LONDON (ShareCast) - (Sharecast News) - Pharmaceutical company Futura Medical updated the market on its topical erectile dysfunction (ED) treatment 'MED3000' on Monday, given it now had CE-mark approval in Europe for the treatment of ED in adult men.
The AIM-traded firm, which was holding its annual general meeting, said that approval paved the way for further approval in a number of countries globally, including in the Middle East, Africa, the Far East and Latin America, which are regions which allow 'fast-track' review based on recognition of the CE mark.

For the United States, it said planning and preparation activities such as active site recruitment were well underway for the start of 'FM71', which is a confirmatory study to be conducted prior to formal regulatory submission to US Food and Drug Administration (FDA) as a 'DeNovo medical device'.

Trial start was on schedule, with first patient dosing expected in the third quarter of 2021.

Securing manufacturing capacity and flexibility to scale-up production of MED3000 to meet projected demand was also a "clear focus" for the board and management, Futura said.

Its first licensing deal, announced in the first quarter, was a joint collaboration agreement for China and south east Asia with a 50-50 share of profits between Futura and its partner, designed to capture long-term value for the company.

The board said those "validating milestones" were driving progress on active commercial discussions with potential licensing and marketing partners.

Discussions were moving forward with a number of other parties for licensing rights for MED3000 in other regions, with the firm continuing to target a number of deals in the coming months.

The impact of Covid-19 on the company had been limited to date, the board added.

"The licensing agreement and financing activities in the first half of 2021 have given the company significant momentum," said chairman John Clarke.

"Futura is rapidly advancing MED3000, looking to capture long term value and working towards creating a Company with substantial revenue streams.

"MED3000 is a breakthrough treatment for erectile dysfunction (ED), approved in Europe as a medical device."

Clarke also noted that the firm had a first, commercial agreement in place for China and south east Asia.

"Our outlook for further deals is optimistic and we look forward to updating the market on Futura's developments during the remainder of 2021.

"The team is laser-focused on preparation and execution of the confirmatory clinical study and the non-clinical study to finalise an over-the-counter label for the regulatory submission for MED3000 in the US, which the company aims to achieve in 2022."

At 0921 BST, shares in Futura Medical were up 0.93% at 43.6p.

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