Futura Medical Regulatory News (FUM)

4 August 2020

Futura update on Cannabidiol Dermasys® (CBD100) First Stage Development Work

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 and currently focused on sexual health and pain, announces completion of initial laboratory and optimisation work on a Dermasys® cannabidiol gel (CBD100) under the joint venture collaboration agreement with CBDerma Technology Limited that was announced in September 2019.

As part of a robust formulation process using strict pharmaceutical development principles, Futura has carried out extensive Dermasys Cannabidiol formulation work and initial in vitro tests on human epidermis. The studies demonstrate highly efficient penetration of cannabidiol into and through the skin, superior to an established, marketed, comparator product. Additionally, cannabidiol is known to be unstable with many common excipients. The Dermasys Cannabidiol gel was specially formulated to minimise this issue and is showing encouraging early stability work, which is expected to ensure potency is retained during shelf-life.

James Barder, Chief Executive of Futura Medical commented: "Our R&D team's development work on CBD100 is further evidence of the broad utility and power of the Dermasys system for effective and controlled transdermal delivery of a wide range of active pharmaceutical ingredients (APIs). We are aiming for CBD100 to be highly differentiated from existing, largely un-regulated, low-tech products in the fast growing cannabidiol market on the basis of quality, stability and efficient delivery to the skin for a number of applications and indications expected to range from cosmeceutical through to pharmaceutical dermal and pain relief treatments. We have now started to explore commercialisation options for CBD100 with CBDerma as stability work continues in parallel."

-ENDS-

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: Investor.relations@futuramedical.com 

Tel: +44 (0) 1483 685 670

www.Futuramedical.com

Nominated Adviser and Sole Broker:

Liberum

Bidhi Bhoma/ Euan Brown/ Kane Collings

Tel: +44 (0) 20 3100 2000

For media enquiries please contact:

Optimum Strategic Communications

Mary Clark/ Eva Haas/ Supriya Mathur

Email: futuramedical@optimumcomms.com

Tel: +44 (0) 203 922 0891

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® technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration and patient convenience. The products 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. 

MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction (ED) through a unique evaporative mode of action. Futura has conducted a Phase 3 study using MED3000 in ED, referred to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, consistently meeting all co-primary endpoints of IIEF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED. MED3000 also begins to work immediately in some patients, with 60% of patients seeing onset of their erection within 10 minutes of application.

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