BioAlliance Pharma : Grant of « orphan designation » for clonidine Lauriad™ in Europe

November 02, 2011 - BioAlliance Pharma SA (Euronext Paris - BIO) , a company dedicated to specialty and orphan oncology products, 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... 

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...About BioAlliance Pharma

Dedicated to cancer and supportive care treatment with a focus on resistance targeting and orphan products –– BioAlliance conceives and develops innovative products, for specialty markets especially in the hospital setting and for orphan or rare diseases.

Created in 1997 and introduced to the Euronext Paris market in 2005, BioAlliance Pharma’s ambition is to become a leading player in these fields by coupling innovation to patient needs. The company’s teams have the key competencies required to identify, develop and register drugs in Europe and the USA; the products’ commercialization rights are licensed to international commercial partners invested in the hospital setting. In areas where medical needs are insufficiently met, its targeted approaches help overcome drug resistance and improve patient health & quality of life... BioAlliance Pharma's Press Releases - Communiqués de Presse de BioAlliance Pharma -