BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the supportive care and treatment of cancer patients, today announced the submission to the European (EMA) and American (FDA) Drug Agencies of an application for orphan medicinal product designation for clonidine Lauriad™, in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer.
Clonidine Lauriad™, presently in phase II clinical trial in Europe, is dedicated to the prevention of oral mucositis, a debilitating inflammation of the oral mucosa possibly altering the general condition of patients with head and neck cancer treated with radiotherapy and radio- and chemotherapy (the number of new patients in Europe and the United States is estimated to be 120,000 per year). Nearly 80% of these patients are affected by this severe disease which currently has no proven cure.
“The orphan drug designation for clonidine Lauriad™, which should be granted by the end of 2011, will permit to optimize its development plan as well as its access to the market. Clonidine Lauriad™ is thus a key asset of our “Orphan Oncology Products” portfolio and its orphan designation in two major territories is particularly important for the continuation of its development. This product joins our orphan product portfolio currently undergoing clinical development”, declares Judith Greciet, COO.
The orphan medicinal product designation is defined by the number of patients affected by the disease, between 200,000 and 250,000 in the US and Europe, and benefits from incentive measures notably related to the development plan and to the patent protection duration of orphan designated products.