Pharming Group N.V.

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Publicatie datum 07 dec 2011 - 06:34

Statutaire naam Pharming Group N.V.

Titel SANTARUS AND PHARMING ANNOUNCE ORAL PRESENTATIONS OF RETROSPECTIVE ANALYSES OF DATA FROM RHUCIN CLINICAL PROGRAM AT WORLD ALLERGY CONGRESS

Bericht Leiden, The Netherlands, December 7, 2011. Biotech company Pharming Group NV (NYSE Euronext: PHARM) and specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) today announced that retrospective analyses of integrated efficacy data and immuno-safety data were presented in two oral presentations at the 2011 Biennial Meeting of the World Allergy Congress (WAC) in Cancun, Mexico on December 6, 2011. The data analyzed are from placebo-controlled and open-label clinical studies conducted with the investigational drug RHUCIN® (recombinant human C1 inhibitor, or C1INH) in patients with hereditary angioedema (HAE). The first oral presentation was titled Clinical Efficacy of Recombinant Human C1 Inhibitor in Patients with Acute Hereditary Angioedema Attacks (A. Reshef, et al). This integrated efficacy dataset included 155 HAE patients treated for 424 angioedema attacks with 100 U/kg, 50 U/kg and 2100 U of RHUCIN, including patients treated for repeated attacks. Median time to the primary endpoint of onset of symptom relief for attacks treated with 100 U/kg, 50 U/kg and 2100 U of RHUCIN were 66, 60 and 61 minutes, respectively, compared with 495 minutes in the placebo-treated group. Median times for time to minimal symptoms were 266, 240 and 241 minutes for the 100 U/kg, 50 U/kg and 2100 U RHUCIN treated attacks, respectively, compared with 1210 minutes for the placebo-treated attacks. Clinical response rates of 93%, 96% and 88% for the 100 U/kg, 50 U/kg and 2100 U doses, respectively, were observed for the RHUCIN treated groups compared with 41% for the placebo group. Abdominal attacks had the fastest onset of symptom relief (50, 36 and 60 minutes), followed by oro-facial-pharyngeal-laryngeal attacks (70, 65 and 120 minutes), and peripheral attacks (75, 84 and 121 minutes) for the100 U/kg, 50 U/kg and 2100 U doses, respectively. None of the RHUCIN treated attacks relapsed. No drug-related serious adverse events or hypersensitivity reactions were observed. The mo

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201112070000000001_Rhucin WAC presentations 120711.pdf (opens in a new window)

Datum laatste update: 14 maart 2026