Jerini Receives FDA Fast Track Designation for Icatibant in Hereditary Angioedema

Business Wire, July 22, 2004

BERLIN -- Jerini received a fast track designation from the U.S. Food and Drug Administration (FDA) for its product Icatibant. The fast track designation covers subcutaneous treatment of hereditary angioedema (HAE). HAE is a debilitating and life-threatening disease characterized by recurrent local swelling at three main sites: subcutaneous tissue, gastrointestinal tract, and larynx. Fast track designation is designed to facilitate the development and expedite the review of new drugs that address unmet medical needs for serious or life-threatening diseases.

Icatibant has shown unambiguous clinical efficacy for treatment of acute attacks of hereditary angioedema. Patients treated with the drug reported a fast and reliable relief of symptoms. No drug-related adverse events were observed. Clinical studies to support market approval of Icatibant subcutaneous will be initiated in the third quarter of 2004.

"Subcutaneous treatment will provide significant patient benefit due to the ability to self-administer the drug," stated Jens Schneider-Mergener, CEO and founder of Jerini. "We will continue to work closely with FDA to make Icatibant available as quickly as possible to patients."

Fast Track Designation

Fast track designation is designed by FDA to facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition and demonstrates the potential to address an unmet medical need. Due to the nature of these types of products, new drug applications (NDAs) filed with fast track designation are eligible for priority review.

Angioedema

The most prominent form of angioedema is the hereditary form. The prevalence of hereditary angioedema (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 area. 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 that affects 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.

Icatibant

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

Jerini AG

Jerini AG (www.jerini.com) is a drug discovery and development company based in Berlin, Germany. The company has built a pipeline of several preclinical and two clinical projects (phase II) with its proprietary Peptides-To-Drugs (P2D) discovery platform. The company's lead molecule Icatibant, a highly potent and specific peptidomimetic bradykinin B2 receptor antagonist is entering pivotal registration trials in the third quarter of this year in the indication Angioedema. P2D was developed by the company to address extra- and intra-cellular targets and to overcome the limitations of conventional HTS or protein-based discovery approaches.

Key Facts: Founded 1994 92 Employees

Executive Board: Prof. Jens Schneider Mergener (CEO) Dr. Jochen Knolle (Head R&D) Dr. Adi Hoess (CBO) Berndt Modig (CFO)