Futura Medical plc (LON:FUM) has advanced transdermal technology which can be incorporated into formulations of well characterised drugs to improve performance and extend their uses. MED2002 is a topical gel of glyceryl trinitrate (GTN) in FUM’s proprietary DermaSys technology. It is applied with a specially designed single-use applicator directly to the glans of the penis, rapidly absorbed to increase blood flow giving a fast onset of action, for the treatment of erectile dysfunction. It is very safe to use because local application eliminates many of the side effects associated with systemic prescription drugs (eg Viagra), such as headache and flushing.
► Strategy: For regulatory approval, FUM is undertaking a pivotal randomised, double-blind, placebo controlled cross-over trial in 192 patients which is due to complete in 1H 2016. Meanwhile, FUM has announced a licensing deal with Quantum Pharma (QP.L) to make MED2002 available in the UK as a ‘Special’.
► ‘Special’: In the UK, doctors can prescribe unlicensed medicines, which have a proven track record regarding safety, for alternative indications to individual patients on a ‘Named Patient’ basis. Such products are known as ‘Specials’. Quantum is a leading manufacturer and supplier of such products.
► Terms: FUM has granted Quantum an exclusive license for the manufacture and supply of MED2002 as an unlicensed medicine in the UK. In return, FUM will receive royalties based on the sales made by Quantum. This extends the total potential return for the company from this product.
► Risks: The risks to Futura Medical Plc are minimal. MED2002 satisfies all the regulatory requirements for classification as a ‘Special’. This deal maximises the potential shareholder returns from MED2002 for the period of time where the product remains unlicensed for erectile dysfunction.
► Summary: Given that the pivotal trial for regulatory approval will not complete until 1H 2016, after which the submission documents need to be prepared, this deal will provide some income on MED2002 for at least 12 months that would otherwise be lost. Also, it is likely to provide some in-market use data and increase awareness prior to full launch. No changes to forecasts at this stage.
