Biotech company Pharming Group NV 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.

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. 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

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.

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.