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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - LIBSED (Libiguins: a remedy for the treatment of sexual dysfunctions)

Teaser

Summary

\"This project has included activities to better understand the market of the current competitors and the potential users of DIC2024. A marketing study including the biggest competitors have been reported. This has included current competitors with advantages and disadvantages, expected sales volumes and prices, also divided on different global markets. One study included interviews with ten men suffering from erectile dysfunction. They gave their view on the current medication available and what they would expect from DIC2024 in order to be perceived as a superior product.
Dicot has closed agreements with a number of suppliers, CRO\'s and CMO\'s to secure the supply of the raw material, the production of the drug substance and continue according to plan with all studies needed.
A lot of work has been put into the supply of the raw material. As these are of plant origin, compliance with \"\"The Nagoya protocol on access and benefit sharing\"\" is mandatory. The efforts linked to this work have taken longer than expected and the reason why is explained in the feasibility report.
As the drug substance DIC2024 is a completely new molecule with a completely new way of synthesis, at lot of efforts have also been put into the drug substance production. From lab scale over to pilot scale, eventually reaching production scale. It is not until production scale has been reached, that enough drug substance is available for larger pharmacological and toxicological pre-clinical trials. This important milestone has now been reached!
Dicot has expanded the members in the project team significantly. All new team members are introduced in the feasibility report.
DIC2024 will be a very important drug product. Sexual dysfunction is a problem that affects both men and women and untreated can lead to depression. Sexual dysfunction among men gets more abundant in an older population and the need for a good treatment is rising. People want to stay sexually active even at higher ages! The overall objective is to show in pre-clinical and clinical trials that DIC2024 has the wanted effect which makes it possible to continue with further clinical studies. The project has shown that Dicot is on the right track and a lot of assumptions have been verified.\"

Work performed

\"This is a summary of the activities that have been made for the application \"\"Libiguins: a remedy for the treatment of sexual Dysfunctionsâ€.
- A clinical development plan has been set up for the pre-clinical studies and the clinical study phase I
- Several important partners have been identified and agreements have been closed with the partners
- The most important markets have been identified
- The markets for the currently approved drugs have been evaluated
- The user needs of the potential users have been identified
- Advantages towards competitors have been analysed
- The price range of the product has been evaluated
- An agreement has been closed with a competent consultant firm for project management to make sure that the regulatory demands will be fulfiled,
- Partnership opportunities is a continued process and will be managed under our Director of IR, Julie Silber. At Dicot since June 2019.
- Dicots CEO GÃ¶ran Beijer continously visits different events to reach key stakeholders
- A business plan has been compiled
- The work continues according to the grant application.\"

Final results

DIC2024 is aiming to be a drug product with the indications erectile dysfunction and premature ejaculation, which affect around 1 billion men worldwide. Erectile dysfunction is more common among older men compared to younger. Men and women are expected to live longer and want to have an active lifestyle which will be easier with DIC2024.