BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to specialty and orphan oncology products, today announced that clonidine Lauriad™ has been granted orphan designation by the European Commission in the prevention of radiotherapy-induced oral mucositis in patients with head and neck cancer.
Oral mucositis is a very frequent inflammation of the oral mucosa in head and neck cancer patients treated with radio- and chemotherapy (98,000 new patients estimated per year in Europe*). Severe oral mucositis occurs in 60% of these patients and may induce intense oral pain and eating disability requiring artificial nutritional support. In 20 to 30% of cases, patients have to be hospitalized and the disease may result in a modification or a stop of the radiotherapy treatment in more than 10% of them**. Radiotherapy-induced oral mucositis has currently no preventive cure.
In Europe, the orphan designation is granted for medicinal products in diseases affecting less than 5/10,000 patients. This status permits to benefit from incentives related to the clinical development, thus enabling a faster registration, and an extra protection with a 10- year commercial exclusivity after market authorization.
“The European designation for clonidine Lauriad™ as an orphan drug is key in shortening its development timeline, optimizing costs and reinforcing its future market access. Clonidine Lauriad™, currently in Phase II clinical trial, is the second product from our “Orphan Oncology Products” portfolio to be granted orphan status in Europe. The portfolio comprises assets with high commercial potential and will leverage our future growth”, stated COO, Judith Greciet.
*Data Globocan 2008 – Prediction 2010, EU-27 (European Union)
** Trotti et al, 2003