SOURCE: Pharming Group N.V.

September 23, 2009 17:44 ET

Pharming's Marketing Authorisation Application for Rhucin Validated by the European Medicines Agency (EMEA)

Evaluation Procedure Has Started Today

LEIDEN, NETHERLANDS--(Marketwire - September 23, 2009) - Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today received confirmation of validation from EMEA of its Marketing Authorization Application (MAA) for Rhucin®. This means that the formal scientific evaluation procedure of the European Medicines Agency (EMEA) has started today.

Pharming submitted the MAA for Rhucin to EMEA earlier this month. Today, the EMEA notified the Company that it has completed the validation of the dossier. As result of this, the Centralized Procedure for scientific evaluation of the MAA by the Committee for Medicinal Products for Human Use (CHMP) has started today. According to the standard timetable of the Centralized Procedure, the CHMP adopts a List of Questions at Day 120. This List of Questions is based on the Day 80 Assessment Report from the Rapporteur and Co-Rapporteur. The Company should submit its responses to these questions within 3 months, after which the 'clock' will restart and the procedure will be continued. Pharming may expect the adoption of the final CHMP opinion within a total of 210 days review time (excluding any clock-stops).. More information on this procedure can be found on www.emea.europa.eu.

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 its recombinant human C1 inhibitor 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, 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.

List of used abbreviations
CHMP   - Committee for Medicinal Products for Human Use
EMEA   - European Medicines Agency
HAE    - Hereditary Angioedema
MAA    - Market Authorization Application
Rhucin - Recombinant human C1 inhibitor for treatment of acute HAE attacks

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.

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

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Press Release (PDF): http://hugin.info/132866/R/1343311/321760.pdf

Contact Information

  • Contact:

    Ms. Marjolein van Helmond
    Pharming Group NV
    T: +31 (0)71 52 47 431
    or
    +31 (0)6 109 299 54