FRENCH biotech firm Vivalis and its British partner GlaxoSmithKline have won US clearance to begin testing for the first time on humans flu vaccines that were produced using Vivalis’s technology.
Vivalis said in a statement that the terms of the milestone were not disclosed. Typically, biotech companies receive fees from partnership deals when a drug progresses in its development.
The Food and Drug Administration (FDA) accepted a so-called investigational new drug application that will allow GSK to test its influenza vaccine produced in Vivalis’s duck stem cell line technology on humans in an early stage Phase I trial.
It is the first time that Vivalis’ technology, which is quicker, simpler and cleaner than developing vaccines in chicken eggs, has been put through regulatory screening.
Vivalis has said the flu vaccine could be the first duck stem cell-based human vaccine to be marketed in 2015.
“We continue in our commitment to advancing innovative technologies in markets where commercial success is defined by safety, efficacy, and efficiency,” said Franck Grimaud chief executive of Vivalis.