FDA grants ISA Pharmaceuticals Orphan Drug Designation for the treatment of Vulvar Intraepithelial Neoplasia with its lead product ISA-HPV-SLP®
Leiden, The Netherlands, October 5th , 2011 – ISA Pharmaceuticals BV, a leader in the development of immunotherapeutic products for oncology and infectious diseases, today announced that orphan drug designation has been granted to its lead compound for the treatment of vulvar intraepithelial neoplasia (VIN) by the Office of Orphan Products Development (OOPD) of the US Food and Drug Administration (FDA). Orphan drug designation is granted by the FDA to promote the development of products that may offer therapeutic benefits for diseases affecting less than 200,000 people in the USA. Orphan drug designations are based on several criteria that include rarity and seriousness of the condition, the lack of therapies and scientific merit of the proposed medicinal product. Orphan medicinal product designation provides opportunities for fee and tax reductions before and after marketing authorization and seven years of market exclusivity following drug approval in the US. EU orphan drug designation was previously also obtained by ISA potentially providing ten years of market exclusivity following drug approval in Europe.
“Receiving the orphan drug designation from the EMA and now also the FDA has been very encouraging and confirms the validity of our scientific approach for the treatment of VIN and other HPV-induced lesions. Indeed, the recognition by these major regulatory organizations is exhilarating and strengthens our commitment. The orphan drug designation provides opportunities to stimulate the development of our program.” said Gerard Platenburg, managing director of ISA Pharmaceuticals BV.