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Futura makes solid progress on approval for erection gel
8th Dec 2020 12:52
(Sharecast News) - Pharmaceutical company Futura Medical updated the market on regulatory processes and commercial activities for MED3000 - its topical gel formulation for treatment of erectile dysfunction (ED).
The AIM-traded firm said it was seeking marketing approval for the product in Europe and the United States for use as an over-the-counter (OTC) clinical treatment for ED, thus removing the need for a doctor's prescription, with plans to file in other regions in due course.
In the US, it said it had recently received the pre-submission minutes of the Food and Drug Administration (FDA) meeting held on 19 October.
The minutes confirmed the outline design of the requested supplemental clinical trial, known as 'FM71'.
Assuming it met its primary endpoints, FM71 would provide the FDA with the necessary reassurance of MED3000's efficacy and safety for up to six months' use by ED patients.
The board said the FDA continued to provide constructive comment on the development of a product label to achieve OTC status for MED3000, which was reflected in the official minutes.
Futura said it had submitted a final detailed clinical study protocol to the FDA, with a meeting scheduled for February to agree details primarily related to the statistical analysis plan.
Meanwhile, it said detailed planning and preparatory activities for the study were continuing, with the company expecting patient enrolment to begin as soon as feasible after final advice on the final FM71 study protocol was received from FDA.
In Europe, Futura announced in mid-July that it had submitted the technical file for MED3000 for the treatment of ED under the European Medical Device Regulation for marketing approval as a class 2B medical device.
The board said the EU approval process was progressing well, with the MED3000 technical file now actively under review by the regulator.
Futura said it was still targeting a 2021 European approval for MED3000.
As regulatory processes continued, the firm said it had been working with retained specialised corporate advisers on active commercial discussions, with potential licensing and marketing partners in line with an agreed process being managed by the advisers.
It announced in late-October that it had given priority to certain negotiations for one specific region for the exclusive marketing rights for MED3000, with certain parties.
On Tuesday, it said those discussions had progressed positively, with the company signing non-binding terms, entering into exclusive negotiations for a specific region.
It said it still had "reasonable expectations" that an agreement could be reached with the party, although no guarantees could be given.
"We are continuing to progress along the regulatory timeline for MED3000 and executing upon our strategic plans," said chief executive officer James Barder.
"Aside from the prioritised regional negotiations, Futura is making steady progress on commercial discussions in multiple other regions.
"We look forward to providing further updates as we move ahead on both regulatory and commercial tracks."
At 1243 GMT, shares in Futura Medical were up 3.65% at 14.62p.
The AIM-traded firm said it was seeking marketing approval for the product in Europe and the United States for use as an over-the-counter (OTC) clinical treatment for ED, thus removing the need for a doctor's prescription, with plans to file in other regions in due course.
In the US, it said it had recently received the pre-submission minutes of the Food and Drug Administration (FDA) meeting held on 19 October.
The minutes confirmed the outline design of the requested supplemental clinical trial, known as 'FM71'.
Assuming it met its primary endpoints, FM71 would provide the FDA with the necessary reassurance of MED3000's efficacy and safety for up to six months' use by ED patients.
The board said the FDA continued to provide constructive comment on the development of a product label to achieve OTC status for MED3000, which was reflected in the official minutes.
Futura said it had submitted a final detailed clinical study protocol to the FDA, with a meeting scheduled for February to agree details primarily related to the statistical analysis plan.
Meanwhile, it said detailed planning and preparatory activities for the study were continuing, with the company expecting patient enrolment to begin as soon as feasible after final advice on the final FM71 study protocol was received from FDA.
In Europe, Futura announced in mid-July that it had submitted the technical file for MED3000 for the treatment of ED under the European Medical Device Regulation for marketing approval as a class 2B medical device.
The board said the EU approval process was progressing well, with the MED3000 technical file now actively under review by the regulator.
Futura said it was still targeting a 2021 European approval for MED3000.
As regulatory processes continued, the firm said it had been working with retained specialised corporate advisers on active commercial discussions, with potential licensing and marketing partners in line with an agreed process being managed by the advisers.
It announced in late-October that it had given priority to certain negotiations for one specific region for the exclusive marketing rights for MED3000, with certain parties.
On Tuesday, it said those discussions had progressed positively, with the company signing non-binding terms, entering into exclusive negotiations for a specific region.
It said it still had "reasonable expectations" that an agreement could be reached with the party, although no guarantees could be given.
"We are continuing to progress along the regulatory timeline for MED3000 and executing upon our strategic plans," said chief executive officer James Barder.
"Aside from the prioritised regional negotiations, Futura is making steady progress on commercial discussions in multiple other regions.
"We look forward to providing further updates as we move ahead on both regulatory and commercial tracks."
At 1243 GMT, shares in Futura Medical were up 3.65% at 14.62p.