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Vancouver, British Columbia, 2nd December, 2021 / Globe Newswire / - KetamineOne
Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA:
MY0), a company focused on consolidating medical clinics and becoming a North
American leader in mental health treatments, is pleased to announce that its
wholly-owned contract research organization, KGK Science Inc. (“KGK” or the
“CRO”), has successfully assisted its client, Hofseth Biocare ASA (HBC.OL)
(“HBC” or the “Client”), to receive New Dietary Ingredient (“NDI”) status from
the United States Food and Drug Administration (the “FDA”) for its patented
CalGo® and OmeGo® branded products. HBC is a leading manufacturer and marketer
of unique and innovative marine-derived calcium, protein, collagen, and lipid
nutritional supplements.
Summary Highlights of the FDA’s NDI Process for HBC:
- The FDA’s NDI notification process is the only pre-market gate for
demonstrating quality as well as safety for both ingredients and
manufacturing processes.
- If the ingredient is an NDI or it has been processed in a novel way, an NDI
notification is required for the US market per federal law (statute).
- Not all companies follow the US statutory obligation to file NDI
notifications.
- The historical acknowledgment rate of NDI notifications by the FDA is only
c. 30%.
- HBC complied with the FDA’s statutory requirement to submit NDI
notifications for the dietary ingredients contained in these novel dietary
supplements, and innovative technology in how these ingredients are
extracted from Norwegian Atlantic salmon.
- The two letters that HBC received for CalGo® and OmeGo® are the highest
safety rating and attestation the company could have received from the FDA.
- CalGo® is allowed to deliver calcium at 874 mg/day, phosphorus at 460 mg/day
and marine collagen protein at 1500 mg/day
- OmeGo® is approved for up to 2000 mg/day for DHA and EPA polyunsaturated
fatty acids.
HBC is now part of an exclusive list of companies that have successfully
obtained NDI status with the FDA for their novel dietary ingredients contained
in these two nutritional supplements. CalGo® has been assigned NDI report number
1225 and OmeGo® has been assigned NDI report number 1226. Approximately 50 NDI
ingredients are reviewed annually by the FDA but historically only around 30%
have received an FDA Acknowledgement (“AKL”) letter. The Client received
separate FDA AKL letters, also called no-objection letters, for its two branded
products based upon identity and safety within the FDA’s 75-day statutory
evaluation period in which to respond.
CalGo® and OmeGo® are globally recognized, high quality nutritional supplements
with patented innovative technology. Over recent years, HBC has invested a
significant amount of capital to research these ingredients and developed a
robust portfolio of patents and trademarks to protect its proprietary rights. It
utilizes a novel, innovative, and sustainable hydrolysis technology to extract
the full nutritional content from Norwegian Atlantic salmon. The FDA’s
evaluation in an NDI review looked at both the identity of the source material
and how it was processed, as well as the safety of the ingredients contained in
the nutritional supplement products.
The Federal Food, Drug, and Cosmetic Act (“FD&C Act”) requires that
manufacturers and distributors who wish to market dietary supplements that
contain “new dietary ingredients” notify the FDA about these ingredients. The
notification should include identity and chemistry information about the novel
ingredients as well as the basis upon which the manufacturer or distributor has
concluded that a dietary supplement containing an NDI will reasonably be
expected to be safe under the conditions of use recommended or suggested in the
labelling. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d).)
“As a valued client of KGK, HBC has a novel and innovative technology for
extracting nutritional components from Atlantic salmon in a very sustainable
way. The FDA evaluated that innovative process and the ingredients contained in
these two novel nutritional supplements and, in return, has offered the highest
safety rating possible. These two acknowledgement letters from FDA speaks to the
quality and safety of HBC’s CalGo® and OmeGo®,” said Najla Guthrie, President &
Chief Executive Officer of KGK. “These FDA no-objection letters also help HBC in
the global market as many countries outside of the US are looking for
attestation that the FDA has reviewed nutritional supplements for safety. HBC
has navigated that regulatory hurdle and can check that box,” added Ms. Guthrie.
