Item 8.01. Other Events.
On November 14, 2012, NewLink Genetics (NASDAQ:NLNK) 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).
The press release is attached hereto as Exhibit 99.1 and incorporated herein by
reference.
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