MED2005 - Commercial
MED2005 - Breakthrough topical treatment for erectile dysfunction
MED2005, our treatment for erectile dysfunction, is a topical gel applied directly to the head (glans) of the penis with a fast onset of action (5-10 minutes) and rapid clearance therefore potentially the fastest-acting ED treatment with a favourable side effects profile.
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 MED2005 could achieve combined peak annual sales in excess of US$1 billion1.
1 Based on external market assessments from market research conducted by Cello Heath Consulting as a prescription product and Ipsos Group as an over the counter product
Targeting a large potential market with clear unmet medical need
2 Manufacturers' Selling Prices 2016: 15 Key ED markets, IMS Health
"The treatment of ED has not seen any new clinical products for 1-2 decades. MED2005 is a novel glyceryl trinitrate (GTN) topical gel with an enhanced absorption delivery system. After application to the glans penis, there is a rapid onset of action (5-10 mins in 70% of spontaneous attempts at intercourse) in contrast to current oral PDE5i's, which take 30-90 mins to act. This novel topical therapy is easy to use, does not have any food or alcohol interactions, and has excellent tolerability for both patient and partner.
"I am excited to be part of an advisory panel helping to shape the future program for MED2005 as it enters Phase 3 studies, and I look forward to ultimate approval by the FDA and regulators around the world. It offers new hope to patients who, for whatever reason, are dissatisfied with current therapies or are precluded from their use."
Professor Wayne Hellstrom
Professor of Urology and Chief of Andrology
Tulane University School of Medicine, New Orleans, US
Past President of the International Society of Sexual Medicine
The market for erectile dysfunction
The ED market is a well-established market with sales of ED treatments worth over $5.6 billion in 20163. 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® which is now available from pharmacies in the UK, 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 and other co-morbidities.
3 - 15 key markets, IMS Health Data (2016) Manufacturers' Selling Prices
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 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 (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 highly supportive 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 MED2005 has the potential to be a first line treatment option for ED with 64% of physicians in the US considering that MED2005 is 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 medication.4
The results highlighted that MED2005 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 the product were given by doctors as key reasons for expected patient uptake of the product. Our external market assessment forecasts that MED2005 as a first line prescription therapy could achieve peak annual sales in excess of US$550 million.
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.
US ED patient populations - Opportunity in each segment
MED2005 - an innovation in the treatment of ED
In addition, MED2005 has the potential to switch to over the counter. The market research firm Ipsos used its validated healthcare forecasting model to forecast peak OTC annual sales for MED2005 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. MED2005's rapid onset of action and favourable safety profile were the key features that attracted respondents to the product.
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.
Because of its efficacy, rapidity and usability as a topical treatment, MED2005 has the potential to offer a new first line treatment option for couples looking for a more intimate and spontaneous solution to erectile dysfunction. MED2005 also represents a potential new treatment option for patients taking nitrates and therefore contra-indicated to oral PDE5s, for those who find PDE5s side effects unacceptable and for those who have discontinued treatment.
The research recently conducted showed that the MED2005 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 MED2005.
MED2005 is backed by strong patent protection which runs until August 2028 in the USA and August 2025 in Europe. An additional patent filing announced in 2017 could extend patent protection through to 2038. Further protection is offered by the EU 10 year data protection from date of first EU approval and in the USA under the Hatch-Waxman Act ability to extend protection beyond patent life. In addition to this MED2005 has very low cost of goods offering the potential for high margins.
The Company has had extensive discussions with a number of interested commercial partners for the out-licensing of MED2005, a breakthrough treatment for ED. In order to maximise the value of MED2005 for shareholders, Futura made the strategic decision to take MED2005 through its Phase 3 development and then partner or sell the asset. An innovative product such as MED2005 with Phase 3 data in hand significantly increases revenue and commercial potential.
"Erectile dysfunction often becomes a barrier to spontaneity and intimacy in a relationship, which harms both the man and his partner over time. MED2005 can be applied as part of foreplay, and with its fast onset of action can help to break down the barriers that have proved so difficult to overcome with existing treatments."
Past President of the European Society of Sexual Medicine
Department of Urology, St James University Hospital, Leeds