TPR100 is partnered for manufacturing and distribution in the UK with Thornton & Ross, one of the UK’s largest consumer healthcare companies and a subsidiary of STADA AG. Under the terms of the agreement, Thornton & Ross Ltd 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 received an upfront payment and will receive a further milestone payment upon the product receiving UK regulatory marketing authorisation along with royalties on product sales.
In July 2018, Thornton & Ross Ltd submitted a product licence application to the Medicines and Healthcare products Regulatory Agency (MHRA) for the marketing authorisation of TPR100 in the UK. In February 2019, the MHRA responded to Thornton & Ross with a number of questions requiring additional laboratory work specifically around the permeation characteristics of TPR100 to be conducted. Futura has completed this additional laboratory formulation adjustment and work.
At a recent scientific advisory meeting with MHRA by Futura in conjunction with its commercial partner, the regulator recognised the improved skin permeation characteristics of TPR100 compared to market-leading diclofenac formulations. In vitro studies demonstrated that a 20% TPR100 dose relative to certain market-leading diclofenac formulations delivered the same permeation of active pharmaceutical ingredient through the skin. Due to this increased potency, a key differentiating characteristic for TPR100, MHRA now require data from a patient efficacy study with TPR100 in support of a marketing authorisation and are willing to consider superiority claims if the study is successful.
Since Voltaren® 1% has recently gained OTC status in the US a new and attractive potential market opportunity has arisen in that geography for TPR100. Futura is therefore exploring designs, funds permitting, for a clinical study to achieve approval for a superior product without a prescription in the US as well as fulfilling data requirements for UK and EU regulatory submissions as a topical pain relief and anti-inflammatory treatment.
Commercial discussions with several potential distribution partners for other countries continue however any further licensing deals are expected to be after a regulatory approval is achieved.