Interim analysis confirms immunosafety of Rhucin®
Leiden, The Netherlands, June 1, 2009. Biotech company Pharming
Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM)
announced today that it has presented an abstract describing the
interim analysis of the immunosafety of Rhucin® (recombinant human C1
inhibitor) in patients with Hereditary Angioedema (HAE) at the 6th
C1-Inhibitor Deficiency Workshop in Budapest. Rhucin® immuno-safety
review is an important part of both the EMEA (European Medicines
Agency) and the FDA (US Food and Drug Administration) upcoming
regulatory submissions. Results of the presented interim-analysis
confirm the absence of immunological side-effects of Rhucin®.
A detailed analysis of possible immunological side-effects of Rhucin®
was requested by the EMEA as part of its evaluation of Rhucin® to
treat patients suffering from acute attacks of HAE. This request was
made since therapeutic recombinant proteins in general often feature
some side-effects that are related to immune responses of the
patients. This is especially the case when the therapeutic product
is used repeatedly.
Currently 140 HAE patients, undergoing more than 350 treatments, have
been systematically followed-up for up to three months
post-treatment. With the exception of one healthy volunteer that
participated in the very first Phase I investigation and had
pre-existing rabbit allergy, no clinical immunological side effects
of Rhucin® were identified. Blood samples were collected from every
person that received Rhucin®, before and after exposure, and tested
for several types of antibodies against: C1-inhibitor and against
possible impurities. An interim analysis of the immunological data of
Rhucin® of more than 200 administrations to symptomatic HAE patients
presented at the Budapest meeting supports the absence of antibody
responses in all these patients, including patients who were treated
with Rhucin® at multiple occasions.
"We are extremely pleased with the results of this extensive
immuno-safety analysis. It, again, confirms the overwhelmingly
positive benefit-risk ratio of Rhucin®. A full immuno-safety analysis
will form an important element of our submissions to the EMEA and FDA
to obtain marketing approval for Rhucin®. It also forms a very strong
basis from which we can develop C1 inhibitor for follow-on
indications, for instance in the important field of rejection of
organ transplants," said Pharming's COO, Dr. Bruno Giannetti.
In the meantime, Rhucin® clinical trials are continuing and data from
them will be included in the dossiers for the FDA and EMEA to
demonstrate yet further increased numbers of patients and treatments.
In addition, Pharming is preparing filings for Rhucin® in territories
outside the USA and the European Union. These activities will, from
time to time, result in new clinical studies being initiated to meet
approval requirements in these specific countries. These trials do
not affect the submission of the Rhucin® dossier to the EMEA and the
submission to the FDA.
A more detailed overview of the interim results as presented at the
Budapest meeting can be found in the investor information section on
our website http://www.pharming.com.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment
of genetic disorders, ageing diseases, specialty products for
surgical indications, intermediates for various applications and
nutritional products. Pharming has two products in late stage
development - Rhucin® for Hereditary Angioedema and human Lactoferrin
for use in food products and one product in early stage clinical
development - Prodarsan® for Cockayne Syndrome. 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 technology
in the field of DNA repair (via DNage). Additional information is
available on the Pharming website, http://www.pharming.com.
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.
Contact:
Sijmen de Vries, Pharming Group NV, T: +31 (0)71 52 47 400 or +31(0)6
519 17 162.
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