10 January 2017

Futura Medical plc (AIM: FUM), the innovative healthcare company focused on transdermal technology, is pleased to announce that it has signed a licensing agreement with the UK subsidiary of STADA Arzneimittel AG ("STADA"), the international healthcare group, for the commercialisation of TPR100, the Company's novel diclofenac gel for pain relief.

The licensing agreement was signed with Huddersfield-based Thornton & Ross Ltd, which was acquired by STADA three years ago and is one of the largest consumer health companies in the UK.

Under the terms of the agreement, Thornton & Ross will conduct the manufacturing scale-up of TPR100 and hold rights to manufacture, market and distribute the product in the UK for the lifetime of the product's patents, which run to at least 2028 in the UK. Futura will receive an upfront payment and milestone payments up to a certain limit along with royalties on product sales. Further financial or other details are not being disclosed.

TPR100, which benefits from the rapid skin permeation rates offered by Futura's proprietary DermaSys® delivery system, demonstrated statistically significant results in a 2015 clinical study comparing the product against both placebo and currently marketed products.

It is expected that no further clinical work will be required ahead of a regulatory submission by Thornton & Ross for UK marketing authorisation expected to be made in the second half of 2017.

Dieno George, Executive Vice President of Brands at STADA, said: "Thornton & Ross is an ideal partner for Futura, with its expertise in both OTC and Rx marketing and we are very excited to bring TPR100 into our product portfolio. TPR100's topical formulation, and positive trial results achieved to date, mean that it has the potential to be a product that very successfully meets patient needs."

James Barder, Futura's Chief Executive, commented: "We're delighted to sign this licensing agreement with Thornton & Ross for the UK rights to our topical diclofenac gel, TPR100. This agreement is an important milestone for Futura as it marks the first commercial validation of the Company's pain relief portfolio. We look forward to working with Thornton & Ross on the initial manufacturing scale-up of TPR100, followed by its registration and subsequent commercial launch."

 

For further information please contact:

Futura Medical plc
James Barder, Chief Executive
+44 (0) 1483 685 670
james.barder@futuramedical.com
www.futuramedical.com

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Notes to editors:

About Futura Medical plc

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups.

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

www.futuramedical.com

About Stada Arzneimittel AG

STADA Arzneimittel AG is a publicly-listed company with headquarters in Bad Vilbel, Germany. STADA focuses on a multi-pillar strategy of generics and branded products (OTC) with an increasingly international market orientation. The Group is the only independent generics producer in Germany. STADA is represented in more than 30 countries with approximately 50 sales companies worldwide.

In financial year 2015, STADA achieved Group sales of Euro 2,115.1 million, adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of Euro 389.4 million and adjusted net income of Euro 165.8 million. As of December 31, 2015, STADA employed 10,532 people worldwide.