REG - Futura Medical PLC - Encouraging New Product Development Pipeline

Futura MedicalAnnouncement

04/11/2024 07:00

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RNS Number : 7143K  Futura Medical PLC  04 November 2024

4 November 2024

Futura Medical plc

("Futura" or the "Company")

Encouraging New Product Development Pipeline Results

 

Futura Medical plc (AIM: FUM), the consumer healthcare company behind
Eroxon(®), that specialises in the development and global commercialisation
of innovative and clinically proven sexual health products, is pleased to
provide an update on two successfully completed proof of concept studies in
its new product development pipeline for the treatment of sexual dysfunction
in men and women.

 

One of the Company's strategic priorities is to broaden its product range,
leveraging its innovative and experienced R&D capability whilst being
mindful of costs and focusing on return on investment for shareholders. As
disclosed at the time of Futura's interim results on 10 September 2024, proof
of concept studies were being undertaken and, following their successful
completion, the Company is now in a position to provide further detail on two
new products: WSD4000 and Eroxon(®) Intense.

 

WSD4000 is a topical treatment designed for sexual dysfunction in women.
Currently, no regulatory approved topical treatment for sexual dysfunction in
women is available over the counter. WSD4000 has the potential to be an
effective, breakthrough treatment for the common symptoms associated with
sexual dysfunction, such as lack of desire, arousal and lubrication.

 

Eroxon(®) Intense provides a potential range extension of the current
Eroxon(®) product and acts as an additional treatment option for erectile
dysfunction, helping those men that may prefer a stronger sensation from
Eroxon(®).

 

WSD4000 - for the treatment of sexual dysfunction in women

 

Between 40% and 50% of women experience at least one symptom of sexual
dysfunction(1), with frequency of symptoms increasing after menopause, yet
women remain chronically underserved. Existing prescription treatments offer a
poor benefit-risk profile and fail to meet the needs of many women.

 

In an initial single-blind randomised crossover study set up by Futura, 16
female subjects blind tested three gel formulations in a clinic. The study
tested one application of each gel with 40% of women and 63% of
post-menopausal women reporting feelings of arousal after using the preferred
gel formulation. Following this initial proof of concept study, the next stage
of development is to mimic a "real world" situation in a home user study with
60 female subjects and multiple product uses. This study is underway with the
aim of being able to provide initial validation for the product with results
expected during Q1 2025.

 

It was important to validate the product concept with the US FDA and take
steps to define the full development program. Thus, a first pre-submission
meeting with FDA was conducted with a successful outcome. The official minutes
of the FDA meeting confirmed the potential OTC(2) status of WSD4000 and a
further meeting with the FDA is planned to  discuss the pivotal clinical
study design following "least burdensome" principles.

 

A new patent for WSD4000 was filed in February 2024, with the potential for
further filings based on the outcomes of the studies. The innovation behind
WSD4000 falls outside of existing commercial partner agreements for
Eroxon(®).

 

The commercialisation strategy for WSD4000 will be determined by the Board
following the completion of the home user study, and evaluation of market
research commissioned by the Company that it expects will complete by early
2025. Discussions with potential commercial partners are ongoing.

 

Eroxon(®) Intense - for strong sustained erections

 

Marketing experience with Eroxon has shown that whilst many men are satisfied
with the current sensorial effect of the product, some men would prefer a
stronger sensation. Eroxon(®) Intense will help those men, thereby broadening
the existing Eroxon(®) range.

 

In a single-blind randomised crossover design study, 16 male subjects blind
tested three enhanced formulations compared with Eroxon(®). 67% of the men
experienced greater sensorial sensitivity on the preferred formulation
compared to Eroxon(®). A preferred enhanced formulation with a favourable
side effect profile has now been selected for further consumer testing during
H1 2025, with regulatory approval in the EU & USA expected by the end of
2025.

 

The Company's commercial partners have shown strong interest for new variants
beyond the original Eroxon(®) product to expand the product range as they
seek to build out the sexual health category within their own businesses.
Therefore, an additional treatment option for erectile dysfunction that is
aimed at helping the cohort of men that may prefer a stronger sensation from
Eroxon(®) is commercially attractive to support users' needs as well as
commercial partners' strategic ambitions. Eroxon(®) Intense will be covered
under Futura's existing intellectual property.

 

Costs associated with the completion of the development of Eroxon(®) Intense
and WSD4000's initial development costs, including the home user study, are
expected to be covered by the Company's existing R&D budget, inclusive of
any contributions from commercial partners. Therefore, guidance around costs
for FY2024 and FY2025 remain unchanged.

 

James Barder, Chief Executive Officer, commented:

 

"I am delighted to announce that our highly experienced R&D team has
wasted no time in focusing on developing exciting new innovation within the
OTC sexual health area. Having successfully developed, commercialised and
signed world class partnerships for our first product, Eroxon(®), we are
excited to announce the next phase of our NPD roadmap.

 

"We have already made significant strides following the launch of Eroxon(®)
internationally, including in the US in October 2024, delivering our maiden
profit in FY24. In a prudent manner, we are now looking to expand our range
especially within the underserved clinically proven treatments for women with
sexual dysfunction, whilst continuing to focus on the rollout of Eroxon(®)
across various geographical markets."

 

 

1.   Source: McCabe MP, Sharlip ID, Lewis R, Atalla E, Balon R etal.
Incidence and Prevalence of Sexual Dysfunction in Women and Men: A Consensus
Statement from the Fourth International Consultation on Sexual Medicine 2015.
J Sex Med. 2016 Feb;13(2):144-52

2.   OTC - over the counter, not requiring a doctor's prescription

 

The information communicated in this announcement contains inside information
for the purposes of Article 7 of the Market Abuse Regulation (EU) No. 596/2014
as amended by the Market Abuse (Amendment) (EU Exit) Regulations 2019.

 

 

Contacts:

 Futura Medical plc              James Barder                                            investor.relations@futuramedical.com

                                                       (mailto:Investor.relations@futuramedical.com)
                                 Chief Executive Officer

                                                       +44 (0)1483 685 670
                                 Angela Hildreth

                                                       www.futuramedical.com (http://www.futuramedical.com/)
                                 Finance Director and COO

 Panmure Liberum                 Emma Earl, Will Goode, Mark Rogers (Corporate Finance)  +44 (0)20 3100 2000

 Nominated Adviser               Rupert Dearden (Corporate Broking)

 and Broker

 Stifel Nicolaus Europe Limited  Alan Selby                                              +44 (0)207 710 7600

 Joint Broker                    Ben Maddison

 Alma Strategic Communications   Rebecca Sanders-Hewett                                  +44 (0)20 3405 0205

                                 Sam Modlin                                              futura@almastrategic.com

                                 Will Ellis Hancock

 

Notes to Editors:

Futura Medical plc (AIM: FUM) is the developer of innovative sexual health
products, including lead product Eroxon(®). Our core strength lies in our
research, development and commercialisation of topically delivered gel
formulations in sexual health products.

Eroxon(®), Futura's clinically proven lead product, has been developed for
the treatment of Erectile Dysfunction ("ED"). The highly differentiated
product, which is the only topical gel treatment for ED available over the
counter and helps men get an erection in ten minutes, addresses significant
unmet needs in the ED market.

ED impacts 1 in 5 men globally across all adult age brackets, with
approximately half of all men over 40 experiencing ED and 25% of all new
diagnoses being in men under 40.

Futura has distribution partners in place in a number of major consumer
markets including Haleon in the US, the largest market for ED in the world,
and Cooper Consumer Health in Europe. Eroxon(®) has been nominated for a
number of healthcare industry awards and has won two to-date.

 

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