Quatrefolic® receives EFSA positive scientific opinion

DESIO, Italy – October, 3rd 2013

The European Food Safety Authority (EFSA) has adopted a positive scientific opinion on the safety and efficacy of Quatrefolic® opening the way for the commercialization of the novel ingredient in Europe in the next months.

The independent Panel issued the positive outcome after a thorough assessment of the safety data and bioavailability studies, a process that has lasted for nearly two and a half year, concluding that Quatrefolic® may be added for nutritional purposes to food supplements as a source of folate.

This key milestone is part of the global strategic plan that started in 2010 with the approval of Quatrefolic® as New Dietary Ingredient (NDI) by FDA that has opened successfully the USA market, where Quatrefolic® has already become a benchmark for innovation, safety and quality in the folate supplementation area.

“Gnosis’ commitment is to make Quatrefolic® available in major nutritional world markets, building a reliable, scientific and innovative platform to support the fourth generation folate” said Renzo Berna, Gnosis’ CEO. “This opinion gives us great opportunities in the market place and a strong competitive position, not only in Europe, but also in other parts of the world that is influenced by regulatory decisions taken in EU”.

Gnosis has established an extensive research and development program aimed at documenting the benefits of Quatrefolic® as a dietary supplement and strives to continuously support the important benefits of reduced folates and their contribution to a healthier lifestyle.

About Quatrefolic®

Quatrefolic® is the innovative folate derivative made up of (6S)-5-methyltetrahydrofolate and glucosamine salt, able to overcome existing limits of previous methyl derivative reduced folates. With high water solubility, improved bioavailability, long lasting stability, established safety and higher formulation flexibility Quatrefolic® meets key requirements of the nutraceutical industry, creating new application prospects for combination vitamin and mineral formulations.

Manufactured under cGMP, Quatrefolic® has received NDI notification from FDA, the GRAS status and the Kosher and Halal certifications. Extensively studied through pre-clinical and clinical studies it is protected by two international patents and is a registered trademark.

Quatrefolic® is declared winner of "Most Effective Strategic Product Development" at the Nutraceutical Business & Technology (NBT) Awards 2011 and has been also noted for its innovative features and market opportunity being selected as a finalist for the 2012 NutrAward "Best New Ingredient".

Gnosis Group

With over 20 years of experience in microbial fermentation and an international manufacturing network dedicated to high-quality and proprietary products Gnosis is specialized in manufacturing and sales of fermentation raw materials and natural finished products used in the pharmaceutical, nutraceutical, and veterinary industries.

The Gnosis Group includes a European manufacturing network made up of three operating divisions and three commercial operations located in Italy, the USA and China. Successful integration between R&D centre and GMP Approved Manufacturing facilities enables the company to constantly work to develop and introduce ground breaking and market leading products to the worldwide market.

Gnosis’ primary branded proprietary ingredients for the nutraceutical industry include: • BiOOptima® Brand Probiotics: S. boulardii • Folate Brands: Quatrefolic® • SAM-e Branded and Non-Branded: Bulk Powders, Tablets, Proprietary Applications SamEspresso®, SAMEDRINK, EZBrain and SupereSSe® • VitaminK2 Brand: vitaMK7® (menaquinone7).

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Headquarters &
Innovation Centre:

Gnosis S.p.A.
Via Lavoratori Autobianchi, 1
20832 Desio (MB) - Italy


Gnosis Bioresearch SA
Via Lischedi, 4 6592 Sant'Antonino - Switzerland

Gnosis Bioresearch Srl
Via Pomarico, 75010 Pisticci Scalo
Pisticci (MT) - Italy

Branch Offices:

Gnosis USA Inc.
169 N. Main Street
Doylestown, PA 18901 - USA

Gnosis China
Room 1001, Hong Kong Plaza
(South Tower), 283 Huaihai Middle Rd., LuWan District, 200021 - Shanghai, China


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GNOSIS S.P.A. Sede Legale: Piazza del Carmine, 4 20121 Milano. P. IVA 02484720129 C. F. 10197170151 Cap. Soc. 3.000.000,00 € i.v. Registro delle imprese di Milano N° 10197170151