Evolva announced the receipt of a letter from the US Environmental Protection Agency shortly ahead of the expected regulatory registration.
REINACH, Switzerland--(BUSINESS WIRE)-- 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 further information.
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 mosquitoes.
About nootkatone
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. HHSO100201700015C.
About Lyme disease and Zika virus
Lyme 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.
About Evolva
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.
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Contacts
Oliver Walker, CEO
oliverw@evolva.com
+ 41 61 485 2034
Paul Verbraeken, IR
paulv@evolva.com
+ 41 61 485 2035
Stephan Herrera, USA
stephanh@evolva.com
+ 1 415 794 4005
Source: Evolva