MED3000 - Novel topical treatment for erectile dysfunction

Lead product, MED3000 is a unique and highly differentiated easy to use topical gel for erectile dysfunction which has Phase 3 clinical data demonstrating highly statistically significant improvement across all ED patient severities with potential peak sales of $1 billion.

External market assessments based on Market Research from Cello Health Consulting as a prescription product and Ipsos Group as an over the counter product, forecast that MED3000 could achieve combined peak annual sales in excess of US$1 billion1.

Targeting a large potential market with clear unmet medical need

  • Global ED prescription market worth US$5.6 billion in 20182.  
  • $560 million potential prescription peak sales at $5 per dose. Research by Cello and model provided by Decision Resources for Futura.
  • $660 million potential ‘Over the Counter’ sales at $5 per dose with 70% incremental to prescription sales. Research and forecast provided by Ipsos Mori for Futura.
  • Commercial out-licensing discussions ongoing.
Erectile dysfunction often becomes a barrier to spontaneity and intimacy in a relationship, which harms both the man and his partner over time. A product -such as MED3000 - that can be applied as part of foreplay could help to break down the barriers that have proved so difficult to overcome with existing treatments.”

Ian Eardley

Consultant Urologist

Past President of the European Society of Sexual Medicine

Department of Urology, St James University Hospital, Leeds

The market for erectile dysfunction

The ED market is a well-established market with sales of ED treatments worth $5.6 billion in 2018. Cialis® is now the market leader though this may change after its patent expired in most markets in November 2017. The market in the UK is changing with the approval by the Medicines and Healthcare products Regulatory Agency in November 2017 of Viagra Connect® which is now available over the counter from pharmacies in the UK, the first major market where a doctor's prescription is no longer required to legitimately 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 and other co-morbidities.

The number of men with ED will increase from 152 million men in 1995 to 322 million men by 20253

Map showing numbers of men with ED around the world

  • Growing population
  • Growth in obesity
  • Ageing population
  • Increased awareness / acceptance

An established market with significant unmet needs

According to independent market research we conducted, 68% of ED patients are not fully satisfied with their treatment and research shows that within just one year of treatment initiation, almost 50% 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. Research conducted on behalf of Futura showed that around 20% of patients cannot take any of the PDE5 inhibitors due to contraindications with other medicines they take.

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 (except for some limited products in the UK and Poland).

There are clearly significant unmet needs for ED patients. Key Opinion Leaders (KOLs) in sexual medicine are supportive of the MED3000 development programme as there has been little innovation in the ED space in recent years. An endorsement and engagement programme is under way.

$1bn market potential as Rx and OTC product

Market research conducted on behalf of Futura by leading healthcare strategy firm Cello Health Consulting ("Cello") showed that a new first-line treatment for ED could capture over 20% patient share, with 64% of physicians in the US considering that such a treatment would be an improvement over current ED treatments, which are dominated by PDE5 inhibitors. The research also revealed that at least 10% of ED patients were contra-indicated to PDE5 inhibitors (such as Viagra® or Cialis®) because of their existing nitrate medicationand in total around 20% of patients cannot take any of the PDE5 inhibitors due to contraindications with other medicines they take.

The results highlighted that a new fast-acting first line treatment for ED could capture between a quarter and a third of the estimated ED patient pools in the US, including newly diagnosed and existing patients. The rapid speed of onset and the spontaneity associated with the use of a topical product were given by doctors as key reasons for expected patient uptake of the product. 

US ED patient populations - Opportunity in each segment

New patient initiation

new patient initiation pie chart

Attributes driving adoption

  1. Safety profile
  2. Improves erectile function
  3. 5-10 min onset of action

Switch from current ed treatment

switch from current ed treatment chart

Drivers to Switch

  1. 5-10 min onset of action
  2. Supports intimacy and Spontaneity
  3. Patient dissatisfied with PDE5i treatment

Switch satisfied ed patients

switch satisfied ed patients pie chart

Drivers to switch

  1. 5-10 min onset of action
  2. Supports intimacy and Spontaneity
  3. Safety profile

Lapsed on ed treatment

lapsed on ed treatment pie chart

Drivers to Re-initiation

  1. 5-10 min onset of action
  2. Safety profile
  3. Supports intimacy and Spontaneity

Market research showed a topical treatment similar to MED3000 had an estimated market potential of $560M as prescription-only and an estimated $660M+ as an over-the-counter (OTC) product with 70% potential incremental sales.

Assuming MED3000 could eventually switch to over the counter, the market research firm Ipsos used its validated healthcare forecasting model to forecast peak OTC annual sales for MED3000 in key countries worldwide of more than US$650 million. Importantly, Ipsos forecasts that 70% of these potential OTC sales would be incremental to the prescription category. The key findings of the market research showed that the respondents believed that the product, once approved, would be highly differentiated from existing products.


MED3000's proposition

Oral PDE5 inhibitors are the cornerstone of modern erectile dysfunction therapy, but do not meet the needs of many men and their partners. Up to half of patients discontinue treatment within one year, citing concerns which include barriers to spontaneity and intimacy, insufficient efficacy, and side effects. Erectile dysfunction affects the patient's emotions and relationships, and an ideal ED treatment should address more than the ability to have and maintain an erection. Our research shows that around a quarter of patients are not satisfied with their ED treatment. Delayed speed of onset associated with PDE5 use is a major barrier to spontaneity and intimacy.

A topical treatment could offer couples an alternative to PDE5i’s and represents a potential new treatment option for patients taking nitrates and therefore contraindicated to oral PDE5is, for those who find PDE5is side effects unacceptable and for those who have discontinued treatment.

The research conducted showed that the MED3000 proposition was highly relevant with 72% of doctors considering that helping to restore spontaneity and intimacy in the relationship would be very appealing to their patients and would be a key driver of patient initiation or switch to MED3000.


Futura has filed a new patent application which has the potential, if successful, to extend protection until 2040 as well as appointed patent advisors to explore additional Intellectual Property opportunities. In addition to this MED3000 has very low cost of goods offering the potential for high margins.

Futura believe MED3000 represents a wider overall commercial opportunity, due to its broader applicability, providing a clinically proven treatment to ED patients as a standalone treatment, including ED patients currently contraindicated from using existing medications such as nitrates, anti-hypertensives, and alpha blockers. An opportunity may also exist with ED patients who might wish to use MED3000 in combination with existing oral ED medications.

  1. Previous market research conducted by Cello Health Consulting as a prescription product and Ipsos Group as an over the counter product on MED2005 showed potential peak sales in excess of $1bn. Whilst MED3000 is a slightly different proposition as it has a different mode of action, it offers the same benefits and therefore the Group believes that the market potential is similar.
  2. Manufacturers' Selling Prices 2018: Data available for 75 countries IQVIA IMS Health.
  3. Adapted from McKinlay JB. Int J Impot Res. 2000;12(suppl 4):S6-S11.
  4. Consistent with their known effects on the Nitric oxide/cyclic guanosine monophosphate (cGMP) pathway PDE5 inhibitors have been shown to potentiate the hypotensive effects of nitrates when co-administered. This combination effect is not expected to occur with MED2005 based on clinical data to date and the regulatory agencies have agreed to the inclusion of a subset of ED patients taking nitrate medication to confirm the safety profile in the Phase 3 clinical programme.