Futura Medical Regulatory News (FUM)

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER ARTICLE 7 OF REGULATION (EU) NO 596/2014 OF THE MAR. UPON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.

Business Update

19 September 2018

Futura Medical plc (AIM: FUM) (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, announces a business update today. The Company has undertaken an extensive review of its pipeline and product portfolio, with the aim of maximising the potential of its products for the benefit of its shareholders.

Highlights

· A number of constructive discussions with potential commercial and regulatory partners for the further development of MED2002, a breakthrough treatment for erectile dysfunction

· Positive results in PK Study conducted earlier in 2018 demonstrating safety at higher doses of MED2002 along with a dose related absorption

· Peer reviewed paper on MED2002 published in Journal of Sexual Health in February 2018

· MED2002 Phase 3 commenced with first patient entering study within the next month

· TPR100 commercial partner Thornton & Ross filed UK regulatory submission in July

· 2-Year shelf life approved for CSD500, the erectogenic condom

· Focus on further development of MED2002 to optimise value for shareholders, subject to funding, with further realisation of value from pain portfolio

MED2002 - Topical gel for erectile dysfunction ("ED")

The Company has had extensive discussions with a number of interested commercial partners for the out-licensing of MED2002, a breakthrough treatment for ED. These discussions are ongoing. However in the majority of instances potential commercial partners would like to see positive phase 3 data on MED2002, especially at the higher doses, ahead of more advanced licensing discussions and have indicated that they are likely to pay more for the product after such data has been generated.

An innovative product with positive Phase 3 data is significantly clinically de-risked and greater value is likely to be obtained by an innovator such as Futura when partnering or out-licensing the product, than structuring an earlier arrangement. Data from Futura's out-licensing advisers and the Company's own ongoing internal assessments of comparable licensing deals indicate that the innovator's share of product net present value increases by approximately 50% moving between phase 2 to phase 3 datasets. Consequently the Board recognises the importance to shareholders of achieving this milestone, in order to maximise shareholder value.

Futura therefore plans to take MED2002 through Phase 3 development and then partner or sell the asset. The first European Phase 3 study, "FM57", a 1,000 patient, study of MED2002 for the treatment of erectile dysfunction is progressing on track with first patients expected to enter study within the next month and with headline data expected by the end of 2019. FM57's protocol has incorporated feedback received from potential commercial partners and also US and EU regulatory agencies to optimise both the commercial value as well as the chances of regulatory approval.

The potential market for this product is large with potential peak sales in excess of US $1 billion. If MED2002 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). It is also reassuring that discussions with prospective partners have included similar estimates of market opportunity, which have been separately sourced at their expense.

CSD500 - Erectogenic condom

In the past week Futura has received approval for a two-year shelf life for CSD500, its erectogenic condom, for its European contract condom manufacturer. This long-awaited milestone is welcome and, with a more commercially viable shelf life for CSD500, allows Futura the opportunity to focus its R&D resource fully on the far greater potential of its leading asset, MED2002.

As an innovative specialist R&D company, Futura does not have the marketing or regulatory medical device resources to support the day-to-day requirements in a growing compliance-driven market and will focus its efforts on licensing the condom product / technology with partners who can accommodate the increasingly complex regulatory obligations. Futura expects to still benefit from the Intellectual Property of CSD500 through potential royalties, but the immediate potential for substantial royalties is low in the absence of a large global brand 'carrier' to take the product forward. The Company will continue to explore national, multi-territory and regional deals where the opportunities arise. The Company would benefit from annual cost savings of approximately £400k in the event that it no longer maintains regulatory clearance itself for CSD500 as a medical device.

Discussions are ongoing with current and potential further distribution partners on next steps with the product in a number of markets.

TPR100 - Topical gel for pain relief

The Company's novel topical pain relief gel TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK's largest consumer healthcare companies and a subsidiary of STADA AG. In July 2018, Thornton & Ross filed the product's marketing authorisation application with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The Company has received expressions of interest from a number of parties to enable Futura to expand the geographical reach of TPR100. Futura is awaiting regulatory authorisation in the UK before progressing further.

James Barder, Chief Executive Officer, Futura Medical said:

"As an innovative specialist R&D company with finite resources, it is very important that our strategy is focused on where we can deliver most value for our shareholders - by developing our portfolio of innovative products for two large market categories, sexual health and pain, and then partnering at the optimum time to generate most value. We believe this more concentrated focus on MED2002 and our pain relief gel will enable us to achieve this."

Futura is exploring a number of options for additional funding whilst it progresses its first Phase 3 programme for MED2002. This will ensure the Company has sufficient resources to maximise shareholder value from the commercial opportunity for MED2002. The Company will also announce its interim results for the six months ended 30 June 2018 on Wednesday, 26 September 2018.

Forward looking statements

This document may contain certain forward-looking statements. Whilst the directors believe all such statements to have been fairly made on reasonable assumptions, there can be no guarantee that any of them are accurate or that all relevant considerations have been included in the directors' assumptions; accordingly, no reliance whatsoever should be placed upon the accuracy of such statements, all of which are for illustrative purposes only, are based solely upon historic financial and other trends and information, including third party estimates, and may be subject to further verification. Neither the Company nor its directors, nor N+1 Singer (together with its associates) makes any representation or warranty in respect of the accuracy, completeness or verification of the contents of the document. N+1 Singer has not authorised or verified the contents of, or any part of, the document.

James Barder, CEO, and Angela Hildreth, FD & COO, arranged for the release of this announcement on behalf of the Company.

For further information please contact:

Futura Medical plc James Barder, Chief ExecutiveAngela Hildreth, Finance Director and COO

Email: Investor.relations@futuramedical.comTel: +44 (0) 1483 685 670 

Nominated Adviser and Broker:N+1 SingerAubrey Powell/ Jen Boorer/ Ben Farrow (Corporate Finance)

Tom Salvesen (Corporate Broking)Tel: +44 (0) 20 7496 3000

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Hollie Vile

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 714 1787

Notes to editors:

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal Dermasys® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.

The first European Phase 3 study for MED2002, referred to as "FM57", will be a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study of MED2002 0.2%, 0.4% and 0.6% w/w Glyceryl Trinitrate for the treatment of erectile dysfunction with an open label extension. FM57 is progressing on track, with first patients expected to enter study within the next month and with headline data expected by the end of 2019.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com