Evolva (SIX:EVE) today announced the receipt of a letter
from the US Environmental Protection Agency (EPA) shortly ahead of the
expected regulatory registration.
In the course of its in-depth review of Evolva’s application to register
nootkatone as a “manufacturing-use product” (MP), the Agency identified
one study for which it could not complete its review and has requested
Evolva is in close interaction with EPA to resolve the identified issue
and to determine the next steps which will include extension of the
regulatory deadline. Evolva will inform its stakeholders accordingly as
soon as it will have gained more visibility.
Evolva remains fully committed to the project and is confident that
nootkatone will be registered as an active ingredient against ticks and
Nootkatone is an ingredient found in minute quantities in the bark of
the Alaska yellow cedar (also known as the Nootka cypress) and in the
skin of grapefruit. Nootkatone has a long history as an approved flavor
and fragrance. It can also be produced on an industrial scale from
brewing via yeast fermentation. Nootkatone has been tested against a
variety of biting arthropods, including the ticks that are responsible
for spreading Lyme disease and the mosquitoes that spread like Zika,
chikungunya, dengue and West Nile viruses.
About Evolva’s collaboration with CDC and BARDA
This project has been funded with Federal funds from the Centers for
Disease Control and Prevention (CDC), and managed by the Office of the
Assistant Secretary for Preparedness and Response (ASPR), Biomedical
Advanced Research and Development Authority (BARDA), under Contract No.
About Lyme disease and Zika virus
disease is caused by the bacterium Borrelia burgdorferi and
is transmitted to humans through the bite of infected blacklegged ticks
(aka deer tick, Ixodes scapularis and Ixodes pacificus). Zika
virus is spread to people primarily through the bite of an infected Aedes
species mosquito (Ae. aegypti and Ae. albopictus).
There is no vaccine or medicine for Zika; the best protection is to
avoid mosquito bites.
About tick- and mosquito-borne illnesses in the US
Last year, the CDC issued a report
stating that illnesses from mosquito, tick and flea bites tripled
from 2004-2016. The report warned that better options are needed in the
fight against these disease vectors. "Widespread and difficult to
control diseases from mosquito, tick, and flea bites are major causes of
sickness and death worldwide. The growing number and spread of these
diseases pose an increasing risk in the U.S." The report found that the
nation needs to be better prepared to face this public health threat.
Evolva solves the supply chain issues of nature through a 21st century
mix of biotechnology and fermentation. We develop, make and sell
ingredients that provide significant health, wellness and nutrition
benefits to people in their daily life, but whose supply chain issues
have limited their use until now. Our flagship ingredients are stevia,
nootkatone and resveratrol. To make our world sustainable requires
nature and technology to work together as one, and our aim is to play a
(small) part in achieving this transformation. For more information see https://www.evolva.com.
This press release contains specific forward-looking statements, e.g.
statements including terms like believe, assume, expect or similar
expressions. Such forward-looking statements are subject to known and
unknown risks, uncertainties and other factors which may result in a
substantial divergence between the actual results, financial situation,
development or performance of the company and those explicitly or
implicitly presumed in these statements. There can be no guarantee that
Nootkatone will be registered as a manufacturing-use product (MP). Nor
can there be any guarantee that Nootkatone as MP (which is intended for
formulation in end-use products (EPs)) will be commercially successful
in the future. In particular, management’s expectations regarding
Nootkatone could be affected by, among other things, the uncertainties
inherent in research and development, including unexpected trial results
and/or any other unexpected deficiencies EPA may still identify in the
course of its continued review of the application. Against the
background of these uncertainties, readers should not place undue
reliance on forward-looking statements. The company assumes no
responsibility to update forward-looking statements or to adapt them to
future events or developments.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190317005021/en/