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 dysfunction1,
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 OTC2 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
Chief Executive Officer
Angela Hildreth
Finance Director and COO
|
investor.relations@futuramedical.com
+44 (0)1483 685 670
www.futuramedical.com
|
Panmure Liberum
Nominated Adviser
and Broker
|
Emma Earl, Will Goode, Mark Rogers
(Corporate Finance)
Rupert Dearden (Corporate
Broking)
|
+44 (0)20 3100 2000
|
|
|
|
Stifel Nicolaus Europe Limited
Joint Broker
|
Alan Selby
Ben Maddison
|
+44 (0)207 710 7600
|
|
|
|
Alma
Strategic Communications
|
Rebecca Sanders-Hewett
Sam Modlin
Will Ellis Hancock
|
+44 (0)20 3405 0205
futura@almastrategic.com
|
|
|
|
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.