“CalGo® is permitted to deliver calcium at 874 mg/day, phosphorus at 460 mg/day
and marine collagen protein at 1500 mg/day. OmeGo® is approved for up to 2000
mg/day for DHA and EPA polyunsaturated fatty acids. The FDA’s NDI process is the
highest benchmark of safety that a manufacturer or distributor of supplements
can achieve. KGK has significant experience in helping its clients achieve their
goals by earning these high marks of achievement and providing them with
significant market distinction,” said Dr. Corey Hilmas, Chief Regulatory Officer
of KGK. “Consumers and retailers are starting to understand what it means to
have an NDI no-objection letter from the FDA. They can have confidence that the
serving levels in these products are correctly chosen, based upon appropriate
scientific methods and FDA review,” added Dr. Hilmas.
Angelika Florvaag, Chief Quality Officer at HBC commented: “At HBC we pride
ourselves in producing superior health ingredients to enhance human health and
quality of life, above and beyond what is currently available in the market
today. CalGo® and OmeGo® are uniquely traceably sourced from fresh, sashimi
grade Norwegian Atlantic salmon. It is very exciting to see the US FDA endorse
to such a degree, the safety and quality of our products with significant dosing
flexibility, which will enable the products to be used in multiple formats and
delivery methods for health supplementation.”
ABOUT HOFSETH BIOCARE
HBC is a Norwegian consumer and pet health ingredient supplier and an incubator
for new drug leads. Research is ongoing to identify the individual elements
within its ingredients that modulate inflammation and the immune response with
pre-clinical studies in multiple clinics and university research labs in several
countries. Lead clinical and pre-clinical candidates are focused
on developing an oral pharmaceutical lead program to treat inflammatory disease
driven by eosinophils. Preclinical trial work with the oil is ongoing to
ameliorate lung inflammation in eosinophilic asthma and COPD (“smokers lung”) as
well as clinical work in COVID. Other leads are focused on the protection of the
Gastro-Intestinal (GI) system against inflammation (including ulcerative colitis
and the orphan condition necrotising enterocolitis) and using peptide fractions
of salmon protein hydrolysate (SPH also known as ‘ProGo’) as a Medical Food to
help treat age-related Sarcopenia, and as a treatment for Iron Deficiency
Anemia.
The company is founded on the core values of sustainability, optimal utilization
of natural resources and full traceability. Through an innovative hydrolysis
technology, HBC can preserve the quality of lipids, proteins and calcium from
fresh salmon off-cuts.
Hofseth BioCare’s headquarters are in Ålesund, Norway with branches in Oslo,
London, Zürich, Chicago, Palo Alto and Tokyo.
ABOUT KGK SCIENCE
Founded in 1997, KGK is a leading North American contract research organization
based in London, Ontario that primarily provides high-quality clinical research
trials with a focus on the nutraceutical, cannabis and emerging psychedelic
industries. The business has successfully helped hundreds of companies with
custom designed clinical trials and claim substantiation strategies to move
products into global markets. KGK’s other existing service lines include expert
regulatory support and compliance solutions, participant recruitment, research
support services and consulting services. On an approximate basis, the business
to date has produced 150 publications, executed over 400 clinical trials across
more than 40 indications, amassed 25,000 participants in its database and
collected 10 million data points.
ABOUT KETAMINE ONE
KetamineOne Capital Limited (formerly Myconic Capital Corp.) is a company
focused on consolidating medical clinics and becoming a North American leader in
mental health treatments. It is working to provide the critical infrastructure
needed to develop and deliver breakthrough mental health treatments. Currently,
Ketamine One has a network of clinics across North America, with plans to
further consolidate the highly fragmented industry. KGK Science Inc. is the
Company’s wholly owned contract research division, which places it at the
forefront of premium clinical research based on the subsidiary’s history and
extensive experience in pharmaceuticals, cannabis, and the emerging psychedelic
medicine industries. As a collective enterprise, Ketamine One is dedicated to
helping solve the growing need for safe and accessible mental health therapy.
For further information, please contact:
Adam Deffett, Interim CEO of KetamineOne or Nick Kuzyk, Investor Relations at
KetamineOne
Tel: 1-844-PHONE-K1 (1-844-746-6351)
Email: IR@ketamine.one
www.ketamine.one
Twitter: @KetamineOne
Dr. Crawford Currie, Head of Medical R&D at Hofseth BioCare ASA
Tel: +44 7968 195 497
E-mail: cc@hofsethbiocare.no
This information is subject to the disclosure requirements pursuant to Section
5-12 of the Norwegian Securities Trading Act
Kilde
