MED3000 - Novel topical treatment for erectile dysfunction
Lead product, MED3000 was approved in April 2021 as a medical device in the EU and becomes the first clinically proven, pan-European OTC topical treatment for erectile dysfunction available without a doctor’s prescription. In April 2022 Futura also received approval for a UKCA mark.
The CE mark approval of MED3000 from the EU Notified Body paves the way for approval in many countries around the world, including in Latin America, the Middle East, Africa and the Far East regions, with many countries considering "fast-track" review based on recognition of the EU CE mark.
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 and recently approved in the EU as a medical device with potential over the counter peak sales of US$650 million1.
One in five men suffer from erectile dysfunction worldwide1 with around 23 million men suffering ED in the US and 20 million men in the UK, France, Italy, Spain and Germany. Erectile dysfunction (ED) is closely linked to age and a number of co-morbidities associated with obesity such as diabetes and heart disease with the incidence of erectile dysfunction expected to increase to 322 million by 20252. Erectile dysfunction can result from organic or psychological causes and is increasingly affecting younger men who can also suffer from performance anxiety due to social pressure and false expectations from easy access to pornography. Erectile dysfunction can lead to low self-esteem, lack of confidence and depression. The detrimental impact on partners and relationships is well documented and acknowledged by the medical community. The discovery and approval of the PDE5i’s to treat ED over 20 years ago (such as Viagra® and Cialis®) not only revolutionised available treatments for men with ED but also dramatically increased awareness in the general public of this significant problem.
The ED market is a well-established market with sales of ED treatments worth US$3.1 billion in 2020. Despite their success PDE5i’s have certain limitations. Although proven highly efficacious, oral PDE5i’s have several adverse effects as well as significant drug-drug interactions in the target population. The most commonly reported adverse events include headache, flushing, dyspepsia, nasal congestion and impaired vision. They are contraindicated for use with a number of medications such as nitrates, anti-hypertensives and alpha blockers. They generally take significant time to work requiring pre-planning for sexual intercourse. Viagra for example only starts to work in 30-60 minutes. As a result many men and their partners are dissatisfied with PDE5i’s and it has been estimated that almost 50% discontinue use after one year5. In most countries oral PDE5i’s are only available as a prescription only product which presents too high a barrier for many men who are too embarrassed to seek treatment, for whom the process is not convenient enough or who find the cost of the physician and medicine prohibitive in countries such as the US.
There are clearly significant unmet needs for ED patients. Key Opinion Leaders (KOLs) in sexual medicine are highly supportive of the MED3000 development programme as there has been little innovation in the ED space in nearly two decades.
Recent ongoing US market research conducted by IPSOS and commissioned by Futura has confirmed that even with increasing volumes the requirement of a doctor’s prescription remains both an economic and emotional barrier to use: US patients spend between US$600 and US$3,500 per annum on ED treatments, when taking into account both prescription costs and doctors’ visits not covered by insurance3. This reconfirms the significant opportunity that MED3000 represents with OTC availability at a likely retail price in the region of US$5 per dose in the USA.
The key findings of the market research showed that the respondents believed that the product, once approved, would be highly differentiated from existing products. In particular consumers found the speed of onset highly appealing.
We are executing upon our strategic plans to establish a global network of licensing and distribution partners with brand building strength, healthcare credibility, regional infrastructure and marketing expertise in order to make MED3000 a long term profitable and sustainable brand for shareholders. profitable. We have chosen partners who have demonstrated their enthusiasm for MED3000 and for whom its success will be meaningful whilst being firmly focused on our goal of delivering long-term and sustainable value to the Company. Over the past year the Company has entered into five commercial licensing deals in key markets for ED in regions such as the EU, China and South-East Asia, South Korea, Latin America and the Middle East.
Following the successful completion of FM71 and expected FDA dossier submission by the end of Q3 2022, Futura has recently commenced the search for a US commercial partner through its specialist corporate advisors.
