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Futura Medical Receives Recommendation for Approval of MED3000 from EU Notified Body

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March 19, 2021

Futura Medical plc is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain.

Today the company announced that the EU Notified Body has successfully completed its review of the Company’s Technical Dossier for MED3000 with a recommendation to certificate MED3000 as a Class 2B approved medical device.

Once the certificate is received, Futura’s breakthrough, topical gel formulation MED3000, will become the first pan-European topical treatment for erectile dysfunction (“ED”) available without the need of a doctor’s prescription.

As announced previously, Futura had submitted the Technical Dossier for MED3000 for treatment of ED under the European Medical Device Regulation for marketing approval in Europe by an EU Notified Body.

European approval for MED3000 will be final upon issuance of a Medical Device Regulation certificate by the panel which is expected before the end of May.

Once EU certification and the resultant CE mark is granted, this paves the way for rapid approval in many countries around the world, in regions including the Middle East, Africa, the Far East, and Latin America, who allow “fast-track” review based on their recognition of the EU CE mark.

The CE marking will also be recognized in Great Britain1 until 30 June 2023 and in the period leading up to this, the Company will secure the new post-Brexit UKCA mark. This will be a streamlined process since it is understood the UK application can bridge to the EU approval.

Futura continues to progress marketing approval for MED3000 in the USA for use as a non-prescription, clinically proven treatment of ED.  With respect to the USA, as announced recently, Futura has had a constructive 4th meeting with the FDA to finalize the clinical trial protocol for the required small supplementary study and is awaiting final meeting minutes.

MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs, across all patient severities in the $5.6 billion global ED market. As such it has the potential to become the first globally available, clinically proven, over-the-counter (“OTC”) treatment for erectile dysfunction. The prevalence of ED disrupts the lives of at least 1 in 5 men globally, with around 23 million men in the US and 20 million men in the UK, France, Italy, and Germany. There has been little innovation in ED treatments for over ten years and many patients continue to suffer dissatisfaction with existing treatments.

In conjunction with the regulatory processes, Futura has been working with retained specialized corporate advisers on active commercial discussions with potential licensing and marketing partners.

Following the Company’s recent announcement of a Joint Collaboration agreement for the China and the South East Asia region, partnering discussions for other countries continue in line with the agreed process being managed by Futura’s corporate advisers.  The Company has now received initial offers from a number of parties and believes the EU approval of MED3000 will assist the Company in its objective of delivering long-term, sustainable value through the licensing of MED3000.

James Barder, Chief Executive of Futura Medical commented: “The recommendation to approve MED3000 in Europe is a huge milestone for Futura in the development of MED3000. We look forward with excitement to bringing MED3000 to patients in Europe as the first, clinically proven treatment for erectile dysfunction that is highly differentiated with its rapid speed of onset. Once the certificate is issued, MED3000 may be marketed throughout the EU without the need for a doctor’s prescription subject to any national marketing restrictions. This will represent a significant commercial opportunity.”

 

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