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Orphan Drug Status Granted to Icatibant

BERLIN--(BUSINESS WIRE)--July 7, 2004--Jerini today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug status to Icatibant, the company's bradykinin receptor antagonist for the treatment of edema in severe burn patients. The orphan drug designation is granted by the FDA to drugs in development addressing rare diseases. Edema is a severe complication in burn patients with more than 20% of skin showing second and third degree burns. Jerini plans to initiate Phase II clinical trials for Icatibant in patients with severe burn injuries next year.

"We are pleased to receive the FDA's orphan drug designation for Icatibant in a second indication," said Jens Schneider-Mergener, Chief Executive Officer of Jerini. "The orphan drug designation is an important component of our development and commercialization strategy."

The FDA grants orphan drug designation to drugs that provide a significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug status provides for U.S. marketing exclusivity for seven years upon marketing approval by the FDA. Additionally the designation qualifies a product for possible funding to support clinical trials, study design assistance from the FDA during development and for financial incentives.

Source: Jerini AG

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