SOURCE: Pharming Group N.V.

June 04, 2009 08:21 ET

Pharming receives agreement on paediatric investigation plan for Rhucin® from the EMEA Paediatric Committee

LEIDEN, NETHERLANDS--(Marketwire - June 4, 2009) -


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

Press Release (PDF): http://hugin.info/132866/R/1320100/308708.pdf

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.



Copyright © Hugin AS 2009. All rights reserved.

Contact Information