VIVALIS ANNOUNCED THE FIRST EVER MARKETING AUTHORIZATION FOR A VACCINE PRODUCED IN EB66® CELL LINE
Nantes (France) - 09 October 2012 - Vivalis (NYSE Euronext: VLS) announced today that The Chemo-Sero Therapeutic Research Institute (Kaketsuken) has received a marketing authorization in Japan from the Ministry of Agriculture, Forestry and Fisheries for a prophylactic veterinary vaccine produced in Vivalis' EB66® cells against Egg Drop Syndrome (EDS) for use in egg laying hens. It is the first vaccine produced in EB66® cells to be approved by any regulatory authority in the world.
Vivalis EB66® cell line was used in veterinary applications for over five years. A key benefit seen with EB66® cell line is the ability to migrate away from traditional egg-based or chicken embryo-based production systems where inefficiencies make some viral vaccines difficult to produce or economically unviable due to high production costs. The EB66® cells, with their ability to grow to high cell densities, their rapid 14 hours population doubling time, and their ability to grow in suspension in single- and multi-use bioreactor systems, make them a desirable substrate for viral vaccine production when costs are a significant concern.
Today, over 30 EB66® commercial and research licenses have been signed with 20 different vaccine companies world-wide, corresponding to more than 70 vaccines under development produced on the EB66® cell line.
Half of these companies represent the veterinary field with the expectation of up to five market approvals within the next three years. The veterinary vaccine market which was established to more than US$ 5 billion in 2012, is representing a very important segment for Vivalis.
In the field of human health, 20 human vaccines are currently under development; the most advanced vaccine is in Phase III clinical trials for human influenza prevention in Japan.
Franck Grimaud, CEO, and Majid Mehtali, CSO, co-managers of Vivalis jointly stated, "We are very happy that Kaketsuken has achieved the approval for this vaccine produced in the EB66® cell line. Having been thoroughly reviewed in a full regulatory context, our Japanese partner has successfully shown that products can be produced and approved in a novel cell substrate, something few organizations have achieved. We have always been enthusiastic of the strong and trustful relationship with the Kaketsuken team here at Vivalis. This first market approval, in a demanding regulatory environment, demonstrates that the shift from traditional egg-based production systems to a cell substrate like the EB66® cell line, is possible and ongoing. We expect other vaccine companies to follow this example in the months to come, in both the veterinary and human vaccine field."
Financial terms of the agreement were not disclosed.
