Pharming provides Update on Rhucin®

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Overig advies 29/01/2008 08:30
Leiden, The Netherlands, January 29, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today provided an update on the development of Rhucin® and its efforts to have the product registered in the European Union and the United States of America through the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) respectively.

In accordance with European regulation (EC) No 726/2004, Pharming requested a re-examination of the grounds for refusal that led to a negative opinion by the Committee for Medicinal Products for Human Use (CHMP), regarding the granting of Market Authorization of Rhucin® for treatment of attacks of Hereditary Angioedema (HAE) in the European Union. Based on these grounds for refusal, the Company will submit detailed grounds for this re-examination request to the EMEA no later than February 11, 2008 (within sixty calendar days after receipt of the negative opinion).

In the re-examination procedure, the CHMP has appointed a new Rapporteur and co-Rapporteur, who will assess the dossier, in particular the elements that form the basis of Pharming's grounds for the request. The Rapporteur and co-Rapporteur will report their findings to the CHMP, to which the Company can respond. The CHMP will issue their final opinion at a CHMP meeting within sixty calendar days following receipt of the grounds for the request. This opinion will form the basis of a decision on the Market Authorization of Rhucin® within the EU. Therefore, such a final decision can be expected in the second quarter of 2008.

Pharming believes that the results obtained in clinical studies form the basis for a positive risk benefit ratio for Rhucin® in treatment of acute HAE-attacks. In a randomized placebo-controlled study, Rhucin® showed statistically significant superiority over placebo in time to first relief of the attack and in time to minimal symptoms. Efficacy was shown earlier in open-label clinical trials. No patient experienced a relapse of the HAE attack or any treatment-related adverse event. Once authorized to enter the market, Rhucin® would make an additional replacement therapy available throughout the EU.

In the US, a double-blinded randomized placebo-controlled clinical trial was completed in the fourth quarter of 2007. When the last patients complete their follow-up visits, the data will be analyzed by an independent statistician. The Company expects to have summary data available later this quarter. The US open-label study is still ongoing. Depending on the outcome of the placebo-controlled study and a pre-BLA (Biologic License Application) meeting with the FDA, the Company anticipates to file the application for a US market approval in 2008.

While the regulatory process of Rhucin® is still ongoing, Pharming continues its preparations for the commercialization of the product. The clinical database is being expanded by continued inclusion of patients in open label studies, of which the resulting data should eventually support marketing efforts. In addition, the commercial protection of Rhucin® has been further strengthened by the recent issuance of European Patent 1252184 entitled "C1 inhibitor produced in the milk of transgenic mammals". The claims of this patent cover production, purification and the use of C1 inhibitor (the scientific name of Rhucin®) in pharmaceutical preparations.



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