Erectile dysfunction is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse.
The launch of Viagra® by Pfizer Inc was as recent as 1998. Since then, Viagra® has revolutionised the market for erectile dysfunction. Annual global sales of treatments for men with erectile dysfunction were over US$4.3 billion in 2011 (estimate based on sales data from 2011 Annual Reports for Pfizer, Lilly and Bayer). Competitors such as Cialis® and Levitra® have since entered the market. Since 1998 there has been a considerable increase in public awareness of the problems of erectile dysfunction.
The Massachussetts Male Ageing Study ("MMAS") estimated that as many as 52% of men aged 40 or over have some degree of erectile dysfunction. Working from the most conservative projections the British Journal of Urology expects the number of men with erectile dysfunction to more than double from 152 million in 1995 to 322 million by 2025. This is linked to the ageing of the global population. Market research indicates that only 1 in 5 men with erectile dysfunction consult a doctor. All existing treatments for erectile dysfunction require a prescription from a doctor. This represents a significant market with unmet needs.
There is also a significant subset of erectile dysfunction sufferers who have stable angina, a condition treated with nitrate medicines. Due to the mode of action of nitrate medicines these patients cannot take any of the PDE5 inhibitors. It is estimated that this subset of patients accounts for 5 to 10% of all erectile dysfunction sufferers. The Directors believe that patients with mild to moderate angina may represent a population with unmet clinical needs.
MED2002, our product for erectile dysfunction, will be a topical gel applied directly to the penis and will have a rapid onset of action. This topical application has considerable advantages compared with oral treatments. The most common side effects with oral treatments are headaches and flushings. The oral dose needs to be taken about an hour prior to intercourse (Viagra® Prescribing information). MED2002 will help bring back spontaneity in the relationship, reducing stress and performance anxiety and will not have the systemic side effects of oral treatments.
Futura regained the global rights to MED2002 from Reckitt Benckiser Group plc in 2012 and is now re-activating the clinical development of MED2002 and its licensing to a suitable commercial partner.