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Sep 21 2006, 4:41 PM EST

Kos Announces Positive Overall Results for Two Phase III Trials of Icatibant for the Treatment of Hereditary Angioedema

News source: Business Wire

Kos Pharmaceuticals, Inc. (Nasdaq:KOSP):

-- Efficacy data for FAST-2 meets primary endpoint, FAST-1 and FAST-2 combined analysis demonstrates a reduction in time to onset of symptom relief

-- Patients receiving Icatibant reported a median time to onset of symptom relief of 2.5 hours in FAST-1 (versus 4.6 hours with placebo) and 2 hours in FAST-2 (versus 12 hours with comparator)

-- Initial submission of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) expected by year-end 2006, with potential launch in 2007

-- Kos collaboration partner Jerini plans to seek expedited review by FDA

Kos Pharmaceuticals, Inc. (Nasdaq:KOSP) announced today preliminary results from two pivotal Jerini AG (FSE: JI4) Phase III Icatibant clinical trials, FAST-1 and FAST-2 (For Angioedema Subcutaneous Treatment), for the subcutaneous treatment of hereditary angioedema (HAE), a debilitating and potentially life-threatening genetic disease. The primary study endpoint was met in FAST-2; and while it was not met in FAST-1, combined analysis of both studies showed a significant reduction in time to onset of symptom relief for patients receiving Icatibant versus those receiving placebo or comparator as measured by a visual analog scale (VAS). Initial application for regulatory approval with the FDA is anticipated in December 2006 and Jerini plans to seek an expedited review by the FDA.

Patients receiving Icatibant reported a median time to onset of symptom relief of 2.5 hours in FAST-1 as compared to a median time of 4.6 hours for those receiving placebo. A median time of 2 hours was reported by patients receiving Icatibant in FAST-2, as compared to 12 hours by those receiving the comparator, tranexamic acid. A total of 56 patients participated in FAST-1, a double-blind, placebo-controlled study conducted in the United States, Canada, Australia and Argentina. The FAST-2 trial treated a total of 74 patients at clinical sites in 10 European countries and in Israel in a double-blind study against the comparator, tranexamic acid. An aggregate of 231 open-label treatments were administered in both trials. The median time to first improvement, as reported by patients receiving Icatibant in the FAST-1 and FAST-2 studies, was consistent with Jerini's Phase II study results.

"The strength and consistency of these trial results demonstrate Icatibant's potential as a safe, effective and much needed therapy for hereditary angioedema," said Adrian Adams, President and CEO, Kos Pharmaceuticals. "We are pleased that, based on these results, Jerini will seek expedited reviews by the FDA and the European Medicine Evaluation Agency, keeping Icatibant on track for a potential 2007 launch. Icatibant is an exciting near-term opportunity for Kos, and is an excellent example of the continued success of our expanded specialty pharmaceutical business model that enhances our growing R&D pipeline through sound and synergistic corporate development and licensing activities."

The primary endpoint of FAST-2, as measured by a VAS, was met with a median time to onset of symptom relief of 2 hours for Icatibant versus 12 hours for tranexamic acid (p less than 0.001). Secondary endpoints entered in the analysis also showed statistically significant differences in favor of Icatibant. Time to onset of relief of key symptoms, as measured by a preset reduction in the VAS, was highly significant for skin swelling (p less than 0.001); skin pain (p=0.002), and abdominal pain (p=0.028). Median time to first improvement of symptoms as reported by patients was 0.8 hours for Icatibant versus 7.9 hours for tranexamic acid (p less than 0.001). Icatibant also showed an exc

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