Periodic Reporting for period 1 - Lipid (The untapped potential of omega-3; from fish oil to healthy bowels) Reporting period: 2015-05-01 to 2015-10-31 Summary of the context and overall objectives of the project Lipid Pharmaceuticals was founded in 2009 by a highly competent scientific research team, through the co-operation of The University of Iceland, The National University Hospital of Iceland and Lýsi hf., Iceland´s leading producer of marine oils.The Company develops medical products from omega-3 fish oil. The Company’s lead product candidate, LP101 suppositories, is currently in Phase II/IIb trials as a rectally administered laxative for pediatric use. Lipid Pharmaceuticals was awarded a Horizon2020 SME instrument grant in 2015 to conduct a feasibility study for the LP101 suppositories. The feasibility study conducted comprised of detailed market analysis for the constipation market based on historical data and market projections and analysis of LP101 suppositories market potential. Furthermore, the Company engaged in initial discussions with potential long term manufacturing partners and prepared a clinical development strategy. The result is a business plan demonstrating clear feasibility the continued development of LP101 suppositories. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far During the reporting period the main emphasis of the work was to map the potential markets for the product and to collect details of the potential markets.Also, considerable work was spent on searching potential manufacturers for both the API and the formulation itself, quotes on the cost of manufacturing were received from various pharma companies and CMOs. This work was deemed as necessary in order to set up a convincing business case, presentable to investors and venture funds.In order to perform a feasibility study Lipid Pharmaceuticals (Lipid) decided to find a collaborator with the right background and competency. The collaborator would have to be able to conduct a search on the potential markets to be entered and would also be able to extract reliable information on sales figures, i.e. value and volume along with prices of currently registered products. The first part of the reporting period was spent on finding a potential collaborator capable of performing the task. After looking at 3-4 companies and talking to few advisors, Lipid made the decision to sign a contract with IMS Health to perform the search. IMS is a very representable company and their historical sales figures data are actual sales figures as opposed to estimates based on epidemiology. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) The main result of the feasibility study is a business plan demonstrating clear feasibility for the continued development of LP101 suppositories. The idea behind the LP101 suppositories is to address the need for a well-studied laxative drug for children. The active pharmaceutical ingredients in the LP101 suppositories are derived from omega-3 fish oils, obtained from natural sources. This creates a product with attractive characteristics for paediatric use and a new approach for creating value from marine products. lipid-logo-blue.jpg
