SuppreMol Receives Orphan Drug Designation for SM101
SuppreMol GmbH announced that the European Commission has granted orphan medicinal product designation for Suppre- Mol's lead product SM101, a recombinant human soluble Fc-gamma receptor IIb, for the treatment of idiopathic thrombocytopenic purpurea (ITP). SM101 is in preclinical development and scheduled to enter Phase I clinical studies in the second half of 2008.
"The orphan drug designation is an important recognition of our approach, offering increased opportunity to engage the EMEA in discussions concerning its further clinical development," said Peter Buckel, CEO of SuppreMol.
The EMEA's orphan drug program is designed to promote the development of drugs to treat rare and life-threatening or very serious conditions (prevalence: < 5 in 10,000 people in the European Union). The designation provides EU market exclusivity for up to ten years in the given indication. Other potential benefits include a reduction in fees associated with various aspects of the regulatory process, including the application for marketing approval as well as EMEA guidance in preparing protocols concerning studies relevant for approval.
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