RCS - Agronomics Limited - First Cultivated Meat Company gets FDA approval

AgronomicsAnnouncement

17/11/2022 07:30

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RNS Number : 7481G  Agronomics Limited  17 November 2022

17th November 2022

Agronomics Limited (https://agronomics.im/)

 

("Agronomics" or the "Company")

 

First Cultivated Meat Company Receives Greenlight from Regulator FDA in the US
Ahead of Commercialisation

 

Agronomics (LON:ANIC), the leading listed company in cellular agriculture, is
pleased to announce cultivated meat company UPSIDE Foods, Inc. ("UPSIDE
Foods"), has received a 'No Questions' letter from the US regulatory body the
US Food and Drug Administration ("FDA"), accepting their conclusion that their
cultivated chicken is safe to eat. This is a momentous achievement for UPSIDE
Foods, and a pivotal moment for the entire cultivated meat industry. This
represents the first company to achieve a greenlight from the FDA in the US,
and a validation of the sector shifting from research and development, towards
commercialisation. We expect this to be the first of many FDA approvals for
the sale of cultivated meat in the US.

The FDA's decision is a major milestone in the evolution of the global
cultivated meat sector and another step towards the commercialisation of
cellular agriculture. The news comes almost two years after the Singapore Food
Agency (SFA) gave regulatory approval to Eat Just's cultivated chicken, which
is now sold through its subsidiary GOOD Meat. At full-scale commercialisation,
cellular agriculture has the capacity to make a meaningful contribution to the
world's food production sustainably. It is projected that by 2040, cultivated
meat could reach 35% of the global meat market.

This is a timely achievement for the sector given global concerns surrounding
food security and climate change, which have come to the forefront in recent
years. There is an urgent need to adopt new methods for food production to
combat these challenges. The Company remains confident that cell culturing
technologies, and cultivated meat produced from these processes, will play a
vital role in the coming decades.

Jim Mellon, Co-Founder and Executive Director of Agronomics commented: -

"We are extremely pleased to see the first approval of a cultivated meat
product in the US.  Not only is this a massive market, but the FDA is
considered one of the most stringent regulatory bodies globally for food
safety.

This approval is a landmark event for the field of cellular agriculture and
should give investors comfort that the path to commercialisation is now clear.
We look forward to news of further approvals from within Agronomics' leading
portfolio of companies."

The full announcement is set out below without any material changes.

 

FDA Completes First Pre-Market Consultation for Human Food Made Using
Animal Cell Culture Technology
Before Entering the U.S. Market, the Food Must Meet Other Federal Requirements
 
Constituent Update

November 16, 2022

The U.S. Food and Drug Administration (FDA) completed its first pre-market
consultation for a human food made from cultured animal cells. We evaluated
the information UPSIDE Foods submitted to the agency and have no further
questions at this time about the firm's safety conclusion. The firm will use
animal cell culture technology to take living cells from chickens and grow the
cells in a controlled environment to make the cultured animal cell food.

 

The FDA's pre-market consultation with the firm included an evaluation of the
firm's production process and the cultured cell material made by the
production process, including the establishment of cell lines and cell banks,
manufacturing controls, and all components and inputs. The voluntary
pre-market consultation is not an approval process. Instead, it means that
after our careful evaluation of the data and information shared by the firm,
we have no further questions at this time about the firm's safety conclusion.

 

The FDA is committed to sharing information about our oversight of human food
made from cultured animal cells and today released:

 

●     The FDA's response letter
(https://www.fda.gov/media/163260/download)   to the firm

 

●     The FDA's scientific memo
(https://www.fda.gov/media/163261/download) that describes our evaluation of
the data and information provided by the firm

 

●     The firm's own assessment
(https://www.fda.gov/media/163262/download) that their food is safe

 

In addition to meeting the FDA's requirements, including facility registration
for the cell culture portion of the process, the firm will need a grant of
inspection from the United States Department of Agriculture Food Safety and
Inspection Service (USDA-FSIS) for the manufacturing establishment.
Additionally, the food itself requires a mark of inspection from USDA-FSIS
before it can enter the U.S. market. As this product comes closer to entering
the U.S. market, we are closely coordinating with USDA-FSIS
(https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell)
to ensure it is properly regulated and labeled.

