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.
Following the Medicines and Healthcare products Regulatory Agency’s (“MHRA”) request for a Phase 3 study to support the improved skin permeation and potential potency of TPR100 including potential superior efficacy claims, Futura has determined that the feasibility of a clinical study that would satisfy the Phase 3 requirements for both UK and US marketing approval will require a US distribution partner prior to the commencement of any Phase 3 programme.
The project is currently on hold as the company focuses its resources on its leading asset, MED3000.