Medarex Inc announced that under the US Orphan Drug Act, the US FDA has granted orphan drug designation to Medarex's fully human anti-CD30 antibody, MDX-060, for the treatment of Hodgkin's disease.

MDX-060 is a fully human antibody that targets CD30, a member of the tumour necrosis factor receptor superfamily and a molecule found on activated lymphocytes. CD30 has been found to be over-expressed in several lymphoproliferative disorders and is present on malignant cells of Hodgkin's disease (HD) and anaplastic large cell lymphoma (ALCL), as well as other CD30-positive lymphomas. Currently, Medarex is conducting an expanded dose-ranging Phase II study with MDX-060 in patients with CD30-positive lymphomas.

Orphan drug designation is granted to products that treat rare diseases or conditions that affect fewer than 200,000 people in the US. Orphan Drug designation provides eligibility for a special seven-year period of market exclusivity at marketing approval, potential tax credits for research, grant funding for research and development, possibly reduced filing fees for marketing applications, and assistance with the review of clinical trial protocols.

"We believe that the MDX-060 has the potential to address a serious unmet medical need, and we expect to continue to rapidly develop this antibody for patients with Hodgkin's disease," said Donald L. Drakeman, President and CEO of Medarex.

According to the American Cancer Society, in 2004 there will be approximately 7,880 new cases of Hodgkin's disease in the United States, and an estimated 1,320 people will die of the disease. The frequency of ALCL in the United States is not known, but worldwide, ALCL accounts for approximately 5 per cent of all non-Hodgkin's lymphoma.

Medarex is a biopharmaceutical company focused on the discovery and development of fully human antibody-based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune and infectious diseases.