FDA approval for the US market

RNS Number : 3152S

Venture Life Group PLC

02 October 2017

 

2 October 2017

VENTURE LIFE GROUP PLC

("Venture Life" or "the Company")

 FDA approval to manufacture OTC drug products for the US market

Long-term distribution agreement for UltraDEX in France

Venture Life Group plc (AIM: VLG), the international consumer self-care group focused on developing, manufacturing and commercialising products for the ageing population, announces its development and manufacturing facility has gained US FDA approval for the manufacture of over the counter ("OTC") drug products for the US market. Separately, it has signed a long-term distribution agreement for UltraDEX in France.

Biokosmes S.r.l. ("Biokosmes"), the Company's manufacturing facility based in Italy, has successfully passed an inspection by the US FDA which means it is now, for the first time, approved to develop and manufacture OTC drug products for sale and marketing in the USA. This means a completely new regulatory category of products that can be manufactured at Biokosmes. Venture Life now has the opportunity to provide this new service to its existing customers, as well as new customers, and it will also allow the Company to develop its own OTC drug products in due course for the US market.

In addition, the Company has signed a long-term distribution agreement for UltraDEX with leading French company La Brosse et Dupont SAS. Founded in 1932, the company is a former subsidiary of LVMH Moet Hennessy Louis Vuitton S.E.  It serves customers through large and medium commercial outlets throughout France and has market leading products within the oral healthcare space. UltraDEX will be added to their branded portfolio and the launch in France will take place in Q1 2018.

Commenting on the news, Jerry Randall, Chief Executive Officer of Venture Life, said: "Gaining the US FDA approval of our facility for the manufacture of OTC drugs is a significant new growth opportunity for the Company both with our existing and potential new partners and it also enables us to develop our own such products for the US market. Also, securing a partner for UltraDEX in France means that we have now extended the distribution of the UltraDEX products into four of the 'big five' EU countries, increasing our European coverage for this important Venture Life brand. These two significant achievements are expected to deliver future growth and value enhancement for the Group."

Venture Life Group PLC			[phone]
Jerry Randall, Chief Executive Officer
Adrian Crockett, Chief Financial Officer
Northland Capital Partners Limited (Nominated Adviser and Joint Broker)			[phone]
Matthew Johnson / Edward Hutton (Corporate Finance)
Bob Pountney / John Howes (Corporate Broking)
Turner Pope Investments (TPI) Ltd (Joint Broker)			[phone]
James Pope / Ben Turner
Walbrook PR	[e-mail] or + 44 (0) 20 7933 8780
Anna Dunphy / Paul McManus		[phone] /  [phone]

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR)

About Venture Life (www.venture-life.com) 

Venture Life is an international consumer self-care company focused on developing, manufacturing and commercialising products for the ageing population. The Group's product portfolio includes some key products such as the UltraDEX oral care products range, food supplements for lowering cholesterol and maintaining brain function, medical devices for women's intimate healthcare and haemorrhoids and dermo-cosmetics for addressing the signs of ageing.

The products, which are typically recommended by pharmacists or healthcare practitioners, are available primarily through pharmacies supplied by the Group's international distribution partners. 

Through its Development & Manufacturing business in Italy, Biokosmes, the Group also provides development and manufacturing services to companies in the medical devices and cosmetic sectors.

 

END

 

 

REAPGUWABUPMGAB