MED2002 - The Market
The market for erectile dysfunction
Erectile dysfunction ("ED") is the inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse.
The ED market is a well-established market with sales of ED treatments worth over $5.6 billion in 20161. With Viagra® losing patent protection in many countries, Cialis® is now the market leader though this may change after it lost its patent in most markets in November 2017. The market in the UK is about to see further change with the approval by the Medicines and Healthcare products Regulatory Agency also in November 2017 of Viagra Connect® to be available from pharmacies in the UK in Spring 2018, the first major market where a doctor's prescription will no longer be required to legimately obtain Viagra.
The Massachusetts Male Ageing Study ("MMAS") estimated that as many as 52% of men aged 40 or over have some degree of erectile dysfunction. The number of men with erectile dysfunction is rising due to the ageing of the global population and the increased incidence of diabetes.
A market with significant unmet needs
According to independent market research we conducted, 68% of ED patients are not fully satisfied with their treatment and doctors expect that within just one year of treatment initiation, 25% of all ED patients will discontinue therapy.
There is also a subset of erectile dysfunction sufferers who would not be prescribed any of the PDE5 inhibitors due to contraindications with other medications taken by them, including those 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 and recent research conducted on behalf of Futura shows this patient group represents at least 10% of ED patients.
Market research indicates that only 15%-30% of men with erectile dysfunction consult a doctor. All existing treatments for erectile dysfunction require a prescription from a doctor.
There are clearly significant unmet needs for ED patients.
MED2002 - Our topical treatment for erectile dysfunction
MED2002, our treatment for erectile dysfunction, is a topical gel applied directly to the penis with a rapid onset of action. This topical application has considerable advantages compared with oral treatments in terms of a rapid speed of onset and safety.
In a placebo-controlled, double blind, home use, crossover pivotal clinical study completed in 2016, MED2002 showed efficacy, safety and a fast speed of onset. With a superior speed of onset, a compelling safety profile and the potential to switch to over-the-counter, external market assessments based on market research from Cello Heath Consulting as a prescription product and Ipsos Group as an over the counter product, forecast that MED2002 could achieve combined peak annual sales in excess of US$1 billion.
Protecting our IP
Futura has both granted patents and a number of further patent applications in relation to its DermaSys® technologies, providing protection to at least 2028. An additional patent filing made in 2017 could extend patent protection through to 2038. In addition under EU rules, as an innovator product filed under Article 8(3) of 2001/83/EC, MED2002 will also benefit from 10 years' European regulatory data and market exclusivity.
1 - 15 key markets, IMS Health Data (2016) Manufacturers' Selling Prices