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Proof-of-Concept Phase 2 Study of Icatibant Concludes With Positive Results

BERLIN--(BUSINESS WIRE)--Aug. 26, 2004--Jerini announced today that its phase II proof-of-concept study in hereditary angioedema (HAE) was concluded with positive results. The study evaluated Jerini's lead compound, Icatibant, for the treatment of HAE. In twenty acute attacks of hereditary angioedema, Icatibant was tested in the intravenous (12 attacks) as well as in the subcutaneous (8 attacks) formulation. No difference in efficacy was observed between the two treatment forms. All tested patients reported a rapid relief of symptoms after administration of Icatibant. The drug was safe and well tolerated. The results obtained strongly support the clinical efficacy of Icatibant for the treatment of acute angioedema attacks. Based on these results, Jerini will shortly begin its pivotal registration study in the US and Europe. The protocols for the registration studies with the subcutaneous formulation of Icatibant have been cleared by the regulatory authorities in the US and in Europe. In the event of an attack, subcutaneous treatment will allow patients to self-administer the drug without the need to visit a hospital.

"With Icatibant, we can help patients suffering from hereditary angioedema", stated Jens Schneider-Mergener, CEO of Jerini. He added that the subcutaneous formulation creates an enormous benefit for patients and will significantly improve the quality of life for patients suffering from HAE.

About Hereditary Angioedema
Hereditary angioedema (HAE) is a debilitating and life-threatening disease characterized by recurrent local swelling at three main sites: subcutaneous tissue, gastrointestinal tract, and larynx. In case of an attack affecting the airway passages, HAE is life threatening. Abdominal attacks are often associated with bouts of severe pain, nausea, and vomiting caused by swelling in the intestinal wall. The prevalence of HAE is believed to be between 1/10,000 and 1/50,000 people worldwide. Hereditary angioedema is caused by an activation of the kinin system leading to elevated bradykinin levels in the affected areas.

About Icatibant
Icatibant is a potent and specific peptidomimetic bradykinin B2 receptor antagonist. Icatibant has exhibited an excellent safety profile in over 850 subjects. Icatibant is tested in clinical trials for treatment of hereditary angioedema and refractory ascites in liver cirrhosis as well as in preclinical models for severe burn injuries.

Source: Jerini AG

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