Futura Medical (Futura) has signed a licensing agreement with the UK subsidiary of STADA Arzneimittel AG (STADA), for the commercialisation of TPR100 (diclofenac), its topical pain relief gel.
The licensing agreement was signed with Huddersfield-based Thornton & Ross Ltd, which was acquired by STADA three years ago.
According to the agreement, Thornton & Ross will work on manufacturing scale-up of TPR100 and will hold rights to producing and selling it in the UK for at least until 2028, when the patent will run out in the UK. Futura did not disclose financial value of the deal, but it said it would receive an upfront payment and milestone payments up to a certain limit along with royalties on product sales.
In interim report and accounts for the period ended June 30, 2016, the company said that it expect its topical treatment should be the first choice for doctors in the initial treatment of pain and therefore represents a substantial opportunity in a market with global sales estimated at $2.9 billion.
In the US, Futura expects that TPR100 would likely be made available only on a prescription only basis and will require additional clinical data.
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, as the gel performed better than placebo and some other competitive products.
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, said: “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.”