Jerini AG Completes Randomization of Last Patient in Phase III Clinical Trial (FAST 1) of Icatibant for the Treatment of Hereditary Angioedema25 April 2006
Jerini AG (FSE:JI4) reported today the randomization of the last patient in its Phase III clinical trial (FAST 1) of Icatibant for the treatment of hereditary angioedema (HAE).
A total of 56 patients were treated at 26 clinical sites in the United States, Canada, Australia, and Latin America in a double blind placebo controlled study. "The completion of the FAST 1 randomization phase represents a significant milestone for Jerini," said Jens Schneider-Mergener, CEO of Jerini. "Additionally, we will complete the randomization of the European FAST 2 Phase III trial shortly and continue to be on track to report top-line results for both studies in the third quarter of this year." Patients participating in the FAST 1 and FAST 2 randomization phase are eligible to receive Icatibant in the ongoing open-label study phase. Filing of a marketing authorization application with Icatibant for the treatment of HAE is planned for the end of 2006 with product launch expected in 2007.
Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. Icatibant's subcutaneous administration, excellent safety profile demonstrated in clinical studies to date, and one-year-stability at room temperature all offer key advantages to HAE patients. Jerini and its US partner Kos Pharmaceuticals, Inc. plan to market Icatibant in a pre-filled syringe, enabling patients to travel and self-administer the drug at the onset of an HAE attack.
HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks in the hands, feet, face, larynx, and abdomen. Icatibant has been granted orphan drug status for the treatment of angioedema from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), potentially securing, upon approval, market exclusivity for seven and ten years, respectively. In addition, the FDA has granted fast-track designation to Icatibant in the indication HAE.
About Jerini AG
Jerini AG is a pharmaceutical company based in Berlin, Germany focusing on the discovery and development of peptide-based drugs. Having recognized the potential of peptides as natural starting molecules for drug discovery, the company has developed state-of-the-art technologies to identify and transform peptides into drugs. The company's lead product, Icatibant, is currently in Phase III clinical trials for the treatment of hereditary angioedema (HAE). It is estimated between 1:10,000 and 1:50,000 people worldwide are affected with this disease. Based on its technology platform, Jerini has established several in-house development programs, which address indications within ophthalmology, oncology, and inflammatory therapeutic areas. The most advanced of these programs targets age-related macular degeneration (AMD), the leading cause of vision loss and blindness in people over the age of 55 in developed countries. Clinical testing with Jerini's drug candidate, JSM 6427, will start in the second half of 2006.
CONTACT: Jerini AG
Stacy Wiedenmann, Director, Investor Relations &
Corporate Communications
+ 49 30 97893 285
Fax: + 49 30 97893 105
wiedenmann@jerini.com
Source: primezone
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