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Committee for  Orphan Medicinal Products January 2007 Meeting |
| EMEA |
| January 10, 2007 |
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The seventy-fifth meeting of the Committee for  Orphan Medicinal Products (COMP) took place on 9- 10 January 2007. The Committee was delighted to officially welcome two COMP members from the new Member States. An updated list of COMP membership is provided in Annex 1.
COMP Opinions
The Committee adopted 6 positive opinions on orphan medicinal product designation during this meeting:
• Artesunate, from ACE Pharmaceuticals BV, for treatment of malaria (review time: day 62)
• Autologous dendritic cells pulsed with autologous cell lysate, from Dorian Regulatory Affairs BV, for treatment of glioma (review time: day 62)
• Ex-vivo cultured adult human mesenchymal stem cells, from Quintiles UK Limited, for treatment of Graft-versus-Host disease (review time: day 62)
• HLA class I/II binding tumour associated peptides (ADF-APO-CCN-GUC-K67-MET-MMPMUC- RGS), from Immatics Biotechnologies GmbH, for treatment of renal cell carcinoma (review time: day 62)
• Idebenone, from Santhera Pharmaceuticals (Deutschland) AG, for treatment of Leber's hereditary optic neuropathy (review time: day 90)
• Recombinant human C1-inhibitor, from Pharming Group N.V., for prevention of delayed graft function after solid organ transplantation (review time: day 90)
Four oral explanations on orphan medicinal product designation took place during the meeting.
Withdrawals of Orphan Medicinal Product Applications
The COMP noted that four applications for orphan medicinal product designation were withdrawn by the sponsor during evaluation phase of the procedure.
Overview of orphan designation procedures
The European Commission granted four positive decisions on orphan designation1 since the last COMP meeting on 5-6 December 2006 (see Annex 2).
The status of orphan designation procedures, to date for 2007, is summarised below:
Figures: see company's website
An overview of orphan designation procedures for 2000-2006 is provided in Annex 3.
Further information on designated orphan medicinal products is publicly available in the form of summarised COMP Opinions2, which the Agency routinely publishes following adoption of the respective decisions on orphan designation by the European Commission.
Applications for Marketing Authorisation for Orphan Medicinal Products
Details of those designated orphan medicinal products that have been the subject of a centralised application for marketing authorisation since the last COMP meeting are provided in Annex 4.
Date of next COMP meeting
The next COMP meeting will be held on 6-7 February 2007.
NOTE: This Press Release, together with other information about the work of the EMEA, may be found on the internet at the following location: http://www.emea.europa.eu
For further information, please contact:
Martin Harvey Allchurch, EMEA press officer
Tel. (+44-20) 74 18 84 27, E-mail: press@emea.europa.eu
ANNEX 1 to 4: see EMEA's website
1 Details of all orphan designations granted to date by the European Commission are entered in the Community Register of Orphan Medicinal Products (http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm)
2 These documents are available on the EMEA web-site.
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