Jerini initiates phase II clinical trial for treatment of Angioedema with Icatibant - Positive Notification for European Orphan Product Designation

Berlin, February 11, 2003 -- Jerini AG today announced the recent initiation of a phase II proof-of-concept study of Icatibant in patients suffering from acute attacks of Angioedema. In the initial phase, the study will investigate the efficacy and safety of Icatibant in patients with Angioedema. Icatibant is a highly potent and very selective peptidomimetic Bradykinin BK 2 receptor antagonist which is currently also tested in a phase IIa clinical study in patients with late stage liver cirrhosis.

Angioedema is a debilitating disease with a tremendous unmet medical need. It is characterized by episodes of edema (swelling) in body parts, most notably the hands, feet, face, and airway passages. In advanced cases, angioedema can progress to complete airway obstruction and death, caused by laryngeal edema. Latest research has demonstrated activation of the kinin system and increased bradykinin concentration. Bradykinin is an important inflammatory mediator that causes neutrophil chemotaxis, capillary dilation, and smooth muscle relaxation, and it has been linked to other forms of angioedema. "We have seen encouraging preclinical and early clinical results with Icatibant regarding safety and full antagonism of bradykinin levels”, said Jochen Knolle, PhD, Jerini Chief Scientific Officer.

On January 10, 2003, Jerini was notified by the Committee for Orphan Medicinal Products (COMP) that Icatibant has received a recommendation for Orphan Drug Designation in Europe as a treatment of Angioedema.

Jens Schneider-Mergener, Chief Executive Officer of Jerini, said, “the commencement of this study and the positive recommendation for Orphan Drug Designation underline the successful deployment of Jerini’s strategy to become a fully integrated pharmaceutical company. Central to our mission is the commitment to excellence in providing patients with innovative new drugs. We aim to combat diseases for which no suitable treatment exists or where improvement of the patient’s quality of life is desirable.”

For further information, please visit the corporate website at: http://www.jerini.com .
For information on Angioedema, please refer to http://www.hereditaryangioedema.com 
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In case you have any questions, please contact:

László D. Kiss
Corporate Communications

Jerini AG 
Invalidenstr. 130 
10115 Berlin 

T + 49 - 30 - 97893 - 118
X + 49 - 30 - 97893 - 105 
kiss@jerini.com