Pharming announces extension of their license agreement for the commercialisation of Ruconest

17-Aug-2011 - Biotech company Pharming Group NV announced that they have agreed an extension of their existing agreement with Swedish Orphan Biovitrum to include new territories in the Balkans, North Africa and the Middle East for the commercialization of Ruconest® (recombinant human C1 inhibitor) for the ...

New data support efficacy of Ruconest across all HAE attack locations

25-May-2011 - Pharming Group NV announced that new clinical data from open-label studies on their recombinant human C1 inhibitor (rhC1INH; conestat alfa; Ruconest(TM) in Europe, Rhucin® in other countries) was presented during the 7th C1INH deficiency workshop in Budapest, Hungary.New data was presented on 194 ...

Pharming and Santarus announce initiation of Phase IIIb clinical study with RHUCIN in Acute Hereditary Angioedema

01-Mar-2011 - Pharming Group NV and Santarus, Inc. announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in ...

Pharming announces topline study results on prophylactic use of Ruconest in Hereditary Angioedema

30-Nov-2010 - Pharming Group NV announced the results of its exploratory Phase II study on the safety and prophylactic effect of recombinant human C1 inhibitor ("rhC1INH") in patients with Hereditary Angioedema (HAE). The study is an open-label exploratory phase II study of the safety and prophylactic effect ...

Pharming's Ruconest(TM) for HAE granted European Marketing Authorization

01-Nov-2010 - Pharming Group NV and Swedish Orphan Biovitrum announced that the European Commission has granted Pharming Marketing Authorization for its lead product Ruconest(TM) for the treatment of acute attacks of Hereditary Angioedema (HAE). Pharming will now receive a €5 million milestone payment from ...

Pharming and Swedish Orphan announce publication of randomized clinical trial results with recombinant human C1 inhibitor

07-Oct-2010 - Pharming Group NV and Swedish Orphan Biovitrum announced the publication of the integrated analysis of Pharming's randomized placebo-controlled clinical trials with recombinant human C1 esterase inhibitor (rhC1INH; conestat alfa; Ruconest(TM) in Europe; Rhucin® in other countries) for treatment ...

Pharming plans submission Rhucin BLA to US FDA end 2010

26-Aug-2010 - Pharming Group NV announced that it intends to submit the Biologic License Application (BLA) to the US Food and Drug Administration (FDA) to obtain marketing approval for Rhucin® for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). Following pre-BLA ...

Pharming receives positive opinion from European Medicines Agency on Rhucin

Product name in Europe changed to Ruconest

28-Jun-2010 - Pharming Group NV announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Ruconest (Rhucin) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). With this positive opinion, the ...

Swedish Orphan Biovitrum and Pharming sign Rhucin distribution agreement

19-Apr-2010 - Swedish Orphan Biovitrum and Pharming Group NV announced an exclusive 10 year distribution agreement, under which Swedish Orphan Biovitrum will distribute Rhucin® in 24 EU countries, Norway, Iceland and Switzerland. Under the agreement, Swedish Orphan Biovitrum will pay to Pharming an ...

Pharming confirms positive results from final analysis of Rhucin studies

02-Jul-2009 - Pharming Group NV announced that, as part of the activities for the regulatory submission files, it has now also completed the final analysis of its Rhucin® randomised placebo-controlled studies. The results confirm the positive and consistent efficacy and safety of Rhucin in the treatment of ...