

profile of Desmoteplase.

 

More at: www.paion.de

 

Contact

Dr. Peer Nils Schroeder

PAION Investor Relations, Public Relations

Martinstrasse 10-12, 52062 Aachen, Germany

Phone +49 (0)241 4453 152

Email pn.schroeder@paion.de