GCIFutura Medical soars after receiving EU medical device clearance
Shares in (FUM ) soared over 100% today after it told investors that the EU notified body is to certify the group’s MED3000 gel as a Class 2B approved medical device.
Once this certificate is received, Futura's topical gel formulation MED3000, which it describes as ‘breakthrough’, will become the first pan-European topical treatment for erectile dysfunction ("ED") available without the need of a doctor's prescription.
Futura submitted the Technical Dossier for MED3000 as a treatment of ED under the European Medical Device Regulation for marketing approval in Europe by an EU Notified Body in mid-July of 2020 with a view to reach European approval during 2021.
Today, it said 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 2021.
Once EU certification and the resultant CE mark is granted, this paves the way for rapid global approval, particularly 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 recognised in the UK until 30 June 2023 and in the period leading up to this Futura will secure the new post-Brexit UKCA mark. It said this will be a streamlined process since it is understood the UK application can bridge to the EU approval.
Meanwhile, Futura told investors that it continues to progress marketing approval for MED3000 in the USA for use as a non-prescription, clinically proven treatment of ED.
Futura said it has had ‘a constructive 4th meeting’ with the FDA to finalise the clinical trial protocol for the required small supplementary study and is awaiting final meeting minutes.
Shares in Futura Medical have increased by nearly 80% in value since the beginning of the year while the stock soared by 127.78% to 41p this morning following the announcement.
Futura said MED3000 has the potential to be a highly differentiated product by addressing significant unmet needs across all patient severities in the $5.6bn global ED market, as well as to become the first globally available, clinically proven, over the counter ED treatments.
Futura noted that 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. To date, the space has seen little to no innovation in ED treatments in over ten years with many patients continuing to suffer dissatisfaction with existing treatments on offer, it said.
On the commercial side, Futura said it has been working with retained specialised 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, the group said partnering discussions for other countries continue in line with the agreed process being managed by its corporate advisers.
The Company said it has now received initial offers from a number of parties. In addition, the group said it believes that the EU approval of MED3000 will assist the Company in its objective of delivering long-term, sustainable value through the licensing of MED3000.
"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,” said James Barder, CEO of Futura.
He added, “Once the certificate is issued, MED3000 may be marketed throughout the EU without the need of a doctor's prescription subject to any national marketing restrictions. This will represent a significant commercial opportunity."
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