 

The FDA is ready to work with additional firms developing cultured animal cell
food and production processes to ensure their food is safe and lawful under
the Federal Food, Drug, and Cosmetic Act. We encourage firms to have these
conversations with us often and early in their product and process development
phase, well ahead of making any submission to us. We are already engaged in
discussions with multiple firms about various types of food made from cultured
animal cells, including food made from seafood cells that will be overseen
solely by the FDA. Our goal is to support innovation in food technologies
while always maintaining as our priority the production of safe food. Human
food made with cultured animal cells must meet the same stringent
requirements, including safety requirements, as all other food.

 

For More Information:

●     Human Food Made with Cultured Animal Cells
(https://www.fda.gov/food/food-ingredients-packaging/human-food-made-cultured-animal-cells)

●     Press Release: FDA Spurs Innovation for Human Food from Animal
Cell Culture Technology
(https://www.fda.gov/news-events/press-announcements/fda-spurs-innovation-human-food-animal-cell-culture-technology)

 

 

About Agronomics (https://agronomics.im/)

Agronomics is a leading listed alternative proteins company with a focus on
cellular agriculture and cultivated meat. The Company has established a
portfolio of 24 companies in this rapidly advancing sector. It seeks to
secure minority stakes in companies owning technologies with defensible
intellectual property that offer new ways of producing food and materials with
a focus on products historically derived from animals. These technologies are
driving a major disruption in agriculture, offering solutions to improve
sustainability, as well as addressing human health, animal welfare and
environmental damage. This disruption will decouple supply chains from the
environment and animals, as well as being fundamental to feeding the world's
expanding population. A full list of Agronomics' portfolio companies is
available at https://agronomics.im/
(https://clicktime.symantec.com/368cVqxx3R6vTFuHpf6MSE66Gi?u=https%3A%2F%2Fagronomics.im%2F)
.

 

About Cellular Agriculture

Cellular Agriculture is the production of agriculture products directly from
cells, as opposed to raising an animal for slaughter, or growing crops. This
encompasses cell culture to produce cultivated meat and materials,
and fermentation processes that harness a combination of molecular biology,
synthetic biology, tissue engineering and biotechnology to massively simplify
production methods in a sustainable manner.

Over the coming decades, the source of the world's food supply traditionally
derived from conventional agriculture is going to change dramatically. We have
already witnessed the first wave of this shift with the consumer adoption of
plant-based alternative proteins but today, we are on the cusp of an even
bigger wave of change. This is being facilitated by advances in cellular
agriculture. This change is necessary, given scientists claims that if we
maintain existing animal protein consumption patterns, then we will not meet
the Paris Agreement's goal of limiting warming to 1.5℃.

 

AT Kearney, a global consultancy firm, projects that cultivated meat's market
share will reach 35% by 2040. This combined with the Good Food
Institute's estimate that a US $1.8 trillion investment will be required in
order to produce just 10% of the world's protein using this technology, means
that we are on the cusp of a multi-decade flow of capital to build out
manufacturing facilities. Funding in the field of cellular agriculture is
accelerating, however still less than US$ 5 billion has been invested
worldwide since the industry's inception in 2016.

 

For further information please contact:

 Agronomics                                       Beaumont              Canaccord                        Cenkos                Peterhouse Capital

 Limited                                          Cornish Limited       Genuity Limited                  Securities Plc        Limited               TB Cardew
 The Company                                      Nomad                     Joint Broker                 Joint Broker          Joint Broker          Public Relations
 Richard Reed                                     Roland Cornish        Andrew Potts                     Giles Balleny         Lucy Williams

 Denham Eke                                       James Biddle          Harry Rees                       Max Gould             Charles Goodfellow    Ed Orlebar

                                                                        Alex Aylen (Head of Equities)    Michael Johnson                             Alistair Walker
 +44 (0) 1624 639396                              +44 (0) 207 628 3396                                   +44 (0) 207 397 8900  +44 (0) 207 469 0936  +44 (0) 20 7930 0777

 info@agronomics.im (mailto:info@agronomics.im)                              +44 (0) 207 523 8000                                                    +44 (0) 7738 724 630

                                                                                                                                                     agronomics@tbcardew.com (mailto:agronomics@tbcardew.com)

 

 

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