Nov. 14, 2012
/PRNewswire/ -- NewLink Genetics Corporation (Nasdaq: NLNK) today announced that the European Commission (EC) has designated HyperAcute-Pancreas® Immunotherapy (algenpantucel-L) as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of
16 December 1999
on Orphan Medicinal Products. NewLink filed the application for orphan designation in
. A positive opinion was adopted by the Committee for Orphan Medicinal Products (COMP) and was formally accepted by the EC. Finalization of the Public Summary is projected for November, 2012. Algenpantucel-L is an "off-the-shelf" product candidate currently being studied in IMPRESS (Immunotherapy Pancreas Resected Survival Study), an open-label, randomized, controlled, multi-center, Phase 3 clinical trial of approximately 700 Stage I and Stage II surgically-resected pancreatic cancer patients, which is being performed under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA).
As a result of the orphan designation NewLink will have access to multiple incentives for the development of the drug in the EU, including reduced fees during development, access to the centralized authorization procedure (a single application for all EU countries), ten years of market exclusivity, and reduced fees for marketing authorization applications, pre-marketing inspections and multiple post-approval fees. Currently, algenpantucel-L has both orphan drug designation and Fast-track status in
the United States
"As emphasized during National Pancreatic Cancer Awareness Month in November, there is a desperate need for new treatment options for this disease and the European Commission's decision to grant orphan drug designation to algenpantucel-L should help us to address this unmet medical need," said Dr.
, CEO and Chairman of NewLink Genetics. "We believe that orphan designation in the European Union will significantly enhance our ability to bring this product globally to patients who have pancreatic cancer."
"Orphan drug designation provides significant incentives for us to accelerate clinical development in the EU," said Dr.
. "We believe that this designation, in combination with data from our ongoing 700 patient IMPRESS Phase 3 study of algenpantucel-L, will expedite advancement of this product through the approval process in Europe.
About Orphan Drug Status in Europe
As established by the European Medicines Agency (EMA), orphan designation is granted to product candidates intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting no more than five in 10,000 people in the EU and for whom satisfactory alternative therapies are not available or where they do exist, the orphan product will be of significant benefit to those affected by that condition. Applications are reviewed by the COMP and encompass evaluations of the underlying science and clinical experience with the product.