As part of building the commercial proposition for MED3000 and supporting its regulatory approval in countries such as the US, Futura has developed an illustrative pack that licensing partners can select to use at their discretion.
Co-High Investment Management Limited (“Co-High”) is a subsidiary of Atlantis Group. Under the terms of the agreement, Futura and Co-High will work together to develop and commercialise MED3000 as a clinically proven OTC treatment for ED throughout South East Asia.
Due to the current political environment and restrictive “Zero-Covid” policy in China, Co-High Investment Management Limited are no longer able to deliver to-date on the key development and regulatory milestones as set out in the agreement entered into between the companies in March 2021. Futura is exploring options to remedy this situation in line with the contractual terms of the agreement as Southeast Asia including China remains a significant commercial opportunity although further phase 3 trials, taking several years, will be required, as previously disclosed.
m8 Pharmaceuticals, Inc ("m8"), is a specialty biopharmaceutical company focused on commercialisation in Latin America.
Under the terms of the agreement Futura and m8 will work together to gain marketing authorisation and commercialise MED3000 as a clinically proven treatment for ED available OTC in Brazil and Mexico, the two biggest commercial ED and healthcare markets in Latin America. The agreement is for an initial term of 15 years.
m8 will be responsible for all costs related to the regulatory approval and marketing of the product. Futura will provide reasonable ongoing technical support for OTC product development and commercialisation. Futura will receive payments on all sales of MED3000 from m8, and up to four milestone payments totalling US$8.5 million based on cumulative sales volumes within the initial term.
Swiss-based specialty pharma Company, Labatec Pharma (“Labatec”) is focused on commercialisation in Europe and the Middle East and North Africa (“MENA”) regions, for the rights to exclusively commercialise MED3000 in the GCC region as well as Jordan, Lebanon and Iraq.
Futura is eligible to receive initial upfront payments, as well as undisclosed milestone payments based on regulatory approval. Labatec will pay an agreed price to Futura for the manufacture and supply of MED3000 by Futura’s Contract Manufacturing Organisation (“CMO”), plus royalties on all sales. Labatec is responsible for all local MED3000 development and regulatory costs as well as all launch and marketing expenses. The initial licence agreement term is for eight years with the ability to extend for successive two-year terms by mutual consent.
Menarini Korea Limited (“Menarini”) will exclusively commercialise MED3000 for the treatment of ED in South Korea. A.Menarini Korea Ltd is a wholly owned subsidiary of the Italian-based specialty pharma Company Menarini Group. Menarini Group is the world's largest Italian biopharmaceutical company with a heritage of over 135 years and over 17,500 employees in more than 140 countries. Menarini Korea possesses the capability to successfully register, launch and commercialise brands in the market, with key strengths in therapeutic areas such as cardiovascular, hemato-oncology/pain, men's health, consumer Health, and specialty/orphan diseases and is a trusted medicines supplier in the region that is ideally placed to market retail products, with local teams that have a deep understanding and experience of the South Korean market.
Futura is eligible to receive initial undisclosed upfront payments and under agreement terms, will support Menarini to gain marketing authorisation and commercialise MED3000 for ED in South Korea. Menarini will be responsible for all costs related to the regulatory approval and marketing of the product in the region including a clinical bridging study, if required. Futura will provide reasonable technical support for product development and commercialisation and provide manufactured product from Futura’s CMO at an agreed price.
Cooper Consumer Health (“Cooper”), is a leading European independent self-care organisation.
Under the terms of the agreement, Cooper will commercialise MED3000 in the EEA, United Kingdom and Switzerland as a clinically proven, safe and fast-acting treatment for ED available without the need for a doctor's prescription.
Futura will receive an initial upfront payment, as well as undisclosed cumulative sales milestone payments and will manufacture and supply the product (through its CMO) for the EEA, United Kingdom and Switzerland to Cooper. The agreement is for an initial term of five years complying with EU competition law. Futura will remain Legal Manufacturer1 and be responsible for supply of MED3000 through its CMO.