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A non-antibiotic treatment for Acne and Onychomycosis

Periodic Reporting for period 1 - GREEN LINE (A non-antibiotic treatment for Acne and Onychomycosis)

Reporting period: 2018-08-01 to 2018-11-30

Infectious diseases of the skin and nails caused by bacteria or fungi are among the most common widespread diseases worldwide. For example, 10% of adults are affected by fungal nail infections. In addition to health-related and cosmetic issues, these people often suffer psychological consequences that have a negative impact on their quality of life. Conventional treatments present several challenges such as intolerable side effects such as skin irritation and reactions that limit medication efficacy, decrease compliance, and may lead to discontinuation of therapy. An additional issue is the increasing incidence of bacterial resistance due to the use of antibiotics in several treatments. Hence, a new product solving these challenges would greatly impact affected patients. MAVENA is developing an innovative anti-infective treatment - Green Line - based on a chemical reaction, avoiding the use of antibiotics. This caters to the efficacy, safety and resistance needs of patients and healthcare systems worldwide.
From a technical point of view, we have prepared several prototype formulations that will be further optimized after a stability test along with the potential packaging. We have elaborated the technical plan to be followed in order to validate the products including the requirements for the clinical validation, including the pre-selection of university hospitals and CRO where these studies will be performed.
From a commercial point of view, we have elaborated a business plan to launch the Green Line project into the targeted markets. In the commercialization plan, FtO has been confirmed and we implemented an in-depth analysis of the targeted markets in order to evaluate the market shares in the sector and the best penetration strategy. A pricing policy has been established as well as the identification of the target audiences and messages for them.
From a financial point of view, we have estimated the costs to bring GREEN LINE to market and elaborated a financial plan, that showed positive figures that encourage the continuation of this project.
Initial tests with the prototype formulations show promising antibacterial and antifungal effect. Once the final formulation is tested and validated, we expect to hit the market by 2021, unblocking €45 million revenues with €17 million of cumulative profits (pre-tax) by 4th year of commercialization. This will entail the enlargement of our workforce with 13 new employees.