(By Balaseshan) NewLink Genetics Corp. (NASDAQ: NLNK) said it has received European orphan designation for algenpantucel-L immunotherapy to treat pancreatic cancer.
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 December 16, 1999 on Orphan Medicinal Products.
Currently, algenpantucel-L has both orphan drug designation and Fast-track status in the United States. As a result of the orphan designation NewLink will have access to multiple incentives for the development of the drug in the EU.
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The multiple incentives include 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.
"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," said Charles Link, CEO and Chairman of NewLink Genetics.
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 about 700 Stage 1 and Stage 2 surgically-resected pancreatic cancer patients, which is being performed under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA).
NLNK closed Tuesday's regular session up 2.36% at $12.13. The stock has been trading between $6.25 and $18 for the past 52 weeks.