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Production back to Europe – through a novel/green manufacturing process of TERbinafine API synthESis

Periodic Reporting for period 1 - TERES (Production back to Europe – through a novel/green manufacturing process of TERbinafine API synthESis)

Reporting period: 2018-05-01 to 2018-08-31

Terbinafine, classified as one of the most effective and safe medicines needed in a health system by the World Health Organization, is required by healthcare and pharma industry as an antifungal medication for the treatment of skin diseases as candidiasis, athlete´s foot, ringworm, onychomycosis, etc. Traditionally produced in China and India using a complex and expensive synthesis reaction, is now facing new stricter environmental regulation severely restricting its production. TERES project, on the other hand, has developed a safer an environmentally friendly manufacturing process, cost-effective (27% cost reduction) and with a better impurity profile, that allows to move its production back to Europe. TERES objectives are to optimize and scale up production capacity and obtain REACH certification to start delivery to our existing customers.
TERES activities started in 2016 with the first theoretical and practical proof of concept at lab scale with 1L terbinafine production capacity. After defining the optimal reactor conditions and properties we increased the yield capacity in glass reactors up to 15L. Finally, we tested the first prototype of 500L pilot plant under operational conditions. Currently, we are at TRL7, and achieved a stereoselective reaction with a yield of 82%, 35% savings in starting material costs, 30% reduction of cycle time and consolidated the interest of many customers in our new synthesis. A commercial assessment showed a rapidly growing market with a 6% CAGR, limited competition, and no IP conflicts and the financial plan confirmed the viability of the project with affordable risks and an attractive annual profit and payback period.
TERES unique synthesis has a better overall performance than the standard terbinafine synthesis process: it uses safer reactants and has less severe side effects, is shorter and has higher yields (82% compared to 42%) and product purity; saves water – 25%, energy – 80%, starting materials used – 35%, and generated waste – 78% and reduces costs generating a 27% cheaper market price in comparison with the current options. TERES’ starting materials can be produced in-house allowing to move production back to Europe and providing 100% independency from Asian supply, boosting reindustrialization and creation of jobs (41 new skilled jobs by 2025) in Europe. TERES will ensure availability in the market of this essential medicine which has no reliable substitute avoiding a public health problem for society