Strategy and objectives
Product development with a focus on proven substances
Karessa's overall strategy is to combine the company's unique and patented Buccal film with proven and well known pharmaceutical substances, in order to thus achieve faster and more reliable medicinal products within different therapeutical areas.
Compared with traditional drug development, this model means both shorter time to market and lower development costs. Because the active substances are already on the market, and are well-proven in terms of both efficacy and safety, the number of studies that need to be conducted, as well as the risks associated with these studies, are limited. The studies that need to be done are partly a dosage study and PK study and a pivotal clinical study, which entail significantly lower risk and costs compared with traditional drug development.
Karessa's organisation is characterised by flexibility, efficiency and competence
Karessa's aim is to build a small cost-effective organisation with a high level of internal competence and capacity. In order to create the maximum flexibility and efficiency, external resources within, among other things, characterisation, manufacturing, clinic, medicine and regulatory processes will be contracted on a specific needs basis.
Full control over the manufacturing process
The medicinal products will be manufactured by contracted partners depending on requirements and scale. Where a licensee wants to set up their own production due to local requirements, Karessa will assist in ensuring that the production is quality-assured GMP production.
Repeatability of the work involved in registration and marketing authorisation
Most of Karessa's relevant geographical markets, such as the USA and Canada accept data from clinical testing on which registration as a medicinal product in Europe is based. The Company will therefore adapt the study as far as possible so that the results can be used for registration in other countries all over the world. This means that special emphasis will be placed on the study design, the size and the methods of analysis – in order to achieve maximum flexibility in terms of how the study can be used.
Karessa's ambition is to become a profitable and growing pharmaceutical company by utilizing our IP protected alginate base buccal film intended for quick and reliable administration through the oral mucosa. Karessa has initiated several projects in the area of erectile dysfunction (ED) using this technology.