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M8 Pharmaceuticals Announces License of Exclusive rights MED3000 from Futura Medical for Latin America

Aug 31, 2021

Futura Medical plc (AIM: FUM) ("Futura" or the "Company"), a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology and currently focused on sexual health and pain, today announces it has entered into a licensing agreement with m8 Pharmaceuticals, Inc ("m8"), a specialty biopharmaceutical company focused on commercialisation in Latin America, for the rights to exclusively develop and commercialise the Company's topical, gel-based Erectile Dysfunction ("ED") treatment MED3000, in Brazil and Mexico.

Commercial Highlights:

Futura to receive payments on all sales of MED3000 from m8 Futura also eligible to receive up to $8.5 million in milestone payments based on deliverable sales volumes, including a small initial upfront payment m8 is responsible for all local MED3000 development and regulatory costs in Brazil and Mexico as well as marketing expenses and ongoing pharmacovigilance and safety within the region m8 is a specialty biopharmaceutical company, headquartered and incorporated in the USA and focused on licensing, marketing and distributing innovative and established therapeutics in the two largest Latin America markets: Brazil and Mexico.

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 without the need for a doctor's prescription ("OTC") in Brazil and Mexico, the two biggest countries and healthcare end 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. m8 and Futura believe the EU (inclusive of the UK) approval of MED3000 granted in April 2021 will facilitate approval in Brazil, Mexico and other countries within Latin America without the need for further clinical development. 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 $8.5 million based on cumulative sales volumes within the initial term.

James Barder, Chief Executive of Futura Medical commented: "We are excited to be entering into this agreement with m8 to expand MED3000's market reach to Brazil and Mexico, both significant markets for ED. We are very pleased to have a partner with m8's dedicated launch, brand-building and marketing experience as well as resources and strong pharmaceutical connections in Latin America. We look forward to working closely with their team."

Joel Barlan, Chief Executive Officer of m8 commented: "We are pleased to license Futura's MED3000, bringing their clinically validated technology to Latin America. We feel that MED3000 could significantly benefit individuals suffering from ED in the region, generating significant value and long term sustainable growth for both Futura and m8 in the process. Our mission at m8 is to continue to positively impact lives and improve the health of patients by making innovative and effective therapies accessible to the Latin American population."

The global ED prescription market is estimated to be approximately US$5 billion1 amongst the leading 15 markets, with the USA ranked first and Brazil and Mexico ranked second and eighth respectively in value terms. Brazil, Mexico and neighbouring countries in Latin America represent a significant opportunity as the economies of these countries continue to outstrip the economic growth of many Western economies. Brazil and Mexico together account for 63% of the region's pharmaceutical market and reached growth rates of 10.3% and 7.3% respectively from 2019 to 2020 Q13.

  1. Source: IQVIA IMS Health 2018
  2. Source: Global Data Epidemiological Analysis 2020
  3. Source: IQVIA Pharmaceutical Market Trends in LATAM, June 2020

Commercial Transaction Advisors JSB Partners served as an adviser to Futura Medical in this transaction

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014 as amended by The Market Abuse (Amendment) (EU Exit) Regulations 2019. Upon the publication of this announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.

About Futura Medical plc Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® technology. Each DermaSys® formulation is separately patented and specifically tailored for the selected indication and application, as well as being optimised for clinical efficacy, safety, administration and patient convenience. The products are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk. MED3000 is Futura's topical gel formulation that is a breakthrough treatment for erectile dysfunction (ED) through a unique evaporative mode of action. Futura has conducted a Phase 3 study using MED3000 in ED, referred to as "FM57". This was a 1,000 patient, dose-ranging, multi-centre, randomised, double blind, placebo-controlled, home use, parallel group study delivering highly statistically significant results compared to pre-treatment baseline, consistently meeting all co-primary endpoints of IIEF, SEP2 and SEP3 (internationally accepted clinical trial endpoints in ED) with over 60% of patients experiencing a clinically meaningful improvement in their ED. MED3000 also begins to work immediately in some patients, with 60% of patients seeing onset of their erection within 10 minutes of application. MED3000 is CE marked in Europe and the UK as a clinically proven topical treatment for adult men with erectile dysfunction.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange.

For further information please contact:

Futura Medical plc James Barder, Chief Executive Angela Hildreth, Finance Director and COO Email: Tel: +44 (0) 1483 685 670

M8 Pharmaceuticals Joel Barlan Chief Executive Officer T: +52 (55) 4431 2933

Rafael Ferrer Vice President of Corporate Development T: +1 (305) 299 6998

Nominated Adviser and Sole Broker:

Liberum Richard Lindley/ Euan Brown/ Kane Collings Tel: +44 (0) 20 3100 2000

For media enquiries please contact:

Optimum Strategic Communications Mary Clark/ Eva Haas/ Hollie Vile Email: Tel: +44 (0) 20 3922 0900