Licensing Agreement for MED2002 as a Special Product
14 October 2015
Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, and Quantum Pharma Plc ("Quantum") (AIM: QP.), a leading UK manufacturer and supplier of unlicensed medicines, have today signed an agreement under which MED2002, Futura's novel treatment for erectile dysfunction, will soon be available as an unlicensed medicine ("Special") (the "Agreement").
Under the terms of the Agreement, Futura has out-licensed exclusive rights to Quantum for the manufacture and supply of MED2002 as an unlicensed medicine ("Special") in the UK. In return, Futura will receive undisclosed royalty payments from Quantum on the sales of the product.
Specials are medicines that have not been authorised and which are requested and prescribed for the treatment on a named patient basis only by appropriately qualified doctors under their own authority. Such requests can only be made subject to a number of conditions being met including the absence of licensed alternatives.
MED2002 meets the UK regulatory criteria for a Special because of the estimated 7.5% of erectile dysfunction sufferers who cannot be prescribed PDE5 inhibitors, such as Viagra®, owing to contraindications with other medicines they take.
MED2002 is currently undergoing a pivotal efficacy study in 192 men suffering from erectile dysfunction. The study results are expected to be reported by the end of H1 2016. It is intended that MED2002 will remain available as a Special until the product gains marketing authorisation.
The Agreement is a related party transaction under the AIM Rules for Companies as Futura and Quantum share the same Non-Executive Chairman, John Clarke. The Directors of Futura, with the exception of Mr. Clarke who has taken no part in the negotiation of the Agreement other than to effect the introduction between the parties to it, consider that, having consulted with Futura's nominated adviser, that the terms of the Agreement are fair and reasonable insofar as its shareholders are concerned.
James Barder, Futura's Chief Executive, commented: "We are very pleased to have signed an agreement with Quantum Pharma to make MED2002 available on prescription on a named patient basis as a Special. We are particularly pleased to be able to meet an unmet medical need in that a significant number of erectile dysfunction sufferers are unable to use the widely prescribed PDE5 inhibitors owing to contraindications with other medicines."
The promotion of unlicensed medicines is prohibited by Human Medicines Regulations 2012. Accordingly, this announcement contains only the factual information necessary to be disclosed to allow the Company to comply with its obligations under the AIM Rules for Companies. It is not intended to be nor should be treated as an advertisement, promotion or endorsement of MED2002 for any medicinal purposes.
For further information please contact:
Aubrey Powell / Liz Yong
Tel: +44 (0) 20 7496 3000
For media enquiries please contact:
Mark Court / Sophie Wills /
Stephanie Watson / Tilly Abraham
Tel: +44 (0) 20 7466 5000
Notes to editors:
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.
MED2002 is the development name for Futura Medical's medicinal treatment for men with erectile dysfunction ("ED"). Futura holds worldwide rights to MED2002, which contains the active ingredient glyceryl tri-nitrate.
A clinical study of MED2002 is currently under way in more than 192 patients with ED. The primary outcome of the study, which is of a randomised, placebo-controlled, double blind, home use, crossover design, is statistically significant efficacy. The clinical trial is expected to report before the end of H1, 2016.
In the most recent data published by the NHS spending on drugs to treat ED in General Practice in England exceeded £80 million per annum1.