Pharming submits response to questions MAA Rhucin
(Thomson Reuters ONE) -
D120 clock stop limited to two months
Leiden, The Netherlands, March 18, 2010. Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has
submitted its response to the Day 120 List of Questions (LoQ) of the Committee
for Medicinal Products for Human Use (CHMP) in regard to its European Marketing
Authorization Application (MAA) for Rhucin. In addition, the dossier for
marketing authorization of Rhucin for HAE has been filed with the Turkish
Ministry of Health and is currently under review.
Pharming submitted the MAA for Rhucin to the European Medicines Agency in
September 2009 and the CHMP issued the Day 120 List of Questions on 21 January
2010, which did not contain any 'major concerns'. Pharming's submission of
responses will result in a clock stop of only two months instead of the usual
three months. The CHMP review of the MAA will continue on March 21 (Day 121).
Another one month clock stop may be expected at Day 180 of the procedure to
permit Pharming to respond to any further questions from the CHMP and, in line
with the regulatory timetable, the CHMP will reach its final opinion no later
than Day 210. More information on this procedure can be found
onwww.ema.europa.eu
Dr. Bruno Giannetti, Chief Operations Officer of Pharming, said: "Pharming
employees have gone the extra mile to achieve a shorter response time and
limiting the clock stop to two months only. We are now anticipating receiving
the CHMP opinion in the third quarter of this year."
Alongside, Pharming's partner Eczac?ba?? ?laç Pazarlama A.?. (Eczaciba?i
Pharmaceuticals Marketing or EIP) has submitted a dossier on Rhucin with the
Turkish Ministry of Health. The dossier includes all data from the European MAA.
The average review time for the Turkish application is approximately 20 months.
The decision to grant a marketing authorization in Turkey is independent of
decisions made in the EU or the USA.
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). 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#1395381]
Press Release (PDF): http://hugin.info/132866/R/1395381/352206.pdf
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Datum: 18.03.2010 - 10:20 Uhr
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