Pharmanutra

Regulatory Filings • Jul 21, 2021

Informazione Regolamentata n. 20106-38-2021		Data/Ora Ricezione 21 Luglio 2021 18:06:14	MTA - Star
Societa'	:	PHARMANUTRA
Identificativo Informazione Regolamentata	:	150139
Nome utilizzatore	:	PHARMANUTRAN02 - Lacorte Roberto
Tipologia	:	REGEM
Data/Ora Ricezione	:	21 Luglio 2021 18:06:14
Data/Ora Inizio Diffusione presunta	:	21 Luglio 2021 18:06:15
Oggetto	:	PR - PHARMANUTRA novel food autorization lipocet 21072021
Testo del comunicato

Vedi allegato.

PHARMANUTRA S.P.A.: EFSA IN FAVOUR OF AUTHORISING LIPOCET (CETILAR®) AS A NOVEL FOOD

PharmaNutra received a positive opinion from EFSA regarding the registration of the Lipocet – the active ingredient of the products in the Cetilar line® – as a Novel Food

Pisa, 21 July 2021 – PharmaNutra S.p.A. (MTA; Ticket PHN), a company specialized in nutritional supplements, based on iron and minerals and medical devices for muscles and joints, is pleased to announce that it has obtained a new, important strategic asset. EFSA (the European Food Safety Authority) has formalized its positive opinion authorizing the classification of Lipocet as a Novel Food, a new oral formulation including cetylated fatty acids (CFAs), the very same active ingredient of the products in the Cetilar line® .

Eligibility for registration as a Novel Food is based on scientific data regarding the safety of CFAs and represents the first, fundamental step for the development of new oral formulations and, consequently, marketing throughout Europe of nutritional supplements based on cetylated fatty acids dedicated to the wellbeing of muscles and joints. Over the next few months, the registration application as a Novel Food will be examined by the European Commission, which will have to officially authorize marketing of the new ingredient, for which PharmaNutra will claim an exclusive five-year use.

"Our R&D department has been working for some time on the development of an oral formulation containing CFAs (cetylated fatty esters), with the aim of bringing the market a new line of patented and specific nutritional supplements for the most common osteo-arthritic conditions", Germano Tarantino, Chief Scientific Officer of PharmaNutra S.p.A. announced. "At the end of 2020, we obtained GRAS (Generally Recognized As Safe) recognition from the US Food and Drug Administration (FDA) for the use of Lipocet, i.e. the oral version of the CFAs, in the United States. With the approval of EFSA, today, a new development scenario opens up for the European market of Cetilar® products, until now for topical use only."

In the meantime, PharmaNutra has already launched further research projects related to the use of Lipocet, to collect new and authoritative scientific evidence on the use of cetylated fatty esters in relation to joint problems. A field of research that over the years has already led the Group to develop a proprietary patent relating to compositions for topical use based on CFAs, as well as a line of specific medical devices, which today includes Cetilar® Crema products, Cetilar® Patch and Cetilar® Tape.

PharmaNutra S.p.A.

Founded and led by President Andrea Lacorte and Deputy President 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. The effectiveness of its products has been demonstrated by extensive scientific evidence, including more than 140 published papers. The Group has distribution and sales operations in Italy and abroad. In Italy, sales are conducted through a network of more than 150 medical representatives, who also handle exclusive marketing of PharmaNutra products to pharmacies across Italy. International sales in more than 50 countries are managed through 39 partners selected from top pharmaceutical companies. PharmaNutra is the leading producer of SiderAL®, iron-based nutritional supplements, an area where it holds important patents for Sucrosomial® Technology. 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