Jerini Plans to Submit US New Drug Application in Third Quarter 2007 for Icatibant in Hereditary Angioedema
- Category: Proteins and Peptides
- Published on Wednesday, 28 February 2007 02:00
- Hits: 2006
BERLIN, Germany | Feb 27, 2007 | Jerini AG (FSE:JI4) announced today, following a pre-NDA meeting with the United States Food and Drug Administration (FDA), its plans to submit a New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE) in the third quarter 2007. In the pre-NDA meeting, the company reviewed with the agency its plans for submission of manufacturing, preclinical, clinical, and safety data to support the NDA for Icatibant.
“The pre-NDA meeting and dialogue with the FDA have provided us with clarity for our NDA submission package,” stated Jens Schneider-Mergener, CEO of Jerini. “Jerini remains committed to rapidly bringing HAE patients a new treatment option that could help them better manage their disease.”
Audio Webcast and Conference Call:
Jerini will host an audio webcast including an open question and answer session on February 28, 2007 to discuss the above information.
Date: Wednesday, February 28, 2007
Time: 3:00 p.m. CET / 9:00 a.m. ET
+49 (0)69 9897 2633 Deutschland
+44 (0)20 7365 1832 UK
+1 718 354 1157 USA
+41 (0)1 800 9659 Schweiz
Please dial-in 10 minutes prior to start of the conference call.
The replay of the audio webcast will be available on the Jerini website two hours after completion of the conference call.
FAST-1 and FAST-2 Clinical Trials
Jerini conducted two multi-center, double-blind Phase III studies for the subcutaneous treatment of HAE. In the FAST-1 study, comparing Icatibant against placebo, 54 patients were randomized in the United States, Canada, Australia, and Argentina. In the FAST-2 study, comparing Icatibant against tranexamic acid, 74 patients were randomized at clinical sites in 10 European countries and Israel.
In both the FAST-1 and FAST-2 trials, randomized patients used visual analog scale (VAS), symptom scores, and Clinical Global Impression (CGI) to evaluate the clinical efficacy of Icatibant or the comparator.
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 has been granted orphan drug status for the treatment of angioedema by the FDA and the 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. Icatibant’s subcutaneous administration, excellent safety profile demonstrated in clinical studies to date, and its one-year-stability at room temperature, all offer key benefits to HAE patients.
About Jerini AG
Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. The company pursues disease indications that have limited or no treatment options and has built a drug pipeline composed of its own programs, as well as others in collaboration with established partners. In September 2006, Jerini reported Phase III clinical results of Icatibant in the subcutaneous treatment of hereditary angioedema. Based on its technology platform, Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease.
SOURCE: Jerini AG