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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (842)	7/8/2004 2:12:05 AM
From: Icebrg	Read Replies (1) \| Respond to of 2240

Mepact, IDM's Most Advanced Product, Receives ''Orphan Medicinal Product'' Designation for the Treatment of Osteosarcoma in the European Union Thursday July 8, 2:00 am ET PARIS--(BUSINESS WIRE)--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. [Mepact came to IDM about a year ago when IDM purchased some assets from Jenner Biotherapies]. PARIS-April 9, 2003-IDM Immuno-Designed Molecules, a biopharmaceutical company, specialized in cellular immunotherapy, announces today that it has acquired certain assets from Jenner Biotherapies, an American biotechnology company based in Wisconsin. These assets include the exclusive rights that Jenner acquired from Eli Lilly and Company concerning the recombinant KSA antigen, better known as EP-CAM. This antigen is expressed in a large number of cancers. An anti-KSA therapeutic vaccine may have an extensive field of therapeutic applications. It will initially be developed by IDM in association with Dendritophages(R) (IDM dendritic cells) for the treatment for prostate cancer. IDM also acquired from Jenner other antigens in liposome form, as well as the rights to use PSA antigen in the treatment of prostate cancer. In addition, IDM acquired the rights for immunopotentiators (molecules that stimulate the immune system) which Jenner had obtained from Novartis. The immunopotentiator, MEPACT, was developed by Jenner for the treatment of osteosarcoma, a serious bone cancer affecting children and adolescents. This product received orphan drug status from the FDA, and IDM plans to continue its development in order to help identify therapeutic options for this unsatisfied medical need. Jenner's assets were acquired with IDM shares. Jean-Loup Romet-Lemonne, President and CEO of IDM, notes: "The technologies, products and licenses obtained in this transaction augment our ability to develop new products for immunotherapy against cancer. I am especially satisfied that this acquisition took place in exchange for IDM shares, thereby preserving our financial reserves."