Pharming receives agreement on paediatric investigation plan for
Rhucin® from the EMEA Paediatric Committee
Leiden, The Netherlands, June 4, 2009. Biotech company Pharming
Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today
announced that the Paediatric Committee (PDCO) of the European
Medicines Agency (EMEA) has adopted an opinion agreeing the
paediatric investigation plan (PIP) for Rhucin® (recombinant human C1
inhibitor) in the therapeutic area of
immunology-rheumatology-transplantation.
"Agreement of the PIP represents a key milestone in Pharming's
regulatory plans for the September 2009 submission of the Rhucin
marketing authorisation application," said Dr. Bruno Giannetti, COO
of Pharming.
According to the EC Regulation 1901/2006 of 12 December 2006,
pharmaceutical companies that submit an application for a marketing
authorisation for a medicinal product (MAA) in the EU, have to
include an approved PIP as part of the regulatory submission.
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
This announcement was originally distributed by Hugin. The issuer is
solely responsible for the content of this announcement.
