06 March 2017

Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to announce that a validated market research model has confirmed the breakthrough potential of MED2002, the Company's novel gel for the treatment of erectile dysfunction ("ED"), as an over-the-counter ("OTC") product. The research, carried out by the global market research and consulting firm Ipsos, complements the previously announced research into the potential of MED2002 as a prescription medicine.

The latest market research further endorses Futura's strategy of developing MED2002 as a prescription product in standard and increased strength dose forms, with the objective of switching the standard dose form to an OTC product at an appropriate time.

Ipsos's validated healthcare forecasting model was used to predict peak OTC annual sales for MED2002 in key countries worldwide in excess of US$650 million. This forecast follows earlier market research commissioned into the potential of MED2002 as a prescription product, which indicated a prescription market size of up to US$600 million in key countries worldwide.

Ipsos forecasts that 70% of OTC product sales will be incremental to the prescription ED category. As a result, the estimated peak annual sales of MED2002 in prescription and OTC versions is predicted to be more than US$1 billion prior to the expiry of the product's expected patent life.

The Ipsos valuation was based on the outcomes from primary market research carried out amongst 400 men with ED or suspected ED in the USA. The respondents were in four groups: satisfied users of PDE5 inhibitors (the class of drugs such as Viagra and Cialis); dissatisfied users of PDE5 inhibitors; diagnosed but untreated ED sufferers; and suspected though undiagnosed ED sufferers. The respondents were shown a concept about MED2002 as part of the market research though they did not use the product as it is currently in clinical development.

The key findings of the market research showed that the respondents believed that the product, once approved, is highly differentiated from existing products and that its claims would meet their needs. MED2002's rapid onset of action, an average of less than five minutes, was the key feature that attracted respondents to the product and could command a price premium compared with existing ED treatments, which have a substantially slower onset of action.

The Ipsos healthcare forecasting model has been demonstrated by Ipsos to be within 20% of actual sales volumes in 9 out of 10 of its forecasts.

Futura expects to commence a placebo-controlled Phase III trial later this year of the standard and increased strength dosage forms of MED2002 in 700 or more patients subject to confirmation from regulatory authorities. In parallel, the Company is continuing in negotiations to out-license the product.

James Barder, Futura Medical's Chief Executive, commented: "Following the successful fundraise in November 2016, we have been developing MED2002 as a prescription product in both standard and increased strength forms. Our belief is that the standard dosage form could be switched, at an appropriate time, from a prescription to an over-the-counter medicine. The Ipsos market research has focused on the potential of MED2002 as an over-the-counter medicine.

"We are delighted that the Ipsos research has confirmed the potential of MED2002 as a US$1 billion+ sales opportunity when taking into account the earlier market research forecasts conducted by Decision Resources Group as a prescription-only product. We are particularly encouraged in the Ipsos research by the respondents' enthusiasm for the product, specifically in terms of its rapid mode of action and safety profile, and by the price premium this could achieve once launched."

This announcement contains inside information.

 

For further information please contact:

Futura Medical plc
James Barder, Chief Executive
+44 (0) 1483 685 670
james.barder@futuramedical.com
www.futuramedical.com

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Notes to editors:

About Futura Medical plc

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange (AIM: FUM).

www.futuramedical.com