PHARMING REPORTS POSITIVE RESULTS IN EUROPEAN PLACEBO-CONTROLLED
TRIAL OF RHUCIN® IN HEREDITARY ANGIOEDEMA
Independent data monitoring committee advises Pharming to stop
placebo arm on ethical grounds
Leiden, The Netherlands, August 20, 2007. Biotech company Pharming
Group N.V. ("Pharming" or "the Company") (Euronext: PHARM) announced
today that it has completed an interim analysis of its European
randomized placebo-controlled double-blind clinical study designed to
evaluate efficacy and safety of Rhucin® in the treatment of acute
attacks of Hereditary Angieoedema ("HAE"). The analysis complements
the earlier publication of results of an open label study which
showed strong positive effects of Rhucin®. None of the patients
receiving Rhucin® showed a relapse of their attack, nor any
treatment-related adverse events during this study, confirming the
safety profile of the product as was determined in earlier studies.
Details of the clinical results will be presented on August 30th at a
meeting in London to analysts and press (see details below).
Based on the results and after consulting with the Independent Data
Monitoring Committee the Company has decided to discontinue further
randomized treatments within the clinical study for methodological
and ethical reasons. All investigators have been informed. All
involved Ethics Committees and Regulatory Authorities have received
or will shortly be receiving appropriate filings.
Pharming has included the analysis in its dossier submitted to the
European Medicines Evaluation Agency ("EMEA") to further support its
request for Marketing Authorization in Europe. Data from the analysis
were also submitted to the FDA in the USA where an independent
placebo-controlled randomized clinical study assessing the safety and
efficacy of Rhucin® is expected to be completed in the next few
months.
Dr. Bruno Giannetti, Chief Operations Officer of Pharming, commented:
"We are extremely pleased with the outcome of this analysis. The data
confirm the results obtained earlier in open label studies and show
that Rhucin® is a very fast acting product that could be of great
therapeutic benefit for patients with HAE. The product has an
excellent safety profile based on the results of various studies in
which, in total, well over 100 infusions were given to subjects.
Importantly, no relapses of any of the attacks occurred. The Company
has filed an amendment to stop further randomized treatments, whereas
open label treatment of acute attacks with Rhucin® remains possible
to allow patients in Europe and elsewhere to get access to and
continue to benefit from this treatment.
A meeting for analysts and press will be held at the offices of
Financial Dynamics in London on August 30th to discuss clinical
results. Please contact Mo Noonan or Claire Rowell at FD on +44 20
7269 7116 for full details.
About Rhucin® and HAE
Rhucin® (recombinant human C1 esterase inhibitor) is a human protein
developed through Pharming's proprietary technology in milk of
transgenic rabbits. Rhucin® is currently under development for
treatment of patients with acute attacks of hereditary angioedema
("HAE"). HAE is a human genetic disorder caused by a shortage of C1
inhibitor activity and resulting in episodes of edema. The disease is
characterized by acute attacks of painful and in some cases fatal
swelling of several soft tissues (edema), which may last up to five
days when untreated. In the Western world, approximately 1 in 30,000
individuals suffers from hereditary angioedema, having an average of
seven acute attacks per year.
About Pharming Group N.V.
Pharming Group NV is developing innovative products for the treatment
of genetic disorders, specialty products for surgical indications,
intermediates for various applications and food products. Pharming
has two products in late stage development - recombinant human C1
inhibitor for hereditary angioedema (MAA submitted to EMEA) and human
lactoferrin for use in functional foods (GRAS notification filed with
FDA). The advanced technologies of the Company include innovative
platforms for the production of protein therapeutics, technology and
processes for the purification and formulation of these products, as
well as technologies in the field of tissue repair (via its
collaboration with Novathera) and DNA-repair (via its acquisition of
DNage BV). Additional information is available on the Pharming
website, http://www.pharming.com and on http://www.dnage.nl
This press release contains forward looking statements that involve
known and unknown risks, uncertainties and other factors, which may
cause the actual results, performance or achievements of the Company
to be materially different from the results, performance or
achievements expressed or implied by these forward looking
statements. The press release also appears in Dutch. In the event of
any inconsistency, the English version will prevail over the Dutch
version.
Contact:
Anne Louise van Julia Philips Rein Strijker
Lynden
Investor Voice Financial Dynamics Pharming Group
N.V.
T: +31 (0)654315549 T: +44 (0)20 7269 T: +31 71
7187 524742434
T: +31 (0)71 524 7431 T: +44 (0)7747 602 739
