MED2002 will be a topical gel applied directly to the penis for the treatment of male erectile dysfunction (“ED”).
MED2002 is based on the active compound Glyceryl Trinitrate (“GTN”) within a patented gel delivery system. GTN is a potent vasodilator and has been used for the treatment of angina and associated cardio-vascular defects for more than 40 years, where it has been determined to be a safe and effective drug with a known side-effect profile.
MED2002 is applied to the glans area of the penis with a single dose applicator. DermaSys®, our skin delivery technology developed for MED2002, enables the active dose to be delivered effectively and rapidly through the skin. This topical application translates into a low systemic uptake which will help to reduce unwanted side effects and minimise the potential for adverse interaction with other centrally acting drugs such as PDE5 inhibitors Viagra®, Cialis® or Levitra® .
This is a less invasive method of application compared with other treatments and is consistent with sexual foreplay. The GTN is absorbed into the penile blood system and is converted to nitric oxide, having the effect of relaxing muscles surrounding the corpus cavernosa and dilating the penile arteries. This allows the corpus cavernosa to engorge with blood and, following sexual stimulation, a natural erection occurs.
MED2002 is expected to become the world's first non-prescription pharmaceutical treatment for men with ED. By being available from pharmacies without the need for a doctor's prescription, MED2002 will be aimed at satisfying a large unmet demand from men with ED.
Futura and SSL International plc (“SSL”) have signed a global development and licensing agreement for the worldwide rights to MED2002. The licensing agreement for MED2002 with SSL further strengthened the existing relationship between Futura and SSL, who also hold the distribution rights for our condom product CSD500.
Under the terms of the agreement with SSL, an undisclosed royalty on MED2002’s sales will be paid to Futura with milestone payments of up to £18 million, subject to certain specified regulatory approvals and sales targets being achieved. SSL and Futura will jointly manage the completion of the clinical development programme of MED2002 currently expected to cost up to £3.65 million, with SSL contributing 65% of the costs and Futura contributing 35%.
A simplified development plan has been outlined for MED2002, which shares the same active compound as CSD500. It is expected that the positioning of MED2002 in the market place and the regulatory strategy will be finalised and progressed following the CE mark approval for CSD500.
MED2002 describes all Futura's different gel formulations applied directly to the penis for the treatment of men with erectile dysfunction. Futura may code certain formulations, for identification purposes, by altering the final digit, eg. MED2001 or MED2004.
Working in partnership with
MED2002 utilises our skin delivery technology
