Pharmanutra

Regulatory Filings • Aug 30, 2023

Informazione Regolamentata n. 20106-35-2023		Data/Ora Inizio Diffusione 30 Agosto 2023 18:02:31	Euronext Star Milan
Societa'	:	PHARMANUTRA
Identificativo Informazione Regolamentata	:	180622
Nome utilizzatore	:	PHARMANUTRAN04 - Roberto Lacorte
Tipologia	:	REGEM
Data/Ora Ricezione	:	30 Agosto 2023 18:02:26
Data/Ora Inizio Diffusione	:	30 Agosto 2023 18:02:31
Oggetto	:	PR - Lipocet to be classified as a Novel Food also in UK
Testo del comunicato

Vedi allegato.

PHARMANUTRA S.P.A.:

LIPOCET (CETILAR®) GETS THE GREEN LIGHT TO BE CLASSIFIED AS A 'NOVEL FOOD' ALSO INTHEUK

FSA and FSS approved the registration of Lipocet (the Cetylated Fatty Acids (CFA) contained in Cetilar® products) as a Novel Food

Pisa, 30th August 2023 – PharmaNutra S.p.A. (MTA; Ticker PHN), a company offering mineral-based nutritional supplements and medical devices for muscles and joints, announces a new important strategic asset. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) - the Food Safety Agencies of England, Wales, Northern Ireland and Scotland, respectively - have, in fact, officially issued their approval for the UK Novel Food classification application of Lipocet, an oral formulation based on cetylated fatty acids (CFAs), the same active ingredient used in the Cetilar® range of products.

In light of the scientific evidence and information provided by PharmaNutra, the FSA and FSS concluded that the composition of this new food is safe under the proposed conditions of use and does not pose any health risk. Cetylated Fatty Acids (CFA) are a patented combination of fatty acids of vegetable origin that, in formulations for topical use, have been shown to be effective in reducing musculoskeletal pain. This is so much that they constitute a research field that over the years has already led the company, founded in 2003 by the Lacorte brothers, to develop a proprietary patent on compositions for topical use as well as a line of specific medical devices that include Cetilar® Cream, Cetilar® Patch, Cetilar® Tape and Cetilar® Gold, to date.

Germano Tarantino, Scientific Manager of PharmaNutra S.p.A., comments: "The completion of the approval process in the UK for Lipocet as a novel food, with a higher dosage than in Europe, represents another step toward the global distribution of our cetylated fatty acid products. We are very pleased with this result because on the one hand it enables us to enter a very important market with excellent prospects, while on the other hand it is yet another confirmation of the strength of our patent and the work we have carried out in recent years. Obviously, we will have to wait for the appropriate regulatory approval before we can begin marketing our products; however, without this necessary step, we would not have been able to move forward".

Following the approval obtained in July 2021 from the EFSA (European Food Safety Authority) and the European Commission (which in February 2022 officially authorised the marketing of the new ingredient in the EU countries for which PharmaNutra has exclusive use), authorisation now extends to the UK. As a result of the further approval obtained for the UK, the Group is better positioned to develop and use CFAs.

Furthermore, in light of the FDA's (Food and Drug Administration) approval for Lipocet use in the US, it is in fact in a position to expand the use of the active ingredient in most Western nations worldwide.

PharmaNutra S.p.A.

Founded and led by Chairman Andrea Lacorte and Vice Chairman Roberto Lacorte, PharmaNutra is a company established in 2003 that develops unique nutritional supplements and innovative medical devices, taking care of the entire production process, from proprietary raw materials to the finished product. PharmaNutra is a leader in the production of iron-based nutritional supplements under the SiderAL®brand, where it holds important patents on Sucrosomal®Technology, and is considered one of the emerging top players in the medical device sector dedicated to restoring joint capacity thanks to the Cetilar®brand. The effectiveness of the products is demonstrated by a number of scientific evidences, including more than 120 publications. In Italy, the sales activity is carried out through a network of over 160 Commercial Scientific Agents serving the medical class and dedicated to the exclusive marketing of products to pharmacies and parapharmacies throughout the national territory. Sales abroad are guaranteed in over 71 countries through 45 partners selected among the leading pharmaceutical companies. Over the years, the Group has developed a precise strategy in the management and production of intellectual property, based on the integrated management of all components: proprietary raw materials, patents, trademarks and clinical evidence. PharmaNutra.it

For further details:

Via Delle Lenze, 216/b - 56122 Pisa, Italy Tel. +39 050 7846500 investorrelation@PharmaNutra.it

Internal Press Office press@calabughi.com

PharmaNutra S.p.A. Press Office - Spriano Communication & Partners

Via Santa Radegonda, 16 - 20121 Milan, Italy Tel. +39 02 83635708

Matteo Russo mrusso@sprianocommunication.com Cristina Tronconi ctronconi@sprianocommunication.com