Positive Regulatory Update on Pain Portfolio

RNS Number : 6813G
Futura Medical PLC
24 November 2015
 



For immediate release  

24 November 2015

 

 

Futura Medical plc

("Futura" or the "Company")

 

Positive Regulatory Update on Pain Portfolio

 

 

Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, announces that, following a positive meeting with a key European regulator, the Company has received clarity on the regulatory pathways for its topical pain relief products, TPR100 (diclofenac) and TIB200 (ibuprofen). Most significantly, Futura has been advised by the regulator that in principle no further clinical efficacy studies are expected to be required for either of the products prior to the submission of regulatory dossiers in Europe.

 

The two products are based on non-steroidal anti-inflammatory drugs (NSAIDs) and benefit from Futura's transdermal delivery system, DermaSyS®, which offers enhanced drug permeation through the skin. TPR100 uses the NSAID diclofenac and TIB200 uses the NSAID ibuprofen. In July this year, Futura announced positive results for the two products, which both showed statistically significant pain relief in a pivotal clinical study.

 

Futura has been developing the positioning and packaging of the products using the strapline, "DermaSys®: Get to the Point with Pain™". Prototype product packs can be viewed at this link:
http://www.futuramedical.com/archive/DermaSys-prototype-pack.pdf  

It is expected that Futura will utilise Europe's decentralised regulatory process to gain Marketing Authorisations in all key EU markets.  The over the counter (OTC) topical pain relief market in the top five EU countries was worth over US$750 million in 20141.

 

The Company is also preparing for a formal meeting with the FDA to establish the US regulatory pathway for the two products, although topical NSAIDs are only currently available with a doctor's prescription in the USA. The topical NSAID market in the USA, where a prescription is required, is was worth US$625 million in 20141.

 

James Barder, Futura's Chief Executive, commented: "We are very pleased to have received such encouraging guidance on the regulatory pathway in Europe for these two novel, DermaSys®-based pain relief products.  We can now focus on the preparation of our regulatory submissions in Europe and on the regulatory pathway for these innovative products in the USA."

 

1. Source: IMS data

 

For further information please contact:

Futura Medical plc


James Barder, Chief Executive

Tel: +44 (0) 1483 685 670

Email to: james.barder@futuramedical.com

www.futuramedical.com

 

N+1 Singer (Nominated Adviser and Broker)


Aubrey Powell / Liz Yong / Tom Smale
 Corporate Finance

 

Tel:+44 (0) 20 7496 3000

For media enquiries please contact:


Buchanan


Mark Court / Sophie Cowles / Stephanie Watson

Tel: +44 (0) 20 7466 5000

 

 

Notes to Editors

 

Futura Medical plc

 

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

 

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.

 

www.futuramedical.com

 

 

 

 

 


This information is provided by RNS
The company news service from the London Stock Exchange
 
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