Mepact, IDM’s Most Advanced Product, Receives ”Orphan Medicinal Product” Designation for the Treatment of Osteosarcoma in the European Union
PARIS, July 8, 2004 – IDM (Immuno-Designed Molecules), a biopharmaceutical company specialized in the development of immunotherapy products for the treatment and control of cancer, announces today that the European Commission has granted its product, Mepact, “orphan medicinal product” designation for the treatment of osteosarcoma. Designation was granted following the positive opinion given by the European Medicines Agency (EMEA) and its Committee for Orphan Medicinal Products (COMP). Mepact obtained “orphan drug” status in the United States in June 2001.
Mepact (L-MTP-PE) is an immune system stimulant designed to promote the destruction of cancer cells by activating macrophages present in the body. A randomized Phase III trial on Mepact administered after surgical resection of tumor, in association with chemotherapies was carried out on close to 800 patients who had recently been diagnosed with Osteosarcoma. The statistical analysis of data from the trial indicates that Mepact provides a significant increase in the disease free survival, as well as a significant increase in the overall survival of patients whose treatment includes Mepact versus treatment with chemotherapy alone. The most frequent adverse events were those typically associated with intensive chemotherapy.
Osteosarcoma is the most common form of bone cancer. It primarily occurs in children and adolescents. The incidence is approximately one thousand new cases per year both in the United States and in Europe.
The European Commission grants “orphan medicinal product” designation to medicines products targeting diseases whose prevalence in the European Union does not exceed 5 per 10,000 persons. To encourage the development of new drugs to treat rare diseases, “orphan medicinal product” designation gives companies specific financial and regulatory incentives as well as market exclusivity that, in the European Union, last for ten years after obtaining marketing authorization.
IDM is currently completing its application to regulatory authorities in order to gain approval to market Mepact in the European Union and the United States.
IDM — The Immunogenics Company(R)
IDM is a biopharmaceutical company focused on the development of innovative products to treat and control cancer while maintaining the patient’s quality of life. IDM is currently developing two lines of products: one aiming at the destruction of residual cancer cells after the use of traditional therapies, and the other to prevent tumor recurrence by triggering an immune response. IDM’s most advanced product has completed a Phase III clinical trial, five other products are in clinical trials and five are in preclinical development.
For more information, please visit IDM’s Web site, http://www.idm-biotech.com.
CONTACT: IDM Nadine Sciacca, +33 (0) 1 40 09 04 11 nsciacca@idm-biotech.com idm@idm-biotech.com
