Futura Medical Plc

Appointment of Liberum as Nominated Adviser and Broker
23 May 2019

Futura Medical plc (AIM: FUM), a pharmaceutical company developing a portfolio of innovative products for sexual health and pain relief, today announces the appointment, with immediate effect, of Liberum Capital Limited ("Liberum") as its Nominated Adviser and sole Broker.


https://www.futuramedical.com/content/ne...230519.asp



https://www.finanzen.net/aktien/Futura_Medical-Aktie

Patentschutz wird es aber höchstens auf die Zusammensetzung der Creme geben, denn die Idee, Nitroglycerin für diese Zwecke zu nutzen, ist uralt (Quelle). Und Cremes, die z.T. sogar ordentliche Mengen Nitroglycerin enthalten, werden bereits in anderen Krankheiten seit langem angewendet (u.a. Angina pectoris, Analfissur). Das könnte durchaus zu Problemen führen, wenn Futura dieses Präparat für eine 'eher spezielle' Anwendung teuer auf den Markt bringen will.

The race to replace Viagra
https://www.theguardian.com/science/2019...lis-eroxon

Viagra 2.0
In the early 2000s, scientists at Futura Medical, a pharmaceutical company in Surrey, came across stories
of a heart disease medication that appeared to accidentally induce erections.
“There were some anecdotal reports of people deliberately spraying this product on to their penises,”
says Ken James, head of research and development at Futura. “These observations had been reported 
in the scientific literature, and the company thought there might be a commercial opportunity.”
The reported effects were due to a particular molecule known as glyceryl trinitrate or GTN, which causes
the dilation of blood vessels in the penis, increasing blood flow. But the reason why Futura were so
intrigued was because, while Viagra, Cialis and other drugs have to be taken orally – meaning they reach
the target area via the bloodstream and so interact with other systems in the body – GTN could be rapidly
absorbed into erectile tissue through the skin. This meant that it could potentially be applied directly as part
of a gel or cream, with almost instantaneous results and none of the troublesome side effects associated with Viagra.

“Viagra and Cialis are quite effective drugs but 50% of people stop using them within a year,”
says James. “60-70% of people have some degree of dissatisfaction with them.
This shows there’s an opportunity if we can come to market with something that addresses
many of those concerns.”

Over the past decade, Futura have developed a GTN-based gel called Eroxon which appears to be capable
of inducing an erection in patients with mild to moderate erectile dysfunction in five to 10 minutes.
Already dubbed the new Viagra by some, it seems to have the potential to be the first genuinely
novel treatment for erectile dysfunction in two decades, and Futura have even tentatively placed its
potential commercial value at $1bn.

After investors showed a renewed interest in backing novel treatments for erectile dysfunction,
Futura completed a clinical trial of 232 patients last year, and have now embarked on a final phase III
trial of 1,000 patients to be completed by the end of 2019.
If this succeeds, Eroxon could become available clinically within the next couple of years, although urologists remain cautious.

“The biggest question from that phase III trial will be how they compare in clinical efficacy to Viagra,”
says Soni. “In the past, we’ve seen that it’s difficult to get similar efficacy with topical administration,
but at the same time, our understanding of how drugs can be absorbed through the skin into the bloodstream
has massively improved.”

Mitte Jänner gekauft und geht noch immer  ab wie  Schmitz Katze. 


Futura Medical PLC Recruitment completed for MED2005 Phase 3 study

Patient recruitment completed for MED2005 Phase 3 study

First European Phase 3 study "FM57" on track to deliver headline data by the end of 2019

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative

products based on its proprietary, transdermal Dermasys® drug delivery technology currently focused on sexual health and pain,

is pleased to announce the completion of patient recruitment for the first European Phase 3 study, "FM57", of MED2005. 

Futura remains on track to deliver headline data by the end of 2019.

FM57 has completed recruitment of over 1,000 patients in the study for the treatment of mild, moderate and severe erectile dysfunction

("ED"). The study includes approximately 60 centres across Central and Eastern Europe and will compare the efficacy of 0.2%, 0.4% and

 0.6% GTN doses of MED2005 against that of placebo with an initial three-month study period for each patient. FM57's protocol

 incorporates feedback received from world leading key opinion leaders ("KOLs") in ED, the US and EU regulatory agencies,

as well as potential commercial partners, to increase the chances of regulatory approval as well as optimising the commercial value.

James Barder, Chief Executive Officer, Futura Medical said: "We are extremely pleased to complete recruitment of over 1,000 patients for the

first European Phase 3 study, "FM57", of MED2005, within our expected timelines and budget and I would like to thank all parties involved

in reaching this important milestone. The Company's focus is now on the Phase 3 data read-out at the end of the year, which we hope

will significantly clinically de-risk MED2005, and help provide commercial partners with greater certainty around the potential opportunity it presents."

The potential market for this product is large with potential peak sales in excess of US $1 billion. If MED2005 is approved,

there is an estimated $560M prescription-only market potential (sources: Decision Resources and Cello), and an estimated incremental

$660M+ market potential as an over-the-counter (OTC) product, in markets where switch is possible. (source: Ipsos Mori forecasts commissioned by Futura).

