27 September 2021

Futura Medical Announces Collaboration with Labatec Pharma to Commercialise MED3000 in the Gulf and Middle East Region

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 Labatec Pharma ("Labatec"), a Swiss-based specialty pharma Company focused on commercialisation in Europe and the Middle East and North Africa ("MENA") regions, for the rights to exclusively commercialise the Company's topical, gel-based Erectile Dysfunction ("ED") treatment MED3000, in the Gulf Co-operation Council ("GCC") region as well as Jordan, Lebanon and Iraq.

Commercial Highlights:

• Futura eligible to receive initial upfront payments, as well as undisclosed milestone payments based on regulatory approval
• Labatec to 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 in GCC and Levant as well as all launch and marketing expenses
• Initial licence agreement term of 8 years with the ability to extend for successive two-year terms by mutual consent

Based in Switzerland and privately-owned, Labatec is a pharmaceutical company with a successful track record of delivering high quality pharmaceutical products to European and MENA markets. Labatec has a presence in both hospital and retail sectors, with prescription and OTC ranges and delivers a trusted brand of medicines manufactured in Europe and Canada.

Labatec Licensing Agreement

Under the terms of the agreement, which is for an initial 8-year period, Futura and Labatec will work together to gain marketing authorisation and commercialise MED3000 as a clinically proven treatment for ED in Jordan, Lebanon, Iraq and the GCC region of Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Oman and Bahrain.

Labatec will be responsible for all costs related to the regulatory approval and marketing of the product in the region. Labatec and Futura believe the EU (inclusive of the UK) approval of MED3000 will facilitate approval in GCC and other countries within the Middle East without the need for further clinical development. Futura will provide reasonable technical support for product development and commercialisation, will receive upfront and milestone payments, manufactured product from Futura's CMO and a royalty rate on all sales.

James Barder, Chief Executive of Futura Medical commented: "This is our third commercial agreement for MED3000, and we are excited to be working with Labatec to expand the product's market reach into Middle Eastern countries as we continue MED3000's regulatory and commercial rollout worldwide. Labatec is a trusted medicines supplier in the region that is ideally placed to market both prescription and retail products, and its local teams have deep understanding of regional markets and experience in rapidly registering and launching new products. We look forward to working closely with them."

Faisal Darwazeh, Chief Executive Officer of Labatec commented: "We are delighted to license Futura's MED3000 for the GCC and other Middle Eastern countries. We feel that there is significant market potential in the region for MED3000 as a trusted, branded medicine for enhancing erectile performance, optimally through pharmacy sales and are confident of generating significant value and long term sustainable growth for both Futura and Labatec with this innovative, clinically proven product."

Commercial Transaction Advisors

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

www.jsb-partners.com

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.

-ENDS-

For further information please contact:

Futura Medical plc

James Barder, Chief Executive

Angela Hildreth, Finance Director and COO

Email: [email protected] 

Tel: +44 (0) 1483 685 670

www.futuramedical.com

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: [email protected]

Tel: +44 (0) 203 922 0900

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. www.futuramedical.com

About Labatec

A Swiss based privately owned pharmaceutical company, based in Meyrin (Geneva) since 1957, Labatec develops and markets medicines that contribute to improving patients' quality of life. Our portfolio includes more than 85 high quality products, manufactured in Europe and Canada and marketed in 10+ countries across MENA markets, Switzerland and neighbouring EU countries. Labatec is a recognised partner choice for Swiss and MENA hospitals  and has an established retail presence, including an OTC range, in the therapeutic categories of musculo-skeletal, urology, and reproductive health. www.labatecpharma.com

In case Labatec contacts are needed:

Viktoria Stepanova, COO

Email:  [email protected]

Tel: +41 22 785 95 00 (Head Office)