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
the treatment of acute attacks of Hereditary Angioedema (HAE) to the
Medicines Agency in September 2009. The Company responded to the D120 List
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
period. In line with the regulatory timetable, the CHMP will subsequently
its final opinion no later than Day 210. More information on this procedure
be found on www.ema.europa.eu.
"There are only a few minor issues left and we are confident that we will
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
through Pharming's proprietary technology where the human protein is
in milk of transgenic rabbits. Pharming is developing Rhucin® for
patients with acute attacks of Hereditary Angioedema (HAE). HAE is a human
genetic disorder caused by a shortage of C1 inhibitor activity and results
overreaction of the immune system. The disease is characterized by acute
of painful and in some cases fatal swelling of several soft tissues
which may last up to five days when untreated. In addition to the
life-threatening nature of the disease, quality of life for individuals
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
disorders, ageing diseases, specialty products for surgical indications,
nutritional products. Pharming's lead product Rhucin® for acute
Hereditary Angioedema has passed clinical development stage and the Market
Authorization Application is under review with the European Medicines
Prodarsan® is in early stage clinical development for Cockayne
lactoferrin for use in food products. The advanced technologies of the
include innovative platforms for the production of protein therapeutics,
technology and processes for the purification and formulation of these
as well as technology in the field of DNA repair (via DNage). Recently the
partial spin- out of DNage was initiated. Additional information is
the Pharming website, http://www.pharming.com.
This press release contains forward looking statements that involve known
unknown risks, uncertainties and other factors, which may cause the actual
results, performance or achievements of the Company to be materially
from the results, performance or achievements expressed or implied by these
forward looking statements.
Marjolein van Helmond, T: +31 (0)71 52 47 431 or +31 (0)6 109 299 54
Press Release (PDF): http://hugin.info/132866/R/1417804/368213.pdf