Business
Futura Medical Interim Results 2022
Futura Medical Interim Results 2022.
About this update from Futura Medical Plc
[{"type":"text","content":"\n \n \n 13 September 2022\n \n \n \n \n \n \n Futura Medical plc\n \n \n \n \n (\"Futura\" or the \"Company\")\n \n \n \n \n \n \n \n \n \n Interim Results for the Six Months ended 30 June 2022\n \n \n \n \n \n \n Futura Medical plc (AIM: FUM), 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, is pleased to announce its unaudited interim results for the six months ended 30 June 2022.\n \n \n \n \n \n \n Operational Highlights\n \n \n \n \n \n \n \n \n \n MED3000 - Regulatory\n \n \n \n · \n Europe:\n MED3000 will be the first pan-European topical treatment for erectile dysfunction (\"ED\") available without the need of a doctor's prescription (\"OTC\").\n \n \n o \n In April 2022, Futura received approval for a UKCA mark for MED3000, supplementing the CE Mark approval received in April 2021.\n \n \n ·\n US:\n In August 2022, Futura received highly positive results from the confirmatory Phase 3 clinical study, (\"FM71\") for MED3000 for the treatment of ED meeting all primary and secondary endpoints.\n \n \n o\n Results demonstrated that MED3000 presents an effective clinically proven treatment for ED with a rapid speed of onset and a favourable benefit versus risk profile ideally suited for OTC classification.\n \n \n o \n Futura expects to file a regulatory dossier with the US Food and Drug Administration (\"FDA\") by the end of September 2022, targeting marketing authorisation for MED3000 in Q1 2023 as the first major ED treatment available OTC throughout the USA.\n \n \n \n \n \n \n \n \n MED3000 - Commercialisation & Manufacturing\n \n \n \n ·\n Futura has signed multiple commercial agreements to date across key markets, as it continues to build a strong network of licensing and distribution partners with strength in brand building, pharmaceutical credibility and marketing expertise for long-term distribution of MED3000 across the globe.\n \n \n o \n In March 2022, Futura announced that it had entered into a licensing agreement with Menarini Korea, a wholly owned subsidiary of Menarini Group, for the exclusive rights to commercialise MED3000 in South Korea.\n \n \n o \n In May 2022, Futura announced ...