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NewLink Genetics Announces Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)

AMES, Iowa, July 25, 2016 (GLOBE NEWSWIRE) -- NewLink Genetics Corporation (NASDAQ:NLNK), announced today that Merck (NYSE:MRK), known as MSD outside the United States and Canada, has reached two key regulatory milestones for the Ebola Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP). The U.S Food and Drug Administration (FDA) has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency (EMA) has provided the vaccine candidate PRIME (PRIority MEdicines) status.

V920 was initially engineered by scientists from the Public Health Agency of Canada and subsequently licensed to NewLink Genetics. In late 2014, when the peak of the Ebola outbreak in western Africa was at its worst, NewLink Genetics licensed V920 to Merck, with the goal of accelerating the development, regulatory approval, and availability of this candidate vaccine. Merck is responsible for the research, development, manufacturing, and regulatory efforts in support of V920. Since that time, Merck continues to work closely with NewLink Genetics and their external collaborators to accelerate development and licensure.

“These regulatory designations reflect great credit upon the extraordinary public-private partnerships which have allowed the vaccine candidate to be included in 12 Phase 1, 2 and 3 studies on three continents in less than two years,” said Thomas P. Monath, M.D., Chief Scientific Officer and Chief Operating Officer of the Infectious Disease Division of NewLink Genetics. Charles L. Link, Jr., M.D., Chairman, Chief Executive Officer and Chief Scientific Officer of NewLink Genetics emphasized that, “While the Ebola Public Health Emergency of International Concern (PHEIC) is over, we know the threat of re-emergence remains. We are encouraged by these FDA and EMA decisions which we hope will aid progress of the candidate vaccine towards potential licensure.”

About NewLink Genetics Corporation

NewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor platforms, to improve the lives of patients with cancer. NewLink Genetics’ portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink Genetics’ product candidates are designed to harness multiple components of the immune system to combat cancer. For more information, please visit http://www.newlinkgenetics.com

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink Genetics that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include any statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink Genetics makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink Genetics' Annual Report on Form 10-K for the year ended December 31, 2015 and other reports filed with the U.S. Securities and Exchange Commission (SEC). The forward-looking statements in this press release represent NewLink Genetics' views as of the date of this press release. NewLink Genetics anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink Genetics' views as of any date subsequent to the date of this press release.

Corporate Contact: Jack Henneman Chief Financial Officer (515) 598-2561 Investor@linkp.com Media and Investor Contact: Beth Kurth LaVoieHealthScience 617-374-8800, ext. 106 bkurth@lavoiehealthscience.com

Source:NewLink Genetics Corporation