Pharmanutra

Regulatory Filings • Feb 14, 2022

Informazione Regolamentata n. 20106-13-2022		Data/Ora Ricezione 14 Febbraio 2022 08:20:09	Euronext Star Milan
Societa'	:	PHARMANUTRA
Identificativo Informazione Regolamentata	:	157389
Nome utilizzatore	:	PHARMANUTRAN02 - Lacorte Roberto
Tipologia	:	REGEM
Data/Ora Ricezione	:	14 Febbraio 2022 08:20:09
Data/Ora Inizio Diffusione presunta	:	14 Febbraio 2022 08:20:09
Oggetto	:	PR - PHARMANUTRA - UE authorises CFA as Novel Food
Testo del comunicato

Vedi allegato.

PHARMANUTRA S.P.A.: THE EUROPEAN UNION AUTHORISES MARKETING OF CFAs AS A NOVEL FOOD

With a notice published in the Official Gazette the European Union has authorised the introduction on the market of cetylated fatty acids (CFAs), patented by PharmaNutra S.p.A., as a novel food pursuant to Regulation (EU) 2015/2283. The Group will have an exclusive right of use of the new ingredient for the next five years throughout the European Union.

Pisa, 14 February 2022 – PharmaNutra S.p.A. (MTA; Ticker PHN), a company specialising in mineral- and iron-based nutritional supplements and medical devices for muscles and joints, is pleased to announce that the European Union had published a notice in the Official Gazette authorising the marketing of cetylated fatty acids as a Novel Food. The novel food (Lipocet® ) is a combination of myristic acid and oleic acid and, to a lesser degree, other cetylated fatty acids, which until now could be used only in Cetilar® -branded products for topical use.

Consequently, PharmaNutra's patented cetylated fatty acids will be included in the EU list of authorised novel foods established in implementing regulation (EU) 2017/2470. The inclusion of the CFAs in the list marks the official completion of the registration procedure under which, in July 2021, the European Food Safety Authority (EFSA) formalised its positive opinion on the safety of CFAs.

The Novel Food authorisation is a fundamental new strategic asset for the Group, as it will enable new nutritional supplements based on CFAs to be developed and marketed. The authorisation also provides a protection for industrial property, giving PharmaNutra exclusive right of use for five-year of the new ingredient throughout the European Union.

"The classification of CFAs as a Novel Food is a hugely important achievement for the company, which has been working on the project for almost eight years. I want to thank all the researchers and professionals in the R&D team who have helped us to reach this objective and contributed to the definition of all the qualitative and safety data of this innovative ingredient. Especially, PhD Elisa Brilli, Group's Head of Research and Training Affairs, managed all the experimental research works and played an essential role in this achievement," said Germano Tarantino, Chief Scientific Officer of the PharmaNutra Group.

"2022 could not have got off to a better start for PharmaNutra from the scientific viewpoint. The inclusion of Lipocet in the EU list of authorised novel foods is an extraordinary event, which opens up commercial prospects that will have a great impact on our company," said PharmaNutra S.p.A. Chairman Andrea Lacorte. "This was a goal we wanted to achieve, and we knew perfectly well from the start that it would have been a long and

difficult road, but it is in circumstances like these, when we set ourselves ambitious and apparently complicated objectives, that PharmaNutra succeeds in giving its best."

PharmaNutra S.p.A.

Founded and led by Chairman Andrea Lacorte and Vice Chairman Roberto Lacorte, PharmaNutra, established in 2003, develops unique nutraceuticals and innovative medical devices, overseeing the entire production process from the proprietary raw materials to the finished product. PharmaNutra is the leading producer, with the SiderAL® trademark, of iron-based nutritional supplements, a field where it holds important patents on Sucrosomial® Technology, and is regarded as one of the top emerging players in medical devices for the rehabilitation of joint capacity thanks to the Cetilar brand. The effectiveness of its products has been demonstrated by extensive scientific evidence, including more than 120 published papers. In Italy, sales are conducted through a network of more than 160 medical representatives, who also handle exclusive marketing of PharmaNutra products to pharmacies and parapharmacies all over the country. International sales in more than 50 countries are managed through 37 partners selected from top pharmaceutical companies. Over the years, the Group has developed a specific intellectual property production and management strategy, based on integrated management of all components: proprietary raw materials, patents, trademarks and clinical data.

PharmaNutra.it

For further information:

Via Delle Lenze, 216/b - 56122 Pisa 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 Tel. +39 02 83635708

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