LEIDEN, NETHERLANDS--(Marketwire - May 25, 2010) - Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announces that it has submitted its response to the Day 180 List of Outstanding Issues (LoOI) to the Committee for Medicinal Products for Human Use (CHMP) in regard to its European Marketing Authorization Application (MAA) for Rhucin without an additional clock stop. The expected date for a CHMP opinion has been advanced with another month and is now expected end of June 2010.
Pharming submitted the MAA for Rhucin to the European Medicines Agency in September 2009. As announced last Friday, Pharming received a list of CHMP’s outstanding issues on Day 180 of the procedure and has submitted its responses immediately without the need for the usual one-month clock stop. The CHMP review of the MAA continues as of today, May 25 (Day 181).
In line with the regulatory timetable, the CHMP will reach its final opinion on the MAA for Rhucin no later than Day 210. Pharming’s prompt response has advanced the expected date for the Day 210 opinion with another month, which is now expected at the CHMP meeting in June 2010. More information on the procedure can be found below and on www.ema.europa.eu.
“The quality of the Rhucin file and the focused commitment of the Rhucin team enabled us back in March to return the answers to the Day 120 List of Questions within only two months clock stop instead of the regular three months. Now, we have been able to submit the Day 180 response without any clock stop at all. I am very pleased with both these accomplishments which have now resulted in an anticipated CHMP opinion already by the end of June”, said Dr. Bruno Giannetti, Chief Operations Officer of Pharming.
About the Centralized Procedure
The Centralized Procedure describes the standard timetable for European marketing authorization. The procedure includes some public phases and several internal and thus confidential steps. A company is only allowed to publish on public steps and may not publish any details of interim reports and conclusion before the actual CHMP opinion. Public steps are linked to preset monthly CHMP meetings and include the following:
D1 Following submission of an MAA by a company and validation of the dossier, the evaluation procedure on the actual content of the dossier starts. D120 The CHMP adopts the list of questions (LoQ) as well as an overall conclusion and review of the scientific data. EMA sends this LoQ to the applying company and the clock stops counting at D120 until a company response is received. D121 The applying company submits its responses to the LoQ and the clock restarts at day 121. D180 The CHMP decides on the adoption of the list of outstanding issues (LoOI). The LoQ is send to the applying company and the clock stops counting. D181 The applying company submits its responses to the LoOI and the clock restarts. D210 The CHMP adopts its opinion and starts the preparation of an assessment report on the product (EPAR), which is published on the EMA website after the decision of the European Commission. This report includes the reasons for the opinion and details of the evaluation. D277 On the basis of the EPAR, the European Commission decides on marketing authorization and subsequently the EPAR is published.
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#1418326]
Press release (PDF): http://hugin.info/132866/R/1418326/368595.pdf
