NewLink Genetics (NLNK) Receives $25M BARDA Contract

October 4, 2016 4:13 PM EDT

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NewLink Genetics Corporation (Nasdaq: NLNK), announced that the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) has issued a $24.8 million contract to a subsidiary of NewLink Genetics to support the advanced development of the investigational rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine candidate, designated V920.

The new award includes an additional $51 million of contract options which may be exercised by BARDA. BARDA has previously awarded $76.8 million in contracts for development of V920. The new funding is in support of manufacturing facility readiness, manufacturing process qualification activities, and additional clinical trials to support regulatory approval of the V920 vaccine.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, has the exclusive worldwide license for research, development, manufacturing and distribution of the rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine. In July 2016, the two companies reported on two key regulatory milestones for V920. The U.S Food and Drug Administration (FDA) granted the V920 Breakthrough Therapy Designation, and the European Medicines Agency (EMA), PRIME (PRIority MEdicines) status.

“This new contract issued by BARDA will enable accelerated full-scale production of V920, once it is approved, and is a critical step in helping to make this vaccine available to the health care community as they work to control epidemics and protect medical workers and others at high risk," said Thomas P. Monath, MD, Chief Scientific Officer and Chief Operating Officer of the Infectious Disease Division of NewLink Genetics.

The rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine candidate was originally engineered by scientists at the Public Health Agency of Canada (PHAC) and was subsequently licensed to NewLink Genetics. In late 2014, Merck licensed the vaccine from NewLink Genetics to apply Merck's vaccine expertise to help accelerate the development of this vaccine candidate. Merck is responsible for and involved in the research, development, manufacturing, distribution and regulatory efforts in support of V920. Clinical studies of the vaccine candidate are ongoing.

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