The Company's main focus is to deliver Phase 3 double-blind headline data by the end of 2019,
given it remains a key value inflection point for us, and we continue discussions with a number of interested commercial partners for the out-licensing of MED2005.

https://www.finanzen.net/aktien/futura_medical-aktie

Investment Perspective

Futura Medical is rapidly approaching a major inflection point as the results of a pivotal Phase III study (FM57) for its lead compound, MED2005, are due to read out in December. MED2005 is a fast-acting glyceryl trinitrate gel that addresses erectile dysfunction (ED). The FM57 data is expected to be positive and will influence the design of the remaining Phase III trial (FM59) required for US approval (and possibly Europe too). 

Die haben gerade -68%. Zum Glück hab ich den Großteil vor ein paar Wochen verkauft,
aber mit diesen Rückschlag habe ich heute auch nicht gerechnet. Hab den letzten Rest gerade
mit einer Limitorder drinnen, aber so beliebt sind die in dieser Stunde nicht.

https://www.proactiveinvestors.co.uk/com...08806.html

Futura Medical says it may have found simpler route to regulatory approval after surprise phase III results

The delivery mechanism for the company's erectile dysfunction drug appeared to have a clinically significant impact on men with the condition

Futura Medical PLC (LON:FUM) believes it has found a "simpler route to regulatory approval” following a surprising read-out from the phase III clinical trial of its erectile dysfunction gel.

These were nuanced results. For while MED2005 showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.

Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever.

However, in the Futura FM57 clinical assessment, researchers used DermaSys, developed by the company to deliver the active ingredient glyceryl trinitrate, or GTN for short.

As Futura said the results from the control group were highly statistically significant this would tend to rule out a small lift one sometimes sees called the placebo effect.

US-Regulierungsprozess

Nach der Aktualisierung des Unternehmens am 16. September hat Futura weiterhin proaktiv mit der FDA zusammengearbeitet, um das Design der beantragten ergänzenden klinischen Studie zu bestätigen, um die notwendige Sicherheit der Wirksamkeit von MED3000 für bis zu sechs Monate zu gewährleisten. Die vorangegangene Studie mit 1.000 Patienten (FM57), deren Ergebnisse im Dezember 2019 bekannt gegeben wurden, erfüllte alle primären Endpunkte im Vergleich zu einer Vorbehandlung und über alle ED-Schweregrade hinweg für eine Wirksamkeit von bis zu drei Monaten und lieferte zudem eine umfassende Sicherheitsbestätigung. Darüber hinaus wurden Fortschritte bei der Entwicklung von Etikett und Packungsbeilage erzielt, so dass das Produkt von der FDA ohne ärztliche Verschreibung zugelassen werden konnte.



Das Unternehmen freut sich, bestätigen zu können, dass nach dem dritten Treffen mit der FDA vor der Einreichung des Zulassungsantrags eine vorläufige Einigung über das Design und den Umfang dieser kleinen ergänzenden Studie, die unter dem Namen "FM71" bekannt ist, vorbehaltlich der Ausgabe des Protokolls der Abschlussbesprechung, erzielt wurde. Das endgültige Studienprotokoll kann erst nach Erhalt des FDA-Protokolls fertiggestellt werden. Basierend auf den Diskussionen vor der Einreichung wird jedoch erwartet, dass FM71 eine vergleichende, randomisierte, offene Studie mit offener Etikettierung, Heimanwendung und Parallelgruppen bei etwa 100 Patienten mit erektiler Dysfunktion sein wird. Etwa 20 Probanden werden sich in den Vereinigten Staaten befinden, um die Gewissheit zu geben, dass die ausserhalb der USA generierten Daten mit der US-Bevölkerung vergleichbar sind. Da es sich um ein offenes Design handelt, wird die Studie weder plazebokontrolliert noch doppelt verblindet sein. Der primäre Endpunkt der Studie wird darin bestehen, die Wirksamkeit von MED3000 im Vergleich zu einem Ausgangswert vor der Behandlung über einen Zeitraum von bis zu sechs Monaten zu vergleichen. Die niedrigste "On-Demand"-Dosierung von Tadalafil, 5 mg (Cialis), wird ebenfalls mit dem Ausgangswert der Vorbehandlung verglichen, damit die FDA eine allgemeine Risiko-/Nutzen-Analyse der beiden Behandlungen über den sechsmonatigen Studienzeitraum hinsichtlich Wirksamkeit, Geschwindigkeit des Behandlungsbeginns und Sicherheit vergleichen kann. 50 Patienten mit ED werden in jeden Behandlungsarm der Studie eingeschlossen.



Die Detailplanung für die Studie hat nun begonnen und Futura strebt die Aufnahme von Patienten im ersten Quartal 2021 an, abhängig vom Abschluss des endgültigen Studienprotokolls für FM71


https://www.investegate.co.uk/article.as...700078454C