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Pharming Group (PHGUF.PK) Receives D180 List of Outstanding Issues on Rhucin MAA


5/21/2010 1:24:06 PM

LEIDEN, NETHERLANDS--(Marketwire - May 21, 2010) - Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) reports that it has received the Day 180 List of Outstanding Issues (LoOI) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

Pharming submitted the Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of Hereditary Angioedema (HAE) to the European Medicines Agency in September 2009. The Company responded to the D120 List of Questions in March 2010. After review of the response, the CHMP has now summarized its outstanding questions in the Day 180 LoOI. Pharming plans to submit its response to these questions within the regular one month clock stop period. In line with the regulatory timetable, the CHMP will subsequently reach its final opinion no later than Day 210. More information on this procedure can be found on www.ema.europa.eu.

"There are only a few minor issues left and we are confident that we will be able to provide our response quickly", said Dr. Bruno Giannetti, Chief Operations Officer of Pharming.

About Rhucin® and HAE

Rhucin® (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming's proprietary technology where the human protein is expressed in milk of transgenic rabbits. Pharming is developing Rhucin® 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 results in an overreaction of the immune system. 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 addition to the life-threatening nature of the disease, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals suffers from HAE and has an average of seven acute attacks per year.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, and nutritional products. Pharming's lead product Rhucin® for acute attacks of Hereditary Angioedema has passed clinical development stage and the Market Authorization Application is under review with the European Medicines Agency. Prodarsan® is in early stage clinical development for Cockayne Syndrome and lactoferrin for use in food products. 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). Recently the partial spin- out of DNage was initiated. 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:

Marjolein van Helmond, T: +31 (0)71 52 47 431 or +31 (0)6 109 299 54

[HUG#1417804]

Press Release (PDF): http://hugin.info/132866/R/1417804/368213.pdf




Read at BioSpace.com

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