New Regulatory Approvals Support DAO Deficiency Solution Expansion
In February 2022, the active ingredient diamine oxidase – or DAO – produced by AB Biotek’s DR Healthcare division, as well as the solutions derived from it, have obtained the GRAS (Generally Recognized As Safe, per sections 201(s) and 409 of the U.S. Food & Drug Act) qualification from the U.S. Food & Drug Administration. This allows for the upcoming launch in the U.S. marketplace.
From the FDA regulations 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS through scientific procedures and scientific evidence and is based on in published studies.
Additionally, at the same time, the Directorate-General for Hygiene, Food Safety & Nutrition in Rome, Italy, and the Ministry of Finance, Economy & Recovery in Paris, France, both approved the launch of DAO products in those two countries.
These three steps represent new support for continued international expansion of DR Healthcare’s solution portfolio targeting consumers with DAO deficiency.
DAO – an enzyme naturally secreted by the human body – is frequently used as a nutritional supplement to treat disorders from histamine accumulation including migraines, fibromyalgia, irritable bowel syndrome (IBS), atopic skin or even attention deficit hyperactivity disorder (ADHD). Approximately 15 percent of the population suffers from a DAO deficiency, both genetic and acquired.
About DR Healthcare
Founded in Barcelona, Spain, in 2007, DR Healthcare is a biomedical company specialized in medical nutrition and dedicated to the research, development, innovation, marketing and licensing of new nutraceuticals, functional foods, active ingredients and customized solutions. Our medical nutrition products are aimed at dietary management of chronic diseases, physiological dysfunctions and/or metabolic diseases, mainly associated with metabolic disorders caused by a deficiency of the intestinal enzyme diamine oxidase (DAO). DR Healthcare also produces DAO for both human and animal use and offers proprietary solutions for the food, veterinary and animal health industries. More information is available at www.dr-healthcare.com/en.
About AB Biotek
AB Biotek contributes to the success of customers through the delivery of customized fermentation-based, sustainable solutions containing proprietary and/or purposefully sourced microorganisms to created differentiated food, beverage, health & nutrition business opportunities. Science and advanced microorganism fermentation technology are core enablers. AB Biotek has commercial scale production and research development facilities located around the world. For more information about our product applications and unmatched technical service capabilities, please visit www.abbiotek.com.
AB Biotek Acquires Spanish Biomedical DR Healthcare
Respective leaders in fermentation science and DAO-based medical nutrition join together to focus on innovative enzyme-based solutions for the human nutrition & health market.
PETERBOROUGH, U.K. 26 may 2021 – AB Biotek, a global business division of Associated British Foods plc – today announces that it has acquired DR Healthcare, a biomedical company focused on the dietary management of chronic diseases based in Barcelona, Spain.
This acquisition enables AB Biotek to boost its growing portfolio of differentiated microbiome modulating solutions for human nutrition and health. The acquisition adds diamine oxidase (DAO), an important intestinal enzyme, that will expand AB Biotek’s already strong commercial portfolio of probiotic yeast strains.
DAO, naturally secreted by the human body, is widely known as a critical enzyme at the core of reducing symptoms of many of today’s ailments, including migraine, food intolerances and attention deficit hyperactivity disorder, prevalent in millions of people around the world.
Juanjo Duelo, the founder of DR Healthcare, will remain with the business.
“With the acquisition of DR Healthcare, we now have the next stepping stone in shaping our science-based organization to serve the fast-growing human nutrition and health space,” said Gerald Dard, global managing director, AB Biotek. “DR Healthcare has a strong track record in this area, and we welcome our new colleagues who are equally passionate about the health and wellness of today’s consumers.”
“I am very excited about this new chapter as our companies have many shared values, from advanced health solutions and deep science to an extreme passion for what we do,” said Juanjo Duelo. “The future is bright under the good ownership of AB Biotek, and the timing is perfect to bring new, innovative technologies to improve the wellbeing of those people who suffer from various pathologies associated with the deficiency of DAO.”
About AB Biotek
AB Biotek contributes to the success of customers through the delivery of customized fermentation-based, sustainable solutions containing proprietary and/or purposefully sourced microorganisms to created differentiated food, beverage, health & nutrition business opportunities. Science and advanced microorganism fermentation technology are core enablers. AB Biotek has commercial scale production and research development facilities located around the world. For more information about our product applications and unmatched technical service capabilities, please visit www.abbiotek.com.
About DR Healthcare
Founded in Barcelona, Spain, in 2007, DR Healthcare is a biomedical company specialized in medical nutrition and dedicated to the research, development, innovation, marketing and licensing of new nutraceuticals, functional foods, active ingredients and customized solutions. Our medical nutrition products are aimed at dietary management of chronic diseases, physiological dysfunctions and/or metabolic diseases, mainly associated with metabolic disorders caused by a deficiency of the intestinal enzyme diamine oxidase (DAO). DR Healthcare produces DAO for both human and animal use and offers proprietary solutions for the food, pharmaceutical, veterinary and animal health industries. More information is available at www.dr-healthcare.com/en.
