NewLink Genetics Receives European Orphan Designation for Pancreatic Cancer Treatment
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 June 2012. 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