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NewLink Genetics Announces Merck Has Begun Rolling Submission of Licensure Application for Ebola vaccine V920
Nov. 15, 2018 08:58AM PST
Pharmaceutical InvestingNewLink Genetics (NASDAQ:NLNK) reported today that Merck has begun the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for V920 (rVSV∆G-ZEBOV-GP, live attenuated). As quoted in the press release: This rolling submission is made pursuant to the FDA’s Breakthrough Therapy Designation for V920, which was announced by Merck in July …
NewLink Genetics (NASDAQ:NLNK) reported today that Merck has begun the submission of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for V920 (rVSV∆G-ZEBOV-GP, live attenuated).
As quoted in the press release:
This rolling submission is made pursuant to the FDA’s Breakthrough Therapy Designation for V920, which was announced by Merck in July 2016 and is anticipated to be completed in 2019.
The FDA’s approval of this Ebola vaccine would trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics has a substantial economic interest. Thereafter, NewLink would have the right to monetize its share of interest in the voucher. This Ebola vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC) and thereafter licensed to NewLink Genetics. Additional information related to this Ebola vaccine candidate may be found in the most recent 10Q and other filings under the “Investors & Media” section on the Company’s website.
“We are pleased that Merck has begun the submission process for Ebola candidate V920,” said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. “Given the recent outbreaks and recurrent risk Ebola poses to global public health, we are encouraged by the potential for this vaccine to address this deadly disease.”