Patrick Barry +1.314.540.3865
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Míriam Cusí mcusi@llorenteycuenca.com
Cristina Vilà cvila@llorenteycuenca.com
DAO deficiency and the COVID-19 pandemic
We live in a time of real uncertainty with the worldwide spread of COVID-19 and anxiety levels are high. It is important to remain calm, listen and apply the advice of the Health Authority.
Considering that the activities of DR Healthcare are focused on the study of histamine, DAO deficiency and histamine intolerance, it is worth mentioning recent publications that support the fact that mast cell activation and histamine release can contribute to the inflammation associated with SARS COV-2 infection (new strain of coronavirus that causes COVID-19) .
Coronavirus infection (regardless of the various types of coronavirus) is primarily attacked by immune cells, including mast cells (MC), which are found in the submucosa of the respiratory tract and in the nasal cavity, representing a protective barrier against microorganisms. Viruses activate mast cells that release early inflammatory chemical compounds such as histamine and protease (1). In people with DAO deficiency who, due to this condition, have high levels of circulating histamine, a greater histamine accumulation caused by the aforementioned virus-activated mastocytosis, may aggravate the inflammatory process generated by the infection.
Under normal conditions, when histamine levels rise above a certain threshold, the enzymes responsible for its metabolism, specifically DAO (Diamino Oxidase) and, to a lesser extent, histamine N-methyl transferase (HNMT), rapidly degrade the excess this amine. However, when the degradation rate is insufficient to cope with the excess, the total level of histamine in the body rises. At a certain critical level, signs and symptoms occur as a result of histamine coupling to its receptors in specific cells.
Histamine is a mediator that intervenes in the inflammation of the immune system by activating intracellular pathways that induce the production of cytokines in the lungs. Cytokines are signaling proteins that regulate interactions of cells of the immune system, thus producing an amplification of inflammatory reactions.
Based on the aforementioned studies and the pathophysiology of the disease, it is important to maximize the basic recommendations to protect against COVID-19, avoiding an accumulation of histamine in people with DAO deficiency and / or mastocytosis. Since inflammation is a concern in the severity of the disease caused by SARS COV-2, it is recommended to reduce the consumption of foods high in histamine in the diet and take supplements that allow maintaining a balance between endogenous and exogenous histamine, avoiding an excess of histamine in the body, and therefore reducing the mast cell / histamine load.
Thus, in addition to the basic general guidelines to prevent the spread of COVID-19 in the entire population, there are a number of added recommendations to consider in people with DAO deficiency and / or intolerance to histamine:
-Avoid eating foods with a high concentration of histamine or other biogenic amines that compete for the DAO enzyme. These include, for example, raw, pasteurized milk and dairy products; citrus, strawberries and banana; seafood, blue fish and fish sauces; the raw sausage, such as sausage, chorizo or bacon; some vegetables, such as tomato, spinach or eggplant, as well as alcoholic beverages.
-Oral supply of DAO enzyme to prevent systemic absorption of exogenous or dietary histamine. This facilitates the metabolism of food histamine locally in the small intestine, restoring the natural balance of histamine and DAO.
–DAOfood® Plus contains the DAO enzyme that complements the body’s own enzyme and increases the degradation capacity of exogenous histamine. It also contains Quercetin that acts as an adjuvant against endogenous histamine. Its intake prevents the absorption and accumulation of circulating histamine and therefore counteracts the release of endogenous histamine as a reaction of the body when it comes into contact with the virus.
It is important to note that because SARS COV-2 is classified as a new strain of coronavirus, there is limited scientific evidence available on its precise mode of action and infection. Therefore, what is indicated in this article is based on what we know so far and on the importance of protecting against the virus, while maintaining control of mastocytosis and DAO deficiency.
The DR Healthcare team is at your entire disposal in case of concern about the implications of COVID-19 in people with DAO deficiency.
References:
1.- Kritas, S. K., Ronconi, G., Caraffa, A., Gallenga, C. E., Ross, R., & Conti, P. (2020). Mast cells contribute to coronavirus-induced inflammation: new anti-inflammatory strategy. Journal of biological regulators and homeostatic agents, 34(1), 10.23812/20-Editorial-Kritas.
Safety and business continuity protocol of DR Healthcare – covid-19
Given the difficult scenario that we are facing caused by the Coronavirus pandemic in general and after the State of Alarm decreed by the Spanish government in particular, DR Healthcare has implemented a safety and business continuity protocol that guarantees the provision of our services, the supply of the active ingredient, and, safeguard the health of all our collaborators and customers.
In this sense, we want to indicate that:
• The staff in the areas of administration, customer service and patient care operate in telework mode to meet themobility and contact requirements, guaranteeing the maintenance of their normal operation and service.
• Laboratory and R&D personnel who cannot carry out their activity remotely, following the security protocol, have established rotating work shifts to avoid human contact.
• The staff of the enzyme production plant has also implemented an intensive schedule protocol with rotating shifts that prevents human contact andensures non-interruption of the DAO enzyme production process.
Likewise, our suppliers and logistics network have adapted their processes to the current situation, ensuringthe safety and continuity of the supply chain of both the active ingredient and finished products up to the final customer, whether national or international.
We thus contribute to the containment of the disease and comply with the measures required by the competent authorities, guaranteeing our best service.
The DR Healthcare team is at your disposal for any additional information you may require.
Sincerely,
CEO DR Healthcare